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 elected Group 1 (claims 1-16), without traverse, in the reply filed on 1/29/2026.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 1-16 have been examined.
Priority
The instant application is a national stage entry of PCT/EP2022/056436 (filed on 3/14/2022), which claims foreign priority under 35 U.S.C. 119(a)-(d) based on application EP21162898.7 (filed on 3/16/2021). Certified copy of the foreign priority document is on file.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 9/13/2023 is in compliance with the provisions of 37 C.F.R. 1.97 and all cited references have been considered.
Claim Objections
Claims 1 and 3-4 are objected to because of the following informalities: incorrect spelling. The term “yong” appears to be a misspelling of the word “young”.
Claim 3 is objected to due to redundancy: the preposition “of” is repeated after the phrase “increasing milk yield of”.
Claims 10 and 14-15 are objected to because of the following informalities: phylum and subphylum are improperly italicized. In standard scientific writing, only genus, species, and subspecies names should be written in italics.
Appropriate corrections are 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.
Claims 4-6, 12, and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5-6 use the phrase “such as”, which renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Similarly, the abbreviation “e.g.” in claim 12 (lines 3 and 16) stands for a Latin phrase that translates to “for example”. This phrase makes said claim indefinite since it cannot be determined whether the limitation(s) after “e.g.” are required or not. See MPEP § 2173.05(d). For the purpose of applying prior art, the limitations following “such as” and “e.g.” are considered optional.
Claims 4 and 16 recites the term “vadility”. It is unclear what the term means. But in the interest of compact prosecution, it is examined as if it refers to “vitality”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Pub. No. CN 103750052 A; English translation) in view of Aureli et al. (Pub. No. US 2018/0184688 A1).
According to Zhang et al., there is a need to overcome the negative effects of early piglet weaning such as growth retardation, diarrhea, and low feed utilization, as well as improve the health of sows and control sow disease (second par., page 2). Zhang et al. therefore discloses a sow feed additive for promoting the growth and/or health of weaning piglets and decreasing weight loss in lactating sows (Abstract, page 1; last par., page 3).
The sow feed additive comprises lysozyme, Enterococcus faecium, and a carrier (last par., page 2). To use it, Zhang et al. teaches adding 500-600 g of the sow feed additive for every ton of the sow diet/grain and feeding it to sows on the 90th to 95th day of pregnancy until end of lactation (first and second par., page 4). Piglets are weaned at 21 days of age (fourth par., page 4).
Feeding the sow feed additive to sows promotes the proliferation of beneficial bacteria in the sow’s intestine, reduces the number of harmful bacteria, and regulates the balance of the intestinal flora of the sow, thereby increasing the weight of weaning piglets, increasing the weight of piglets 3 weeks after weaning, and decreasing the incidence of diarrhea (fifth par., page 5; last par., page 8; Table 4, page 9). In addition, it reduces the weight loss of sows at the end of the lactation period (second par., page 5; table 2, page 8).
Zhang et al.’s method of using the disclosed sow feed additive is comparable to the instant application’s methods for the following reasons:
Regarding claims 1-4: feeding the sow feed additive to sows (i.e., female pigs) during gestation and lactation, wherein said sow feed additive contains lysozyme (also known as muramidase), is analogous to the step “administering to the female animal one or more microbial muramidases”.
The sow feed additive’s effects of decreasing weight loss in lactating sows and promoting the growth and health of piglets meets the intended function “for improving health status and/or performance of a female animal during gestation and/or lactation and yong animals thereof” (claim 1). Its ability to reduce the weight loss of sows during lactation (Table 2, page 8) satisfies “for reducing weight gain loss and/or backfat loss of a female animal during gestation and/or lactation” (claim 2). The prior art also shows that administering the sow feed additive leads to higher number of litter (Table 2, page 8), as well as greater body weight and daily weight gain of piglets (last par., page 8), thus fulfilling “for increasing litter size of yong animals born by of a female animal and increasing milk yield of of a female animal” (claim 3) and “for improving weight gain and/or vadility of yong animals born by a female animal” (claim 4).
Zhang et al. is different from the claimed invention in that the lysozyme used is not specified to be “microbial” (i.e., not limited to a lysozyme produced by microbes like bacteria, fungi, viruses, and protozoa).
It is known in the art, however, that all lysozymes have the same fundamental function. While lysozymes from different sources vary in type and structure, they all catalyze hydrolysis of the glycosidic bonds of peptidoglycans present in bacterial cell walls as substantiated by Aureli et al. (par. [0003]-[0005]). By breaking down bacterial cells in an animal’s gut, lysozymes minimize intestinal inflammation and make the gut lining healthier. Consequently, digestion/absorption of nutrients is enhanced and feed efficiency is increased.
For example, Aureli et al. teaches a method of improving animal performance by administering an animal feed or animal feed additive comprising one or more microbial lysozymes to a monogastric animal (par. [0002], [0010]) like piglets and sows (par. [0052], [0080], [0106]-[0107]). The one or more microbial lysozymes include lysozymes from fungi such as from the phylum Ascomycota and sub-phylum Pezizomycotina (par. [0081], [0108], [0238]). In one embodiment, the microbial lysozyme comprises the amino acid sequence of SEQ ID NO: 1, which is a GH25 lysozyme from Acremonium alcalophilum, or an allelic variant thereof (par. [0110]; Example 1, par. [0292]). In another embodiment, the microbial lysozyme comprises the amino acid sequence of SEQ ID NO: 4, which is a GH24 lysozyme from Trichophaea saccata, or an allelic variant thereof (par. [0117]; Example 4, par. [0318]). Experiments demonstrate that both lysozymes inhibited the growth of a pathogenic bacterial strain in livestock, Clostridium pefringens DSM756 (Table 3, par. [0333]-[0334]). Moreover, these particular lysozymes also improved feed conversion ratio during the starter period and whole period of study compared to the negative control (Table 13, par. [0385]).
A person with ordinary skill in the art before the effective filing date of the claimed invention would have modified Zhang et al.’s method by replacing the lysozyme used with a microbial lysozyme such as a GH25 lysozyme from A. alcalophilum or GH24 lysozyme from T. saccata. Since Aureli et al. shows that these microbial lysozymes have antimicrobial activity against harmful bacteria and can increase feed efficiency, such substitution is expected to improve the health of sows and piglets, as well as promote the growth of piglets. Obviousness is based on the rationale that substitution of one known element for another known element, both elements having equivalent effect, is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v. Teleflex Inc. 550 US 398, 82 USPQ2d 1385 (2007).
Hence, claims 1-4 are obvious over Zhang et al. in view of Aureli et al..
Regarding claim 5: Aureli et al. teaches using microbial lysozyme at a dose of 8-250 ppm enzyme per kg animal feed (par. [0068], [0224]), which is equivalent to 8-250 mg/kg.
MPEP 2144.01(I) states that a prima facie case of obviousness exists when the claimed ranges "overlap or lie inside ranges disclosed by the prior art". 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that suitable protection’ is provided if the protective layer is about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). Since the disclosed dose of 8-250 mg/kg overlaps with the limitation “wherein the microbial muramidase is dosed at a level of 100 to 1000 mg enzyme protein per kg animal feed”, the instant claim is deemed obvious.
Regarding claim 6: the modified method entails feeding the modified sow feed additive to a sow meets “wherein the animal is selected from the group consisting of swine such as sows and gilts…”.
Regarding claim 7: a sow is identical to “wherein the animal is sow or gilt”.
Regarding claim 8: feeding a sow during pregnancy and lactation is the same as “wherein the microbial muramidase may be fed to the female animal during gestation and/or during lactation”.
Regarding claim 9: feeding sows on 90th-95th day of pregnancy (about 19-24 days before farrowing) until end of lactation (first par., page 4; third par., page 7), which corresponds to 21 days after farrowing since piglets were weaned when they were 21 days old, reads on “wherein the microbial muramidase is fed to sows or gilts from day 7 before farrowing to day 26 post-farrowing”.
Regarding claim 10: the microbial lysozyme can originate from fungi belonging to the phylum Ascomycota or the sub-phylum Pezizomycotina (par. [0081]), such as from fungal species A. alcalophilum or T. saccata, thereby meeting “wherein the microbial muramidase is obtained or obtainable from the phylum Ascomycota, or the subphylum Pezizomycotina”.
Regarding claim 11: the microbial lysozyme being a GH25 lysozyme from A. alcalophilum (ex. SEQ ID NO: 1) or GH24 lysozyme from T. saccata (ex. SEQ ID NO: 4) is the same as “wherein the microbial muramidase comprises one or more domains selected from the list consisting of GH24 and GH25”.
Regarding claim 12: the embodiment of using a microbial lysozyme comprising the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 4 satisfies “wherein the microbial muramidase is selected from the group consisting of: (a) a polypeptide having at least 50%... sequence identity to SEQ ID NO: 1” and “…(d) a polypeptide having at least 50%... sequence identity to SEQ ID NO: 4”. Sequence-to-sequence analysis reveals that Aureli et al.’s SEQ ID NO: 1 and SEQ ID NO: 4 are 100% identical to applicant’s SEQ ID NO: 1 and SEQ ID NO: 4, respectively.
Applicant’s SEQ ID NO: 1 vs. Aureli et al.’s SEQ ID NO: 1
Query Match 100.0%; Score 1188; DB 1; Length 213;
Best Local Similarity 100.0%;
Matches 213; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SPIRRRIPGFDISGWQPTTDFARAYANGDRFVYIKATEGTTFKSSAFSRQYTGATQNGFI 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SPIRRRIPGFDISGWQPTTDFARAYANGDRFVYIKATEGTTFKSSAFSRQYTGATQNGFI 60
Qy 61 RGAYHFAQPAASSGAAQARYFASNGGGWSKDGITLPGALDIEYNPNGATCYGLSQSAMVN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RGAYHFAQPAASSGAAQARYFASNGGGWSKDGITLPGALDIEYNPNGATCYGLSQSAMVN 120
Qy 121 WIEDFVTTYHGITSRWPVIYTTTDWWTQCTGNSNRFANRCPLWIARYASSVGTLPNGWGF 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 WIEDFVTTYHGITSRWPVIYTTTDWWTQCTGNSNRFANRCPLWIARYASSVGTLPNGWGF 180
Qy 181 YTFWQYNDKYPQGGDSNWFNGDASRLRALANGD 213
|||||||||||||||||||||||||||||||||
Db 181 YTFWQYNDKYPQGGDSNWFNGDASRLRALANGD 213
Applicant’s SEQ ID NO: 4 vs. Aureli et al.’s SEQ ID NO: 4
Query Match 100.0%; Score 1317; DB 1; Length 245;
Best Local Similarity 100.0%;
Matches 245; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 YPVKTDLHCRSSPSTSASIVRTYSSGTEVQIQCQTTGTSVQGSNVWDKTQHGCYVADYYV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 YPVKTDLHCRSSPSTSASIVRTYSSGTEVQIQCQTTGTSVQGSNVWDKTQHGCYVADYYV 60
Qy 61 KTGHSGIFTTKCGSSSGGGSCKPPPINAATVALIKEFEGFVPKPAPDPIGLPTVGYGHLC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 KTGHSGIFTTKCGSSSGGGSCKPPPINAATVALIKEFEGFVPKPAPDPIGLPTVGYGHLC 120
Qy 121 KTKGCKEVPYSFPLTQETATKLLQSDIKTFTSCVSNYVKDSVKLNDNQYGALASWAFNVG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KTKGCKEVPYSFPLTQETATKLLQSDIKTFTSCVSNYVKDSVKLNDNQYGALASWAFNVG 180
Qy 181 CGNVQTSSLIKRLNAGENPNTVAAQELPKWKYAGGKVMPGLVRRRNAEVALFKKPSSVQA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CGNVQTSSLIKRLNAGENPNTVAAQELPKWKYAGGKVMPGLVRRRNAEVALFKKPSSVQA 240
Qy 241 HPPKC 245
|||||
Db 241 HPPKC 245
Regarding claim 13: Aureli et al.’s SEQ ID NO: 1 has identical amino acids in positions 1 to 213 as illustrated above. In addition, Aureli et al.’s SEQ ID NO: 4 has identical amino acids in positions 1 to 245. These teachings fulfill “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: 4 and amino acids 1 to 208 of SEQ ID NO: 10”.
Regarding claim 14: the modified method of Zhang et al. and Aureli et al. involving feeding a sow feed additive comprising a lysozyme such as a microbial lysozyme to sows, which leads to a decrease in weight gain loss, is analogous to “A method for reducing weight gain loss and/or backfat loss of sows or gilts during gestation and/or lactation, comprising administering to the sows or gilts one or more microbial muramidases”.
Applicable microbial lysozyme includes a GH25 lysozyme from A. alcalophilum or GH24 lysozyme from T. saccata. These fungi belong to Ascomycota, thus meeting the limitation “wherein: (a) the microbial muramidase is a GH24 or GH 25 muramidase obtained or obtainable from the phylum Ascomycota”.
The feeding being performed every day from 90th-95th day of the sow’s pregnancy until end of lactation satisfies “(b) the microbial muramidase is fed on a daily basis during gestation and lactation of the sows or gilts”.
None of the prior art specifically teaches using a dose of “300 to 500 mg enzyme protein per kg animal feed”. Aureli et al. only teaches administering 8-250 mg of the microbial lysozyme per kg of animal feed (par. [0068], [0224]).
Nevertheless, Aureli et al. teaches that the dose of microbial lysozyme depends on the specific activity of the purified enzyme used to formulate a composition and would have to be calculated (par. [0186]-[0188]). One with ordinary skill in the art would have recognized that as the specific activity of a purified lysozyme decreases, the higher the amount is needed to be added to an animal feed. Accordingly, the claimed dose would have been determined through routine experimentation and optimization.
Furthermore, MPEP 2144.05(I) indicates that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).
Claim 14 is therefore obvious over Zhang et al. in view of Aureli et al..
Regarding claims 15-16: the modified method comprising feeding a microbial lysozyme-containing sow feed additive to sows, which results in increasing the number of litter and increasing the weight gain of piglets, is equivalent to “A method for increasing litter size of piglets born by sows or gilts, and/or increasing milk yield of sows or gilts” (claim 15) and “A method for improving weight gain and/or vadility of piglets” (claim 16), wherein both methods comprise “administering to the sows or gilts one or more microbial muramidases”.
Using a GH25 lysozyme from A. alcalophilum or GH24 lysozyme from T. saccata (both belong to the phylum Ascomycota) fulfills “wherein: (a) the microbial muramidase is a GH24 or GH 25 muramidase obtained or obtainable from the phylum Ascomycota”.
Feeding the sow with the sow feed additive every day from 90th-95th day of the sow’s pregnancy until end of lactation meets “(b) the microbial muramidase is fed on a daily basis during gestation and lactation of the sows or gilts”.
Zhang et al. and Aureli et al. differ from the instant claim in that neither one teaches “dosed at a level of 300 to 500 mg enzyme protein per kg animal feed”.
But as explained above (see rejection for claim 14), this limitation is considered obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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