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 .
Specification
The amendments to the specification filed 13 October 2025 have been entered. The examiner would like to note in the corrections to SEQ ID NO: 1 in the amended specification changed the representation of the amino acid sequence from a three letter code (ex: ALA) to a single letter code (Ex: A). Both are proper means of expressing an amino acid but a note is made here to prevent any confusion.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-13 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Marcussen et al. (herein referred to as Marcussen, US 20180242615 A1) in view of Aureli et al. (herein referred to as Aureli, US 20210292725 A1).
With regard to Claim 1, Marcussen teaches an animal feed additive comprising a polypeptide having protease activity (Claim 35, Claim 43). Marcussen teaches the polypeptide is formulated in granules ([0022]) and include extruded granules ([0168]) and spray-dried granules ([0165]).
With regard to the sequence identity, Marcussen teaches using commercially available proteases including Ronozyme™ Pro ([0071]). 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®.
However, Marcussen 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 first important to note that Marcussen teaches utilizing a generic Ronozyme™ Pro (Marcussen, [0071]) but is silent with regard to the specifics. As a result, this generic disclosure would motivate one of ordinary skill in the art look to the related art to see which specific products under the Ronozyme Pro name are used.
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, Marcussen 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 3, 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 ([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])
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, Marcussen teaches the polypeptide is formulated in granules ([0022]) and includes spray-dried granules ([0165]).
Thus Marcussen teaches a substantially identical product and therefore renders the claim obvious.
With regard to Claim 5, Marcussen teaches the carbohydrate is dextrin ([0050], [0125]).
With regard to Claim 6, Marcussen teaches the granule of the present invention may have a matrix structure where the components are mixed homogeneously or it may be a layered granule comprising a core and one or more layers surrounding the core ([0021]). Marcussen teaches the core may be an inert particle wherein the inert particle can be salt ([0025], [0029] [0131]). Marcussen teaches the enzyme comprising matrix (i.e., polypeptide) or region of the granule may be the core of the granule, a layer surrounding the core, or the granule as such, if the structure of the granule is homogenous throughout the granule ([0025]). Marcussen teaches the granules may have additional coating layers wherein the coatings The coatings of the present invention generally are applied as one or more layers surrounding the core. Embodiments include one, two, three or four protective coating layers. Suitable coating materials are polymers, carbohydrates, proteins, lipids, fats and oils, fatty acids, inorganic salts, and gums and mixtures thereof ([0144]-[0150]). The examiner acknowledges that some of the coating embodiments include wax or salt. However, Marcussen teaches numerous embodiments wherein the outer coating later does not comprise a wax or salt and therefore reads on the claimed limitation.
With regard to Claim 7, Marcussen teaches the core may be an inert particle wherein the inert particle can be an inorganic salt ([0025], [0029], [0131]). Marcussen teaches the inorganic salt can be sodium sulfate or sodium chloride ([0131]).
With regard to Claim 8, Marcussen teaches suitable particle sizes of the granule of the present invention is found to be 20-2000 μm ([0023]). 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, Marcussen teaches the granule was prepared in a fluid bed apparatus ([0172], Claim 54).
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."
Marcussen teaches the granules can comprise cellulose and/or a cellulose derivative ([0125], [0133]) and one or more salts ([0025], [0029], [0131]).
Therefore, because the combination of Marcussen 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 Marcussen and Aureli teaches substantially the same product the prior art reads on the claimed limitation being obvious.
With regard to Claim 12, Marcussen teaches the granules may have additional coating layers wherein the coatings The coatings of the present invention generally are applied as one or more layers surrounding the core. Embodiments include one, two, three or four protective coating layers. Suitable coating materials are polymers, carbohydrates, proteins, lipids, fats and oils, fatty acids, inorganic salts, and gums and mixtures thereof ([0144]-[0150]). The examiner acknowledges that some of the coating embodiments include wax or salt. However, Marcussen teaches numerous embodiments wherein the outer coating later does not comprise a wax or salt and therefore reads on the claimed limitation.
However, Marcussen teaches using a steam test to simulate the residual activities that are found after steam pelleting in large scale ([0208]-[0209]) 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, Marcussen teaches an animal feed additive comprising a polypeptide having protease activity (Claim 35, Claim 43). Marcussen teaches the polypeptide is formulated in granules ([0022]) and include spray-dried granules ([0165]).
With regard to the sequence identity, Marcussen teaches using commercially available proteases including Ronozyme™ Pro ([0071]). 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®.
However, Marcussen 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 Claim 15, 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).
With regard to Claims 16-21, , Marcussen teaches using a steam test to simulate the residual activities that are found after steam pelleting in large scale ([0208]-[0209]) 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 with respect to claims 1-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In this case, the rejection has been changed from a U.S.C. 102 rejection to a U.S.C. 103 rejection over Marcussen (US 20180242615 A1) in view of Aureli (US 20210292725 A1) and therefore any arguments involving the U.S.C. 102 anticipation rejection with Aureli (US 20210292725 A1) are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792