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 .
Receipt is acknowledged of the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 01/27/26.
Claims 2-5, 9-22, 24, 25, 28-30 are pending. Claims 24, 25, 28 were withdrawn. Claims 6-8, 23, 26, 27 were previously cancelled. Claims 2-5, 9-22, 29, and 30 have been examined on the merits.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/27/26 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-5, 9-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2012/147044).
Regarding Claim 2: Berger discloses an animal feed composition containing a strain of L. rhamnosus [abstract; pg. 2, sentences 6-9; pg. 7, 4th paragraph].
The prior art reference above discloses the use of Lactobacillus rhamnosus for the purpose of producing an animal feed. The difference between the strains is considered to be so slight that the prior art microorganisms are likely to inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been disclosed to share. The claimed strain would have been obvious to one of ordinary skill in the art, and therefore the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.”
Further, despite Applicants’ recitation of Lacticaseibacillus rhamnosus (Lactobacillus rhamnosus) strain FNZ118 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Berger as also having growth improving ability, absent any clear and convincing evidence otherwise. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shifts to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of Berger; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with food preserving properties and utilize such strains within the known methods of Berger.
Although Berger does not disclose the specific strains as presently claimed, it would have been obvious to one of ordinary skill in the art to use Lactobacillus rhamnosus strains capable of used in fermented animal feeds. Absent any evidence to contrary and based on the teachings of the cited reference, there would have been a reasonable expectation of success in fermenting substrates for production of ruminant feed.
Regarding Claim 3: Berger discloses as discussed above in claim 2. Berger discloses ruminant feed [abstract].
Regarding Claims 4 and 9: Berger discloses as discussed above in claim 2. Berger discloses that the animal feed increases body weight, milk production [pg. 3, sentences 4-6].
Regarding Claim 5: Berger discloses as discussed above in claim 4. Berger discloses the composition further comprising probiotics (Propionibacterium jensenii) [abstract; pg. 2, sentences 7-9; pg. 7, sentences 5-6].
Regarding Claim 10: Berger discloses a method of making an animal feed composition containing a strain of L. rhamnosus [abstract; pg. 2, sentences 6-9; pg. 7, 4th paragraph]. Berger discloses that the animal feed increases body weight, milk production, and methane reduction [pg. 3, sentences 4-6; pg. 4, sentences 3-6; pg. 4, last full paragraph pg. 19, Methane Production].
The prior art reference above discloses the use of Lactobacillus rhamnosus for the purpose of producing an animal feed. The difference between the strains is considered to be so slight that the prior art microorganisms are likely to inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been disclosed to share. The claimed strain would have been obvious to one of ordinary skill in the art, and therefore the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.”
Further, despite Applicants’ recitation of Lacticaseibacillus rhamnosus (Lactobacillus rhamnosus) strain FNZ118 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Berger as also having growth improving ability, absent any clear and convincing evidence otherwise. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shifts to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of Berger; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with food preserving properties and utilize such strains within the known methods of Berger.
Although Berger does not disclose the specific strains as presently claimed, it would have been obvious to one of ordinary skill in the art to use Lactobacillus rhamnosus strains capable of used in fermented animal feeds. Absent any evidence to contrary and based on the teachings of the cited reference, there would have been a reasonable expectation of success in fermenting substrates for production of ruminant feed.
Regarding Claim 11: Berger discloses as discussed above in claim 10. Berger discloses reducing methane producing bacteria [pg. 3 last sentence].
Regarding Claim 12: Berger discloses as discussed above in claim 10. Berger discloses animal feed as the administered composition [abstract; pg. 5, 5th paragraph].
Regarding Claim 13: Berger discloses as discussed above in claim 12. Berger discloses grain, hay, silage, grass, corn, dried grain, alfalfa, any feed ingredients and food or feed industry by-products as well as bio-fuel industry by-products and corn meal and mixtures thereof [pg. 9, 1st full paragraph].
Regarding Claim 14: Berger discloses as discussed above in claim 10. Berger discloses including microorganisms at According to the present invention, said effective amount of said at least one strain of bacterium is typically comprised between 105 CFU and 10.sup.13 CFU per animal and per day [pg. 8, 4th paragraph].
Regarding Claim 16: Berger discloses as discussed above in claim 10. Berger discloses the composition further comprising probiotics (Propionibacterium jensenii) and L. plantarum [abstract; pg. 2, sentences 7-9; pg. 7, sentences 5-6].
Regarding Claim 17: Berger discloses as discussed above in claim 10. Berger discloses the composition further comprising probiotics (Propionibacterium jensenii) and L. plantarum [abstract; pg. 2, sentences 7-9; pg. 7, sentences 5-6].
Regarding Claim 18: Berger discloses as discussed above in claim 10. Berger discloses that the animal feed increases body weight, milk production, and methane reduction [pg. 3, sentences 4-6; pg. 4, sentences 3-6; pg. 4, last full paragraph pg. 19, Methane Production].
Regarding Claim 19: Berger discloses as discussed above in claim 10. Berger discloses feeding to ruminants and wherein the ruminant can be bovine (cattle), goat, sheep, bison, yak, water buffalo, deer, camel, alpaca, llama, wildebeest, antelope, or nilgai [pg. 3, sentences 9-11].
Regarding Claim 20: Berger discloses as discussed above in claim 10. Berger discloses feeding to ruminants [pg. 3, sentences 9-11]. Berger discloses feeding the ruminant feed to lactating cows [pg. 12, “Animals, diets…].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2012/147044) as applied to claim 10 above and in further view of Pimentel (US 2016/0045604).
Regarding Claim 11: Berger discloses as discussed above in claim 10. Berger does not explicitly disclose wherein the method inhibits the growth of methylotrophic methanogens in the forestomach of the animal.
Pimentel discloses anti-methanogenic compositions and that L. rhamnosus can be administered to inhibit the growth of methanogens [abstract; 0124; 0125]. Pimentel discloses inhibiting the growth of Methanosphaera sp. and Methanobrevibacter sp.[0130].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Berger which includes L. rhamnosus would have inhibited the growth of methanogens as disclosed in Pimentel.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2012/147044) as applied to claim 10 and in further view of Kazemi et al. (US 2019/0192587).
Regarding Claim 15: Berger discloses as discussed above in claim 10. Berger does not disclose wherein the derivative of L. rhamnosus FNZ118 is a metabolite of the strain, or a culture supernatant of the strain.
Kazemi discloses using metabolites produced from the culturing of microbes for use in the treatment and prevention of disease in animals [abstract; 0089]. Kazemi discloses using L. rhamnosus [0028]. Kazemi discloses reducing the amount of methane produced [0082]. Kazemi discloses application in animal feed including for cows, goats, sheep, llamas, alpacas [0101].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the Berger to include using metabolites of L. rhamnosus culture as in Kazemi in order to aid in the treatment and prevention of disease and including reducing methane production.
Claims 21, 22, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2012/147044) as applied to claims 10, 2, and 12 and in further view of Jury et al. (US 2021/0267232).
Regarding Claims 21 and 22: Berger discloses as discussed above in claim 10. Berger does not disclose wherein the administering is to a pre-weaning animal and wherein the inhibition of the growth of methane-producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane emissions, for example methane production, by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists post-weaning. (claim 21); wherein the inhibition of the growth of methane-producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane emissions, for example methane production, by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists for at least 2 days, 3 days, 5 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months 8 months, 9 months, 10 months, 11 months, 1 year, 2 years, 3 years,
4 years, 5 years, 6 years, or 7 years after the last administration of L. rhamnosus FNZ118; or for the life of the ruminant animal.
Jury discloses a microbial feed supplement administered to ruminants and particularly as an additive to milk for calves that have not been weaned [abstract; 0156; 0160; 0169]. Jury discloses comparing the growth weight of calves after weaning or at weaning age [0175; 0177; 0178; 0179]. Jury discloses L. rhamnosus as a suitable Lactobacilli species [0069-0072].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Berger would have been beneficial in being administered to pre-weaned calves as in Jury since Jury discloses the administration of microbial feed additives including L. rhamnosus as improving the growth of calves and the development of the gastrointestinal tract of calves when compared to nontreated calves after feeding for a time period and measuring weights and the development of the GI tracts.
The references do not disclose that the method has the effect of the inhibition of the growth of methane-producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane emissions, for example methane production, by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists for at least 2 days, 3 days, 5 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months 8 months, 9 months, 10 months, 11 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, or 7 years after the last administration of L. rhamnosus FNZ118; or for the life of the ruminant animal, however, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claim 29: Berger discloses as discussed above in claim 2. Berger does not disclose wherein the food or feed composition comprises milk, milk powder, milk replacement, milk fortifier, and/or colostrum.
Jury discloses a microbial feed supplement administered to ruminants and particularly as an additive to milk for calves that have not been weaned [abstract; 0156; 0160; 0169]. The microbial is added to a milk containing material.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Berger as modified by Jury would have utilized milk and similar ingredients since it was administered to pre-weaned calves. The composition would have been beneficial in being administered to pre-weaned calves as in Jury since Jury discloses the administration of microbial feed additives including L. rhamnosus as improving the growth of calves and the development of the gastrointestinal tract of calves when compared to nontreated calves after feeding for a time period and measuring weights and the development of the GI tracts.
Regarding Claim 30: Berger discloses as discussed above in claim 12. Berger does not disclose wherein the food or feed composition comprises milk, milk powder, milk replacement, milk fortifier, and/or colostrum.
Jury discloses a microbial feed supplement administered to ruminants and particularly as an additive to milk for calves that have not been weaned [abstract; 0156; 0160; 0169]. The microbial is added to a milk containing material.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Berger as modified by Jury would have utilized milk and similar ingredients since it was administered to pre-weaned calves. The composition would have would have been beneficial in being administered to pre-weaned calves as in Jury since Jury discloses the administration of microbial feed additives including L. rhamnosus as improving the growth of calves and the development of the gastrointestinal tract of calves when compared to nontreated calves after feeding for a time period and measuring weights and the development of the GI tracts.
Claims 2-5, 9, 10, 12-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez-Ulibarri et al. (US 2021/0112827).
Regarding Claim 2: Lopez-Ulibarri discloses an animal feed composition containing L. rhamnosus [abstract; 0016; 0196; 0197; 0213; claim 1 and 63].
The prior art reference above discloses the use of Lactobacillus rhamnosus for the purpose of producing an animal feed. The Lactobacillus rhamnosus appears to be identical to the presently claimed strain and is considered to anticipate the claimed microorganism since Lactobacillus rhamnosus is taught to improve feed performance. Alternatively, even if the claimed microorganisms are not identical to the prior art strains, the difference between the strains is considered to be so slight that the prior art microorganisms are likely to inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been disclosed to share. The claimed strain would have been obvious to one of ordinary skill in the art, and therefore the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.”
Further, despite Applicants’ recitation of Lacticaseibacillus rhamnosus (Lactobacillus rhamnosus) strain FNZ118 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Lopez-Ulibarri as also having growth improving ability, absent any clear and convincing evidence otherwise. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shifts to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of Lopez-Ulibarri; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with food preserving properties and utilize such strains within the known methods of Lopez-Ulibarri.
Although Lopez-Ulibarri does not disclose the specific strains as presently claimed, it would have been obvious to one of ordinary skill in the art to use Lactobacillus rhamnosus strains capable of used in fermented animal feeds. Absent any evidence to contrary and based on the teachings of the cited reference, there would have been a reasonable expectation of success in fermenting substrates for production of ruminant feed.
Regarding Claim 3: Lopez-Ulibarri discloses as discussed above in claim 2. Lopez-Ulibarri discloses ruminant feed [0090].
Regarding Claims 4 and 9: Lopez-Ulibarri discloses as discussed above in claim 2. Lopez-Ulibarri discloses improving growth performance of farm animals; improving efficiency, body weight gain amongst other features [0008; 0091].
Regarding Claim 5: Lopez-Ulibarri discloses as discussed above in claim 4. Lopez-Ulibarri discloses the composition further comprising probiotics [abstract; 0006; ].
Regarding Claim 10: Lopez-Ulibarri discloses an animal feed composition containing L. rhamnosus [abstract; 0016; 0196; 0197; 0213; claim 1 and 63].
The prior art reference above discloses the use of Lactobacillus rhamnosus for the purpose of producing an animal feed. The Lactobacillus rhamnosus appears to be identical to the presently claimed strain and is considered to anticipate the claimed microorganism since Lactobacillus rhamnosus is taught to improve feed performance. Alternatively, even if the claimed microorganisms are not identical to the prior art strains, the difference between the strains is considered to be so slight that the prior art microorganisms are likely to inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been disclosed to share. The claimed strain would have been obvious to one of ordinary skill in the art, and therefore the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.”
Further, despite Applicants’ recitation of Lacticaseibacillus rhamnosus (Lactobacillus rhamnosus) strain FNZ118 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Lopez-Ulibarri as also having growth improving ability, absent any clear and convincing evidence otherwise. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shifts to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of Lopez-Ulibarri; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with food preserving properties and utilize such strains within the known methods of Lopez-Ulibarri.
Although Lopez-Ulibarri does not disclose the specific strains as presently claimed, it would have been obvious to one of ordinary skill in the art to use Lactobacillus rhamnosus strains capable of used in fermented animal feeds. Absent any evidence to contrary and based on the teachings of the cited reference, there would have been a reasonable expectation of success in fermenting substrates for production of ruminant feed.
Regarding Claim 12: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses animal feed as the administered composition [abstract; 0090].
Regarding Claim 13: Lopez-Ulibarri discloses as discussed above in claim 12. Lopez-Ulibarri discloses forage, soybean, grains, legumes [0090; 0092;0096].
Regarding Claim 14: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses including microorganisms at 1×10.sup.4 and 1×10.sup.14 CFU/kg of dry matter or 1×10.sup.6 and 1×10.sup.12 CFU/kg of dry matter [0215].
Regarding Claim 16: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses further including L. johnsonii or Lactobacillus acidophilus [0212].
Regarding Claim 17: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses further including prebiotics [0219].
Regarding Claim 18: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses improving growth performance of farm animals; improving efficiency, body weight gain amongst other features [0008; 0091].
Regarding Claim 19: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses feeding to ruminants [0090]. Lopez-Ulibarri does not disclose wherein said ruminant animal is a bovine, goat, sheep, bison, yak, water buffalo, deer, camel, alpaca, llama, wildebeest, antelope, or nilgai. However, since Lopez-Ulibarri discloses ruminant feed it would have been obvious that it would include specific ruminant animals and thus at least one of the claimed animals.
Regarding Claim 20: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri discloses feeding to ruminants [0090]. Lopez-Ulibarri does not disclose wherein said ruminant animal is a lactating animal, b. said ruminant animal is a pre-weaning animal, for example a calf or a lamb, c. said ruminant animal is a post-weaning animal, or d. the Z. rhamnosus FNZ118 is administered to the ruminant animal both prior to weaning and after weaning. However, these groups encompass all levels of development in a ruminant and therefore it would have been obvious that at some point in the development of the ruminant the composition would have been fed to the ruminant whether it be a lactating adult ruminant, a pre-weaned young ruminant, or post-weaned ruminant.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez-Ulibarri et al. (US 2021/0112827) as applied to claim 10 above and in further view of Pimentel (US 2016/0045604).
Regarding Claim 11: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri does not disclose wherein the method inhibits the growth of methylotrophic methanogens in the forestomach of the animal.
Pimentel discloses anti-methanogenic compositions and that L. rhamnosus can be administered to inhibit the growth of methanogens [abstract; 0124; 0125]. Pimentel discloses inhibiting the growth of Methanosphaera sp. and Methanobrevibacter sp.[0130].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Lopez-Ulibarri which includes L. rhamnosus would have inhibited the growth of methanogens as disclosed in Pimentel.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez-Ulibarri et al. (US 2021/0112827) as applied to claim 10 and in further view of Kazemi et al. (US 2019/0192587).
Regarding Claim 15: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri does not disclose wherein the derivative of L. rhamnosus FNZ118 is a metabolite of the strain, or a culture supernatant of the strain.
Kazemi discloses using metabolites produced from the culturing of microbes for use in the treatment and prevention of disease in animals [abstract; 0089]. Kazemi discloses using L. rhamnosus [0028]. Kazemi discloses reducing the amount of methane produced [0082]. Kazemi discloses application in animal feed including for cows, goats, sheep, llamas, alpacas [0101].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the Lopez-Ulibarri to include using metabolites of L. rhamnosus culture as in Kazemi in order to aid in the treatment and prevention of disease and including reducing methane production.
Claims 21, 22, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez-Ulibarri et al. (US 2021/0112827) as applied to claims 10, 2, and 12 and in further view of Jury et al. (US 2021/0267232).
Regarding Claims 21 and 22: Lopez-Ulibarri discloses as discussed above in claim 10. Lopez-Ulibarri does not disclose wherein the administering is to a pre-weaning animal and wherein the inhibition of the growth of methane-producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane emissions, for example methane production, by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists post-weaning. (claim 21); wherein the inhibition of the growth of methane-producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane emissions, for example methane production, by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists for at least 2 days, 3 days, 5 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months 8 months, 9 months, 10 months, 11 months, 1 year, 2 years, 3 years,
4 years, 5 years, 6 years, or 7 years after the last administration of L. rhamnosus FNZ118; or for the life of the ruminant animal.
Jury discloses a microbial feed supplement administered to ruminants and particularly as an additive to milk for calves that have not been weaned [abstract; 0156; 0160; 0169]. Jury discloses comparing the growth weight of calves after weaning or at weaning age [0175; 0177; 0178; 0179]. Jury discloses L. rhamnosus as a suitable Lactobacilli species [0069-0072].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Lopez-Ulibarri would have been beneficial in being administered to pre-weaned calves as in Jury since Jury discloses the administration of microbial feed additives including L. rhamnosus as improving the growth of calves and the development of the gastrointestinal tract of calves when compared to nontreated calves after feeding for a time period and measuring weights and the development of the GI tracts.
The references do not disclose that the method has the effect of the inhibition of the growth of methane-producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane emissions, for example methane production, by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists for at least 2 days, 3 days, 5 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months 8 months, 9 months, 10 months, 11 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, or 7 years after the last administration of L. rhamnosus FNZ118; or for the life of the ruminant animal, however, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claim 29: Lopez-Ulibarri discloses as discussed above in claim 2. Lopez-Ulibarri does not disclose wherein the food or feed composition comprises milk, milk powder, milk replacement, milk fortifier, and/or colostrum.
Jury discloses a microbial feed supplement administered to ruminants and particularly as an additive to milk for calves that have not been weaned [abstract; 0156; 0160; 0169]. The microbial is added to a milk containing material.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Lopez-Ulibarri as modified by Jury would have utilized milk and similar ingredients since it was administered to pre-weaned calves. The composition would have been beneficial in being administered to pre-weaned calves as in Jury since Jury discloses the administration of microbial feed additives including L. rhamnosus as improving the growth of calves and the development of the gastrointestinal tract of calves when compared to nontreated calves after feeding for a time period and measuring weights and the development of the GI tracts.
Regarding Claim 30: Lopez-Ulibarri discloses as discussed above in claim 12. Lopez-Ulibarri does not disclose wherein the food or feed composition comprises milk, milk powder, milk replacement, milk fortifier, and/or colostrum.
Jury discloses a microbial feed supplement administered to ruminants and particularly as an additive to milk for calves that have not been weaned [abstract; 0156; 0160; 0169]. The microbial is added to a milk containing material.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the method of Lopez-Ulibarri as modified by Jury would have utilized milk and similar ingredients since it was administered to pre-weaned calves. The composition would have would have been beneficial in being administered to pre-weaned calves as in Jury since Jury discloses the administration of microbial feed additives including L. rhamnosus as improving the growth of calves and the development of the gastrointestinal tract of calves when compared to nontreated calves after feeding for a time period and measuring weights and the development of the GI tracts.
Response to Arguments
The Applicants assert that there is high variability within L. rhamnosus sp. and that there is no basis for the strain of primary reference Lopez-Ulibarri as being identical to the instantly claimed strain.
The Examiner maintains the rejection. The claim does not only recite L. rhamnosus sp. FNZ118 but also recites derivatives thereof. Applicants argue high variability among L. rhamnosus sp. but have claimed the strain and derivatives thereof. Further, there is nothing new in using L. rhamnosus in feed. Further, the later claimed purposes or features of the bacteria are disclosed in Lopez-Ulibarri. Further, Applicants assert features of L. rhamnosus that are not recited in the independent claims. Therefore Applicants arguments are not commensurate with the scope of the claims.
15. The Affidavit filed 1/27/26 has been acknowledged. The Declarant asserts that none of the references discloses a claimed strain or a strain of L. rhamnosus. The Declarant asserts that Lopez-Ulibarri included fungal muramidase; and uses a combination of probiotics of which L. rhamnosus is not included. The Declarant asserts that the feed efficiency in Lopez-Ulibarri can be attributed to the muramidase and/or the probiotic combo rather than the L. rhamnosus. The Declarant asserts that Pimentel only discloses methane reduction due to statin drugs and mentions probiotics as a possible additional therapeutic agent. The Declarant asserts that Kazemi does not test L. rhamnosus and mentions methane reduction once in an optimal way. The Declarant asserts that none of the examples in Jury mentioning weight gain, mention L. rhamnosus. The Declarant asserts that the weight gain in Jury is attributed to three other lactobacilli.
The Examiner notes that the claims are to a feed containing L. rhamnosus. The claims are to a feed containing one or up to 9 features. The claims are not limited to the ability of the L. rhamnosus to reduce methane and other features. The Examiner maintains that a feature of the overall feed itself is that it possesses one or all of the claimed properties including the ability to reduce methane.
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., the L. rhamnosus strain having anti-methanogen activity) are not recited in the rejected claim. 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).
Further, 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).
Further, the Examiner disagrees with the Declarant’s characterization of the references. For example contrary to Declarant’s assertion, Pimentel does attribute L. rhamnosus among other lactic acid bacteria as able to inhibit the growth of methanogens. Pimentel also further discloses that the bacteria can for example inhibit growth by competing against/out growing the methanogens [0125].
16. The Declarant asserts that the ability of L. rhamnosus to reduce methanogen activity is not predictable and only three strains of lactic acid bacteria out of 1,712 were able to show a level of inhibition comparable to the claimed strain. Other strains showed less than 50% inhibition.
The Examiner notes that a level of reduction/inhibition has not been claimed. Therefore any level of inhibition would read on the claim.
17. The Declarant asserts a long felt unsolved need to reduce methane emission from ruminants and to increase feed efficiency.
The Examiner maintains that the art shows that the issue is a known issue and that it is known to add probiotics to animal feed to increase feed efficiency and to reduce methane production. Applicant is using known components to obtain expected results. There is nothing patentable unless the applicant, by a proper showing, further establishes a coaction or cooperative relationship between the selected ingredients, which produces a new, unexpected, and useful function. It is not seen where Applicant has provided support for unexpected results. In the absence of a showing of unexpected results, the amounts claimed are merely a matter of choice and well within the skill of the art. At most the amounts are seen merely as optimization.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Phillippeau et al. Journal of Dairy Science 2017 discloses effects of direct fed microbials on methane emissions [abstract]. Discloses the combination of a strain of Propionibacterium and a strain of L. rhamnosus and that it reduces methane production [abstract; Introduction].
Conclusion
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/Felicia C Turner/Primary Examiner, Art Unit 1793