DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/14/2025 has been entered.
Claims 1, 8, 11 and 13 are pending and have been considered on the merits herein. All arguments and amendments have been considered.
*It should be noted that claim 13 comprises a non-compliant amendment because the claim includes limitations not previously presented and entered, which are not currently presented with markings to indicate the changes made. Specifically, the newly added limitation of “adding and mixing the animal feed with the L28 and Lactobacillus salivarius…is all newly added texts; however, only a portion of the added text is underlined to indicate added matter. In an effort to practice compact prosecution, applicants have been notified herein of the issue.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 8, 11, 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the claims have been amended to (Claim 1) A method for inhibiting the growth of food-borne pathogenic microorganisms comprising obtaining an animal feed, biosanitizing a stainless-steel vessel with L. salivarius L28 (in an amount and for a time) sufficient to inhibit L. monocytogenes in the stainless-steel vessel used to make animal feed, adding L. salivarius L14, and mixing the animal feed in the stainless-steel vessel with the L28 eliminates L. monocytogenes and L14 eliminates Salmonella in the animal feed. Claim 8 is drawn to eliminating food-borne pathogenic microorganisms in a rendered meat product comprising obtaining a rendered meat product, biosanitizing a stainless-steel vessel with L. salivarius L28, wherein the L28 is antimicrobial and eliminate L. monocytogenes in the stainless-steel vessel used to make an animal feed, adding L. salivarius L14, and mixing the rendered meat product in the stainless-steel vessel (treated with L14 and L28) to eliminate Salmonella in the animal feed. Claim 11 is drawn to increasing the storage time of a food for pets or animals by reducing spoilage microorganisms comprising obtaining an animal feed, biosanitizing a stainless-steel vessel with L. salivarius L14 and L28, and adding and mixing the animal feed in the stainless-steel vessel eliminates L. monocytogenes with the L28 and L14 to eliminate Salmonella in the animal feed, and Claim 13 is drawn to eliminating L. monocytogenes in and Salmonella animal feed (taken to mean eliminating L. monocytogenes and Salmonella in animal feed) by biosanitizing L. monocytogenes in a stainless-steel vessel by contacting the stainless steel vessel with L. salivarius L28, and adding and mixing the animal feed with the L28 in the stainless-steel vessel from which L. monocytogenes was eliminated and adding and mixing the animal feed with L28, L14 and FS56 to eliminate Salmonella in the animal feed. Claims 1, 8, 11, and 13 introduce new matter, not described in the specification as originally filed. When looking to applicants’ specification (p. 11, lines 24-p. 12, lines 1-14 (0051-0053)), the teachings of inhibiting, reducing and eliminating L. monocytogenes on a stainless-steel surface/vessel are;
(0051)The present invention also provides Lactic Acid Bacteria (L28, FS56) as bio-sanitizers to inhibit Listeria monocytogenes on stainless steel surfaces. Listeria monocytogenes is known to have the ability to attach and form biofilms on many surfaces including stainless steel. Biofilm is not easily removed with common chemical sanitizing methods used in the industry. Therefore, finding innovative ways to inhibit Listeria monocytogenes growth and biofilm formation is necessary. The present invention provides Lactic Acid Bacteria (L28) and commercially available (FS56) Lactic Acid Bacteria in inhibition of Listeria monocytogenes (N1-002) on stainless steel coupons.
(0052) Sterile stainless steel coupons (2cm×2cm) were placed into 6-well plates with 2m1 of Listeria monocytogenes (log.sub.10 5.00 cfu/ml) and incubated 24 hrs for attachment. After the 24 hrs the Listeria monocytogenes was removed and each treatment and control were added. The treatments were with strains L28, FS56 at a concentration of log.sub.10 8.00 cfu/ml and the control was with a blank of de Man, Rogosa and Sharpe (MRS) Broth. The Listeria monocytogenes counts were evaluated on modified oxford agar.
(0053) Statistical differences (P<0.05) among all of the treatments and the control for counts of Listeria monocytogenes were observed. By the end of the 24 hrs the MRS control had increased to log 5.76 cfu/cm.sup.2 of Listeria monocytogenes. For the treatments, FS56 and L28 had log reduction of 3.1 cfu/cm.sup.2 and 5.76 cfu/cm.sup.2 respectively. The L28 Lactic Acid Bacteria was so effective that the Listeria monocytogenes was not detectable by means of direct agar plating method indicating it is more effective than the FS56 which is currently commercially available.
And the teachings directed to eliminating Salmonella in a food product are
[0041] The present invention shows a reduction of Salmonella on dry kibble pet food using lactic acid bacteria L28. A collection of Lactic Acid Bacteria isolated from various food sources have shown great inhibitory activity against Salmonella when grown in co-culture conditions in laboratory media. Isolate, denoted here as L28, has led to the greatest reductions of Salmonella in vitro. L28 isolates have been shown to reduce the Listeria monocytogenes on stainless steel to undetectable levels after 24 hrs. In addition, L28 isolates have been shown to significantly reduce Salmonella in raw chicken fat after 24 hrs and brought to undetectable levels after day 3. L28 isolates have been shown to reduce significantly Salmonella on dry pet food kibble after 4 hrs and undetectable levels after 3 days.
[0046] Application on kibble. For both control group and treatment group ½ (212 grams) pound of dog food was weighed out. The 60 ml of respective chicken fat slurry was added to control and treatment. The initial concentration of Salmonella on the dry kibble at zero hour was approximately log.sub.10 6.00 cfu/g. The dry kibble was given 4 hours to dry under the hood and absorb the chicken fat slurry and facilitate attachment of salmonella to the dry kibble.
[0049] FIG. 6 is an image of the inhibition of Salmonella by lactic acid bacteria (L14, L28). The present invention provides novel isolated lactic acid bacteria (LAB)(L14, L28) that reduce the amount of Salmonella (typhimurium, enteritdis and newport) in raw chicken fat stored at room temperature. Chicken fat was provided by commercial dog food company. For both control and treatment groups, approximately 40 ml of chicken fat was inoculated with a 3-strain salmonella for a final concentration of log 3.00 cfu/ml. Each treatment group got respective treatment of (L14 or L28) for a final concentration of log 6.00 cfu/ml. The 40 ml chicken fat was aliquot by 10 ml for each time point, and enumerated on day 0, 1 and 3 on Xylose Lysine deoxycholate (XLD) agar. After day 1 there were statistical significant differences between the control and the treatments for counts of Salmonella. By day 1 and 3 the salmonella in the control chicken fat had grown to approximately log 5.49 cfu/ml and log 7.13 cfu/ml, respectively. For the L14 treatment on day 3, there was a 4.06 log reduction of Salmonella. Moreover, on day 3 for L28 treatment there was a 7.13 log reduction and not detectable by means of direct agar plating method.
The specification does not teach
1). obtaining an animal feed or rendered meat product and adding and mixing it in a stainless-steel vessel (used to make an animal feed) and treating with L14 and L28 (or L14, L28 and FS56),
2). the use of L14 (according to claims 1, 8, 11, 13) or FS56 (according to claim 13) to eliminate Salmonella (only strain L28 effectively eliminates Salmonella, while L14 reduces amounts of Salmonella, and strain FS56 is only taught to be used to biosanitize stainless steel surfaces against L. monocytogenes)
3). the elimination and reduction of the food-borne pathogen/spoilage microorganism Listeria monocytogenes and Salmonella in a rendered food product or animal feed by treating a stainless-steel vessel with L14 and L28, and adding and mixing the rendered food product or animal feed in the stainless-steel vessel, and
4). Biosanitizing a stainless-steel surface with L14
The specification only teaches inhibiting the growth of food-borne microorganisms in a rendered meat product added to pet food, wherein only Salmonella is disclosed to be eliminated or reduced (0017, 0018, Fig. 5, 0041, 0042, 0045-0049) by treating with L28 and L14 (respectively). L28 is effective in reducing Salmonella in raw chicken fat (a rendered meat product) after 24 hours and brought to undetectable levels after day 3 (0041, 0042); however, L14 is taught to show a 4.06 log reduction of Salmonella (0049). The specification only demonstrates reducing Salmonella on dog kibble when chicken fat was inoculated with a Salmonella cocktail and added to dog kibble (0041, 0042, 0045-0049).
Regarding Listeria, the specification teaches that the claimed Lactobacillus strain L28 is capable of reducing Listeria monocytogenes on stainless steel to undetectable levels after 24 hours (0051-0053) and FS56 reduces L. monocytogenes on stainless steel surfaces.
There are no teachings directed to adding and mixing a rendered meat product or animal feed with L. salivarius L14, L28 (and FS56) in a stainless-steel vessel or adding the rendered product or animal feed to the vessel. Therefore, the claim amendments change the scope of the claims and applicants’ invention for which no support is provided. This is a new matter rejection.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 8, 11, 13 (and dependent claims 2, 3, 6, 9, 10) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are drawn to eliminating and reducing food-borne pathogenic/spoilage microorganisms in a rendered meat product or animal feed by biosantizing a stainless-steel vessel with Lactobacillus salivarius L28 to inhibit growth of and eliminate L. monocytogenes on the vessel to undetectable levels after 24 hours; and claims 1 and 8 have been amended to add a step of adding Lactobacillus salivarius L14, however, the amended claims do not clearly point out to what the L14 strain is added to, i.e. to the vessel, or to the feed/product. Further claim 1 then states “mixing the animal feed in the stainless-steel vessel with L28 eliminates L. monocytogenes and L14…eliminates Salmonella in the animal feed. It is unclear if the mixing of the animal feed with L28 is intended to eliminate L. monocytogenes in the animal feed or the vessel. The claim already states that L28 inhibits growth of L. monocytogenes in the vessel and is undetectable after 24 hours on the vessel. Thus, it cannot be determined if applicants intend the L28 to eliminate L. monocytogenes in the animal feed or the vessel. If the latter is true, the limitation is redundant.
Further, claims 1, 8, 11 and 13 are not clear if L28 is present in the vessel at the time of mixing and it is not clear how biosantizing a vessel with L28 (and L14) eliminates the microorganisms in a product/feed. Current claims do not include a step of adding the L14 and L28 microorganism to the rendered meat product or animal feed having said pathogenic/spoilage microorganisms within, but rather treating a surface which has L. monocytogenes thereon, and thus it is not clear how the microorganisms are reduced and eliminated in the feed/food products.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 8, 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al. (US2014/0341872 A1) in view of Ware at al. (US8980611) and Smittle et al. (WO2015/120100 A1).
Ware teaches a method of improving food safety by inhibiting and preventing pathogenic contamination of, specifically Listeria monocytogenes and Salmonella, in food products and in food processing facilities and equipment (abstract, 0003). Ware teaches that food sources prone to contamination include meat, meat products (0005, 0038) and the common pathogenic bacteria L. monocytogenes and Salmonella are responsible for numerous food-borne outbreaks and are known meat product contaminant and food processing equipment contaminants (0006, 0007, 0056). Lactic acid bacteria have been used to inhibit L. monocytogenes in meat products; however, L. monocytogenes remains a problem in the food industry because of its ability to survive on food product surfaces as well as food processing equipment, by adhering and forming biofilms on solid materials (0006, 0007, 0011, 0040, 0056). Ware teaches a method of improving food safety comprising contacting food and/or food processing equipment with a composition comprising one or more lactic acid microorganisms to reduce the number of pathogenic bacteria in the food or food processing equipment (0008, 0043) and the equipment is taught to include a stainless-steel surface (0028-0032, 0068, Ex. 3 0069-0078). The lactic acid microorganism is used in an amount effective to prevent, inhibit, or disrupt the biofilm formation by L. monocytogenes on the surface (0009, 0015-0018, 0024, 0025). Ware teaches that the composition comprises an effective amount of the microorganism to reduce to the total number of pathogens to 0 CFU/sq ft. after the composition is in contact with the surface for 24 hours (0021, 0060, 0061) and after a contacting step, the pathogen content is less than before contact, preferably 100% less, thereby eliminating L. monocytogenes (0058, 0061). The lactic acid microorganism for use in the method includes Lactobacillus salivarius (0049).
Ware additionally teaches inhibiting the growth of food-borne pathogens, increasing the storage time by reducing spoilage microorganisms and reducing pathogenic load in food products comprising inoculating a food product with lactic acid producing microorganisms including a Lactobacillus strain and L. salivarius (0049) to control the growth of pathogen microorganisms in the food product including Listeria and Salmonella (0008, 0011, 0015-0018, 0038, 0040, 0043). Regarding the limitation of inhibiting/eliminating/reducing the food-borne/spoilage microorganisms, Ware teaches that the lactic acid composition is applied in an amount to reduce the total number of pathogens to 0 CFU after the composition was in contact with the surface or food material for 24 hours (0021, 0024).
Additionally, Ware at al. (US8980611) teaches method of inhibiting the growth of food-borne pathogens (col. 3, lines 40-45) including Salmonella typhimurium (col. 6, lines 35-40) in food, meat and/or meat products and animal feed (abstract, col. 2, lines 25-62, col, 3, lines 25-39, 45-54, 61-col. 4, lines 1-55, col. 6, lines 51-56, for example) comprising contacting the pathogenic microorganisms and food products comprising the pathogenic microorganisms with an amount of Lactobacillus salivarius (col. 5, line 60) sufficient to reduce pathogen of lactic acid bacteria (abstract, col. 1-2, col. 3, lines 1-10, col. 3, lines 40-55, col. 6, lines 41-56). Lactic acid bacteria are used for inhibiting pathogens in meat and meat products and can be administered to the animals from which the products are produced and/or added to the meat or meat products (col. 2, lines 52-67-col. 3, lines 40-55, col. 4, lines 21-36, 56-67, col. 6, lines 25-34, Ex. 2-11). Ware teach reducing pathogen content or concentration by about 100% (col. 2, lines 56-68).
While Ware does not teach that the food product is a rendered meat product specifically, they do teach known food-borne pathogenic bacteria to be L. monocytogenes and Salmonella which contaminate meat, meat products and food processing equipment; and which can be effectively treated with lactic acid bacteria including L. salivarius to inhibit and reduce the contamination in food and on food processing equipment. Thus, regardless of what the product is, the lactic acid bacteria including Lactobacillus salivarius would be expected by a posita to perform as taught, i.e., to effectively inhibit and reduce growth of the pathogens on a food, food product and food processing equipment.
Regarding applicant’s limitations of obtaining an animal feed or rendered meat product, WO’100 teaches methods for reducing and inhibiting the growth of food-borne pathogenic microorganisms, and increasing storage time of a food by reducing spoilage microorganisms comprising obtaining a meat and/or food product and contacting said product with a composition comprising a food-safety/preserving bacteria including Lactobacillus salivarius (0003, 0005, 0008, 0010-0013, 0020, 0049, 0051, 0052, 0053, 0054, 0079, 0080). WO’100 teaches the food product to be a pet food, typically contaminated with pathogens including Listeria and Salmonella (0003). The pet foods include kibble, soft foods, wet foods, treats, meat pieces or chunks, livestock feed (0015, 0078) and wherein a meat product containing the microbe is applied to kibble (0030-0035). WO’100 teaches that meat used in pet foods are often byproducts of the rendering process, typically producing food contaminated with Salmonella (0003). WO’100 teaches the pathogenic/spoilage microorganisms include Salmonella and Listeria monocytogenes (0087) and the reference teaches incubating the food product with the food-safety/preserving bacteria for about 72 hours to promote elimination of pathogens and/or spoilage microorganisms including Salmonella (0072, 0086, Ex. 2, 4).
WO’100 teaches that the composition is also used to sanitize inedible surfaces (0002) including equipment used to process/produce human and pet foods which typically require deactivation of pathogenic and food-spoilage microorganisms (0003, 0005).
Thus, regardless of what the meat/feed product is or surface treated, the lactic acid bacteria Lactobacillus salivarius would be expected by a POSITA to perform as taught, i.e. to effectively inhibit, reduce and eliminate Listeria monocytogenes and Salmonella on/in a food, food product and food processing equipment. Therefore, before the effective filing date of the claimed invention, the prior art teaches that the contacting of a stainless-steel surface (for making food or animal feed) and the contacting of a feed/meat product with Lactobacillus salivarius effectively inhibits, reduces and eliminates L. monocytogenes and Salmonella from the food and surface. Therefore, it would have been obvious to a posita to have used L. salivarius for not only inhibiting, reducing and eliminating L. monocytogenes on both a surface and in a food at risk for Listeria contamination but for reducing and inhibiting the growth of pathogenic food-borne pathogenic microorganisms when contacted with foods and surfaces having or suspected of containing the pathogenic microorganisms including Salmonella given the teachings of the prior art.
The prior art reference teaches the use of the lactic acid bacterium Lactobacillus salivarius to inhibit food-borne pathogenic microorganisms by contacting the pathogenic microorganisms with the lactic acid bacterium and contacting food products and food processing equipment comprising the pathogenic microorganisms with the lactic acid bacterium. The referenced microorganism appears to be identical to the presently claimed strain and is considered to anticipate the claimed microorganism since L. salivarius is taught to inhibit the growth of the same claimed food-borne pathogenic microorganisms when contacted with the Lactobacillus strain. Even if the claimed microorganisms are not identical to the referenced strains with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced microorganisms are likely inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been shown to share ( such as assignment to the same genus or species and capability of inhibiting food-borne pathogenic microorganisms ). Thus, the claimed strain would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Therefore, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants L. salivarius strains differ, and if so to what extent, from the L. salivarius of the prior art. Accordingly, and as stated in the rejections and arguments above, it has been established by the prior art references that the prior art strains are of the same genus and species and share the same property of inhibiting growth of L. monocytogenes in food products and on food processing equipment including stainless steel surfaces and therefore demonstrate a reasonable possibility that the strains are either identical or sufficiently similar and whatever differences exist, are not patentably significant. Therefore, the burden of establishing non-obviousness by objective evidence is shifted to Applicants.
Clear evidence that the L. salivarius strains of the prior art do not possess a critical characteristic that is possessed by the claimed strains would advance prosecution.
Claim(s) 1, 8, 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Castillo et al., (Poster Abstract, March 29, 2016) in view of each of Ware et al. (US2014/0341872 A1) and Ware (US8980611), and WO2015/120100 A1.
Castillo teach a method of inhibiting the growth of a Salmonella cocktail including S. Typhimurium, S. Newport, and S. Enteritidis (a food-borne pathogenic and spoilage microorganism) in a rendered meat product, i.e., chicken fat used as a dog food ingredient, and contacting the chicken fat containing the pathogenic microorganism with lactic acid strains L14 and L28. The treatment effectively eliminated, reduced and inhibited Salmonella by day 3. Therefore, the method effectively inhibits and reduces the growth of a food-borne pathogenic and spoilage microorganism, thereby increasing the storage time of a rendered meat product. The rendered meat product is one which is taught to be used as a dog food ingredient (added to pet kibble).
The claims are drawn to inhibiting, reducing and eliminating Salmonella, and Listeria monocytogenes with L. salivarius. The effect is interpreted to be taking place via contact with the meat/feed product with the claimed L. salivarius in an amount sufficient to inhibit the food-borne pathogenic microorganisms. The method of Castillo is drawn to the same method as claimed, i.e., contacting a meat product (contaminated with a food-borne pathogenic and spoilage microorganism) with L28 and L14, wherein Salmonella is eliminated within 3 days. While the reference is silent regarding Listeria monocytogenes, it is the Examiners position that these pathogens would inherently be inhibited or eliminated (if present) when practicing the method of Castillo because this function is inherent to claimed strains. One would necessarily expect to achieve the same results when practicing the method of Castillo, which is the same as applicants claimed method, i.e. contacting a product with L28 and/or L14.
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
While the reference teaches that raw chicken fat is a dog food ingredient, they do not teach the step of adding to a food for pets or animals. The reference does not teach the limitations of inhibiting, reducing or eliminating Listeria (with Salmonella) according the amended claims.
Ware teaches a method of improving food safety by inhibiting and preventing pathogenic contamination of, specifically Listeria monocytogenes and Salmonella, in food products and in food processing facilities and equipment (abstract, 0003). Ware teaches that food sources prone to contamination include meat, meat products (0005, 0038) and the common pathogenic bacteria L. monocytogenes and Salmonella are responsible for numerous food-borne outbreaks and are known meat product contaminant and food processing equipment contaminants (0006, 0007, 0056). Lactic acid bacteria have been used to inhibit L. monocytogenes in meat products; however, L. monocytogenes remains a problem in the food industry because of its ability to survive on food product surfaces as well as food processing equipment, by adhering and forming biofilms on solid materials (0006, 0007, 0011, 0040, 0056). Ware teaches a method of improving food safety comprising contacting food and/or food processing equipment with a composition comprising one or more lactic acid microorganisms to reduce the number of pathogenic bacteria in the food or food processing equipment (0008, 0043) and the equipment is taught to include a stainless-steel surface (0028-0032, 0068, Ex. 3 0069-0078). The lactic acid microorganism is used in an amount effective to prevent, inhibit, or disrupt the biofilm formation by L. monocytogenes on the surface (0009, 0015-0018, 0024, 0025). Ware teaches that the composition comprises an effective amount of the microorganism to reduce to the total number of pathogens to 0 CFU/sq ft. after the composition is in contact with the surface for 24 hours (0021, 0060, 0061) and after a contacting step, the pathogen content is less than before contact, preferably 100% less, thereby eliminating L. monocytogenes (0058, 0061). The lactic acid microorganism for use in the method includes Lactobacillus salivarius (0049).
Ware additionally teaches inhibiting the growth of food-borne pathogens, increasing the storage time by reducing spoilage microorganisms and reducing pathogenic load in food products comprising inoculating a food product with lactic acid producing microorganisms including a Lactobacillus strain and L. salivarius (0049) to control the growth of pathogen microorganisms in the food product including Listeria and Salmonella (0008, 0011, 0015-0018, 0038, 0040, 0043). Regarding the limitation of inhibiting/eliminating/reducing the food-borne/spoilage microorganisms, Ware teaches that the lactic acid composition is applied in an amount to reduce the total number of pathogens to 0 CFU after the composition was in contact with the surface or food material for 24 hours (0021, 0024).
Additionally, Ware at al. (US8980611) teaches method of inhibiting the growth of food-borne pathogens (col. 3, lines 40-45) including Salmonella typhimurium (col. 6, lines 35-40) in food, meat and/or meat products and animal feed (abstract, col. 2, lines 25-62, col, 3, lines 25-39, 45-54, 61-col. 4, lines 1-55, col. 6, lines 51-56, for example) comprising contacting the pathogenic microorganisms and food products comprising the pathogenic microorganisms with an amount of Lactobacillus salivarius (col. 5, line 60) sufficient to reduce pathogen of lactic acid bacteria (abstract, col. 1-2, col. 3, lines 1-10, col. 3, lines 40-55, col. 6, lines 41-56). Lactic acid bacteria are used for inhibiting pathogens in meat and meat products and can be administered to the animals from which the products are produced and/or added to the meat or meat products (col. 2, lines 52-67-col. 3, lines 40-55, col. 4, lines 21-36, 56-67, col. 6, lines 25-34, Ex. 2-11). Ware teach reducing pathogen content or concentration by about 100% (col. 2, lines 56-68).
While Ware does not teach that the food product is a rendered meat product specifically, they do teach known food-borne pathogenic bacteria to be L. monocytogenes and Salmonella which contaminate meat, meat products and food processing equipment; and which can be effectively treated with lactic acid bacteria including L. salivarius to inhibit and reduce the contamination in food and on food processing equipment. Thus, regardless of what the product is, the lactic acid bacteria including Lactobacillus salivarius would be expected by a posita to perform as taught, i.e., to effectively inhibit and reduce growth of the pathogens on a food, food product and food processing equipment.
Further, WO’100 teaches methods for reducing and inhibiting the growth of food-borne pathogenic microorganisms, and increasing storage time of a food by reducing spoilage microorganisms comprising obtaining a meat and/or food product and contacting said product with a composition comprising a food-safety/preserving bacteria including Lactobacillus salivarius (0003, 0005, 0008, 0010-0013, 0020, 0049, 0051, 0052, 0053, 0054, 0079, 0080). WO’100 teaches the food product to be a pet food, typically contaminated with pathogens including Listeria and Salmonella (0003). The pet foods include kibble, soft foods, wet foods, treats, meat pieces or chunks, livestock feed (0015, 0078) and wherein a meat product containing the microbe is applied to kibble (0030-0035). WO’100 teaches that meat used in pet foods are often byproducts of the rendering process, typically producing food contaminated with Salmonella (0003). WO’100 teaches the pathogenic/spoilage microorganisms include Salmonella and Listeria monocytogenes (0087) and the reference teaches incubating the food product with the food-safety/preserving bacteria for about 72 hours to promote elimination of pathogens and/or spoilage microorganisms including Salmonella (0072, 0086, Ex. 2, 4).
WO’100 teaches that the composition is also used to sanitize inedible surfaces (0002) including equipment used to process/produce human and pet foods which typically require deactivation of pathogenic and food-spoilage microorganisms (0003, 0005).
Thus, regardless of what the meat/feed product is or surface treated, the lactic acid bacteria Lactobacillus salivarius would be expected by a POSITA to perform as taught, i.e. to effectively inhibit, reduce and eliminate Listeria monocytogenes (on a surface and food) and Salmonella on/in a food, food product and food processing equipment, whether the composition is first applied to a surface/equipment and then added to and mixed with a food product or applied separately to perform as taught by the art. Therefore, before the effective filing date of the claimed invention, the prior art teaches that the contacting of a stainless-steel surface (for making food or animal feed) and the contacting of a feed/meat product with Lactobacillus salivarius effectively inhibits, reduces and eliminates L. monocytogenes and Salmonella from the food and surface. Therefore, it would have been obvious to a posita to have used L. salivarius for not only inhibiting, reducing and eliminating L. monocytogenes on both a surface and in a food at risk for Listeria contamination but for reducing and inhibiting the growth of pathogenic food-borne pathogenic microorganisms when contacted with foods and surfaces having or suspected of containing the pathogenic microorganisms including Salmonella given the teachings of the prior art.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive. Applicant argues the Castillo reference. While the Castillo reference was not relied upon in the last Office action mailed on 8/14/2025, it has been applied against previously presented claims, and its teachings discussed at length.
Applicant argues that the prior art references of Castillo, Smittle and Ware fail to teach biosanitizing a stainless-steel vessel prior to the addition of an animal feed. Applicant state that the claims clarify that L28 is used to biosanitize the stainless-steel vessel and the addition of L14 and/or FS56, in conjunction with L28, eliminate Salmonella in the animal feed, thus eliminating both Listeria and Salmonella from the animal feed.
As can be seen herein, applicants’ specification does not have support for biosanitizing a stainless-steel vessel prior to the addition of an animal feed and the addition of L14 and/or FS56, in conjunction with L28, eliminating Salmonella in the animal feed, thus eliminating both Listeria and Salmonella from the animal feed.
Regarding the teachings of the art, the combined references teach that L. salivarius is used to effectively inhibit and reduce both Listeria (in food and on food processing equipment) and Salmonella (in food products including animal feed and meat products added to animal feed). Thus, although the combined teachings do not teach biosanitizing a vessel before adding an animal feed thereto and then adding L. salivarius to eliminate both Listeria and Salmonella from the animal feed, as argued by applicant, one of ordinary skill in the art would have a reasonable expectation of successfully eliminating Listeria and Salmonella from equipment surfaces and in animal feed/products because compositions comprising L. salivarius are taught by the art to effectively eliminate Listeria and Salmonella (on surfaces and in food) and therefore whether or not the composition is first added to a stainless steel vessel and then the food/feed is added to said vessel with the composition, one of ordinary skill in the art would expect the composition to function as taught by the prior art references, i.e. to effectively eliminate Listeria and Salmonella (on surfaces and in food).
Conclusion
NO claims are allowed.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/
Supervisory Patent Examiner, Art Unit 1651