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 3/2/26.
Claims 16-20, 22-40 are pending and have been examined on the merits. Claim 21 has been cancelled. Claim 40 is new.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/2/26 has been entered.
Withdrawn Rejections
The 103(a) rejections of claims 16-21, and 29-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hornbaek et al. (US 2014/0093487) in view of Serata et al. “Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Severson et al. (US 5,416,020) have been withdrawn due to the amendments to the claims.
The 103(a) rejections of claims 22-24 over Hornbaek et al. (US 2014/0093487) and Serata et al. (“Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Severson et al. (US 5,416,020) as applied to claim 16 above and in further view of Georgieva et al. (US 2015/0218507) have been withdrawn due to the amendments to the claims.
The 103(a) rejections of claims 25-28 over Hornbaek et al. (US 2014/0093487) and Serata et al. (“Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Severson et al. (US 5,416,020) as applied to claim 16 above and in further view of Makarova et al. “Comparative Genomics of the lactic acid bacteria” PNAS October 17 2006 vol. 103 No. 42 pages 15611-15616 have been withdrawn due to the amendments to the claims.
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 16-20, and 29-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hornbaek et al. (US 2014/0093487) in view of Serata et al. “Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Raccach et al. (EP 0130228).
Regarding Claims 16, 19, 29 30, and 40: Hornbaek discloses a direct vat starter culture composition for fermenting food product and providing an antimicrobial composition [abstract; 0070]. Hornbaek discloses that the lactic acid bacteria are usually supplied as frozen or freeze-dried cultures for bulk starter propagation or in a frozen, dried, or freeze-dried form as Direct vat set cultures [0034; 0070]. Hornbaek discloses L. rhamnosus and L. paracasei as lactic acid bacteria having antimicrobial effect [abstract]. Hornbaek discloses including at least 1010 cfu/g in the composition [0070]. Hornbaek discloses an improvement in the inhibition of fungi and more specifically yeast and mold [0074; 0075; 0086; 0134].
Hornbaek does not disclose where the content of manganese is 30 to 600ppm; 40 to 600ppm (claim 19); 40-400 ppm (claim 40).
Hornbaek does not disclose that the bacteria contains a manganese transporter.
Serata discloses that lactobacilli contain a manganese transporter which is used to accumulate manganese in the absence of manganese SOD [abstract].
Raccach discloses a food fermented with lactobacilli [abstract; pg. 6, lines 3-14]. Raccach discloses formulating a bacterial culture from lactobacilli and including manganese [abstract]. Raccach discloses forming a concentrated lactobacilli culture containing manganese salt and that the concentrates can be frozen or lyophilized [pg. 5, lines 17-34; pg. 9, Ex. 1]. Raccach discloses the bacterial concentrates containing at least about 1x107 cells/g to up to about 1 x1015 cells/g [pg. 5, lines 17-22]. Raccach discloses adding manganese in a bacterial culture at .015 to 50% (100 ppm to 500,000 ppm) [pg. 6, lines 3-14]. Although not directly using the words direct vat set or DVS, Raccach essentially discloses DVS because it produces a concentrated bacterial culture, this culture can be freeze dried or frozen for later use and it is directly inoculated into a food product without the need for propagation beforehand [abstract; claim 1].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the lactobacilli would have contained a manganese transporter since Serata disclose lactobacilli contain a manganese transporter which is used to accumulate manganese in the absence of manganese SOD [abstract].
At the effective filing date of the invention it would have been obvious to include manganese in the fermenting of the microorganisms of Hornbaek at the amounts of 100 ppm to 500,000 ppm as disclosed in Raccach since Raccach discloses that the amounts of manganese as stimulatory to the lactic acid bacteria and provides a sufficient rate of growth to accelerate the growth of the bacteria in the food/meat product improve the rate of lactic acid production.
Although Raccach does not explicitly disclose 30 pm to 600ppm, 40 ppm to 600 ppm, 40ppm to 400ppm one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Severson overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553
Regarding Claims 17 and 18: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek does not disclose whether the LAB is free of superoxide dismutase; is free of manganese superoxide dismutase (claim 17).
Serata discloses lactobacilli as not containing manganese superoxide dismutase [abstract; Introduction]. Serata discloses that manganese is accumulated not by manganese superoxide dismutase but by manganese transports [abstract; Introduction].
At the effective filing date of the invention it would have been obvious to one of ordinary skill that the Lactobacilli of Hornbaek would not have contained manganese superoxide dismutase (SOD) as disclosed in Serata since Serata discloses that while of the lactic acid bacteria lactococci and streptococci contain SOD, that lactobacilli do not [Introduction].
Regarding Claim 20: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses lactic acid bacteria content of at least 1011 cfu/g [0070].
Regarding Claim 31: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses for inhibiting and/or preventing the growths in the genera of Yarrowia, Candida, Debaromyces [abstract; 0075].
Regarding Claim 32: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses for inhibiting and/or preventing the growths in the genera of Debaromyces hansenii [abstract; 0075].
Regarding Claim 33: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses for inhibiting and/or preventing the growths in the genera of Penicillium spp, Cladiosporium sp., Aspergillus sp. [abstract; 0075].
Regarding Claim 34: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses for inhibiting and/or preventing the growths in the species Penicillium crustosum [abstract; 0075].
Regarding Claim 35: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses a food product containing the composition [0045].
Regarding Claim 36: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses where a food product containing the composition is a fermented food [0034; 0035;0045].
Regarding Claim 37: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek discloses where a food product containing the composition is a thermophilic food or mesophilic fermented food [0035; 0036].
Regarding Claim 38: Hornbaek discloses where a food product containing the composition is a fermented yogurt or cheese [0035; 0036].
Regarding Claim 39: Hornbaek discloses a method for inhibiting growth of fungi by providing and administering a direct vat starter culture composition for fermenting food product and providing an antimicrobial composition [abstract; 0070]. Hornbaek discloses L. rhamnosus and L. paracasei as lactic acid bacteria having an antimicrobial effect [abstract]. Hornbaek discloses including at least 1010 cfu/g in the composition [0070]. Hornbaek discloses the inhibition of fungi and more specifically yeast and mold [0074; 0075].
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hornbaek et al. (US 2014/0093487) and Serata et al. (“Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Raccach et al. (EP 0130228) as applied to claim 16 above and in further view of Georgieva et al. (US 2015/0218507).
Regarding Claims 22-24: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek does not disclose wherein the composition is selected from: a freeze-dried direct vat set (FD-DVS) composition comprising an additive in an amount from 2% to 70% by dry weight of additive per weight of FD-DVS, wherein the additive is substantially free of or free of manganese; and a frozen direct vat set (F DVS) composition comprising an additive in an amount from 2% to 70% by dry weight of additive per weight of F-DVS, wherein the additive is substantially free of or free of manganese (claim 22); wherein the additive comprises one or more selected from sodium caseinate, inositol, monosodium glutamate, sodium ascorbate, sucrose, maltodextrin, inosine monophosphate (IMP), inosine, polysorbate 80, glutamic acid, lysine, sodium glutamate, malt extract, whey powder, yeast extract, gluten, collagen, gelatin, elastin, keratin, and albumin (claim 23); wherein the additive comprises sodium caseinate, inositol, monosodium glutamate, and sodium ascorbate (claim 24).
Georgieva discloses a frozen bacteria containing concentrate which contains an additive/cryoprotectant in the form of inosine, inositol, IMP, trehalose, [0022; 0217; 0219]. Georgieva discloses a cryoprotectant at 0 to 10% [0098]. Georgieva discloses freeze dried or frozen direct vat set [0217]. Georgieva does not require manganese as an additive.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition to include a non-manganese cryoprotectant including inosine, inositol, IMP as in Georgieva in order to stabilize and to provide the lactic acid bacteria with protection from damage.
Although Georgieva does not explicitly disclose an additive at 2 to 70% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Georgieva overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hornbaek et al. (US 2014/0093487) and Serata et al. (“Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Raccach et al. (EP 0130228) as applied to claim 16 above and in further view of Makarova et al. “Comparative Genomics of the lactic acid bacteria” PNAS October 17 2006 vol. 103 No. 42 pages 15611-15616.
Regarding Claims 25-28: Hornbaek as modified discloses as discussed above in claim 16. Hornbaek does not disclose wherein the LAB comprise a manganese transporter having at least 55% sequence identity to any one of SEQ ID NOs: 1-3 (claim 25); wherein the LAB comprise a manganese transporter having at least 95% sequence identity to any one of SEQ ID NOs: 1-3 (claim 26); wherein the LAB comprise a manganese transporter having at least 98% sequence identity to any one of SEQ ID NOs: 1-3. 28 (claim 27); wherein the LAB comprise a manganese transporter having the sequence of any one of SEQ ID NOs: 1-3 (claim 28).
Makarova discloses Lactobacillus paracasei (strain ATCC 334 / BCRC 17002 / CCUG 31169 /CIP 107868 / KCTC 3260 / NRRL B-441) LACP3 Mn2+ and Fe2+ transporter of the NRAMP family with 99.7% sequence identity with Seq ID 3.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the LAB to include a manganese transporter as in Makarova in order to properly accumulate manganese for its antioxidant properties and since the lactobacilli do not express superoxide dismutase [Makarova pg. 15614 1st partial paragraph].
Regarding Claim 28, the Seq Id at 99.7% is substantially close to that of the instant claims, one of ordinary skill would have expected compositions that are in such close proportions to those in prior art to be prima facie obvious and to have same properties. Titanium Metals Corp., 227 USPQ 773 (CAFC 1985).
Response to Arguments
The 103(a) rejections of claims 16-21, and 29-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hornbaek et al. (US 2014/0093487) in view of Serata et al. “Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Severson et al. (US 5,416,020) have been withdrawn due to the amendments to the claims.
The 103(a) rejections of claims 22-24 over Hornbaek et al. (US 2014/0093487) and Serata et al. (“Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Severson et al. (US 5,416,020) as applied to claim 16 above and in further view of Georgieva et al. (US 2015/0218507) have been withdrawn due to the amendments to the claims.
The 103(a) rejections of claims 25-28 over Hornbaek et al. (US 2014/0093487) and Serata et al. (“Effect of superoxide dismutase…” Bioscience of Microbiota, Food and Health vol. 37 No. 2 pages 31-38 2018 and Severson et al. (US 5,416,020) as applied to claim 16 above and in further view of Makarova et al. “Comparative Genomics of the lactic acid bacteria” PNAS October 17 2006 vol. 103 No. 42 pages 15611-15616 have been withdrawn due to the amendments to the claims.
Pertinent Prior Art
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Orme et al. (US 2011/0200708) discloses a composition for activating or stabilizing microorganisms [abstract]. Orme discloses starter cultures which are direct vat set [0005]. Orme discloses a formulated culture concentrate that can be used as a direct vat set [0123]. Orme discloses a formulated culture concentrate containing 0.1 to 10% (1000 ppm to 10,000 ppm) manganese [claim 8, 9, 10].
Miura et al. (EP 2119766) discloses improving the viability of lactic acid bacteria by adding manganese [abstract]. Miura discloses adding 5ug/100g or more of manganese [abstract]. Miura discloses adding manganese 100ug/100g or more or 1000µg/100g or more (10ppm or more) [0027].
Conclusion
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/Felicia C Turner/Primary Examiner, Art Unit 1793