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 status
The examiner acknowledged the amendment made to the claims on 10/02/2025.
Claims 1, 4, 6, 7, 12, 28, 34, 36, 45, 47, 53, 55, 57 and 63-68 are pending in the application. Claim 1 is currently amended; claims 2-3, 5, 8-11, 13-26, 29-33, 35, 38-44, 46, 48-52, 54, 56 and 58-62 remain cancelled. Claims 27 and 37 are newly cancelled. Claims 53 and 64-65 are withdrawn without traverse in response to the restriction/election requirement. Rest of claims are previously presented. Claims 1, 4, 6, 7, 12, 28 , 34, 36, 45, 47, 55, 57, 63 and 66-68 are hereby examined on the merits.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Claim Objections
Claim 36 is objected to for missing a period in the end. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 34 recites that the fermentation time is at least 24 hours and/or fermentation is at a pH of 5-6. However, since claim 1 recites a fermentation time of 24-48 hours, the time limitation as recited in claim 34 fails to further limit the fermentation time as recited in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 6, 7, 12, 28, 34, 36, 47, 55, 57, 63, 66-67 are rejected under 35 U.S.C. 103 as being unpatentable Prakitchaiwattana WO2015/133973 A1 (hereinafter referred to as Prakitchaiwattana) in view of Lotzbeyer CA 2985875 A1 (hereinafter referred to as Lotzbeyer), Hu CN106819973 A (English translation relied up for reference, hereinafter referred to as Hu) and Santos, “Production of dextransucrase, dextran and fructose from sucrose using Leuconostoc mesenteroides NRRL B512(f)”, Biochemical Engineering Journal, 2000, 4, pages 177–188 (hereinafter referred to as Santos).
Regarding claims 1, 6, 7, 12, 28, 34, 36, 55, and 67, Prakitchaiwattana teaches a process of preparing a sugar-reduced (e.g., low sugar) fruit juice from a 100% fruit juice such as pineapple juice and orange juice, comprising a single fermenting of the juice with a lactic acid bacteria (LAB) such as Lactobacillus plantarum for 24-120 hours to reduce the sugar amount therein, followed by mixing the sugar-reduced juice with a main juice (e.g.,100% juice) at any percentage; wherein the sugar in the fermented juice is reduced by 10-70%, and wherein the sugar content in the main juice is reduced 5-50% (Abstract; Example 1-2; page 6 , line 4-6 and 12-19).
Further, Prakitchaiwattana teaches that “Low sugar fruit juice from 100% fruit juice can be kept as fresh, frozen, pasteurized in hermetically sealed package” (Abstract), and that “Low sugar fruit juice from 100% fruit juice can be preserved by methods such as freezing, pasteurization, commercial sterilization, UHT, or other methods to reduce or inactivate microorganisms to extend its shelf life” (page 6, line 25-27), thus suggesting a post-treatment step (e.g., pasteurization) after fermentation. Regardless, Prakitchaiwattana teaches that either LTLT or HTST is suitable for pasteurizing a juice to preserve the juice (page 4, line 16-25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have subjected the final mixed juice to HTST with reasonable expectation of success, for the reason that prior art has established that HTST is a suitable pasteurization method to preserve a juice.
Prakitchaiwattana teaches an LAB such as Lactobacillus plantarum thus being silent regarding the LAB being L. mesenteroides. Prakitchaiwattana teaches pineapple juice or orange juice thus being silent regarding the biomass being a juice from Rosaceae. Prakitchaiwattana is further silent regarding adjusting the pH of the juice to 5-7 or 5-6 before or during fermentation.
Lotzbeyer teaches a method of reducing sugar in a fruit substances (e.g., fruit educts) comprising fermenting the fruit substances with a bacteria such as L. mesenteroides, wherein the method can be used to prepare a fruit juice (Abstract; page 6, para. 1-2 from the bottom; page 10, bottom para.; claims 1 and 7). Lotzbeyer further discloses that suitable fruits to be used are pineapple, apple, pear, plum, orange, etc. (page 1, bottom para.; page 3 the table; page 16 the table).
Hu teaches that the fermentation of a fruit product (e.g., mulberry) with L. mesenteroides should be performed at a pH of 5.5-6.5 (Abstract; page 3, 3rd para.).
Santos teaches a method of producing an oligosaccharide (e.g., dextran) through the fermentation of a lower sugar (e.g., sucrose) by L. mesenteroides (Abstract). Further, Santos teaches that although a higher pH such as 6.7 favors L. mesenteroides cell growth, a lower pH such as 5.5 is advantageous for enzymatic activity (Abstract; the para. that bridges page 177 and 178; page 180, 3.2 “Effect of pH”).
Both Prakitchaiwattana and Lotzbeyer are directed to reducing sugar contents in a fruit product through lactic acid fermentation. Both Prakitchaiwattana and Hu are directed to subjecting a fruit product to lactic acid fermentation. Both Prakitchaiwattana and Santos are directed to synthesizing a higher sugar from a lower sugar through lactic acid fermentation. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Prakitchaiwattana by substituting L. mesenteroides for Lactobacillus plantarum as the fermentative LAB for reducing sugar in the fruit product of Prakitchaiwattana with reasonable expectation of success, for the reason that prior art has established that L. mesenteroides is an art-recognized LAB suitable for fermenting fruit product for the purpose of reducing sugar in a fruit product. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Prakitchaiwattana by substituting apple juice/ pear juice/plum juice for the pineapple juice / orange juice as the juice substrate for reducing sugar therein with reasonable expectation of success, for the reason that prior art has established that each of the aforementioned juices is an art-recognized juice substrate suitable for being fermented by a LAB for the purpose of reducing sugar therein. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07. Apple juice, pear juice or plum juice is known to contain sucrose, glucose, and fructose.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have adjusted the pH of the juice before or during fermentation so as to arrive at a pH that could strike a balance between optimal L. mesenteroides cell growth and optimal enzymatic activity (e.g., 5.5). As such, the pH range of 5-7 or 5-6 as recited in claims 1, 34 and 67 are merely obvious variants of the prior art.
Regarding the limitation about further reducing the sugar via post-treating, or the percent of sugar reduced by post-treating, given that page 24-25 and page 23 of the instant disclosure describe that heating such as HTST will cause the sugar to reduce and that Prakitchaiwattana teaches HTST pasteurization, it logically follows that the pasteurization as disclosed by prior art would cause the further reduction of sugar in the biomass. See also In re Best.
For the same reason set forth above, the pasteurization as disclosed by Prakitchaiwattana would have increased the activity of the bacteria or enzymes produced therefrom as recited in claim 7. See also In re Best.
On the limitation that the fermentation is for 24-48 hours, Prakitchaiwattana as recited above teaches fermenting the juice with Lactobacillus plantarum for 24-120 hours to reduce 10-70% of the sugar amount therein; further Lotzbeyer teaches the that the sugar content in the fruit substance is reduced by 30-80% (Abstract), and with suitable microorganisms it is possible to completely degrade the sugar substance within 40 hours (page 27, third para.). As such, one of ordinary skill in the art would have recognized that the fermentation time would determine the degree of sugar reduction in the fruit substrate. Therefore, one of ordinary skill in the art would have been motivated to manipulate the duration of fermentation for desired degree of sugar reduction. As such, the duration of fermentation as recited in claim 1 is merely an obvious variant of the prior art.
Regarding claim 4, Prakitchaiwattana teaches removing microorganism such as LAB after fermentation (page 6, line 8-9).
Regarding claims 34, Prakitchaiwattana as recited above teaches a fermentation of juice with Lactobacillus plantarum for 24-120 hours followed by post-treatment (e.g., pasteurization); wherein the sugar in the juice is reduced by 10-70% (Abstract; Example 1-2; page 6 , line 4-6). In the case of fermentation of juice with L. mesenteroides as in the modification of Prakitchaiwattana with Lotzbeyer, knowing that the amount of sugar that is reduced is a parameter of the duration of fermentation, one of ordinary skill in the art would have been motivated to manipulate the fermentation time such that 10-70% sugar is reduced. As such the fermentation time as recited in the claim is merely an obvious variant of the prior art.
Regarding claim 47, Prakitchaiwattana teaches heating the juice before fermentation (e.g., thermally treated with pasteurization) (page 5, line 21; page 7, line 23).
Regarding claim 57, Prakitchaiwattana as recited above teaches that the total sugar is reduced by 10-70% after fermentation; Prakitchaiwattana as recited above also teaches the sugar content in the main juice is reduced 5-50% upon mixing of the 100% juice with fermented juice. Further, given that un-treated juice has a total sugar content of 110-160 g/L (page 1, line 15-17), the fermented juice will have a total sugar content that overlaps with the range recited in the claim. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Additionally, given that the amount of sugar in the fermented juice is a parameter of the fermentation reaction such as duration of the fermentation, one of ordinary skill in the art would have been motivated to manipulate the fermentation time so as to obtain a fermented juice with desired sweetness. As such, the amount of sugar in the fermented juice is merely an obvious variant of the prior art.
Regarding claim 63, the sugar in the fermented juice is reduced by 10-70%, and wherein the sugar content in the main juice is reduced 5-50% (page 6 , line 4-6 and 12-19). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 66, Prakitchaiwattana as modified by Lotzbeyer, Hu and Santos teaches fermenting fruit juice with L. mesenteroides but is silent regarding L. mesenteroides being selected from L. mesenteroides ATCC 8293, L. mesenteroides NRRL B-512F, L. mesenteroides BF1 V17/0217229 and L. mesenteroides BF2 V17/021730 as recited in claim 66. However, where Prakitchaiwattana as modified by Lotzbeyer teaches fermenting fruit juice with an L. mesenteroides LAB, it would have been obvious to have selected any L. mesenteroides strain such as ATCC 8293, NRRL B-512F, BF1 V17/0217290 and BF2 V17/021730 to ferment a fruit juice, as one of ordinary skill would have had the reasonable expectation that any L. mesenteroides strain (e.g., ATCC 8293, NRRL B-512F, BF1 V17/0217229 or BF2 V17/021730) would function effectively to ferment a juice to reduce its sugar content. This is merely selecting from a group of suitable options, absent a clear showing of the criticality associated with the strains of L. mesenteroides as recited in the claim.
Further, Santos teaches that L. mesenteroides NRRL B-512F is able to ferment sucrose to produce an oligosaccharide such as dextran (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Prakitchaiwattana by using L. mesenteroides NRRL B-512F to ferment the juice with reasonable expectation of success, for the reason that prior art has established that L. mesenteroides NRRL B-512F is a suitable LAB for fermenting a product that has sucrose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Prakitchaiwattana as modified by Lotzbeyer, Hu and Santos as applied to claim 1 above, and further in view of Hugenholtz US Patent Application Publication No. 2015/0320099 A1 (hereinafter referred to as Hugenholtz).
Regarding claim 45, Prakitchaiwattana teaches fermenting a juice with a Lactobacillus lactic acid bacteria but is silent regarding adding nitrogen and phosphate before fermentation. However, Santos teaches adding a nitrogen source (e.g., yeast extract) in a L. mesenteroides fermentation medium (page 178, right hand column, 2nd para.).
Further, Hugenholtz in the same field of endeavor teaches a method of reducing sugar in juice by fermentation with a LAB such as Lactobacillus in which the LAB is grown and cultured in MRS medium ([0004; 0015; 0026; 0104]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Prakitchaiwattana by including yeast extract or MRS medium such that the LAB could be grown and cultured.
MRS medium is known to contain phosphate and nitrogen source.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Prakitchaiwattana as modified by Lotzbeyer, Hu and Santos as applied to claim 1 above, and further in view of Bachmann US Patent Application Publication No. 2012/0288573 A1 (hereinafter referred to as Bachmann).
Regarding claim 45, Prakitchaiwattana teaches a sugar reduced juice such as orange juice but is silent regarding adding calcium after step i).
Bachmann teaches adding inter alia, calcium to a juice such as orange juice so as to provide a diet for preventing bone metabolism disorder (Abstract; Example 3; 0016).
Both Prakitchaiwattana and Bachmann are directed to orange juice. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Prakitchaiwattana by adding calcium to the orange juice of Prakitchaiwattana so as to provide a diet for preventing bone metabolism disorder.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Prakitchaiwattana as modified by Lotzbeyer, Hu and Santos as applied to claim 1 above, and further in view of Yeom, “Effects of Pulsed Electric Fields on the Quality of Orange Juice and Comparison with Heat Pasteurization”, J. Agric. Food Chem., 2000, 48, pages 4597-4605 (hereinafter referred to as Yeom).
Regarding claim 68, Prakitchaiwattana teaches pasteurization after fermentation (Abstract); Prakitchaiwattana further teaches that HTST is suitable for pasteurizing a juice to inactivate microorganisms (page 4, line 16-25). Prakitchaiwattana is silent regarding pasteurization at 80 -121 °C for 5-60 seconds.
Yeom teaches that heat pasteurization of a juice such as orange juice at a temperature of 90-99 °C for 15-30 seconds (for example, 94.6 °C for 30 seconds) is “normal in commercial practice” to control spoilage microorganisms (Abstract; page 4597, ”Introduction”, 1st para.; “Materials and methods”, 3rd para.).
Both Prakitchaiwattana and Yeom are directed to pasteurizing a fruit juice. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have subjected the fermented juice to heat pasteurization at a temperature of 90-99 °C for 15-30 seconds with reasonable expectation of success, for the reason that prior art has established that such a heat pasteurization condition is suitable for preserving a juice.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but found not persuasive.
Applicant argues on pages 8-10 of the Remarks that one of ordinary skill in the art would not be led to apply the teaching of Lotzbeyer to modify the primary reference Prakitchaiwattana, for the reason that since Prakitchaiwattana process appears to work just fine, in particular, applicant argues that Prakitchaiwattana teaches using a LAB to develop fermented fruits, that every strain of LAB tolerates low pH of 3.5 and that juice is acidic (pH < 4.6), thus there is no need to modify Prakitchaiwattana to incorporate the L. mesenteroides. Applicant further argues that Prakitchaiwattana “teaches away” from adjust the pH of the juice, since Prakitchaiwattana’s process uses a LAB that could tolerate a low pH.
The argument is considered but found unpersuasive because prior art in its entirety has established that L. mesenteroides and Lactobacillus plantarum are functional equiv. in fermenting a fruit juice to reduce the sugar content therein thus it would have been obvious to substitute one for another. See also MEPE 2144.06. Further, based on applicant’s reasoning, no 35 USC 103 rejection should be made in any application because a primary reference relied upon in a 103 rejection mostly works just fine thus there is no need to modify the primary reference. Such a reasoning makes little sense.
Unfortunately, applicant has not shown any new result associated with L. mesenteroides strain.
Further, the examiner submits that there is no teaching away in Prakitchaiwattana from adjusting the pH to a higher level, since Prakitchaiwattana teaches that a LAB would merely “tolerate” the low pH, as opposed to fermenting the substrate optimally. To this end, where prior art has established the optimal pH for the fermentation of a lactic acid bacterial (see the instant office action), one of the ordinary skill in the art would have been motivated to increase the pH of the substrate to optimal level for superior performance of the LAB strain. Applicant’s reasoning is like: since a man could tolerate low temperature, then there is no need or motivation for the man to put on heavy jacket or turn on the heater. Such a reasoning makes little sense.
Applicant argues on page 10 of the Remarks that there is no reasonable expectation of success to modify Prakitchaiwattana with Santos, since Santos discloses a simple sucrose solution as a substrate for L. mesenteroides, as opposed to the fermentation of a biomass, a much more complicated system.
The examiner disagrees. Santos is cited to teach the pH for L. mesenteroides to display optimal enzymatic activity in the capacity of converting a lower sugar to an oligosaccharide or polysaccharide, thus is reasonably instructive for the practice of cleaving of another substrate that comprises the lower sugar (e.g., juice) by the same LAB strain, and would at least have some degree of expectation that the pH will work. To this end, applicant’s attention is drawn to MPEP 2143.02 II, which states that obviousness does not require absolute predictability.
Regardless, Hu as cited teaches that the fermentation of a fruit product (e.g., mulberry) with L. mesenteroides should be performed at a pH of 5.5-6.5 (Abstract; page 3, 3rd para.).
Applicant asserts unexpected result on page 11 of the Remarks. In particular, applicant argues that the inventors have surprisingly found that pre-fermented pH adjustment in combination with a single fermentation for 24-48 hours produces an advantageous sugar reduction profile compared to products produced without the initial pH adjustment.
The argument and the assertion are considered but found not sufficient in rebutting the prima facie case of obviousness set forth in the previous office action because those are essentially conclusive remarks that lack evidentiary support. To this end, MPEP 716.01(c) II states that attorney arguments cannot take the place of evidence. See also MPEP 2145 I, which states that argument does not replace evidence where evidence is necessary.
Further, the examiner submits that where prior art has established that optimal fermentation pH for L. mesenteroides is higher than the pH of a fruit juice, it is more expected than unexpected if one finds out increasing the pH of the juice to a higher level would be advantageous for the strain to reduce sugar.
For the reasons set forth above, applicant’s arguments on pages 12-13 of the Remarks regarding claims 45 and 68 are not persuasive, either.
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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/CHANGQING LI/Primary Examiner, Art Unit 1791