DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
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, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hugo et al (CURRENT TRENDS IN NATURAL PRESERVATIVES FOR FRESH SAUSAGES PRODUCTION) (see IDS filed 08/21/2021) in view of Campano et al (US 2013/0171314 A1) and Gutierrez et al (Effect of fermented broth from lactic acid bacteria on pathogenic bacteria proliferation).
Claim 1 has been amended to recite the following limitations:
An
a combination of and filtered fermentation broth wherein the fermentation products are potassium enriched products of microbial fermentation of carbohydrates from sweet potato and cassava sources by bacterial strain Saccharomyces cerevisiae NCIM 3594, Acetobacter aceti NCIM 2094 and Lactobacillus plantarum NCIM 2084, wherein the solution prevents spoilage of fresh meats and sausages under refrigeration and imparts an enhanced shelf life along with flavor improving efficiency for the preserved meat products.
Claim 15 recites similar limitations.
The limitation of “fermentation products; wherein the fermentation products are potassium enriched products of microbial fermentation of carbohydrates from sweet potato and cassava sources by bacterial strain Saccharomyces cerevisiae NCIM 3594, Acetobacter aceti NCIM 2094 and Lactobacillus plantarum NCIM 2084,” is directed to a process of making the organic, natural antimicrobial preservative, comprising a combination of naturally produced organic salts, including lactates and acetates. It is further noted that claim 1 is a product-by-process claim.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The limitation of “which prevents spoilage of fresh meats and sausages under refrigeration and imparts an enhanced shelf life along with flavor improving efficiency for the preserved meat products” is directed to an intended use of the composition and recites the result of using the naturally produced organic lactates and acetates in the production of fresh meats and sausages.
Hence, the composition of claims 1 and 15 is characterized by the presence of natural lactates and acetates of potassium.
In regard to claims 1 and 15, Hugo et al discloses that synthetic preservatives possess life-threatening side effects (page 12 Col. 2). Hugo et al discloses various natural preservatives including organic acids/salts (page 17 Col. 2). Hugo et al discloses that organic acids are natural antimicrobials produced during lactic acid fermentation and have generally recognized as safe (GRAS) status for meat products (page 17 Col. 2). Hugo et al discloses that diacetates have effectivity against yeast and bacteria in meat (page 17 Col. 2). Hugo et al discloses that lactates are effective against bacteria in meat and meat products (page 17 Col. 2). Hugo et al further discloses that study reported that addition of a mixture of sodium lactate 90% and sodium acetate 10% at different concentrations (from 0 to 20g/kg) on Merguez sausages significantly reduced microbial cell load during storage at 8C (page 18 Col. 1 2nd paragraph). Table 3 on page 16 shows sodium lactate and sodium acetate mixture activity against fatal aerobic count.
Hence, Hugo et al discloses an organic, natural antimicrobial preservative, comprising a combination of naturally produced organic salts, including lactates and acetates produced by microbial fermentation, wherein the combination such salts is effective as an antimicrobial when applied to meat and meat products. Hugo et al does not specifically discloses potassium salts.
Campano et al discloses antimicrobial preservative composition for meat products including potassium lactate, potassium acetate, and sodium diacetate (Abstract, paragraphs 6, 7, 8, 20, 24, 25, 36, 38, 39, 40, 55, 59, 68, 76, 79, 80, 84, claims 1-4, 6-9, 14, 18).
More specifically in regard to meat products, Campano et al discloses:
[0029] Embodiments of the present invention can be used in making, and can include, a variety of food products. As an example, embodiments included herein can be used to make ready-to-eat (RTE) meat products. Examples of RTE meat products include wieners (hot dogs), frankfurters, bologna, all meat loaves (including chicken loaves, ham loaves, luncheon loaves, and other loaves, mixed loaves (with vegetables and with cereal), sausages (including pepperoni, firm types, and softer types), liver loaves, liver sausages, jerky, beef sticks, mortadella, and deli meats (including cold cuts such as turkey, chicken, ham, salamis, corned beef, and roast beef), amongst others. However, it will also be appreciated that embodiments herein can also be used to make other types of food products beyond RTE meat products.
Hugo et al discloses sodium lactate and sodium acetate significantly reduced microbial cell load during storage at 8C (page 18 Col. 1 2nd paragraph). Hugo et al discloses that synthetic preservatives possess life-threatening side effects (page 12 Col. 2). Hugo et al discloses various natural preservatives including organic acids/salts (page 17 Col. 2). Hugo et al discloses that organic acids are natural antimicrobials produced during lactic acid fermentation and have generally recognized as safe (GRAS) status for meat products (page 17 Col. 2). Both references disclose lactates and acetates as antimicrobials in treatment of meats. Hugo discloses natural lactates and acetates obtained by microbial fermentation. Campano et al discloses that potassium lactate and potassium acetate also effective as antibacterial in treatment of meat products. Therefore, one of ordinate skill on the art would have been motivated to modify Hugo et al in view of Campano et al and to employ potassium containing base in the acid-base neutralization reaction with natural acetic and lactic acid to produce organic acids salts of potassium that are also suitable for antimicrobial treatment of meats.
Hugo et al does not disclose the presence of the fermentation broth in the antimicrobial preservative composition. Gutierrez et al discloses:
In this study, the effect that 5 fermented broths of lactic acid bacteria (LAB) strains have on the viability or proliferation and adhesion of 7 potentially pathogenic microorganisms was tested. The fermented broth from Lactococcus lactis C660 had a growth inhibitory effect on Escherichia coli K92 that reached of 31%, 19% to Pseudomonas fluorescens, and 76% to Staphylococcus epidermidis. The growth of Staph. epidermidis was negatively affected to 90% by Lc. lactis 11454 broth, whereas the growth of P. fluorescens (25%) and both species of Staphylococcus (35% to Staphylococcus aureus and 76% to Staph. epidermidis) were inhibited when they were incubated in the presence of Lactobacillus casei 393 broth. Finally, the fermented broth of Lactobacillus rhamnosus showed an inhibitory effect on growth of E. coli K92, Listeria innocua, and Staph. epidermidis reached values of 12, 28, and 76%, respectively. Staphylococcus epidermidis was the most affected strain because the effect was detected from the early stages of growth and it was completely abolished. The results of bacterial adhesion revealed that broths from Lc. lactis strains, Lactobacillus paracasei, and Lb. rhamnosus caused a loss of E. coli K92 adhesion. Bacillus cereus showed a decreased of adhesion in the presence of the broths of Lc. lactis strains and Lb. paracasei. Listeria innocua adhesion inhibition was observed in the presence of Lb. paracasei broth, and the greatest inhibitory effect was registered when this pathogenic bacterium was incubated in presence of Lc. lactis 11454 broth. With respect to the 2 Pseudomonas, we observed a slight adhesion inhibition showed by Lactobacillus rhamnosus broth against Pseudomonas putida. These results confirm that the effect caused by the different LAB assayed is also broth- and species-specific and reveal that the broth from LAB tested can be used as functional bioactive compounds to regulate the adhesion and biofilm synthesis and ultimately lead to preventing food and clinical contamination and colonization of E. coli K92, B. cereus, and Ls. innocua.
In regard to the recitation of the filtered fermentation broth, Gutierrez et al disclose removing cells from the fermented broth:
To obtain the cell-free fermented broth, the cultures were centrifuged at 10,000 × g for 5 min at room temperature, and these were combined with fresh medium to prevent the depletion of nutrients and used to check the growth capacity of the different pathogenic strains (page 2656).
Hence, Gutierrez et al discloses that fermented broth from Lactococcus lactis C660 had a growth inhibitory effect on various p[athogenic bacteria. Hence, Gutierrez et al discloses that fermented broth from Lactococcus lactis C660 has antimicrobial properties. As stated above, Hugo et al discloses that organic acids are natural antimicrobials produced during lactic acid fermentation and have generally recognized as safe (GRAS) status for meat products (page 17 Col. 2). Hugo et al discloses that lactates are effective against bacteria in meat and meat products (page 17 Col. 2). Hugo et al further discloses that study reported that addition of a mixture of sodium lactate 90% and sodium acetate 10% at different concentrations (from 0 to 20g/kg) on Merguez sausages significantly reduced microbial cell load during storage at 8C (page 18 Col. 1 2nd paragraph). Table 3 on page 16 shows sodium lactate and sodium acetate mixture activity against fatal aerobic count. Gutierrez et al discloses that fermented broth from Lactococcus lactis C660 has antimicrobial properties. One of ordinary skill in the art would have been motivated to modify Hugo et al in view of Gutierrez et al and to further include fermented broth from Lactococcus lactis C660 in the antimicrobial composition to further increase antimicrobial effect of the composition.
In regard to the concentration of salts as recited in claim 15, it is noted that one of ordinary skill in the art would have been motivated to vary amount of salts based on the desired antimicrobial effect.
Further in regard to the concentration recitations, it is noted that:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05, II A).
Claim 14 recites the following limitations:
The organic, natural antimicrobial preservative as claimed in claim 1, wherein the preservative at a dilution of 10.0 % (v/v) in demineralized water is applied at 10 mL per Kg of meat weight during the brining process of fresh ground meat before vacuum packaging and refrigeration of fresh ground meat/ beef / pork preparations and preservative at a dilution of 10.0 % (v/v) in demineralized water is applied at 0.5 % v/w of meat weight during the hydration process to impart long term preservation and shelf life to meat products for a period of more than 20-25 days for fresh brined meat and more than 6-8 months for processed and cured, refrigerated meats.
The recitation of “the preservative at a dilution of 10.0 % (v/v) in demineralized water is applied at 10 mL per Kg of meat weight during the brining process of fresh ground meat before vacuum packaging and refrigeration of fresh ground meat/ beef / pork preparations preservative at a dilution of 10.0 % (v/v) in demineralized water is applied at 0.5 % v/w of meat weight during the hydration process to impart long term preservation and shelf life to meat products for a period of more than 20-25 days for fresh brined meat and more than 6-8 months for processed and cured, refrigerated meats” is directed to the process of using the naturally produced organic lactates and acetates in the production of meats and sausages.
Response to Arguments
Applicant's arguments filed June 27, 2025 have been fully considered but they are not persuasive.
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). Hugo et al is not relied upon as a teaching of potassium salts. Another prior art reference to Campano et al was made as a teaching of potassium salts. Campano et al discloses antimicrobial preservative composition for meat products including potassium lactate, potassium acetate, and sodium diacetate (Abstract, paragraphs 6, 7, 8, 20, 24, 25, 36, 38, 39, 40, 55, 59, 68, 76, 79, 80, 84, claims 1-4, 6-9, 14, 18).
More specifically in regard to meat products, Campano et al discloses:
[0029] Embodiments of the present invention can be used in making, and can include, a variety of food products. As an example, embodiments included herein can be used to make ready-to-eat (RTE) meat products. Examples of RTE meat products include wieners (hot dogs), frankfurters, bologna, all meat loaves (including chicken loaves, ham loaves, luncheon loaves, and other loaves, mixed loaves (with vegetables and with cereal), sausages (including pepperoni, firm types, and softer types), liver loaves, liver sausages, jerky, beef sticks, mortadella, and deli meats (including cold cuts such as turkey, chicken, ham, salamis, corned beef, and roast beef), amongst others. However, it will also be appreciated that embodiments herein can also be used to make other types of food products beyond RTE meat products.
Hugo et al discloses sodium lactate and sodium acetate significantly reduced microbial cell load during storage at 8C (page 18 Col. 1 2nd paragraph). Hugo et al discloses that synthetic preservatives possess life-threatening side effects (page 12 Col. 2). Hugo et al discloses various natural preservatives including organic acids/salts (page 17 Col. 2). Hugo et al discloses that organic acids are natural antimicrobials produced during lactic acid fermentation and have generally recognized as safe (GRAS) status for meat products (page 17 Col. 2). Both references disclose lactates and acetates as antimicrobials in treatment of meats. Hugo discloses natural lactates and acetates obtained by microbial fermentation. Campano et al discloses that potassium lactate and potassium acetate also effective as antibacterial in treatment of meat products. Therefore, one of ordinate skill on the art would have been motivated to modify Hugo et al in view of Campano et al and to employ potassium containing base in the acid-base neutralization reaction with natural acetic and lactic acid to produce organic acids salts of potassium that are also suitable for antimicrobial treatment of meats.
Applicant’s arguments are directed to the fermentation process. The instant claims are not directed to the fermentation process. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., fermentation process) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The limitation of “fermentation products; wherein the fermentation products are potassium enriched products of microbial fermentation of carbohydrates from sweet potato and cassava sources by bacterial strain Saccharomyces cerevisiae NCIM 3594, Acetobacter aceti NCIM 2094 and Lactobacillus plantarum NCIM 2084,” is directed to a process of making the organic, natural antimicrobial preservative, comprising a combination of naturally produced organic salts, including lactates and acetates. It is further noted that claim 1 is a product-by-process claim.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In response to applicant's arguments regarding the filtered fermentation broth and the 37 C.F.R 1.132 Declaration, it is noted that claim(s) 1, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hugo et al (CURRENT TRENDS IN NATURAL PRESERVATIVES FOR FRESH SAUSAGES PRODUCTION) (see IDS filed 08/21/2021) in view of Campano et al (US 2013/0171314 A1) and Gutierrez et al (Effect of fermented broth from lactic acid bacteria on pathogenic bacteria proliferation). Hugo et al does not disclose the presence of the fermentation broth in the antimicrobial preservative composition. Gutierrez et al discloses:
In this study, the effect that 5 fermented broths of lactic acid bacteria (LAB) strains have on the viability or proliferation and adhesion of 7 potentially pathogenic microorganisms was tested. The fermented broth from Lactococcus lactis C660 had a growth inhibitory effect on Escherichia coli K92 that reached of 31%, 19% to Pseudomonas fluorescens, and 76% to Staphylococcus epidermidis. The growth of Staph. epidermidis was negatively affected to 90% by Lc. lactis 11454 broth, whereas the growth of P. fluorescens (25%) and both species of Staphylococcus (35% to Staphylococcus aureus and 76% to Staph. epidermidis) were inhibited when they were incubated in the presence of Lactobacillus casei 393 broth. Finally, the fermented broth of Lactobacillus rhamnosus showed an inhibitory effect on growth of E. coli K92, Listeria innocua, and Staph. epidermidis reached values of 12, 28, and 76%, respectively. Staphylococcus epidermidis was the most affected strain because the effect was detected from the early stages of growth and it was completely abolished. The results of bacterial adhesion revealed that broths from Lc. lactis strains, Lactobacillus paracasei, and Lb. rhamnosus caused a loss of E. coli K92 adhesion. Bacillus cereus showed a decreased of adhesion in the presence of the broths of Lc. lactis strains and Lb. paracasei. Listeria innocua adhesion inhibition was observed in the presence of Lb. paracasei broth, and the greatest inhibitory effect was registered when this pathogenic bacterium was incubated in presence of Lc. lactis 11454 broth. With respect to the 2 Pseudomonas, we observed a slight adhesion inhibition showed by Lactobacillus rhamnosus broth against Pseudomonas putida. These results confirm that the effect caused by the different LAB assayed is also broth- and species-specific and reveal that the broth from LAB tested can be used as functional bioactive compounds to regulate the adhesion and biofilm synthesis and ultimately lead to preventing food and clinical contamination and colonization of E. coli K92, B. cereus, and Ls. innocua.
In regard to the recitation of the filtered fermentation broth, Gutierrez et al disclose removing cells from the fermented broth:
To obtain the cell-free fermented broth, the cultures were centrifuged at 10,000 × g for 5 min at room temperature, and these were combined with fresh medium to prevent the depletion of nutrients and used to check the growth capacity of the different pathogenic strains (page 2656).
Hence, Gutierrez et al discloses that fermented broth from Lactococcus lactis C660 had a growth inhibitory effect on various p[athogenic bacteria. Hence, Gutierrez et al discloses that fermented broth from Lactococcus lactis C660 has antimicrobial properties. As stated above, Hugo et al discloses that organic acids are natural antimicrobials produced during lactic acid fermentation and have generally recognized as safe (GRAS) status for meat products (page 17 Col. 2). Hugo et al discloses that lactates are effective against bacteria in meat and meat products (page 17 Col. 2). Hugo et al further discloses that study reported that addition of a mixture of sodium lactate 90% and sodium acetate 10% at different concentrations (from 0 to 20g/kg) on Merguez sausages significantly reduced microbial cell load during storage at 8C (page 18 Col. 1 2nd paragraph). Table 3 on page 16 shows sodium lactate and sodium acetate mixture activity against fatal aerobic count. Gutierrez et al discloses that fermented broth from Lactococcus lactis C660 has antimicrobial properties. One of ordinary skill in the art would have been motivated to modify Hugo et al in view of Gutierrez et al and to further include fermented broth from Lactococcus lactis C660 in the antimicrobial composition to further increase antimicrobial effect of the composition.
In regard to the concentration of salts as recited in claim 15, it is noted that one of ordinary skill in the art would have been motivated to vary amount of salts based on the desired antimicrobial effect.
Further in regard to the concentration recitations, it is noted that:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05, II A).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/VERA STULII/Primary Examiner, Art Unit 1791