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 .
Election/Restrictions
Applicants’ election without traverse of claims 1-8 in the reply filed on 07 July 2026 is acknowledged. Claims 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07 July 2026.
Claim Objections
Claims 7 and 8 are objected to because of the following informalities:
Claim 7, line 2: insert “egg laying” before “birds”
Claim 8, line 2: insert “egg laying” before “birds”
Claim 8, line 4: “GH 25” should read “GH25”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 7 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the muramidase must be obtained from Acremonium alcalophilum or Trichophaea saccate or if the muramidase can be obtained from the phylum Ascomycota or the subphylum Pezizomycotina. For the purpose of examination, claim 3 will be interpreted as the muramidase can be obtained from the phylum Ascomycota or the subphylum Pezizomycotina.
Regarding claim 7, lines 1-3 recite a method comprising administering to the birds a composition, an animal feed or an animal feed additive. Lines 5-6 recite the muramidase is dosed at a level of 150 to 300 mg enzyme protein per kg animal feed. It is unclear if the animal feed of lines 5-6 is the same animal feed recited in line 2 or whether the animal feed of lines 5-6 is an additional animal feed that the composition, animal feed or animal feed additive of lines 1-3 has been added to. For the purpose of examination, the animal feed of claim 7, line 6 will be interpreted as an additional animal feed that the composition, animal feed or animal feed additive of lines 1-3 has been added to.
Regarding claim 7, lines 7-8 recite “the egg laying birds are selected from the group consisting of swine, piglet, growing pig, sow…” It is unclear how the swine, piglet, growing pig and sow satisfy the claim limitation of being egg laying birds. For the purpose of examination, claim 7 will be interpreted as: the egg laying birds are selected from the group consisting of chicken, broiler, layer, pullet and chick.
Regarding claim 8, lines 1-3 recite a method comprising administering to the birds a composition, an animal feed or an animal feed additive. Lines 4-6 recite the muramidase is dosed at a level of 150 to 300 mg enzyme protein per kg animal feed. It is unclear if the animal feed of lines 4-6 is the same animal feed recited in line 2 or whether the animal feed of lines 4-6 is an additional animal feed that the composition, animal feed or animal feed additive of lines 1-3 has been added to. For the purpose of examination, the animal feed of claim 8, line 6 will be interpreted as an additional animal feed that the composition, animal feed or animal feed additive of lines 1-3 has been added to.
Regarding claim 8, lines 7-8 recite “the egg laying birds are selected from the group consisting of swine, piglet, growing pig, sow…” It is unclear how the swine, piglet, growing pig and sow satisfy the claim limitation of being egg laying birds. For the purpose of examination, claim 8 will be interpreted as: the egg laying birds are selected from the group consisting of chicken, broiler, layer, pullet and chick.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cardoso Bittencourt (WO 2020/053276 A1, published 19 March 2020).
Regarding claim 1, Cardoso Bittencourt discloses a method of administering to a monogastric animal an animal feed, animal feed or animal feed additive comprising one or more microbial muramidases (p2, lines 20-22). Cardoso Bittencourt discloses the monogastric animal may be poultry such as chickens (egg laying birds) (p5, lines 28-33).
As to the claim language "for improving egg production and/or egg quality in egg laying birds", this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering one or more muramidases of Cardoso Bittencourt is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Additionally, Cardoso Bittencourt discloses the method of administering muramidases to a monogastric animal results in a significant benefit of improving pigmentation by carotenoids. Cardoso Bittencourt further discloses pigmentation refers to the coloring of animal derived products, including eggs (as for example the coloring of egg yolks) by pigment such as carotenoids (p7, lines1-10). Cardoso Bittencourt’s disclosure of improving the pigmentation by carotenoids in eggs and egg yolks is considered to satisfy the claim language of “for improving egg production and/or egg quality in egg laying birds.
Regarding claim 2, Cardoso Bittencourt discloses the monogastric animal may be chicken, ducks, geese, quail, turkey, guinea fowl, or pigeon (p5, lines 28-32).
Regarding claim 3, Cardoso Bittencourt discloses preferably, the microbial muramidase is obtained or obtainable from the phylum Ascomycota, such as the subphylum Pezizomycotina. Additionally, Cardoso Bittencourt discloses the microbial muramidases may comprise or consist of the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 4 or SEQ ID NO: 10 (p9, line 19 – p10, line 4). Cardoso Bittencourt discloses SEQ ID NO: 1 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum, SEQ ID NO: 4 is the mature amino acid sequence of a wild type GH24 muramidase from Trichophaea saccate and SEQ ID NO: 10 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum as described in WO 2013/076253 (p2, line 24-p3, line 8).
Regarding claim 4, Cardoso Bittencourt discloses the microbial muramidase is a microbial muramidase comprising one or more domains selected from the list consisting of GH24 and GH25 (p12, lines 3-8).
Regarding claims 5 and 6, Cardoso Bittencourt discloses SEQ ID NO: 1 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum with N-terminal SPIRR as described in WO 2013/076253, SEQ ID NO: 4 is the mature amino acid sequence of a wild type GH24 muramidase from Trichophaea saccate and SEQ ID NO: 10 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum as described in WO 2013/076253 (p2, line 23-p3, line 8). The instant specification recites SEQ ID NO: 1 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum with N-terminal SPIRR as described in WO 2013/076253. SEQ ID NO: 2 is the mature amino acid sequence of a wild type GH24 muramidase from Trichophaea saccata. SEQ ID NO: 3 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum as described in WO 2013/076253 (Instant specification, p2, Overview of Sequence Listing).
A sequence to sequence alignment was conducted comparing SEQ ID No: 1, SEQ ID No: 2 and SEQ ID No: 3 from the instant application to SEQ ID No: 1, SEQ ID No: 4 and SEQ ID No:10, respectively, from US 2021337828 A1 (the US equivalent of Cardoso Bittencourt WO 2020/053276 A1 relied upon here).
Figure 1a, shows that SEQ ID NO: 1 from the instant application is a 100% match with SEQ ID NO: 1 from Cardoso Bittencourt.
Figure 1b, shows that SEQ ID NO: 2 from the instant application is a 100% match with SEQ ID NO: 4 from Cardoso Bittencourt.
Figure 1c shows that SEQ ID NO: 3 from the instant application is a 100% match with SEQ ID NO: 10 from Cardoso Bittencourt. Therefore SEQ ID No: 1, 4 and 10 disclosed by Cardoso Bittencourt meet the claim 5 limitation of: wherein the microbial muramidase is a polypeptide having at least 50%, e.g., at least 60%, at least 70%, at least 75%, at least 80%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%,at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO: 1, 2 or 3.
As can be seen in figure 1a below; the amino acids 1-213 of SEQ ID No: 1 of the instant application are identical to amino acids 1-213 of SEQ ID No: 1 of Cardoso Bittencourt.
As can be seen in figure 1b below; the amino acids 1-245 of SEQ ID No: 2 of the instant application are identical to amino acids 1-245 of SEQ ID No: 4 of Cardoso Bittencourt.
As can be seen in figure 1c below; the amino acids 1-208 of SEQ ID No: 3 of the instant application are identical to amino acids 6-213 of SEQ ID No: 10 of Cardoso Bittencourt.
Therefore, SEQ ID No: 1, 4 and 10 disclosed by Cardoso Bittencourt meet the claim 6 limitation of: wherein the microbial muramidase is selected from the group consisting of amino acids 1 to 213 of SEQ ID NO:1, amino acids 1 to 245 of SEQ ID NO: 2 and amino acids 1 to 208 of SEQ ID NO: 3.
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Figure 1a. SEQ ID No:1 of instant application vs. SEQ ID No: 1 of Cardoso Bittencourt
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Figure 1b. SEQ ID No:2 of instant application vs. SEQ ID No:4 of Cardoso Bittencourt
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Figure 1c. SEQ ID No:3 of instant application vs. SEQ ID No:10 of Cardoso Bittencourt
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cardoso Bittencourt (WO 2020/053276 A1, published 19 March 2020).
Regarding claim 7, Cardoso Bittencourt discloses a method of administering to a monogastric animal an animal feed, animal feed or animal feed additive comprising one or more microbial muramidases (p2, lines 20-22). Cardoso Bittencourt discloses the monogastric animal may be poultry such as chickens (egg laying birds) (p5, lines 28-33).
Cardoso Bittencourt discloses the microbial muramidase is a microbial muramidase comprising one or more domains selected from the list consisting of GH24 and GH25 (p12, lines 3-8).
Cardoso Bittencourt discloses the microbial muramidases may be dosed at a level of 100-1000 mg enzyme protein per kg animal feed (p7, lines 25-27), which encompasses the claimed range of 150-300 mg enzyme protein per kg animal feed. 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).
Cardoso Bittencourt discloses the monogastric animal may be chicken, broilers, chicks or layers (p5, lines 28-32).
As to the claim language "of improving egg production and/or egg quality in egg laying birds", this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering one or more muramidases of Cardoso Bittencourt is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Additionally, Cardoso Bittencourt discloses the method of administering muramidases to a monogastric animal results in a significant benefit of improving pigmentation by carotenoids. Cardoso Bittencourt further discloses pigmentation refers to the coloring of animal derived products, including eggs (as for example the coloring of egg yolks) by pigment such as carotenoids (p7, lines1-10). Cardoso Bittencourt’s disclosure of improving the pigmentation by carotenoids in eggs and egg yolks is considered to satisfy the claim language of “of improving egg production and/or egg quality in egg laying birds.
Regarding claim 8, Cardoso Bittencourt discloses a method of administering to a monogastric animal an animal feed, animal feed or animal feed additive comprising one or more microbial muramidases (p2, lines 20-22). Cardoso Bittencourt discloses the monogastric animal may be poultry such as chickens (egg laying birds) (p5, lines 28-33).
Cardoso Bittencourt discloses the microbial muramidases may comprise or consist of the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 4 or SEQ ID NO: 10 (p9, line 19 – p10, line 4). Cardoso Bittencourt discloses SEQ ID NO: 1 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum, SEQ ID NO: 4 is the mature amino acid sequence of a wild type GH24 muramidase from Trichophaea saccate and SEQ ID NO: 10 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum as described in WO 2013/076253 (p2, line 24-p3, line 8).
Cardoso Bittencourt discloses the microbial muramidases may be dosed at a level of 100-1000 mg enzyme protein per kg animal feed (p7, lines 25-27), which encompasses the claimed range of 150-300 mg enzyme protein per kg animal feed. 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).
Cardoso Bittencourt discloses the monogastric animal may be chicken, broilers, chicks or layers (p5, lines 28-32).
As to the claim language "of improving egg production and/or egg quality of egg laying birds", this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering one or more muramidases of Cardoso Bittencourt is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Additionally, Cardoso Bittencourt discloses the method of administering muramidases to a monogastric animal results in a significant benefit of improving pigmentation by carotenoids. Cardoso Bittencourt further discloses pigmentation refers to the coloring of animal derived products, including eggs (as for example the coloring of egg yolks) by pigment such as carotenoids (p7, lines1-10). Cardoso Bittencourt’s disclosure of improving the pigmentation by carotenoids in eggs and egg yolks is considered to satisfy the claim language of “of improving egg production and/or egg quality of egg laying birds.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 12, 15, 17 and 18 of U.S. Patent No. 10,568,344 B2 (herein referred to as ‘344). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 2, ‘344 claim 1 discloses a method comprising administering a monogastric animal an animal feed or animal feed additive comprising one or more microbial lysozymes (also called muramidases). ‘344 claims 11 and 12 disclose the monogastric animal may be poultry, turkey, duck, quail, guinea fowl, goose, pigeon, squab, chicken, broiler, layer, pullet and chick (egg laying birds).
As to the claim language "of improving egg production and/or egg quality of egg laying birds", this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering one or more muramidases of ‘344 is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Regarding claim 3, ‘344 claim 15 discloses wherein the microbial lysozyme is obtained or obtainable from the phylum Ascomycota.
Regarding claim 4, ‘344 claim 17 discloses wherein the microbial lysozyme comprises one or more domains selected from the list consisting of GH24 and GH25.
Regarding claims 5 and 6, ‘344 claim 18 discloses wherein the microbial lysozyme is selected from the group consisting of amino acids 1 to 213 of SEQ ID NO: 1, amino acids 1 to 245 of SEQ ID NO: 4 and amino acids 1 to 208 of SEQ ID NO: 12.
A sequence to sequence alignment was conducted comparing SEQ ID No: 1, SEQ ID No: 2 and SEQ ID No: 3 from the instant application to SEQ ID No: 1, SEQ ID No: 4 and SEQ ID No:12, respectively, from ‘344.
Figure 2a, shows that SEQ ID NO: 1 from the instant application is a 100% match with SEQ ID NO: 1 from ‘344.
Figure 2b, shows that SEQ ID NO: 2 from the instant application is a 100% match with SEQ ID NO: 4 from ‘344.
Figure 2c shows that SEQ ID NO: 3 from the instant application is a 100% match with SEQ ID NO: 12 from ‘344. Therefore SEQ ID No: 1, 4 and 12 disclosed by ‘344 meet the claim 5 limitation of: wherein the microbial muramidase is a polypeptide having at least 50%, e.g., at least 60%, at least 70%, at least 75%, at least 80%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%,at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO: 1, 2 or 3.
As can be seen in figure 2a below; the amino acids 1-213 of SEQ ID No: 1 of the instant application are identical to amino acids 1-213 of SEQ ID No: 1 of ‘344.
As can be seen in figure 2b below; the amino acids 1-245 of SEQ ID No: 2 of the instant application are identical to amino acids 1-245 of SEQ ID No: 4 of ‘344.
As can be seen in figure 2c below; the amino acids 1-208 of SEQ ID No: 3 of the instant application are identical to amino acids 6-213 of SEQ ID No: 12 of ‘344.
Therefore, SEQ ID No: 1, 4 and 12 disclosed by ‘288 meet the claim 6 limitation of: wherein the microbial muramidase is selected from the group consisting of amino acids 1 to 213 of SEQ ID NO:1, amino acids 1 to 245 of SEQ ID NO: 2 and amino acids 1 to 208 of SEQ ID NO: 3.
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Figure 2a. SEQ ID No:1 of instant application vs. SEQ ID No: 1 of ‘344
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Figure 2b. SEQ ID No:2 of instant application vs. SEQ ID No: 4 of ‘344
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Figure 2c. SEQ ID No:3 of instant application vs. SEQ ID No: 12 of ‘344
Regarding claim 7, ‘344 claim 1 discloses a method comprising administering a monogastric animal an animal feed or animal feed additive comprising one or more microbial lysozymes (also called muramidases). ‘344 claims 11 and 12 disclose the monogastric animal may be poultry, turkey, duck, quail, guinea fowl, goose, pigeon, squab, chicken, broiler, layer, pullet and chick (egg laying birds).
‘344 claim 17 discloses wherein the microbial lysozyme comprises one or more domains selected from the list consisting of GH24 and GH25.
‘344 claim 1 recites the microbial lysozyme is administered at a level of 8-250 ppm enzyme protein per kg of animal food, which overlaps with the claimed range of 150-300 mg enzyme protein per kg animal food. 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).
As to the claim language "of improving egg production and/or egg quality of egg laying birds", this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering one or more muramidases of ‘344 is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12 and 17 of of U.S. Patent No. 10,568344 (herein referred to as ‘344) in view of Cardoso Bittencourt (WO 2020/053276).
Regarding claim 8, ‘344 claim 1 discloses a method comprising administering a monogastric animal an animal feed or animal feed additive comprising one or more microbial lysozymes (also called muramidases). ‘344 claims 11 and 12 disclose the monogastric animal may be poultry, turkey, duck, quail, guinea fowl, goose, pigeon, squab, chicken, broiler, layer, pullet and chick (egg laying birds).
‘344 claim 17 discloses wherein the microbial lysozyme comprises one or more domains selected from the list consisting of GH24 and GH25.
‘344 claim 1 recites the microbial lysozyme is administered at a level of 8-250 ppm enzyme protein per kg of animal food, which overlaps with the claimed range of 150-300 mg enzyme protein per kg animal food. 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).
‘344 does not disclose the GH24 or GH25 muramidase is obtained from Acremonium alcalophilum or Trichophaea saccate.
Cardoso Bittencourt discloses a method of administering to a monogastric animal an animal feed, animal feed or animal feed additive comprising one or more microbial muramidases (p2, lines 20-22). Cardoso Bittencourt discloses the monogastric animal may be poultry such as chickens (egg laying birds) (p5, lines 28-33).
Cardoso Bittencourt discloses the microbial muramidases may comprise or consist of the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 4 or SEQ ID NO: 10 (p9, line 19 – p10, line 4). Cardoso Bittencourt discloses SEQ ID NO: 1 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum, SEQ ID NO: 4 is the mature amino acid sequence of a wild type GH24 muramidase from Trichophaea saccate and SEQ ID NO: 10 is the mature amino acid sequence of a wild type GH25 muramidase from Acremonium alcalophilum as described in WO 2013/076253 (p2, line 24-p3, line 8).
Cardoso Bittencourt discloses the microbial muramidases may be dosed at a level of 100-1000 mg enzyme protein per kg animal feed (p7, lines 25-27).
Cardoso Bittencourt discloses the monogastric animal may be chicken, broilers, chicks or layers (p5, lines 28-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selected the GH24 or GH25 muramidase is obtained from Acremonium alcalophilum or Trichophaea saccate of Cardoso Bittencourt as the source of GH25 and GH24 of ‘344 since the selection of a known material based on its suitability for its intended use supports a case for prima facie obviousness. In the instant case Cardoso Bittencourt discloses GH24 or GH25 muramidase obtained from Acremonium alcalophilum or Trichophaea saccate is suitable for inclusion in animal feed for birds.
As to the claim language "of improving egg production and/or egg quality of egg laying birds", this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering one or more muramidases of ‘344 is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Conclusion
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/CARRIE GLIMM/Examiner, Art Unit 1793
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