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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Nov. 25, 2025 has been entered.
Claim Amendment
3. The amendment filed Nov. 25, 2025 has been entered. Claims 1 and 17 have amended. Claims 7, 11-12 and 14 are canceled. Claims 1-6, 8-10, 13 and 15-22 are under consideration in this Office Action.
Withdrawal of Rejections
4. The rejection of claims 1-6, 8-10, 13 and 17-21 under 35 U.S.C. 103 as being unpatentable over Murphy et al., and Molly et al., in view of CN109423460 is withdrawn in view of Applicants amendments.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Claims 17-20 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 17-20 and 22 are determined to be directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. The rationale for this determination is explained below:
Claims 17-20 and 22 are drawn to a feed product formulated for swine, the feed product comprising: a complete base feed manufactured in meal, crumble, or pellet form and comprising one or more of: ground corn, sugar, dehulled soymeal, soy isolate, hydrolyzed soy protein, dried distillers grains with solubles, poultry byproduct meal, vitamins, or minerals; and a mitigant composition comprising:
a direct-fed microbial composition formulated for admixing with the complete base feed and comprising two or more strains of Bacillus selected from strains of Bacillus pumilus, Bacillus subtilis, and/or Bacillus amyloliquefaciens;
a medium chain fatty acid composition comprising a dry composition formulated for admixing with the complete base feed and comprising one or more of caprylic acid, capric acid, or lauric acid, wherein the medium chain fatty acid composition constitutes about 20 wt% to about 60 wt% of the feed product
one or more anti-caking agents, desiccants, emulsifiers, preservatives, stabilizers, or combinations thereof; and
a carrier component provided as a coating around one or both of the direct-fed microbial composition or medium chain fatty acid composition, the carrier component constituting less than about 42 wt% of the mitigant composition,
wherein the carrier component in the feed product excludes silica, wherein the mitigant composition is included in the complete base feed at an inclusion rate of about 5 lbs./ton to about 20 lbs./ton.
The Bacillus pumilus, Bacillus subtilis, and/or Bacillus amyloliquefaciens that are not “markedly different” in structure than naturally occurring Bacillus pumilus, Bacillus subtilis, and/or Bacillus amyloliquefaciens. Bacillus pumilus is a naturally occurring bacterium that is especially common in soil and on dead plant tissue. Bacillus subtilis is found in soil and the gastrointestinal tract of ruminants, humans and marine sponges. Bacillus amyloliquefaciens, a ubiquitous Gram-positive, aerobic bacterium, is commonly found in soil environments. Caprylic acid (octanoic acid) is a medium-chain fatty acid that is naturally found in palm oil, coconut oil, and the milk of humans and some animals. Capric acid is a short-chain, saturated acid occurring naturally in palm and coconut oils, as well as certain types of milk. Lauric acid is a fatty acid, esters of which occur in natural substances such as coconut milk and palm kernel oil. Ground corn, soymeal, soy, sugar grains, vitamins and minerals and the like are all naturally occurring.
Naturally occurring food stabilizers are substances that come from plants, animals, or fungi and are used to improve the texture, stability, and shelf life of food products. Examples include pectin, agar-agar, carrageenan, guar gum, and xanthan gum. Stabilizers can help thicken, emulsify, and gel food, preventing separation and maintaining desired textures. Naturally occurring food emulsifiers are substances that allow oil and water to mix and stay mixed in a stable emulsion, and they are found in various foods and derived from natural sources. Common examples include lecithin, pectin, gum arabic, guar gum, and xanthan gum. Naturally occurring food preservatives are substances that come from organic sources and can be used to extend the shelf life of food by inhibiting the growth of microorganisms and preventing spoilage. Examples include salt, sugar, vinegar, citric acid, and various herbs and spices. Naturally occurring desiccants used in food are rice, salt, and clay. Rice and salt are readily available pantry staples, while clay desiccants are food-grade and often used in food packaging. Naturally occurring anti-caking agents, like rice flour, and corn starch, help prevent food products from clumping by absorbing moisture and preventing them from sticking together. These natural alternatives are often used in powdered foods, seasonings, and spices to maintain their flowability and prevent clumping. Thus, all of the ingredients are therefore not markedly different from their counterparts found in nature. Additionally, the fact that the components have been manufactured has not changed their natural makeup.
These claims fail to satisfy the non-naturally occurring requirement. Furthermore, there is no structural difference because of the mere aggregation of natural occurring strains of Bacillus. Medium chain fatty acids and the other components together as a composition; the composition does not change the structure of the naturally occurring ingredients.
Moreover, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional components do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. The additional elements in dependent claims such as preservatives, emulsifiers, desiccants, anti-caking and/or stabilizers are all recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections.
If the applicant chooses to amend the instant claims, the examiner recommends that applicant consider the U.S. Supreme Court ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. Such putative additional steps, when viewed as a whole, might add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June 13, 2013). Also see the December 4, 2014 and May 4, 2016 Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance).
Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101.
Response to Arguments
6. Applicant's arguments filed Nov. 25, 2025 have been fully considered but they are not persuasive.
Applicants argue that hydrolyzed soy protein is not a naturally occurring product, however Applicants is reminded that hydrolyzed soy protein is not required by the instant claims. The claims recite”…two or more of: ground corn, sugar, dehulled soymeal, soy isolate, hydrolyzed soy protein, dried distillers grains with solubles, poultry byproduct meal, vitamins, or minerals…;”.
Vitamins and Minerals are clearly natural products as required by the instant claims. The claim requires two or more of ground corn, sugar, dehulled soymeal, soy isolate, hydrolyzed soy protein, dried distillers grains with solubles, poultry byproduct meal, vitamins, or minerals. Therefore, vitamins, minerals, and sugar meet the at least two requirement and are naturally occurring ingredients.
Naturally occurring ground corn refers to whole-grain cornmeal produced by grinding dried, non-GMO, or organic heirloom corn kernels without synthetic additives or preservatives. It is often stone-milled to retain the nutrient-dense germ, bran, and endosperm, providing a rustic texture and rich flavor for cornmeal, polenta, and baking. As to Applicants arguments, that ground corn does not occur naturally; Applicants argument is not persuasive. Accordingly, this claim is focused on the corn per se (a nature-based product), and must be analyzed for markedly different characteristics, to determine whether the claimed ground corn is a “product of nature” exception. There is no indication in the specification that the claimed corn has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring corn provided by heirloom corn kernels. Thus, the claimed ground corn does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
Naturally occurring sugars are carbohydrates inherently present in whole foods, such as fruits (fructose, glucose), vegetables, and dairy products (lactose), rather than added during processing.
Naturally occurring dehulled soymeal is a high-protein (typically 47–49%) livestock feed ingredient produced by removing hulls from soybeans before oil extraction. This process reduces fiber (<3%) and increases nutrient density, offering excellent amino acid digestibility (e.g., >90% lysine) and high metabolic energy for poultry, swine, and aquaculture. There is no indication in the specification that the claimed soymeal has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring corn provided by soybeans. Thus, the claimed soymeal does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
Naturally occurring soy isolate is a high-purity (90%+) plant-based protein derived from soybeans by removing fat and fiber, often via water extraction. It is a complete protein containing all nine essential amino acids. There is no indication in the specification that the claimed soy isolate has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring soy. Thus, Applicants have not pointed to any markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
Dried Distillers Grains with Solubles (DDGS) is a nutrient-rich co-product of ethanol production, consisting of leftover grain, yeast, and nutrients after fermentation. Applicants are reminded that fermentation is a naturally occurring process; Dried Distillers Grains with Solubles is not a required component of the instant claims and Applicants have not pointed to any markedly different characteristics from what occurs in nature.
Naturally occurring poultry byproduct meal (PBPM) is a high-protein, rendered ingredient made from clean, slaughtered poultry parts, including necks, feet, undeveloped eggs, gizzards, and intestines.
Therefore the claims do not require any non-naturally occurring components.
Applicants argue that a complete base feed manufactured in meal, crumble, or pellet form is not naturally occurring. However Applicant is reminded that there is no indication in the specification or in Applicants current argument that the claimed mixture of bacteria and naturally occurring additional components has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring nature based products and bacteria. The manufacturing in meal, crumble or pellets does not change the structure of those components. Manufacturing of naturally occurring products is very common. Furthermore, there is no indication in the specification that the claimed meal, crumble or pellet form has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring components. There, the claimed ground corn does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
Applicants amendment with respect to the carrier constituting less than about 42 wt% of the mitigant composition does not overcome the rejection. Because the carrier can be 0% to 42%, but must also have a mitigant composition of about 5 lbs/ton to about 20 lbs/ton. There is no enlargement of the range of carrier’s utilities. Each bacterial species has the same effect it always had. Their use in combination does not improve in any way their natural functioning. The carrier serve the ends nature originally provided and acts quite independently of any effort of Applicants.
Applicants are reminded that the mixture still does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101. See the ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948) and Example 6 entitled Bacterial Mixtures within the Subject Matter Eligibility guideline issued between December 16, 2014 through December 15, 2016). Additionally, nor the anti-caking agents, desiccants, emulsifiers, preservatives, and/or stabilizers, each encompass naturally occurring examples which are all recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections.
Applicants argue that a carrier component provided as a coating around one or both of the direct-fed microbial composition or medium chain fatty acid composition,
Is not naturally occurring. However there is no requirement or structure to define the carrier coating as not naturally occurring. Bacillus pumilus, Bacillus subtilis and Bacillus amyloliquefaciens are all naturally occurring bacterium that is especially common in soil environments. Bacillus is manufactured using industrial fermentation in bioreactors, where the bacteria are grown in a liquid growth medium containing naturally found components.
Therefore this argument is not persuasive because none of the components acquire a different use or wherein the combination exhibited characteristics different from the naturally occurring counterpart. The combination of constituents produces no new bacteria, no new bacterial properties no change in the ground corn, sugar, soy, emulsifier, desiccant, preservative and other recited products, the Bacillus species, caprylic acid, capric acid, or lauric acid. There is no enlargement of the range of any of their utilities. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. Applicants did not point out any new abilities or characteristics produced resulting from the components mixture.
Thus, each separate component naturally provides improved health benefits to animals. Therefore Applicants have not pointed to any markedly different characteristics found by the combinations of constituents. Accordingly, Applicants argument is not persuasive and the rejection is maintained.
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.
7. Claims 1-6, 8-10, 13, 15-16 and 17-22 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.
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 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]. 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.
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 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 to Murphy et al., and Molly et al., method of mitigating pathogenic infection in an animal, in order to provide a feed which also promotes animal 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 to Murphy et al., and Molly et al., 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, further comprising Bacillus strains and medium chain fatty acids in order to provide a feed mixture that effectively inhibits infectious Streptococcus suis. Especially when Molly et al., MCFAs where included with Murphy et al., 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, 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.
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 swine 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 animal'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 an animal, 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
8. Applicant’s arguments, filed Nov. 25, 2025, with respect to the rejection of claims 1-6, 8-10, 13 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable
over Murphy et al., and Molly et al., in view of JP5463109. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made.
Applicants amended claims 1 and 17 and argued that Murphy and Molly et al., do not method of mitigating PRRS infection in an animal. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, 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 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. Murphy teach 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].
As previously discussed, Murphy et al., and Molly et al., teach a range within the instantly claimed range. Murphy et al., teach an animal feed comprising the synergetic composition according to the invention from 0.001% to 20% by weight. Molly et al., teach the 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% (about 5 lbs./ton) to about 1% (to about 20 lbs./ton). Therefore, both Murphy et al., and Molly et al., teach the instantly recited limitation.
Murphy and Molly et al., teach the animal feed composition or animal feed pre-mix may contain base feed. 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. Murphy et al., teach the therapeutic compositions described herein may be a solid, such as pellets. Molly et al., teach the compositions will mostly be present in a form of a dry powder or mini-granules.
The compositions of Murphy et al., and Molly et al., are taught for admixing with the complete base feed. Molly et al., teach an animal feed comprising the MCFA synergetic composition according to the invention from 0.001% to 20% by weight and comprising standard animal feed from 80% to 99.999% by weight.
Murphy et al., teach 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. Molly et al., teach the instantly claimed “coatings”. Therefore Murphy et al., and Molly et al., teach the newly claimed carrier, coatings and release profile just as instantly claimed.
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 to Murphy et al., and Molly et al., method of mitigating pathogenic infection in an animal, in order to provide a feed which also promotes animal growth and suppresses the PRRS virus.
Applicants amended claim 1 to recite the carrier component constituting less than about 42 wt% of the mitigant composition and argued that Murphy et al., Molly et al., and CN109423460 do not teach an adequate mitigant composition.
Applicants point to the claim language drawn to a method of mitigating pathogenic infection in an animal the method comprising providing the mitigant feed mixture to the animal in an amount effective to mitigate the pathogenic infection, wherein the pathogenic infection comprises a porcine reproductive syndrome virus infection.
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]. CN109423460 teach a bacillus subtilis strain to pig and the relevant pathogen of poultry with high inhibition effect and probiotics [abstract]. 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 anti-PRRS virus agent of the present invention contains, as an active ingredient, one or two or more medium chain fatty acid (MCFA). Molly et al., also teach medium-chain fatty acids (MCFA) having 6 to 12 carbon atoms have been reported for use in feedstock. Therefore, the prior art teach the mitigation of PRRS pathogenic infection in animals and feedstock.
Murphy et al., and Molly et al., teach a range within the instantly claimed range. Murphy et al., teach an animal feed comprising the synergetic composition according to the invention from 0.001% to 20% by weight. Molly et al., teach the 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% (about 5 lbs./ton) to about 1% (to about 20 lbs./ton). The prior art clearly teach carrier component constituting less than about 42 wt% of the mitigant composition. CN109423460 teach a bacillus subtilis strain to pig and the relevant pathogen with high inhibition effect and probiotics.
Murphy et al., teach the animal feed pre-mix may comprise the compositions described herein (including the therapeutic compositions) at any suitable concentration. The compositions of Murphy et al., and Molly et al., are taught for admixing with the complete base feed. Molly et al., teach an animal feed comprising the MCFA synergetic composition according to the invention from 0.001% to 20% by weight. 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. Additionally, claims 1 and 17 are drawn to a feed product formulated for swine, the feed product comprising: a complete base feed manufactured in meal, crumble, or pellet form. Murphy and Molly et al., teach the animal feed composition or animal feed pre-mix may contain base feed.
Pertinent Art
9. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. US 2021/0378261; US 2009/0280090; US 2019/0021341; US 2018/0243228; US 2016/0317653.
Conclusion
10. No claims allowed.
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 Dan Kolker, can be reached on 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/ Primary Examiner, Art Unit 1645