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 .
Receipt is acknowledged of the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 3/25/26.
Claims 1-13, 15, and 18-20 are pending and have been examined. Claims 14 was previously cancelled. Claims 16, 17, and 21 were previously withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/25/26 has been entered.
Withdrawn Rejections
The 35 USC 103(a) rejections of claims 1-5, 10-13, and 15 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) have been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 6 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Sjoeholm et al. (US 2004/0161448) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 7 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Anderson et al. (US 20120282658) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 8 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Hansen et al. (US 2002/0160080) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 9 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Wik et al. (US 2008/0292753) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejections of claims 18-20 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022), Hansen et al. (US 2002/0160080) and Wik et al. (US 2008/0292753) have been withdrawn due to the amendments to claim 1.
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 1-5, 8-13, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022), Zhai et al. (US 2022/0049230), and Hansen et al. (US 2002/0160080).
Regarding Claims 1, 8-12: Marcussen discloses the enzyme granule composition containing a core unit and a protective coating [abstract; 0035-0042; 0168]. Marcussen discloses enzyme granules containing a homogenous mixture of at least two classes of enzymes and therefore discloses a co-granule [abstract; 0017; 0036; 0041; 0272]. Marcussen discloses that the enzyme granules can contain phytase and xylanase [0062; 0064; 0091; 0092; 0249]. Marcussen discloses that the active compounds are homogenously combined and that the active compounds include enzymes [0003; 0007; 0016; 0046; 0049]. Marcussen discloses enzymes as the active compound and discloses enzymes as forming the core of the granule [0010; 0016; 0045].
Marcussen does not explicitly disclose wherein the ratio of the phytase and the xylanase in the core of each co-granule is 80% to 120% of the ratio of the phytase and the xylanase in at least 90% of the other co-granules.
Marcussen does not disclose wherein the co-granules comprise a xylanase selected from the group consisting of polypeptides having at least 90% sequence identity to one or more of SEQ ID NO:19.
Marcussen does not disclose wherein the co-granules comprise a xylanase selected from the group consisting of polypeptides having at least 90% sequence identity to one or more of SEQ ID NO:1.
Mao discloses a composite enzyme composition containing xylanase and phytase [pg. 2 “Content of the Invention”]. Mao discloses the ratio of the enzymes in a composite enzyme preparation in xylanase, cellulase, maltogenic amylase, amylase, protease, the mass ratio of the phytase is (2-10): (1-5): (4-10): (2-5): (1-5): (5-10) [pg. 3, 3rd sentence]. Mao therefore discloses the ratio of phytase : xylanase at 5-10 : 2-10. Mao discloses including the enzyme composition in animal feed [abstract].
Zhai discloses a phytase Seq ID NO: 12 containing 100% sequence identity to Seq ID NO: 19 of the instant invention [pg. 16-17]. Zhai discloses using phytase in animal feed and feed additives [0006; 0046; 0278].
Hansen discloses a xylanase Seq ID NO:2 containing 100% sequence identity to Seq ID NO: 1 of the instant invention [pg. 16-17]. Hansen discloses using xylanase in animal feed and feed additives [abstract].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include the phytase of Zhai since it discloses it as beneficial for use in animal feed and animal feed additives.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include the xylanase of Hansen since it discloses it as beneficial for use in animal feed and animal feed additives.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include enzymes at the proportions disclosed in Mao in order to provide the enzymes in effective amounts according how they affect their substrates and that since the enzymes are homogenously distributed that the ratio would have been within the claimed ratio of the distribution of the enzymes throughout the granules.
Further, regarding the amounts of phytase and xylanase, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include amounts of the enzymes in relation to each other depending on the level of activity of the specific enzymes of the final composition. To vary the ratio of phytase and xylanase in the composition would be within theordinary ingenuity of one of ordinary skill in the art.
In Marcussen, the enzymes are homogenously distributed within a solution that contains the enzymes [0035-0041]. Marcussen defines a solution as a homogenous mixture of two or more substances [0017; 0123; 0124 a), b)]. Mao discloses ratio of phytase : xylanase at 5-10 : 2-10. Therefore it would have been obvious that the quantity of each enzyme in one co-granule is 80-120% of the quantity of the same enzyme in at least 90% of the co-granules in said composition since the homogenous distribution of the enzymes and their potential equal quantity in the composition would have lent them to be about equally distributed and the amounts distributed would have been similar.
Regarding the ratios alternatively, although Mao does not explicitly disclose a ratio of phytase: xylanase of at least 5:1, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mao overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claim 2: Marcussen discloses as discussed above in claim 1. Marcussen discloses carbohydrases, protease, lysozyme (muramidase), and combinations [0063; 0064].
Regarding Claim 3: Marcussen discloses as discussed above in claim 1. Marcussen further discloses amylases, mannanase, cellulase, β-glucanase, polygalacturonase, protease, lysozyme (muramidase) and combinations [0064; 0090; 0091].
Regarding Claim 4: Marcussen discloses as discussed above in claim 1. Marcussen discloses β-glucanase, and combinations [0091].
Regarding Claim 5: Marcussen discloses as discussed above in claim 1. Marcussen discloses endo 1,4-beta- xylanase and combinations [0064].
Regarding Claim 13: Marcussen discloses as discussed above in claim 1. Marcussen does not disclose wherein the ratio (wt./wt.) of the at least two classes of enzymes is at least 5:1.
Mao discloses a composite enzyme composition containing xylanase and phytase [pg. 2 “Content of the Invention”]. Mao discloses the ratio of the enzymes in a composite enzyme preparation in xylanase, cellulase, maltogenic amylase, amylase, protease, the mass ratio of the phytase is (2-10): (1-5): (4-10): (2-5): (1-5): (5-10) [pg. 3, 3rd sentence]. Mao therefore discloses the ratio of phytase : xylanase at 5-10 : 2-10. Mao discloses including the enzyme composition in animal feed [abstract]. Mao discloses at least a ratio of 5:1 by virtue of the ratio of the disclosure of a ratio of 10:2.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include enzymes at the proportions disclosed in Mao in order to provide the enzymes in effect amounts according how they affect their substrates.
Regarding the ratios alternatively, although Mao does not explicitly disclose a ratio of at least 5:1 one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mao overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claim 15: Marcussen discloses enzyme granules as discussed in claim 1. Marcussen discloses adding the enzyme granules to animal feed [0239; 0240].
Regarding Claims 18 and 19: Marcussen discloses the enzyme granule composition containing a core unit and a protective coating [abstract; 0035-0042; 0168]. Marcussen discloses enzyme granules containing a homogenous mixture of at least two classes of enzymes and therefore a co-granule [abstract; 0017; 0036; 0041; 0272]. Marcussen discloses that the granule can be a single granule or several granules [0025]. Marcussen discloses the enzyme granules containing phytases and xylanase [0062; 0064; 0091; 0092; 0249]. Marcussen discloses that the active compounds are homogenously combined and that the active compounds include enzymes [0003; 0007; 0016; 0046; 0049]. The enzymes are homogenously distributed within the solution that contains the enzymes and therefore it would have been obvious that the quantity of each enzyme in one co-granule is 80-120% of the quantity of the same enzyme in at least 90% of the co-granules in said composition since the homogenous distribution of the enzymes would have lent them to be about equally distributed.
Marcussen does not explicitly disclose wherein the ratio of the phytase and the xylanase in the core of each co-granule is 80% to 120% of the ratio of the phytase and the xylanase in at least 90% of the other co-granules.
Marcussen does not disclose wherein the co-granules comprise a xylanase selected from the group consisting of polypeptides having at least 95% sequence identity to one or more of SEQ ID NO:19.
Marcussen does not disclose wherein the co-granules comprise a xylanase selected from the group consisting of polypeptides having at least 95% sequence identity to one or more of SEQ ID NO:1.
Mao discloses a composite enzyme composition containing xylanase and phytase [pg. 2 “Content of the Invention”]. Mao discloses the ratio of the enzymes in a composite enzyme preparation in xylanase, cellulase, maltogenic amylase, amylase, protease, the mass ratio of the phytase is (2-10): (1-5): (4-10): (2-5): (1-5): (5-10) [pg. 3, 3rd sentence]. Mao therefore discloses the ratio of phytase : xylanase at 5-10 : 2-10. Mao discloses including the enzyme composition in animal feed [abstract]. Mao discloses at least a ratio of 5:1 by virtue of the ratio of the disclosure of a ratio of 10:2.
Zhai discloses a phytase Seq ID NO: 12 containing 100% sequence identity to Seq ID NO: 19 of the instant invention [pg. 16-17]. Zhai discloses using phytase in animal feed and feed additives [0006; 0046; 0278].
Hansen discloses a xylanase Seq ID NO:2 containing 100% sequence identity to Seq ID NO: 1 of the instant invention [pg. 16-17]. Hansen discloses using xylanase in animal feed and feed additives [abstract].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include the phytase of Zhai since it discloses it as beneficial for use in animal feed and animal feed additives.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include the xylanase of Hansen since it discloses it as beneficial for use in animal feed and animal feed additives.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include enzymes at the proportions disclosed in Mao in order to provide the enzymes in effective amounts according how they affect their substrates and that since the enzymes are homogenously distributed that the ratio would have been within the claimed ratio of the distribution of the enzymes throughout the granules.
Further, regarding the amounts of phytase and xylanase, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include amounts of the enzymes in relation to each other depending on the level of activity of the specific enzymes of the final composition. To vary the ratio of phytase and xylanase in the composition would be within theordinary ingenuity of one of ordinary skill in the art.
Regarding Claim 19, At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include enzymes at the proportions disclosed in Mao in order to provide the enzymes in effect amounts according how they affect their substrates.
Regarding the ratios alternatively, although Mao does not explicitly disclose a ratio of phytase: xylanase of at least 5:1, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mao overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
In Marcussen, the enzymes are homogenously distributed within a solution that contains the enzymes [0035-0041]. Marcussen defines a solution as a homogenous mixture of two or more substances [0017; 0123; 0124 a), b)]. Mao discloses ratio of phytase : xylanase at 5-10 : 2-10. Therefore it would have been obvious that the quantity of each enzyme in one co-granule is 80-120% of the quantity of the same enzyme in at least 90% of the co-granules in said composition since the homogenous distribution of the enzymes and their potential equal quantity in the composition would have lent them to be about equally distributed and the amounts distributed would have been similar.
Regarding Claim 20: Marcussen discloses enzyme granules as discussed in claim 18. Marcussen discloses adding the enzyme granules to animal feed and therefore discloses an animal feed containing phytase and xylanase [0239; 0240].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022), Zhai et al. (US 2022/0049230), and Hansen et al. (US 2002/0160080) as applied to claim 1 above and in further view of Sjoeholm et al. (US 2004/0161448).
Regarding Claim 6: Marcussen discloses as discussed above in claim 1. Marcussen does not disclose wherein the co-granules comprise a protease selected from the group consisting of polypeptides having at least 80% sequence identity to one or more of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 32, SEQ ID NO: 39 and SEQ ID NO: 40.
Sjoeholm discloses a protease Seq IID NO: 1 containing 100% sequence identity to Seq ID NO: 15 of the instant invention [pg. 15]. Sjoeholm discloses using protease in animal feed and feed additives [abstract].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include the protease of Sjoeholm since it discloses it as beneficial for use in animal feed and animal feed additives.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022), Zhai et al. (US 2022/0049230), and Hansen et al. (US 2002/0160080) as applied to claim 1 above and in further view of Anderson et al. (US 20120282658).
Regarding Claim 7: Marcussen discloses as discussed above in claim 1. Marcussen does not disclose , wherein the co-granules comprise an amylase selected from the group consisting of polypeptides having at least 80% sequence identity to one or more of SEQ ID NO: 2, SEQ ID NO: 34 and SEQ ID NO:36.
Anderson discloses an amylase Seq ID NO: 6 containing 100% sequence identity to Seq ID NO: 2 of the instant invention [pg. 46-48]. Anderson discloses using amylase in animal feed and feed additives [0006; 0227].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Marcussen to include the amylase of Anderson since it discloses it as beneficial for use in animal feed and animal feed additives.
Response to Arguments
The 35 USC 103(a) rejections of claims 1-5, 10-13, and 15 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) have been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 6 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Sjoeholm et al. (US 2004/0161448) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 7 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Anderson et al. (US 20120282658) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 8 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Hansen et al. (US 2002/0160080) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejection of claim 9 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022) as applied to claim 1 above and in further view of Wik et al. (US 2008/0292753) has been withdrawn due to the amendments to claim 1.
The 35 USC 103(a) rejections of claims 18-20 over Marcussen et al. (US 2015/0245640) in view of Mao et al. (CN 114190471 Machine Translation March 2022), Hansen et al. (US 2002/0160080) and Wik et al. (US 2008/0292753) have been withdrawn due to the amendments to claim 1.
Regarding the rejections, the Applicants assert that the Examiner’s arguments are based on flawed arguments of inherency. The Applicants assert that the Examiner has not submitted evidence that Marcussen would have satisfied the limitation of homogenous distribution. The Applicants assert that the office undermines its own allegations of inherency.
The Examiner disagrees. First, the Examiner did not rely on inherency to reach the limitation. Further the Examiner maintains that Marcussen discloses a homogenous blend of active compounds and wherein the active compounds are enzymes. Further, in view of Mao, amounts of phytase and xylanase were disclosed and therefore render at least ratios of phytase and xylanase modifiable.
The rejections have been modified to meet the limitations of the newly amended sequence limitations.
Pertinent Prior Art
20. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Raab et al. (US 2020/0299709) discloses an animal feed containing phytase and an exogenous enzyme which can be xylanase [abstract; pg. 18, Nos. 1, 5, 20, pg. 19, Nos. 28-33]. Raab discloses phytase from 3,000 FTU/g to 60,000 FTU/g and greater than or equal to 250 FTU/g [0126; pg. 18, No. 36].
Ceballos (US 202110360944) discloses a cellulose degrading enzyme complex containing at least one of xylanase and phytase [abstract; 0049; claims 11 and 16].
Conclusion
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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