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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06 July 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In this case, Claim 1 was amended to recite “wherein said animal feed additive does not comprise a zinc salt of an organic acid”, looking at the applicant’s specification page 38 lines 22-26, the specification states “one or more additional components selected from the group consisting of: one or more vitamins; one or more minerals; one or more amino acids; one or more phytogenics; one or more prebiotics; one or more organic acids; and one or more other feed ingredients”. Further the specification defines examples of organic acids as “propionic acid, formic acid, citric acid, lactic acid, sorbic acid, malic acid, acetic acid, fumaric acid, benzoic acid, butyric acid and tartaric acid or their salt”. None of the listed examples would be considered a “zinc salt of an organic acid”. Further looking into the specification, the only mention of zinc is on page 38 where zinc is listed as an example of a trace mineral. Therefore, because there is nowhere in the specification which discusses the feed additive either containing or not containing a zinc salt of an organic acid the new amendment fail to comply with the written description requirement. The examiner recommends the applicants amends the claim to recite, “wherein said animal feed does not comprise an organic acid.” Because the applicants specification supports excluding all organic acids but, as discussed above, does not support excluding just zinc salts of organic acids.
Claims 2-13 and 15-21 are also rejected due to their dependence on rejected 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 1-2, 4-13, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Haahr et al. (herein referred to as Haahr, WO 2019043191 A1) in view of Aureli et al. (herein referred to as Aureli, US 20210292725 A1).
With regard to Claim 1, Haahr teaches an animal feed additive comprising a polypeptide having protease activity (page 1, lines 10-11) Haahr teaches the polypeptide is formulated into granules wherein the granule may comprise a core and one or more coatings (page 35, lines 3-5). Haahr additionally teaches the granule may be extruded (page 60 lines 16-21) or spray-dried (page 60 lines 4-6). Haahr teaches the animal feed additive does not comprise a polypeptide having enzymatic activity other than the said one or more polypeptides having protease activity (whole document). The examiner would like to note that Haahr states the granule may (emphasis added) contain one or more addition enzymes (page 37, line 17). However, this is not a requirement for the composition and is merely an optional embodiment of the granule. Therefore, Haahr still reads on the limitation of the additive not comprising a polypeptide having enzymatic activity other than the said one or more polypeptides having protease activity. Haahr teaches the animal feed additive does not comprise a zinc salt of an organic acids (whole document). It is important to note that Haahr teaches the if the granule may comprise salts. Haahr teaches a list of salts that may be selected for use, and the list includes zinc citrate which would be considered a zinc salt of an organic acid (page 59 lines 11-19, page 61 lines 24-34). However, this limitation is not a requirement for the feed additive and is merely listed in a group of potential salts wherein the other salts are not zinc salts of an organic acid. Thus, Haahr still reads on the limitation of the animal feed additive not comprising a zinc salt of an organic acids.
However, Haahr is silent to the protease having at least 95% sequence identity to SEQ ID NO: 1.
Aureli teaches an animal feed additive comprising a polypeptide having protease activity (abstract). Aureli teaches the polypeptide is formulated into granules ([0209]) selected from extruded granules ([0211]), spray-dried granules ([0213]), granules comprising a salt core ([0225]) and a layer that contains said polypeptide ([0214], [0226]), and granules produced by high-shear granulation ([0211]).
With regard to the sequence identity, Aureli teaches there are no limitations on the origin of the acid stable serine protease for use according to the invention ([0115]). Aureli teaches the term protease includes not only natural or wild-type proteases, but also any mutants, variants, fragments etc. thereof exhibiting protease activity, as well as synthetic proteases, such as shuffled proteases, and consensus proteases. Such genetically engineered proteases can be prepared as is generally known in the art, e. g. by Site-directed Mutagenesis, by PCR (using a PCR fragment containing the desired mutation as one of the primers in the PCR reactions), or by Random Mutagenesis ([0115]). In addition Aureli teaches using a commercially available serine protease derived from Nocardiopsis called Ronozyme®ProAct® (DSM Nutritional Products AG) ([0114]). Per the applicant specification, the invention being claimed provides novel granules or formulations of the polypeptide of Ronozyme®ProAct® and variants thereof (see applicants specification “Summary of Invention” page 3). In examples 8 and 9 in applicant's specification, the applicant further defines SEQ ID NO:1 as Ronozyme®ProAct®.
Thus, because Aureli clearly teaches using Ronozyme®ProAct®, the art clearly teaches the limitation of the protease having 95% sequence identity to SEQ ID No:1 ([0283]).
It is important to note that Haahr teaches an embodiment wherein the invention comprises commercially available proteases such as Ronozyme®ProAct® (page 68 lines 28-33). However Haahr teaches the Ronozyme®ProAct® protease as an additional enzyme (page 67 line 18). Thus Haahr teaches a protease having 95% sequence identity to SEQ ID No:1 may be used in the granule with additional enzymes while Aurelia shows that a protease having 95% sequence identity to SEQ ID No:1 can be used as the sole polypeptide in the granule.
Therefore, Aureli imparts reasoning for obviousness because the teaching shows that the claimed protease sequence was known to have been successfully used in an animal feed additive and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the polypeptide of Ronozyme®ProAct® and variants thereof. because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 2, Haahr is silent to the polypeptide being obtained or obtainable from Nocardiopsis sp. NRRL 18262
Aureli teaches the polypeptide is obtained or obtainable from Nocardiopsis sp. NRRL 18262 ([0199]).
Therefore, Aureli imparts reasoning for obviousness because the teaching shows that obtaining and utilizing a polypeptide from Nocardiopsis sp. NRRL 18262 was known to have been successfully used in an animal feed additive and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a polypeptide from Nocardiopsis sp. NRRL 18262 because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 4, The examiner would like to note the claim is a product-by-process claim. The limitation which states “prepared by a spray-drying process comprising preparing a spray liquid comprising the polypeptide and a carbohydrate; and spraying the spray liquid in a spray tower” is a description of the process in which the product is made not a limitation of the animal feed additive itself. See MPEP 2113(I) “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
Regardless, Haahr teaches the polypeptide is formulated into granules (page 35, lines 3-5). Haahr additionally teaches the granule may be spray-dried (page 60 lines 4-6).
Thus Haahr teaches a substantially identical product and therefore renders the claim obvious.
With regard to Claim 5, Haahr teaches the carbohydrate is dextrin (page 59 lines 20-26)
With regard to Claim 6, Haahr teaches formulating the granules with a core and one or more coatings (page 59 lines 27-39). Haahr teaches the core comprises salt (page 61 lines 17-19, 21-23, 26-34). Haahr teaches a layer contains the polypeptide (page 60 lines 7-12). Haahr teaches the core may be surrounded by at least one coating and optional coatings(s) may include a salt and/or wax and/or flour coating, or other suitable coating materials (page 62 lines 1-3). Thus Haahr reads on the limitation of the granules not comprising an outer layer of wax or salt because both the wax and salt taught by Haahr are optional and the granule is not limited to just utilizing wax or salt as layers.
With regard to Claim 7, Haahr teaches the core may comprise sodium sulfate or sodium chloride (page 61 lines 26-34)
With regard to Claim 8, Haahr teaches the particle sizes of the granule of the present invention is found to be 20-2000 μm (page 59 lines 30-33). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to Claim 9, The examiner would like to note the claim is a product-by-process claim. The limitation which states “prepared in a fluid bed apparatus” is a description of the process in which the product is made not a limitation of the animal feed additive itself. See MPEP 2113(I) “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
Regardless, Haahr teaches the granule was prepared in a fluid bed apparatus (page 59 lines 33-36 page 61 lines 6-9).
With regard to Claim 10, The examiner would like to note the claim is a product-by-process claim. The limitation which states “prepared by a high-shear granulation process” is a description of the process in which the product is made not a limitation of the animal feed additive itself. See MPEP 2113(I) “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
Haahr teaches the granules can comprise cellulose (page 59 lines 20-26) and one or more salts (page 59 lines 11-19)
Therefore, because the combination of Haahr and Aureli teaches substantially the same product the prior art reads on the claimed limitation being obvious.
With regard to Claim 11, the examiner would like to note the claim is a product-by-process claim. The limitations of “(a) mixing said cellulose and/or a cellulose derivative and said one or more salts to form a powder: and (b) adding an aqueous liquid comprising said one or more polypeptides having protease activity and at least 95% sequence identity to SEO ID NO: 1 to said powder” are descriptions of the process in which the product is made not a limitation of the animal feed additive itself. See MPEP 2113(I) “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
The combination of Haahr and Aureli teaches substantially the same product the prior art reads on the claimed limitation being obvious.
With regard to Claim 12, Haahr teaches formulating the granules with a core and one or more coatings (page 59 lines 27-39). Haahr teaches the core comprises salt (page 61 lines 17-19, 21-23, 26-34). Haahr teaches a layer contains the polypeptide (page 60 lines 7-12). Haahr teaches the core may be surrounded by at least one coating and optional coatings(s) may include a salt and/or wax and/or flour coating, or other suitable coating materials (page 62 lines 1-3). Thus Haahr reads on the limitation of the granules not comprising an outer layer of wax or salt because both the wax and salt taught by Haahr are optional and the granule is not limited to just utilizing wax or salt as layers.
Haahr teaches using a steam test to evaluate the residual activity of the protease (page 91 lines 26-28) but is silent to one or more polypeptides retain at least 75% residual protease activity after exposure of said granule to steam treatment at 95°C for 90 seconds.
With regard to the residual activity, Aureli teaches there are no limitations on the origin of the acid stable serine protease for use according to the invention ([0115]). Aureli teaches the term protease includes not only natural or wild-type proteases, but also any mutants, variants, fragments etc. thereof exhibiting protease activity, as well as synthetic proteases, such as shuffled proteases, and consensus proteases. Such genetically engineered proteases can be prepared as is generally known in the art, e. g. by Site-directed Mutagenesis, by PCR (using a PCR fragment containing the desired mutation as one of the primers in the PCR reactions), or by Random Mutagenesis ([0115]). In addition Aureli teaches using a commercially available serine protease derived from Nocardiopsis called Ronozyme®ProAct® (DSM Nutritional Products AG) ([0114]). Per the applicant specification, the invention being claimed provides novel granules or formulations of the polypeptide of Ronozyme®ProAct® and variants thereof (see applicants specification “Summary of Invention” page 3). In examples 8 and 9 in applicant's specification, the applicant further defines SEQ ID NO:1 as Ronozyme®ProAct®.
Thus, because Aureli clearly teaches using Ronozyme®ProAct®, the art clearly teaches the limitation of the protease having 95% sequence identity to SEQ ID No:1 ([0283]) and therefore, the Ronozyme®ProAct® would inherently retain 75% residual activity after exposure of the granule to a steam treatment at 95℃ for 90 seconds because a. chemical composition and its properties are inseparable. See MPEP 2112.01(II) which teaches "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Therefore, Aureli imparts reasoning for obviousness because the teaching shows that the claimed protease sequence was known to have been successfully used in an animal feed additive and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the polypeptide of Ronozyme®ProAct® and variants thereof. because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 13, Haahr teaches an animal feed additive comprising a polypeptide having protease activity (page 1, lines 10-11) Haahr teaches the polypeptide is formulated into granules (page 35, lines 3-5). Haahr additionally teaches the granule may be spray-dried (page 60 lines 4-6).
However, Haahr is silent to the protease having at least 95% sequence identity to SEQ ID NO: 1.
Aureli teaches an animal feed additive comprising a polypeptide having protease activity (abstract). Aureli teaches the polypeptide is formulated into granules ([0209]) selected from extruded granules ([0211]), spray-dried granules ([0213]), granules comprising a salt core ([0225]) and a layer that contains said polypeptide ([0214], [0226]), and granules produced by high-shear granulation ([0211]).
With regard to the sequence identity, Aureli teaches there are no limitations on the origin of the acid stable serine protease for use according to the invention ([0115]). Aureli teaches the term protease includes not only natural or wild-type proteases, but also any mutants, variants, fragments etc. thereof exhibiting protease activity, as well as synthetic proteases, such as shuffled proteases, and consensus proteases. Such genetically engineered proteases can be prepared as is generally known in the art, e. g. by Site-directed Mutagenesis, by PCR (using a PCR fragment containing the desired mutation as one of the primers in the PCR reactions), or by Random Mutagenesis ([0115]). In addition Aureli teaches using a commercially available serine protease derived from Nocardiopsis called Ronozyme®ProAct® (DSM Nutritional Products AG) ([0114]). Per the applicant specification, the invention being claimed provides novel granules or formulations of the polypeptide of Ronozyme®ProAct® and variants thereof (see applicants specification “Summary of Invention” page 3). In examples 8 and 9 in applicant's specification, the applicant further defines SEQ ID NO:1 as Ronozyme®ProAct®.
Thus, because Aureli clearly teaches using Ronozyme®ProAct®, the art clearly teaches the limitation of the protease having 95% sequence identity to SEQ ID No:1 ([0283]).
With regard to the residual activity, because Aureli clearly teaches using Ronozyme®ProAct®, the art clearly teaches the limitation of the protease having 95% sequence identity to SEQ ID No:1 ([0283]) and therefore, the Ronozyme®ProAct® would inherently retain 75% residual activity after exposure of the granule to a steam treatment at 95℃ for 90 seconds because a. chemical composition and its properties are inseparable. See MPEP 2112.01(II) which teaches "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Therefore, Aureli imparts reasoning for obviousness because the teaching shows that the claimed protease sequence was known to have been successfully used in an animal feed additive and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the polypeptide of Ronozyme®ProAct® and variants thereof. because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claims 18-21, Haahr teaches using a steam test to evaluate the residual activity of the protease (page 91 lines 26-28) but is silent to one or more polypeptides retain at least 75% residual protease activity after exposure of said granule to steam treatment at 95°C for 90 seconds.
With regard to the residual activity, Aureli teaches there are no limitations on the origin of the acid stable serine protease for use according to the invention ([0115]). Aureli teaches the term protease includes not only natural or wild-type proteases, but also any mutants, variants, fragments etc. thereof exhibiting protease activity, as well as synthetic proteases, such as shuffled proteases, and consensus proteases. Such genetically engineered proteases can be prepared as is generally known in the art, e. g. by Site-directed Mutagenesis, by PCR (using a PCR fragment containing the desired mutation as one of the primers in the PCR reactions), or by Random Mutagenesis ([0115]). In addition Aureli teaches using a commercially available serine protease derived from Nocardiopsis called Ronozyme®ProAct® (DSM Nutritional Products AG) ([0114]). Per the applicant specification, the invention being claimed provides novel granules or formulations of the polypeptide of Ronozyme®ProAct® and variants thereof (see applicants specification “Summary of Invention” page 3). In examples 8 and 9 in applicant's specification, the applicant further defines SEQ ID NO:1 as Ronozyme®ProAct®.
Thus, because Aureli clearly teaches using Ronozyme®ProAct®, the art clearly teaches the limitation of the protease having 95% sequence identity to SEQ ID No:1 ([0283]) and therefore, the Ronozyme®ProAct® would inherently retain the claimed residual activity after exposure of the granule to the claimed steam treatment because a chemical composition and its properties are inseparable. See MPEP 2112.01(II) which teaches "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Therefore, Aureli imparts reasoning for obviousness because the teaching shows that the claimed protease sequence was known to have been successfully used in an animal feed additive and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the polypeptide of Ronozyme®ProAct® and variants thereof. because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Claim 3 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Haahr (WO 2019043191 A1) in view of Aureli (US 20210292725 A1) and Marcussen et al. (herein referred to as Marcussen, US 20180242615 A1)
With regard to Claim 3, Haahr teaches the polypeptide is formulated into granules (page 35, lines 3-5). Haahr additionally teaches the granule may be extruded (page 60 lines 16-21).
However, Haahr is silent to the extruded granules comprising a hydrophobic substance selected from oils and waxes; and a solid carrier selected from plant-based absorbents and mineral sourced absorbents.
Marcussen teaches the polypeptide is formulated in granules ([0022]) and include extruded granules ([0168]). Marcussen teaches the granules comprise a hydrophobic substance selected from oils and waxes as binders and stabilizing agents ([0095], [0099]-[0100], [0137], [0152]) and a solid carrier can be a plant-base ([0029] Marcussen reads such that the carrier can be flour) and/or mineral source absorbent ([0029]).
It would have been obvious to one with ordinary skill in the art to modify Haahr in view of Marcussen to use a hydrophobic substance selected from oils and waxes as binders and stabilizing agents. In addition Marcussen imparts reasoning for obviousness because the teaching shows that the claimed solid carrier being a plant-based absorbent or a mineral sources absorbent was successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to selected a plant-base or mineral source absorbent for the solid carrier of an animal feed additive because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 15, Haahr is silent to hydrophobic substance comprising a hydrogenated plant-based oil or wax, and wherein said solid carrier comprises a plant-based absorbent the extruded granules comprising a hydrophobic substance selected from oils and waxes; and a solid carrier selected from plant-based absorbents and mineral sourced absorbents.
Marcussen teaches the hydrophobic substance comprises a hydrogenated plant-based oil or wax ([0112]) and wherein the solid carrier comprised a plant-based absorbent ([0029] Marcussen reads such that the carrier can be flour).
Marcussen imparts reasoning for obviousness because the teaching shows that the claimed hydrogenated plant-based oil or wax and plant-based absorbent were successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to selected hydrogenated plant-based oil or wax as the hydrophobic substance and plant-based absorbent for the solid carrier of an animal feed additive because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claims 16-17, Haahr teaches using a steam test to evaluate the residual activity of the protease (page 91 lines 26-28) but is silent to one or more polypeptides retain at least 75% residual protease activity after exposure of said granule to steam treatment at 95°C for 90 seconds.
With regard to the residual activity, Aureli teaches there are no limitations on the origin of the acid stable serine protease for use according to the invention ([0115]). Aureli teaches the term protease includes not only natural or wild-type proteases, but also any mutants, variants, fragments etc. thereof exhibiting protease activity, as well as synthetic proteases, such as shuffled proteases, and consensus proteases. Such genetically engineered proteases can be prepared as is generally known in the art, e. g. by Site-directed Mutagenesis, by PCR (using a PCR fragment containing the desired mutation as one of the primers in the PCR reactions), or by Random Mutagenesis ([0115]). In addition Aureli teaches using a commercially available serine protease derived from Nocardiopsis called Ronozyme®ProAct® (DSM Nutritional Products AG) ([0114]). Per the applicant specification, the invention being claimed provides novel granules or formulations of the polypeptide of Ronozyme®ProAct® and variants thereof (see applicants specification “Summary of Invention” page 3). In examples 8 and 9 in applicant's specification, the applicant further defines SEQ ID NO:1 as Ronozyme®ProAct®.
Thus, because Aureli clearly teaches using Ronozyme®ProAct®, the art clearly teaches the limitation of the protease having 95% sequence identity to SEQ ID No:1 ([0283]) and therefore, the Ronozyme®ProAct® would inherently retain the claimed residual activity after exposure of the granule to the claimed steam treatment because a chemical composition and its properties are inseparable. See MPEP 2112.01(II) which teaches "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Therefore, Aureli imparts reasoning for obviousness because the teaching shows that the claimed protease sequence was known to have been successfully used in an animal feed additive and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the polypeptide of Ronozyme®ProAct® and variants thereof. because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Response to Arguments
Applicant's arguments filed 06 July 2026 have been fully considered but they are not persuasive.
Applicant argues that with the newly amended claim 1 now reciting, “wherein said animal feed additive does not comprise a zinc salt of an organic acid” the amendment overcomes the rejection in view of Marcussen. The claim is no longer rejected in view of Marcussen and is now rejected in view of Haahr which does not teach the use of zinc salt of an organic acid and thus reads on the newly amended claim. Additionally this argument is not found persuasive because the new amendment to claim 1 introduces new matter and therefore is rejected under 112(a) and applicants argument is not found to be persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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/K.I.D./ Examiner, Art Unit 1792
/ERIK KASHNIKOW/ Supervisory Patent Examiner, Art Unit 1792
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