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 .
Claim Amendments
Claim 25 has been amended to omit “N-acetyl muramidase” as one of the feed additives, as well as delete the requirement that the systemic and/or local inflammation is reduced by at least 10% and the optional limitations. Claims 31-43 have also been added. It has been verified that no new matter has been added.
Election/Restrictions
Claims 1-24 and 30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
With the addition of claims 31-43, claims 25-29 and 31-43 have been considered on the merits.
Specification
RE: Objection to the specification
Applicant has resolved most of the minor informalities except for the trademark “Balancius” left unlabeled in Figure 5 and the species “B. thetaiotamicron” still non-italicized in the Abstract. Thus, the objection to the specification has been maintained.
Maintained objection
The disclosure is objected to because of the following informalities:
The use of the term “Balancius”, which is a trade name or mark used in commerce, has been noted in this application (Figure 5). This term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
In addition, the taxonomic name “B. thetaiotamicron” in the Abstract is not properly written. Genus and species names should be italicized. Appropriate correction is required.
Claim Objections
Claim 40 is objected to because of the following informalities: redundant use of the conjunction “or”. To rectify this minor informality, “a pellet or powder or solution or syrup” should be amended to “a pellet, powder, solution, or syrup”.
Claim 43 is objected to due to typographical errors. The apostrophe in the limitation “10’000 units/kg feed and 30’000 units/kg feed” should be replaced with a comma such that it reads as “10,000 units/kg feed and 30,000 units/kg feed”.
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.
RE: Rejection of claims 25-29 under 35 U.S.C. 112(b) for indefiniteness
The limitations following the terms “preferably” and “e.g.” in claim 25 have been deleted. The rejections have therefore been withdrawn.
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.
RE: Rejection of claims 25 and 29 under 35 U.S.C. 103 as being obvious over Lopez-Ulibarri et al. in view of Ragland et al. and Derde et al.
Applicant has removed “N-acetyl muramidase” as one of the feed additives recited in claim 25. Since Lopez-Ulibarri et al. is directed to an animal feed comprising muramidase, it is argued that said removal is sufficient to overcome the prior art rejections.
Applicant’s argument has been considered and is found persuasive. It is conceded that Lopez-Ulibarri et al.’s method relies on using muramidase to lessen inflammation. Hence, the prior art rejections have been withdrawn.
New grounds of rejection
Claims 25, 29, 31-32, 35, 37-40, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Schnorr et al. (Pub. No. WO 2020/200322 A1) in view of Luchan et al. (Scientific Reports 2021, Vol. 11, article 23727, pages 1-13), Mittal et al. (Antioxidants & Redox Signaling 2014, Vol. 20, pages 1126-1167), and Manni et al. (American Journal of Pathology 2011, Vol. 178, pages 2752-2759).
Schnorr et al. discloses polypeptides of fungal origin, an animal feed additive comprising one or more said polypeptides, and an animal feed comprising said animal feed additive (Abstract; lines 4-5, page 137). The animal feed additive comprises an enzyme component, wherein the enzyme component consists of a catalase (CAT) of fungal origin and a superoxide dismutase (SOD) (lines 27-28, page 1; lines 3-6, page 2; lines 1-3, page 137).
Schnorr et al. also provides a method of reducing inflammation, improving immune response, and/or modulating gut microflora in an animal by administering to the animal the disclosed animal feed additive or animal feed (lines 7-10 and 25-30, page 15; lines 22-27, page 161). In one embodiment, the method is directed to reducing or preventing inflammation in the intestinal tract of a monogastric animal. Suitable animals include monogastric animals like pigs, poultry such as turkeys, broiler chickens, and layer hens, as well as pets like cats and dogs (lines 5-9, page 47; lines 10-24, page 160; lines 20-34, page 162).
SOD catalyzes the dismutation of the superoxide radical (O2-, which is a type of reactive oxygen species) into either molecular oxygen (O2) or hydrogen peroxide (H2O2) (lines 1-3, page 69), while catalase catalyzes degradation of hydrogen peroxide into water and oxygen (lines 15-16, page 1). These enzymes in the animal feed additive work by decreasing or preventing oxidative stress. According to Schnorr et al., oxidative stress has been associated with initiation and progression of several infectious diseases and is characterized by a disturbance between antioxidant/oxidant status in favor of excessive generation or slower removal of free radicals like reactive oxygen species (ROS). Excessive ROS content damages proteins, lipids, and nucleic acids, which results in loss of their biological functions and tissue injury (lines 25-32, page 19; lines 1-8, page 162). Thus in an embodiment, the method entails feeding a monogastric animal with a feed additive comprising an enzyme component, wherein the enzyme component consists of a polypeptide having catalase activity and a polypeptide having superoxide dismutase activity (lines 30-36, page 19; lines 8-14, page 162).
Working examples show that SOD and CAT are linked to reduction in the expression of heat shock protein (indicative of reduced inflammation), iNOS (a mediator of inflammation), as well as inflammatory markers IL-10, TNF-alpha, and INF-gamma (Figures 10-15).
The method of Schnorr et al. is comparable to the following claims:
Regarding claim 25: feeding to an animal the animal feed additive comprising a catalase and superoxide dismutase is equivalent to “feeding said animal with one of more of the following feed additives: protease, superoxide dismutase and/or catalase”.
Performing the method in order to reduce inflammation is akin to “reducing systemic inflammation and/or local inflammation of an animal caused by E. coli infection”. Schnorr et al. differs from the claimed invention in that it does not specify the type of inflammation being reduced.
Nonetheless, a person with ordinary skill in the art before the effective filing date of the claimed invention would have recognized that catalase and superoxide dismutase are capable of treating inflammation caused by Escherichia coli infection. It is known in the art that infection by bacteria like E. coli triggers an inflammatory response that promotes migration of inflammatory cells to the site of infection and production of ROS. ROS, in turn, activates inflammasomes leading to the formation of inflammatory caspases and cytokines according to Mittal et al. (Abstract, page 1126; Figure 4, pages 1132) and contributes to oxidative damage according to Luchan et al. (Abstract, page 1). Luchan et al. also teaches that scavenging ROS significantly mitigates oxidative damage. Since superoxide dismutase acts as a ROS scavenger by catalyzing the degradation of ROS into hydrogen peroxide, which can be further broken down by catalase into water and oxygen as substantiated by Schnorr et al. (lines 15-16, page 1; lines 1-3, page 69), it can be expected that administering the disclosed animal feed containing SOD and catalase would scavenge ROS and consequently alleviate inflammation induced by E. coli. In addition, Manni et al. teaches that SOD promotes killing of bacteria such as E. coli through phagocytosis and limits the resulting inflammation (Abstract, page 2752; Discussion, pages 2757-2758). There is therefore reasonable expectation that performing Schnorr et al.’s method would also kill the E. coli causing the inflammation.
Hence, claim 25 is obvious over Schnorr et al. in view of Luchan et al., Mittal et al., and Manni et al..
Regarding claim 29: applicable animals include monogastric animals like pigs and poultry such as turkeys, broiler chickens, and layer hens (lines 5-9, page 47; lines 10-24, page 160; lines 20-34, page 162), which are considered production animals and correspond to “wherein said animal is a production animal”.
Regarding claim 31: the SOD meets the limitation “wherein the feed additive is selected from the group consisting of a protease and a superoxide dismutase”.
Regarding claims 32 and 35: examples of SOD that can be used include the polypeptides of SEQ ID NO: 1 and SEQ ID NO: 84.
SEQ ID NO: 1 is the amino acid sequence for the cDNA of SEQ ID NO: 5 which is a polypeptide from Trichoderma reesei, whereas SEQ ID NO: 84 is the amino acid sequence for the cDNA of SEQ ID NO: 87 which is a polypeptide from Aspergillus versicolor (lines 15-16, page 22; lines 9-11 and 21-22, page 30; Table 1a, page 44). Sequence-to-sequence alignments demonstrate that Schnorr et al.’s SEQ ID NO: 1 and SEQ ID NO: 84 are 94.1% and 100% identical to applicant’s SEQ ID NO: 77 and SEQ ID NO:78, respectively (see below), thereby satisfying “wherein the superoxide dismutase is selected from the group consisting of: (a") a polypeptide having at least 75% sequence identity to SEQ ID NO: 77; (b") a polypeptide having at least 75% sequence identity to SEQ ID NO:78…”.
Applicant’s SEQ ID NO:78 (“Qy”) vs. Schnorr et al.’s SEQ ID NO: 84 (“Db”)
Query Match 100.0%; Score 1122; DB 1; Length 206;
Best Local Similarity 100.0%;
Matches 206; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MNLKFLPAAVLGLLISTTAAQDNNADTTDTDTNAPVITDNEPLSFHHASLLKKENTTVYG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNLKFLPAAVLGLLISTTAAQDNNADTTDTDTNAPVITDNEPLSFHHASLLKKENTTVYG 60
Qy 61 AITITTRRESAAVQVDVSIGGIPEGEYLNYHIHAARVPDDGNCYLTGAHLDPHGRGQEPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AITITTRRESAAVQVDVSIGGIPEGEYLNYHIHAARVPDDGNCYLTGAHLDPHGRGQEPP 120
Qy 121 CTITAPQTCEVGDLSGKHGPAWAPAGEEFRATYSDFFLANTPGDDAYYGDLSWVVHGSNG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CTITAPQTCEVGDLSGKHGPAWAPAGEEFRATYSDFFLANTPGDDAYYGDLSWVVHGSNG 180
Qy 181 DRLTCGNFDGFSGGGFGNWGGQKSKA 206
||||||||||||||||||||||||||
Db 181 DRLTCGNFDGFSGGGFGNWGGQKSKA 206
Applicant’s SEQ ID NO:77 (“Qy”) vs. Schnorr et al.’s SEQ ID NO: 1 (“Db”)
Query Match 94.1%; Score 1509; DB 1; Length 287;
Best Local Similarity 100.0%;
Matches 287; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 21 KDAPVVIDNPQGVEFKASLPKKPFFAGAALVGNVKGSVSATAGPAGKGVRFRVQFENLPK 80
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 KDAPVVIDNPQGVEFKASLPKKPFFAGAALVGNVKGSVSATAGPAGKGVRFRVQFENLPK 60
Qy 81 TGGPFLYHIHEEPAVNGNCTSTLAHLDPYHRGETPACNASEPQTCQVGDLSGKYGKITSD 140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TGGPFLYHIHEEPAVNGNCTSTLAHLDPYHRGETPACNASEPQTCQVGDLSGKYGKITSD 120
Qy 141 PFVAEYFDLYTSLQPGSPAFFGNRSIVIHYANKTRLTCANFAKLPVPAATTVPSTTGAHH 200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PFVAEYFDLYTSLQPGSPAFFGNRSIVIHYANKTRLTCANFAKLPVPAATTVPSTTGAHH 180
Qy 201 TAIHGPLATGGAQHNLTGSHNTTGHHNFTSPHRTTGAASPSDVYTLTSVVTVPGSPTTSS 260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TAIHGPLATGGAQHNLTGSHNTTGHHNFTSPHRTTGAASPSDVYTLTSVVTVPGSPTTSS 240
Qy 261 SLTTTDDAGSGGASATSSVVPFPGAASGNRVSLSLLSGVVAAIFFSL 307
|||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SLTTTDDAGSGGASATSSVVPFPGAASGNRVSLSLLSGVVAAIFFSL 287
Regarding claim 37: the animal can be a monogastric animal like pig, poultry like turkey, pet like cat/dog, fish like salmon, and crustacean like shrimp. This teaching fulfills “wherein the animal is selected from the group consisting of poultry, seafood, sheep, cow, cattle, buffalo, bison, pig, cat, dog, rabbit, goat, guinea pig, donkey, camel, horse, pigeon, ferret, gerbil, hamster, mouse, rat, and bird”.
Regarding claim 38: the animal being poultry, fish (a seafood), pig, cat, or dog are the same as “wherein the animal is selected from the group consisting of poultry, seafood… pig, cat and dog”.
Regarding claim 39: examples of suitable poultry include layer hens, broiler chickens, and turkey, which are identical to “wherein the animal is selected from layer hens, broiler chickens, turkey…”. The shrimp, pig, cat, and dog also satisfy “shrimp… pig, cat, and dog”.
Regarding claim 40: the polypeptides can be formulated as a liquid or solid (lines 16-17, page 163) such as spray dried powder (lines 13-14, page 164), thus fulfilling “wherein the additive is a pellet or powder or solution or syrup”.
Regarding claim 43: the polypeptide having superoxide dismutase activity is preferably dosed at 100-5,000 U/kg animal feed (25-31, page 160), which reads on “wherein the feed comprises a superoxide dismutase in an amount of 1000-100,000 IU”.
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 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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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