DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendment
2. The amendment filed June 23, 2026 has been entered. Claim 1 was amended. Claims 4 and 7, 11-12, 14, 17-20 and 22 are canceled. Claims 1-3, 5-6, 8-10, 13, 15-16 and 21 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 13, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawal of Rejections
4. The rejection of claims 17-20 and 22 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is withdrawn in view of Applicants amendments and arguments.
5. The rejection of claims 17-20 and 22 under 35 U.S.C. 103 as being unpatentable over Murphy et al; Molly et al., and further in view of CN109423460 and JP5463109 is withdrawn in view of Applicants amendments and arguments.
New Grounds of Rejection
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.
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.
6. Claims 1-3, 5-6, 8-10, 13, 15-16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al., (WO2017083520 published May 2017, priority to Nov. 2016); Molly et al., (WO2003043441A1 published May 2003; priority to Nov 2002) and further in view of CN109423460 (published Mar 2019; priority to Aug 2017; See Google Patents for the English version of the document or WO2017207371) and JP5463109 published June 2010, priority to Sept 2009).
See Google Patents for the English version of the document.
It is noted that the instant specification states:
The term “feed product” may refer to or be used interchangeably with
“mitigant composition.” A feed product or mitigant composition may be
defined as the composition of active components, which may also include
one or more carrier components. The disclosed feed products may be
formulated for inclusion with one or more base feeds, the resulting
combination of which may be referred to as a mitigant feed mixture in some examples [para 19].
The claims are drawn to a method of mitigating pathogenic infection in an animal, the method comprising: admixing a mitigant composition with a base feed to form a mitigant feed mixture, wherein the mitigant composition comprises a medium chain fatty acid composition and a direct-fed microbial composition and excludes a silica carrier, wherein the inclusion rate of mitigant composition in the base feed is about 5lbs/ton to about 20lbs/ton, wherein the direct-fed microbial composition comprises two or more strains of Bacillus selected from strains of Bacillus pumilus, Bacillus subtilis, and Bacillus amyloliquefaciens, wherein the medium chain fatty acid composition comprises a dry composition constituting about 20 wt% to about 60 wt% of the mitigant composition and comprising one or more of caprylic acid, capric acid, or lauric acid; wherein the direct-fed microbial composition constitutes about 0.1 wt% to about 5.0 wt% of the mitigant composition, wherein the carrier component constitutes less than about 42% of the mitigant composition; and providing the mitigant feed mixture to the animal in an amount effective to mitigate the pathogenic infection and a feed product composition and the animal comprises a piglet.
Murphy et al., teach compositions such as animal feed compositions or animal feed pre-mixes for administration to animals suitable for improving animal health, including, for example, to treat diseases or disorders or to enhance animal growth [abstract and para 1]. The compositions are suitable for use to improve animal health, including (i) enhancing growth in animals, (ii) reducing occurrence of a disease or disorder in animals, and/or (iii) treating a disease or disorder in animals by administering a therapeutic composition to the animal [para 3]. The animal is a mammal, such as a pig [para 33]. It is noted that the definition of a "pig" generally includes a "piglet". A piglet is defined as a young, baby, or recently born pig. While "piglet" is used to specifically identify a baby pig, the term "pig" acts as the broad, umbrella term for the entire species (porcine) regardless of age, size, or breed.
The bacteria are disease-associated bacteria, pathobionts or pathogens that may be modulated by the therapeutic compositions described herein, and may reside predominantly in one or more specific regions of the gastrointestinal tract [para 186]. It should be understood that any variations of the compositions described may be combined with any of the organic acids, the probiotics, other therapeutic agents, and the pharmaceutical acceptable vehicles, as if each and every combination was individually listed [para 130].
The therapeutic compositions further comprise at least one organic acid. The organic acid may include, for example caproic acid, caprylic acid, and/or lauric acid, benzoic acid [para 131]. The organic acids are fatty acids, including a medium-chain fatty acid (MCFA) [para 132]. Thus teaching claims 6 and 19. The therapeutic compositions described herein may further comprise probiotic organisms [para 137]. The compositions comprise Bacillus subtilis, Bacillus subtilis, and Bacillus amyloliquefaciens [para 140]. The compositions (including the therapeutic compositions) may further comprise any combination of the probiotics [para 144]. The compositions further comprise at least one aromatic compound such as a flavonoid, anthocyanins, dihydroflavonols, flavanols, flavanones, flavones, flavonols and isoflavonoids [para 135]. Thus teaching claims 3 and 18. The compositions further comprise suitable pharmaceutically acceptable vehicles, which may include, for example, stabilizers, surfactants, foaming agents, permeation enhancers, solubilizers, colorants, flavorants, or adjuvants, or any combinations thereof [para 125]. Thus teaching claim 20. The animal can be a pig or swine and includes nursery animals [para 33 and 494]. Thus teaching claim 4. The compositions, including the animal feed compositions and animal feed pre-mixes have a lower mortality rate than animals provided a diet that does not include such compositions, but which does include one or more antibiotics, one or more ionophores, soluble corn fiber, modified wheat starch, or yeast mannan, or any combinations thereof. Thus Murphy et al., teach alternatives and does not require glucans/mannans [para 244]; thereby teaching claim 21. The type of base feed combined with the therapeutic composition may also vary depending on the animal. The animal feed composition or animal feed pre-mix may contain base feed and any therapeutic composition described herein [para 154]. The base feed may include animal products, for example chicken meal, fish meal, bone meal, or blood, or any combinations thereof. In another variation, base feed may include hay, straw, silage, oils, grains, legumes, bone meal, blood meal, and meat, or any combinations thereof. The base feed for monogastrics, may include wheat, corn and/or soybean [para 154]. Thus teaching claims 9 and 17 including coatings. In some variations, the therapeutic compositions is administered to an animal as a dose of 0.1 mg/g to 20,000 mg/g body weight, or 1 to 500 mg per day [para 191]. Thus teaching claim 13. The animal feed pre-mix may comprise the compositions described herein (including the therapeutic compositions) at any suitable concentration. In some embodiments, the animal feed pre-mix comprises at least 1 wt%, at least 5 wt% [para 168]. In some variations, inclusion rate refers to the amount of therapeutic composition included in the total animal feed composition, on a dry weight basis. For example, adding 1 g of dry therapeutic composition to 999 g of dry base feed results in an animal feed composition with a therapeutic composition inclusion rate of 1 g/kg, or 0.1 %, or 1000 ppm [para 194]. It is noted the inclusion rate of mitigant composition in the base feed is about 5lbs/ton to about 20lbs/ton, equates to about 0.25% to about 1% where Murphy teach a range within the instantly claimed range. Additionally, Murphy the carrier component constitutes less than about 42% of the mitigant composition.
The delivery vehicle may be in various forms. In some variations, the delivery vehicle may be one or more coatings for the carbohydrates and sugars. In other variations, the delivery is in the form of a matrix in which the carbohydrates and sugars are dispersed; or a pill, which may include a tablet, a capsule, a microneedle pill, that incorporates the carbohydrates and sugars. The release profile of the composition may be adjusted by varying the thickness, size or density of the vehicle [para 124]. Thus teaching claims 17 and 22. Examples of diluents may include dry starch, ground corn meal, ground wheat meal, corn flour, wheat flow, ground rice hulls, [para 128]. Examples of binders may include starch e.g., corn starch and pregelatinized starch [para 128]. Examples of disintegrants may include starches, alginic acid, potassium or sodium starch glycolate, clays, celluloses, and gums [para 128]. Any other suitable compounds may be present in the base feed, including, for example, salts [para 157]. In another variation, the delivery vehicle is pectin, and/or guar gum [para 123]. Thus teaching the stabilizers, preservatives, emulsifiers and/or desiccants as recited by claim 17 including “coatings”. In another variation, the carrier material is ground rice hulls. In yet another variation, the carrier material is ground oat hulls [para 163]. Thus Murphy et al., teach alternatives and does not require silica [para 163]; thereby teaching claims 1 and 17.
For example, in some embodiments, therapeutic compositions described herein are administered over a shorter period of time to treat a disease or disorder in an animal, and administered over a longer period of time to enhance the growth of an animal over a shorter time period, a single time or multiple times, or during certain diet phases. [para 200]. Thus teaching claim 2. Therefore, Murphy et al., teach a method of mitigating pathogenic infection in an animal, the method comprising: admixing a mitigant composition with a base feed to form a mitigant feed mixture, wherein the mitigant composition comprises a medium chain fatty acid composition and a direct-fed microbial composition and excludes a silica carrier, where the inclusion rate of mitigant composition in the base feed is about 5lbs/ton to about 20lbs/ton, equates to about 0.25%, wherein the direct-fed microbial composition comprises two or more strains of Bacillus selected from strains of Bacillus pumilus, Bacillus subtilis, and Bacillus amyloliquefaciens, and comprising one or more of caprylic acid, capric acid, or lauric acid; and providing the mitigant feed mixture to the animal in an amount effective to mitigate the pathogenic infection and a feed product composition; but does not teach MCFAs comprises a dry composition constituting about 20 wt% to about 60 wt% of the mitigant composition.
Molly et al., teach a composition as an antimicrobial agent and to an animal feed comprising said composition and to a method for the improvement of growth and/or for reducing feed conversion and/or for improving feed value and/or for improving health and well-being of an animal by providing said animal with a feed comprising a composition [abstract]. As herein used, the term "meat-producing animals refer to livestock animals including but not limited to swine including pigs and hogs, and their progeny, such as sucking pigs, piglets [para 54]. In a preferred embodiment an animal feed according to the invention is fed to piglets during a period comprised between weaning and up to 20 kg [para 55]. In view of the economic interest of modern animal husbandry systems to increase productivity and maintain profitability, it has become a general practice to increase the growth rate by subjecting specific animals such as piglets to an early weaning pig [para 5].
It was well known that feed additives to improve the animal's well-being and hence its ability to efficiently convert feed into food products are increasingly being used and include feed acidifiers for improved feed preservation and/or improved protection of the digestive tract against proliferation of pathogenic bacteria. Also medium-chain fatty acids (MCFA) having 6 to 12 carbon atoms have been reported for use in feedstock; e.g. US Patent 5,462,967 discloses the use of MCFAs having 6 to 12 carbon atoms for anti-protozoiasis effect and suppression of an excess formation of systematic fat of, in particular, domestic fowl [para 9]. The composition comprising a MCFA component and at least one additional growth promoting component selected from the group comprising organic acids, inorganic acids, animal feed antibiotics, conventional growth promoters and plant extracts like oreganum and allicin [para 12]. Thus teaching claim 5. The methods for improving growth and/or reducing feed conversion and/or for improving feed value and/or for improving health and well-being of an animal by providing said animal with a feed [para 14]. As used herein, the term "MCFA component" refers to a fraction in the composition according to the present invention consisting essentially of MCFA, salts, or derivatives, or mixtures thereof. As used herein, the term "MCFA" refers to a medium chain fatty acid with said "medium chain fatty acid" meaning a saturated fatty acid, unsaturated fatty acid, or mixture thereof, having 6 to 14 carbon atoms. By "medium chain saturated fatty acid," as used herein, is meant C6 (caproic), C8 (caprylic), C10 (capric), C12 (lauric), or myristic (C14) saturated fatty acids, or mixtures thereof. Particularly suitable is the use of a C8/C10 mixture in equal amounts. The C7, C9, C11, and C13 saturated fatty acids are not commonly found, but they are not excluded from the possible medium chain fatty acids [para 19]. The composition comprises an amount from 50% to 99.9% by weight of MCFA component [para 48]. Thus teaching an overlapping range, just as instantly required.
Additional useful growth-promoting components include but are not limiting to prebiotics such as oligosaccharides including inulins, fructo-oligosaccharides, and galacto-oligosaccharides; and probiotics such as Bacillus subtilis [para 22]. The presence of a MCFA component in combination with a growth-promoting component has a synergistic effect on feed conversion improvement leading to much reduced FCRs (Feed Conversion Ratios). The compositions according to the present invention have antimicrobial, especially antifungal and/or antiviral and/or antibacterial activity [para 59]. The present invention would be suitable for the suppression of the development these pathogens in feed and in the gastrointestinal tract of animals [para 60]. By fast elimination of enteric pathogens from the gastrointestinal tract, in a second instance, better performances, which reflect in daily growth and feed conversion of the treated animals are obtained. The overall growth promoting effect of the feed additive composition of the present invention is readily and clearly visible at the elution level of the enriched enteric pathogen population from the gastrointestinal tract of the animal [para 61]. The administration of a composition according to the present invention to animals allows for a specific sequential action in the gastrointestinal tract, i.e. the enumeration of the enteric pathogens prior to a wash-out of the enumerated enteric pathogens. As a result of the synergistic action of the compositions of the present invention, efficient inhibition of microbial outgrowth by killing of the microbial cells is obtained [para 62].
Main ingredients of standard animal feed include but are not limited to wheat flour, starch, dextrin, cereal grains such as corn, milo, etc., oil seed meals, such as soybean meal, rapeseed meal, cottonseed meal, linseed meal, chaffs and brans, such as rice bran, de-oiled rice bran, wheat bran, fish meals, oils and fats, such as beef tallow, soybean oil, palm oil, coconut oil, and fish oil [para 52]. Thus teaching claim 9. The compositions will mostly be present in a form of a dry powder or mini-granules but may also be present in humidified, pasta-like emulsion-like. A powder additive may be prepared by dry blending of the ingredients, but it may also be prepared by wet-blending of the ingredients followed by drying, grinding and possible sifting [para 57]. Thus teaching the instantly claimed “coatings”. The composition provides an effective inhibition of digestive pathology in the animal's gastrointestinal tract. It is a further object of the present invention to provide a composition which improves the microbial balance of the intestinal microflora. It is a further object of the present invention to provide a composition which provides a low FCR without increasing the feed cost per unit weight [para 11].
It is noted the inclusion rate of mitigant composition in the base feed is about 5lbs/ton to about 20lbs/ton, equates to about 0.25% to about 1% where Molly et al., teach a range within the instantly claimed range. Molly et al., clearly teach the carrier component constitutes less than about 42% of the mitigant composition. Molly et al., teach an animal feed comprising the synergetic composition according to the invention from 0.001% to 20% by weight. As used herein, the term "standard animal feed" refers to feed for animals, i.e. feed that can be used in the animal husbandry field and is suitable to be fed to meat-producing animals to supply part or all of the meat-producing animal's nutrient requirements [para 52]. Molly et al’s animal feed comprises a synergetic composition from 0.5% to 2% by weight. Here, Molly et al’s standard animal feed equates to the instantly claimed base feed, and Molly teach a range of mitigant (synergistic composition) and base feed (standard animal feed) with a range of 0.5 to 2% which overlaps and encompasses applicants instantly claimed range of about 0.25% to about 1%. Molly et al., teach the direct-fed microbial composition constitutes about 0.1 wt% to about 5.0 wt% of the mitigant composition, and where the carrier component constitutes less than about 42% of the mitigant composition.
The an animal feed is provided for use as feed for meat-producing animals. As herein used, the term "meat-producing animals refer to livestock animals including but not limited to cattle such as ruminants, sheep, swine including pigs and hogs, horses, and poultry, and their progeny, such as sucking pigs, piglets, calves, lambs kids, foals and chickens etc [para 54]. Thus teaching claim 4. It is noted that Molly et al., do not teach the inclusion of a silica carrier, and the feed mixture excludes glucans and/or mannans.
Murphy et al., and Molly et al., have been discussed above as teaching a method of mitigating pathogenic infection in an animal, the method comprising: admixing a mitigant composition with a base feed to form a mitigant feed mixture, wherein the mitigant composition comprises a medium chain fatty acid composition and a direct-fed microbial composition, and excludes silica carrier, wherein the inclusion rate of the mitigant composition in the base feed is about 5 lbs/ton to about 20 lbs/ton wherein the direct-fed microbial composition comprises two or more strains of Bacillus selected from strains of Bacillus pumilus, Bacillus subtilis, and Bacillus amyloliquefaciens, wherein the medium chain fatty acid composition constitutes about 20 wt% to about 60 wt% of the mitigant composition and comprises one or more of caprylic acid, capric acid, or lauric acid; and providing the mitigant feed mixture to the animal in an amount effective to mitigate the pathogenic infection and a feed product composition wherein the carrier excludes silica and the feed mixture excludes glucans and/or mannans. However, neither Murphy et al., nor Molly et al., taught the pathogenic infection was porcine reproductive respiratory syndrome virus (PRRS virus).
CN109423460 teach a bacillus subtilis strain to pig and the relevant pathogen of poultry with high inhibition effect and probiotics [abstract].
The Bacillus bacterial strain effectively inhibits infectious bacteria, especially C.perfringens, Clostridium, Streptococcus gallinarum, Streptococcus suis, Campylobacter coli, jejunum Campylobacter and Enterococcus durans [Description]. Thus teaching claim 8. CN109423460 teach C. perfringens is the main reason for causing piggy necrotic enteritis. It has been found that the enteron aisle of A type and the pig with mild necrosis enterocolitis and the pig that do not wean and nursing of Villus atrophy Disease is related. Clostridium difficile is a kind of important new pathogen, mainly results in newborn diarrhea of pigs. Impacted piggy is likely to occur Expiratory dyspnea, abdominal distension and edema of scrotum. The production capacity of animal " improve " specifically refers to any following situations: increase the output of wean newborn animal.
The Bacillus strains preferably also generates lactate, and preferably can also degradative fungi toxin [Description]. Bacillus subtilis is considered through multifaceted, available nutriment and generate the antibacterial metabolin which selectivity and passes through germ competition, thus inhibiting pathogenic bacteria, to enhance the health, particularly intestinal health of animal. Bacillus subtilis can help to establish balance by the nutriment of offer predigestion. Compared to antibiotic, the huge advantage of probiotics is that it both will not indistinguishably kill bacterium, will not cause Pathogenic bacteria generate antibiotic resistance [description]. Other probiotics (DFM) for use in the present invention that can be applied in combination with bacterial strain and prepared product of the invention are preferable. For the bacterium selected from following strain: bacillus subtilis, bacillus pumilus (Bacillus pumilus) [description].
Bacillus subtilis strains and/or prepared product is in feed or food Probiotic composition (DFM) purposes. The feed conversion rate of animals will reduce mortality of animals, improve animal survival rate, improve animal weight gain, improve the production capacity of the animal, improve animal diseases resistance and/or improve animal immune response [Description]. The composition is used for treating and/or preventing poultry or the bacterial infections in pigs and weaning animals.
Examples of such carriers can add alone or in combination. These carriers can be selected from anti-caking agent, antioxidant, and/or protective agent; thus teaching claim 20. A preferred embodiment is a concentrate composition, particularly feed addition compositions, that is, is suitable to use. The composition is prepared to include at least one bacterial strains of the invention and at least one carrier above-mentioned, wherein it is 0.1 to 10 weight % that at least one bacterial strain, which is preferably measured, more preferably amount is 0.2 to 5 weight %, particularly amount is 0.3 to 3 weight %, preferred amount are 0.4 to 2.2 weight % [Description]. Teaching claims 10-11.
JP5463109 teach an anti-PRRS virus (pig breeding / respiratory syndrome virus) agent and a pork feed for suppressing a PRRS virus, comprising a medium chain fatty acid having 6 to 12 carbon atoms and / or a salt thereof as an active ingredient. The invention is used to improve the mortality, suppress the weight loss of the born piglets. Example 3 teach the effect of the confirmation test on PRRS in weaned piglets.
The anti-PRRS virus agent of the present invention contains, as an active ingredient, one or two or more medium chain fatty acid (MCFA). Examples of other medium chain fatty acids having 6 to 12 carbon atoms include straight chain saturated fatty acids having 6 to 12 carbon atoms such as lauric acid. Examples of the medium chain fatty acid having 8 carbon atoms, preferably linear saturated and unsaturated fatty acids having 8 carbon atoms. More preferably, it is a linear saturated fatty acid such as caprylic acid. Examples of the medium chain fatty acid having 10 carbon atoms include, preferably linear saturated and unsaturated fatty acids having 10 carbon atoms. More preferably, it is a linear saturated fatty acid such as capric acid. Thus teaching the MCFA of claims 1 and 17. The ratio of the chain fatty acid and / or its salt (c) can be arbitrarily selected, but for example, 0 to 20:50 to 70:20 to 50 (mass%) with respect to 100 mass% of the total of (a) to (c). Furthermore, this invention relates to the method of suppressing PRRS virus which uses a C6-C12 medium chain fatty acid and/or its salt as an active ingredient [abstract]. Thus teaching claim 7. Medium chain fatty acids having 6, 8, 10 carbon atoms, it has an excellent effect on the control of porcine disease viruses, especially PRRS viruses. The anti-PRRS virus agent is used to improve the mortality of the born piglets and for suppressing weight loss of a born piglet. It is expected that the feeding performance and productivity of pigs can be improved by promoting the growth while suppressing the PRRS virus. Thus teaching claim 15. The subject to be fed with the anti-PRRS virus agent of is preferably a pig which is an animal species infected with the PRRS virus. Pigs infected with PRRS virus cause reproductive and respiratory problems. In particular, respiratory disorders in PRRS are often seen in piglets to fattening pigs. Therefore, as a subject to which the composition and feed of the present invention are fed, for example, piglets to fattening pigs, and mother pigs. JP5463109 teach the amount of PRRS virus in the serum was measured by real-time PCR and at 30 days, see Example 1 and Table 15 for reduction in viral loads, weight loss, weight gain and mortality rate. Thus teaching claim 16.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply JP5463109’s teaching of caprylic, capric and lauric acids which are medium chain fatty acids strains for piglets to Murphy et al., and Molly et al., method of mitigating pathogenic infection in a piglet, in order to provide a feed which also promotes piglet’s growth and suppresses the PRRS virus. Additionally, it would have been prima facie obvious at the time of applicants’ invention to apply CN109423460 teaching of B. subtills strains and additional Bacillus strains for piglets to Murphy et al., and Molly et al., method of mitigating pathogenic infection in a piglet, the method comprising: admixing a mitigant composition with a base feed to form a mitigant feed mixture, further comprising Bacillus strains and medium chain fatty acids in order to provide a feed mixture that effectively inhibits infectious Streptococcus suis in a piglet. Especially when Molly et al., MCFAs where included with Murphy et al., method of mitigating pathogenic infection in a piglet, the method comprising: admixing a mitigant composition with a base feed to form a mitigant feed mixture, further comprising Bacillus strains and medium chain fatty acids including caprylic acid, capric acid, or lauric acid
in order to provide a feed mixture with a growth-promoting component has a synergistic effect on feed conversion improvement leading to much reduced FCRs for piglets.
One of ordinary skill in the art would have a reasonable expectation of success by incorporating Molly et al., amount of MCFAs when Murphy et al., already taught the inclusion of MCFAs, because Molly et al., teach MCFAs having 6 to 12 carbon atoms for anti-protozoiasis effect and suppression of an excess formation of systematic fat.
Furthermore, one of ordinary skill in the art would have a reasonable expectation of success by incorporating the same Bacillus strains Murphy et al., taught in order to inhibit multiple species of pathogenic bacteria, enhance piglet health, and will not cause pathogenic bacteria generate antibiotic resistance. Moreover, one of ordinary skill in the art would have a reasonable expectation of success by incorporating the same MCFA acids as recited by Murphy et al., and Molly et al., in order to improve mortality of piglets, and suppress weight loss of born piglets. Finally, Molly et al’s MCFAs allows for effective inhibition of digestive pathology in the piglet's gastrointestinal tract; improves the microbial balance of the intestinal microflora and provides a low FCR without increasing the feed cost per unit weight.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of mitigating pathogenic infection in a piglet, wherein there is no change in the respective function of the caprylic, capric and lauric medium chain fatty acids, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
7. Applicant’s arguments, filed June 23, 2026, with respect to the rejection of claims 1-3, 5-6, 8-10, 13, 15-16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al., Molly et al., and further in view of CN109423460 and JP5463109 is maintained despite the claim amendment drawn to the animal comprises a piglet; the rejection is maintained.
Applicants argue that Murphy, Molly and CN109423460 do not teach why a person skilled in the art endeavoring to develop a method of mitigating PRRS in piglets. Contrary to Applicants arguments, the prior art reference clearly teach the inclusion of piglets. Applicants attention is drawn to Murphy et al., teach compositions such as piglet/animal feed compositions or animal/piglet feed pre-mixes for administration to pigs and piglets suitable for improving the animal’s health, to treat diseases or disorders or to enhance the animal’s growth. The animal is a mammal, such as a pig [para 33]. It is noted that the definition of a "pig" generally includes a "piglet". A piglet is defined as a young, baby, or recently born pig. The term "pig" acts as the broad, umbrella term for the entire species (porcine) regardless of age, size, or breed.
Molly et al., teach a composition as an antimicrobial agent and to an animal feed comprising said composition and to a method for the improvement of growth. As herein used, the term "meat-producing animals refer to livestock animals including but not limited to swine including pigs and hogs, and their progeny, such as sucking pigs, piglets [para 54]. In a preferred embodiment an animal feed according to the invention is fed to piglets during a period comprised between weaning and up to 20 kg [para 55]. In view of the economic interest of modern animal husbandry systems to increase productivity and maintain profitability, it has become a general practice to increase the growth rate by subjecting specific animals such as piglets to an early weaning pig [para 5].
CN109423460 teach a bacillus subtilis strain to pig and the relevant pathogen of poultry with high inhibition effect and probiotics [abstract]. The Bacillus bacterial strain effectively inhibits infectious bacteria, especially C.perfringens, Clostridium, Streptococcus gallinarum, Streptococcus suis, Campylobacter coli, jejunum Campylobacter and Enterococcus durans [Description]. Thus teaching claim 8. CN109423460 teach C. perfringens is the main reason for causing piggy necrotic enteritis. It has been found that the enteron aisle of A type and the pig with mild necrosis enterocolitis and the pig that do not wean and nursing of Villus atrophy Disease is related. Clostridium difficile is a kind of important new pathogen, mainly results in newborn diarrhea of pigs. Impacted piggy is likely to occur Expiratory dyspnea, abdominal distension and edema of scrotum. The production capacity of animal "improve" specifically refers to any following situations: increase the output of wean newborn animal.
JP5463109 teach an anti-PRRS virus (pig breeding / respiratory syndrome virus) agent and a pork feed for suppressing a PRRS virus, comprising a medium chain fatty acid having 6 to 12 carbon atoms and / or a salt thereof as an active ingredient. The invention is used to improve the mortality, suppress the weight loss of the born piglets. Example 3 teach the effect of the confirmation test on PRRS in weaned piglets.
Therefore, the prior art references JP5463109, CN109423460 and Molly specifically recite a piglet, contrary to Applicants arguments regarding the teachings of the references. Murphy et al., clearly teach a pig which is an umbrella term inclusive of piglets. Applicants have provided no evidence that the term pig is not an inclusive or umbrella term. Moreover, JP5463109, CN109423460 and Molly specifically teach the inclusion of piglets, newborn pigs, suckling pigs, and/or weaning pigs. Thus, the argument is not persuasive, because the prior art references clearly teach the inclusion of piglets.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been prima facie obvious at the time of applicants’ invention to apply JP5463109’s teaching of caprylic, capric and lauric acids which are medium chain fatty acids strains for piglets to Murphy et al., and Molly et al., method of mitigating pathogenic infection in a piglet, in order to provide a feed which also promotes animal growth and suppresses the PRRS virus. Therefore, Applicants’ argument are not found persuasive since the prior art references specifically teach piglets.
Pertinent Art
8. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Pig: Broadly refers to the species, though in the US, it often specifically refers to younger, immature swine (especially those under market weight).
See also US 2021/0378261; US 2009/0280090; US 2019/0021341; US 2018/0243228; US 2016/0317653.
Conclusion
9. No claims allowed.
10. THIS ACTION IS MADE FINAL. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JANA A HINES/Primary Examiner, Art Unit 1645
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