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 .
Priority
The instant application was filed 21 May 2021 and is the national stage entry of PCT/EP2019/083765 filed 05 December 2019. The Applicant claims priority to foreign application EP18210418.2 filed 05 December 2018. The Applicant has provided an English copy of the foreign document. Therefore, the effective filing date of the instant application is 05 December 2018.
Examiner’s Note
Following the Board of Appeals Decision dated 15 June 2026, prosecution is herein reopened. The Applicant's amendments and arguments filed 23 July 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 23 July 2026, it is noted that claims 16, 18-21, 23-26, 28, 35, and 36 have been amended and claim 37 has been newly added. Support for the amendment(s) and/or new claim(s) can be found on pg. 6 of the specification. No new matter has been added.
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.
Claim(s) 16-28, 31-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Outchkourov et al. (WO 2017/162610 A1) in view of Becker et al. (US 2004/0229329 A1), as evidenced by Marcussen et al. (WO 2006/034710 A1) and Victor (pelletizermill.com).
Regarding claim 16, Outchkourov teaches an enzyme composition in the form of a water-soluble granule (pg. 6, lns. 11-13) and method of spraying onto animal feed pellets (abs; pg. 7, lns. 9-16), which is also interpreted as mash feed (evidenced by Victor, entire teaching). The enzyme composition may be dissolved in water (abs), forming a solution. The composition may comprise citric acid (pg. 6, lns. 20-21), which is a microbial stabilizer (instant specification, pg. 6).
Regarding claim 17, the composition comprises at least 75% of enzymes (pg. 13, lns. 19-22).
Regarding claim 22, Outchkourov provides examples of using a 10 g/L solution (1% w/v or roughly 1% w/w) (pg. 11, lns. 9-11).
Regarding claims 23, 25, and 26, the composition may comprise citric acid (pg. 6, lns. 20-21), which is a microbial stabilizer (instant specification, pg. 6).
Regarding claim 37, Outchkourov teaches an enzyme composition in the form of a water-soluble granule (pg. 6, lns. 11-13) and method of spraying onto animal feed pellets (abs; pg. 7, lns. 9-16). The enzyme composition may be dissolved in water (abs), forming a solution. The composition may comprise citric acid (pg. 6, lns. 20-21), which is a microbial stabilizer (instant specification, pg. 6).
Outchkourov does not teach an enzyme granule composition made of a core and layers in at least claim 16, 18-21, 24, 27, 28, 35, 36, and 37. Outchkourov does not teach results for the Heubach Type 1 assay or Elutriation assay in claims 31-34.
Becker teaches a granule composition comprising an active ingredient and a coating (abs) that may be used in agrochemical manufacturing (para. 3). The enzyme active ingredient may be incorporated into the water-soluble core (para. 8). The granules are soluble or dispersible when in contact with water (para. 23). The amount of enzyme may be at least 0.5% (para. 40). The granule may have a Heubach dust test of 3.0 ug/g or less of enzyme dust (3 ppm) and an Elutriation dust test of 0.5 mg/g or less (less than 500 ppm) (para. 17). The composition may further include citric acid (para. 31) and sodium sulfate (para. 31) in at least the core. Sodium sulfate and other excipients or ingredients, such as amylases (para. 37) may be included in the core or other layers of the granule, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). A waxing substance may be included in the coating layers (para. 48).
Regarding claims 16, 18-21, 24, 27, 28, 35, 36, and 37, Outchkourov teaches that maintaining enzyme activity is an issue in the art (pg. 8, ln. 25-pg. 9, ln. 5), especially when the formulation is subjected to high temperatures during the manufacturing process (pg. 15, lns. 20-24). Becker teaches that in the agrochemical industry, enzyme formulations in their dry form, such as particles or granules, can result in the formation of dust and possibly leading to health problems (paras. 3-6). Becker’s solution is to produce a granule composition with a water-soluble core, water-soluble active ingredient over the core, and a water-soluble coating over the layer (paras. 8, 15, 17, 20, 23, 30, 36, 37, 40, 41, 60). Becker’s resulting granules are protected against temperature, humidity, or harsh chemical and physical forces because they are more robust and produce less dust, as measured via the Repeated Impact Test and Heubach dust test (paras. 10, 17, and 60). Therefore, one of ordinary skill in the art would have been led to combine Outchkourov’s and Becker’s teachings with a reasonable expectation of success in achieving an improved and more stable enzyme granule composition. Marcussen generally teaches how to form animal feed enzyme granules (evidenced by Marcussen, entire teaching). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Response to Arguments
Applicant's arguments filed 23 July 2026 have been fully considered but they are not persuasive.
The Applicant argues that the cited references would not have been motivated to practice the claimed method of using the enzyme granules comprising one or more microbial stabilizer (Remarks, pgs. 1-2).
Applicant’s argument is not found persuasive. Outchkourov teaches an enzyme composition that may be in the form of water-soluble granules (pg. 6, lns. 11-13) and sprayed onto animal feed pellets (abs; pg. 7, lns. 9-16) (step b). The enzyme composition may be dissolved in water (abs) (step a). Outchkourov does not teach the enzyme granule comprising a core, enzyme layers, or outer coating layer in claim 16. Becker teaches a granule composition comprising an enzyme active ingredient and a coating (abs) (iii) used in agrochemical manufacturing (para. 3). The enzyme composition comprises an enzyme active ingredient (ii) in the core or layered on top of the core (para. 8) (i).
Both Outchkourov and Becker teach citric acid (a microbial stabilizer, instant claim 25) (Outchkourov, pg. 6, lns. 20-21 and Becker, para. 31). A skilled artisan would have therefore been led to combine the teachings with a reasonable expectation of success, especially given Appellant's open "comprising" language that allows the incorporation of further ingredients.
Since Becker teaches a layered enzyme granule composition for use in agrochemical products, wherein the layered composition adds robustness to the product (para. 15) and Outchkourov teaches an enzyme granule composition for animal feed pellets, a person of ordinary skill in the art would have been motivated to use the teachings together. Outchkourov teaches that maintaining enzyme activity is an issue in the art (pg. 8, ln. 25-pg. 9, ln. 5), especially when the formulation is subjected to high temperatures during the manufacturing process (pg. 15, lns. 20-24). Becker teaches that in the agrochemical industry, enzyme formulations in their dry form, such as particles or granules, can result in the formation of dust and possibly leading to health problems (paras. 3-6). Becker’s resulting granules are protected against temperature, humidity, or harsh chemical and physical forces because they are more robust and produce less dust, as measured via the Repeated Impact Test and Heubach dust test (paras. 10, 17, and 60). Therefore, one of ordinary skill in the art would have been led to combine Outchkourov’s and Becker’s teachings with a reasonable expectation of success in achieving an improved and more stable enzyme granule composition. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
In response to the Applicant’s argument that the references fail to show certain features of applicant’s invention, it is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)).
The Applicant argues that for dependent claims 18 and 19, Becker does not teach sodium sulfate and potassium sulfate in the layers of the granule (Remarks, pg. 3).
Applicant’s argument is not found persuasive. Becker teaches sodium sulfate (para. 31) and other excipients that may be incorporated into the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of sodium sulfate in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the art does not teach using an oil or wax in dependent claim 20 (Remarks, pg. 3).
Applicant’s argument is not found persuasive. Becker teaches a waxing substance in the coating layers (para. 48). The Appellant argues that Becker does not teach a microbial stabilizer in dependent claim 21 (Remarks, pg. 4).
Applicant’s argument is not found persuasive. Becker teaches incorporation of citric acid (para. 31) in at least the core of the granule.
The Applicant argues that the prior art teachings do not teach inclusion of a microbial stabilizer in the layers in claim 23 (Remarks, pg. 4).
Applicant’s argument is not found persuasive. Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the prior art teachings do not teach the inclusion of microbial stabilizers in the layers in dependent claim 24 (Remarks, pg. 5).
Applicant’s argument is not found persuasive. Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the prior art teachings do not teach the inclusion of microbial stabilizers in the layers and that Outchkourov teaches away from microbial stabilizers in claims 25, 35, and 36 (Remarks, pg. 5).
Applicant’s argument is not found persuasive. In response to the Applicant’s argument that the references fail to show certain features of applicant’s invention, it is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)). Furthermore, Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the prior art teachings do not teach the inclusion of microbial stabilizers in the layers and that Outchkourov teaches away from microbial stabilizers in claim 26 (Remarks, pg. 5).
Applicant’s argument is not found persuasive. In response to the Applicant’s argument that the references fail to show certain features of applicant’s invention, it is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)). Furthermore, Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the prior art teachings do not teach the dusting properties in claims 31-34 (Remarks, pg. 6).
Applicant’s argument is not found persuasive. Since Becker teaches results with the Heubach dust test and Elutriation dust test for their granule composition, a skilled artisan would have been led to use Becker's teachings for the different assays and for the composition of mechanically robust or sensitive granules. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Furthermore, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
The Applicant argues that the prior art teachings do not teach the inclusion of microbial stabilizers in the layers in claim 35 (Remarks, pg. 7).
Applicant argument is not found persuasive. Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the prior art teachings do not teach the inclusion of microbial stabilizers in the layers in claim 36 (Remarks, pg. 7).
Applicant’s argument is not found persuasive. Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
The Applicant argues that the prior art teachings do not teach or suggest new claim 37 (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. Outchkourov teaches an enzyme composition that may be in the form of water-soluble granules (pg. 6, lns. 11-13) and sprayed onto animal feed pellets (abs; pg. 7, lns. 9-16) (step b). The enzyme composition may be dissolved in water (abs) (step a). Outchkourov does not teach the enzyme granule comprising a core, enzyme layers, or outer coating layer in claim 16. Becker teaches a granule composition comprising an enzyme active ingredient and a coating (abs) (iii) used in agrochemical manufacturing (para. 3). The enzyme composition comprises an enzyme active ingredient (ii) in the core or layered on top of the core (para. 8) (i). Becker teaches citric acid (para. 31) as an excipient in the core. Becker teaches use of excipients in the layers of the granule as well, depending on what the granule is used for and what is known to the skilled artisan (paras. 49-51). Therefore, a skilled artisan would have been motivated to use Becker's teaching of citric acid in their layered granule composition with a reasonable expectation of success.
Regarding the limitation of the Heubach type 1 assay or Elutriation assay, since Becker teaches results with the Heubach dust test and Elutriation dust test for their granule composition, a skilled artisan would have been led to use Becker's teachings for the different assays and for the composition of mechanically robust or sensitive granules. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Furthermore, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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