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 .
Status of Claims
Claims 39 -58 are pending.
Claims 39 – 58 are rejected.
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) 39 – 47, 49 – 53 are rejected under 35 U.S.C. 103 as being unpatentable over Shapira et al. (WO 2021/165964, effectively filed date of Feb. 19, 2020).
The rejected claims cover, inter alia, a process for enriching L-lactate enantiomer from an enantiomeric mixture derived from decomposed organic waste, the process comprising the steps of: (a) obtaining decomposed organic waste comprising an enantiomeric mixture of D- and L-lactate and a counterion other than magnesium; (b) optionally performing at least one of neutralizing the D- and L-lactate and removing solid particles from the decomposed organic waste; and (c) adding a magnesium salt to the enantiomeric mixture of step (a) or (b) to thereby precipitate magnesium L-lactate salt with enriched enantiomeric purity.
Dependent claim 40 further limits the enrichment of L-Lactate enantiomer. Dependent claims 41 and 42 further limits the decomposed waste. Dependent claim 43 further limits the enantiomeric mixture. Dependent claim 44 further limits the counterion. Dependent claims 45 – 47 further limit step (b) neutralizing step. Dependent claim 49 further limits step (c). Dependent clams 50 and 51 further limit the separation and purification of the obtained magnesium L-lactate salt. Dependent claim 52 further limits the form and/or amount of magnesium L-lactate obtained. Dependent claim 53 further limits the process of claim 39.
However, Shapira provides methods and systems for highly efficient production of an enantiomerically pure lactate salt, particularly an L-lactate salt, by combined recycling of organic waste and PLA waste. More particularly, the method of Shapira integrates production of L-lactate monomers by lactic acid fermentation of organic waste with chemical hydrolysis of PLA to its constituting monomers (L- and optionally D- lactate monomers). As disclosed herein, L-lactate monomers produced by fermentation and lactate monomers produced by chemical hydrolysis of PLA are combined and purified together in a single downstream purification and recovery process to obtain a pure L-lactate salt. (pp. 6, ln 7 – 15).
The fermentation broth according to the present invention may contain D-lactic acid originating from the organic waste. In addition, D-lactic acid may be present in the PLA hydrolysis slurry, either from degraded PLA or formed by racemization during hydrolysis. (pp. 24, ln 10 – 13).
In additional embodiments of Shapira, the magnesium salt in step (c) is added in solid form. In alternative embodiments, the magnesium salt in step (c) is added as an aqueous solution. In further embodiments, the magnesium salt in step (c) is gradually added. In particular embodiments, the magnesium salt in step (c) is magnesium sulfate. (pp. 12, ln 19 – 22).
The overall L-lactate production is typically increased by 10% or more. (pp. 9, ln 5 – 13 & pp. 23, ln 11 – 16).
The difference between Shapira and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. §2131: "[t]he identical invention must be shown in as complete detail as is contained in the ...claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).).
However, based on the above, Shapira teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. (see M.P.E.P. § 2143).
Regarding claim 42, the method for producing an L-lactate salt further comprises pretreatment of the PLA waste prior to step (a). In specific embodiments, pretreatment comprises a mechanical pretreatment selected from the group consisting of grinding, chipping, shredding, milling, and a combination thereof. (pp. 10, ln 14 – 17).
Regarding clam 43, In Shapira As used herein, "elimination", when referring to D-lactic acid/D-lactate, refers to reduction to residual amounts such that there is no interference with downstream processes of producing L-lactic acid and subsequently polymerization to poly(L-lactic acid) that is suitable for industrial applications. "Residual amounts" indicates less than 1% (w/w) D-lactate, and even more preferably less than 0.5 % (w/w) D-lactate, out of the total lactate (L+D) in a treated mixture of a fermentation broth at the end of fermentation together with products of PLA hydrolysis. In some particular embodiments, elimination of D-lactate is reduction to less than 0.5 % (w/w) D-lactic acid out of the total lactate in a treated mixture of a fermentation broth at the end of fermentation together with products of PLA hydrolysis. (pp. 25, ln 1 – 10)>
Regarding claim 44, as disclosed in Shapira, lactic acid fermentation is carried out in the presence of an alkaline compound that adjusts the pH during fermentation, resulting in a fermentation broth comprising L-lactate monomers and a counterion. The PLA hydrolysis is carried out using a metal oxide or a hydroxide, resulting in a hydrolysis slurry comprising lactate monomers (L- and optionally D-) and a counterion. The alkaline compound used during fermentation and the metal oxide or the hydroxide used for PLA hydrolysis according to the present invention produce L-lactate monomers and a counterion which may be the same or different with each possibility representing a separate embodiment. When using the same counterion, the L-lactate monomers and the counterions can be combined and purified together to obtain a pure lactate salt. When using a different counterion, at least one of the counterions can be exchanged thereby resulting in the same counterion which together with the L-lactate monomers can be subjected to subsequent combined purification. (pp. 6, ln 23 to pp. 7, ln 3).
Regarding claims 45 – 46, the biological process of fermentation includes L-lactic acid fermentation by an L-lactic acid-producing microorganism. Due to the formation of L-lactic acid, endogenous lowering of the pH occurs. Thus, the fermentation process is carried out in the presence of an alkaline compound to adjust the pH during fermentation. The alkaline compound neutralizes the pH resulting in the formation of a counterion. When PLA waste is hydrolyzed with a base, selected from sodium, potassium and ammonium, the hydrolysis slurry is neutralized with a acid selected from hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid, and combinations thereof. (pp. 12, ln 13 – 16).
Regarding claim 47, the removing of unhydrolyzed PLA waste comprises solid-liquid separation. (pp. 12, ln 17 – 18).
Regarding claim 49, , the magnesium salt in step (c) is added in solid form. In alternative embodiments, the magnesium salt in step (c) is added as an aqueous solution. In further embodiments, the magnesium salt in step (c) is gradually added. In particular embodiments, the magnesium salt in step (c) is magnesium sulfate. (pp. 12, ln 19 – 22).
Regarding claims 50 and 51. In the downstream purification of magnesium lactate, the separation of insoluble impurities may include filtration or centrifugation. (pp. 26, ln 25 – 26). Additional purification may include at least one of crystallization, recrystallization, distillation, partitioning, silica gel chromatography, preparative HPLC, and combinations thereof. Each possibility represents a separate embodiment. (pp. 11, ln 16 – 19).
Regarding claim 52, in certain embodiments, the lactate salt is magnesium L-lactate. In particular embodiments, the lactate salt is crystalline magnesium L-lactate. In specific embodiments, the lactate salt is crystalline magnesium L-lactate dihydrate. Pp. 9, ln 4-16). In further embodiments, the obtained L-lactate salt is acidified to form L-lactic acid by at least one of hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid, and combinations thereof. Each possibility represents a separate embodiment. In particular embodiments, the L-lactic acid is used for subsequent polylactic acid formation. (pp. 11, ln 20 – 23). Lastly, regarding the obtained magnesium L-lactated salt comprising less than 3% magnesium D-lactate, the Examiner turns to Shapira’s teaching on page 25. It is disclosed that D-lactic acid is reduced to less than 0.5% (w/w) out of the total lactate in the treated mixture of fermentation broth at the end of fermentation together with the products of PLA hydrolysis. As such, when adding the magnesium salt to that treated mixture, less than 0.5% (w/w) magnesium D-lactate is likely to be produced. Further, Applicant is reminded that less than, interpreted broadly, means zero.
Regarding claim 53, the methods of Shapira as discussed above, are intended for highly efficient production of an enantiomerically pure lactate salt, particularly an L-lactate salt.
Claim Rejections - 35 USC § 103
Claim(s) 39, 41, 44, 45, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Bioresource Technology, 2015), in view of Niu et al. (Microbial Cell Factories, 2014).
The rejected claims cover, inter alia, a process for enriching L-lactate enantiomer from an enantiomeric mixture derived from decomposed organic waste, the process comprising the steps of: (a) obtaining decomposed organic waste comprising an enantiomeric mixture of D- and L-lactate and a counterion other than magnesium; (b) optionally performing at least one of neutralizing the D- and L-lactate and removing solid particles from the decomposed organic waste; and (c) adding a magnesium salt to the enantiomeric mixture of step (a) or (b) to thereby precipitate magnesium L-lactate salt with enriched enantiomeric purity.
Dependent claim 41 further limits the decomposed organic waste being obtained from a lactic acid fermentation process. Dependent claim 44 further limits the counterion. Dependent claims 45 further limit step (b) neutralizing step. Dependent clam 47 further limits step (b) to removing solid particles form the waste by solid-liquid separation. Dependent 48 claim further limits the temperature of step (c) the addition of the magnesium salt.
However, Wang discloses a process for magnesium lactate (L-lactate) production using yeast and glucose and in situ removal said product by crystallization, when magnesium lactate crystals form during fermentation from a fermentation medium (abstract, & pp. 660 Section 3). Also, discloses that the fermentation medium comprises NaCl, sodium acetate, triammonium citrate, KH2PO4, MgSO4 7H20 and MnSO4 7H2O (pp. 658, 659). The time for crystallization was kept at 42°C. (pp. 659, left col. last para.). Wang discloses adding MgO as a neutralizer into the fermentation medium at the temperature of 42°C. (pp. 659, section 2.2). Wang discloses that redissolution of the crude magnesium lactate crystals obtained in the process and centrifugalizing (or filtration) are required to separate biomass (pp. 661, rt. col. last para.). Further, Wang discloses purification of magnesium lactate (pp. 662, left col. first partial par.).
Wang does not use the term 'decomposed organic waste' as in present claims, however it is well known that organic waste comprises glucose. Fermentation of glucose results in formation of L-lactate and D-lactate (see Niu (Table 3), p. 4, 5 (Flask fermentation experiments)). Thus, fermented glucose in Wang comprises a mixture of L-lactate and D-lactate.
The difference between Wang and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. §2131: "[t]he identical invention must be shown in as complete detail as is contained in the ...claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).).
However, based on the above, Wang teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. (see M.P.E.P. § 2143).
Claim Rejections - 35 USC § 103
Claim(s) 54 is rejected under 35 U.S.C. 103 as being unpatentable over He Meiling et al. (CN105018538 (see English translation)) in view of Niu et al. (Microbial Cell Factories, 2014).
The rejected claim covers, inter alia, a process for producing magnesium L-lactate salt from decomposed organic waste in high or enriched purity, the process comprising the steps of: (a) obtaining decomposed organic waste comprising L-lactate and a counterion other than magnesium; (b) optionally performing at least one of neutralizing the L-lactate and removing solid particles from the decomposed organic waste; and (c) adding a magnesium salt to the decomposed organic waste of step (a) or (b) to thereby precipitate magnesium L-lactate salt in high or enriched purity.
However, Meiling discloses a method for producing magnesium lactate by fermentation that comprises in-situ separation of magnesium lactate by crystallization, and the solid-liquid separation realized after the crystallization, wherein MgO is used as the neutralizing agent ([0023], [0024]). Said method comprises a composition of the fermentation medium comprising glucose, yeast extract, sodium chloride, sodium acetate, ammonium citrate, potassium dihydrogen phosphate, magnesium sulfate heptahydrate ([00863] – [0098]). Meiling discloses adding MgO as a neutralizer into the fermentation medium at the temperature of 42°C. ([0035] & [0042]).
Meiling does not use the term 'decomposed organic waste' as in present claims, however it is well known that organic waste comprises glucose. Fermentation of glucose results in formation of L-lactate and D-lactate (see Niu (Table 3), p. 4, 5 (Flask fermentation experiments)). Thus, fermented glucose in Wang comprises a mixture of L-lactate and D-lactate.
The difference between Meiling and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. §2131: "[t]he identical invention must be shown in as complete detail as is contained in the ...claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).).
However, based on the above, Meiling teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. (see M.P.E.P. § 2143).
Claim Rejections - 35 USC § 103
Claim(s) 55 - 58 are rejected under 35 U.S.C. 103 as being unpatentable over Shapira et al. (WO 2021/165964, effectively filed date of Feb. 19, 2020).
The rejected claim covers, inter alia, a process for producing magnesium L-lactate salt from decomposed organic waste, the process comprising the steps of (a) decomposing organic waste by performing at least one of organic waste fermentation using a lactic acid-producing microorganism and PLA hydrolysis in the presence of an alkaline compound to obtain decomposed organic waste comprising L-lactate and a counterion other than magnesium; (b) optionally performing at least one of neutralizing the L-lactate and removing solid particles from the decomposed organic waste; and U S National Stage of International Application No PCT/IL2022/050832 (c) adding a magnesium salt to the decomposed organic waste of step (a) or (b) to thereby precipitate magnesium L-lactate salt.
Dependent claim 56 further limits the alkaline compound. Dependent claim 57 further limits how NH4Oh is obtained. Dependent claim 58 further limits where magnesium salt of step (c) is obtained.
However, Shapira provides methods and systems for highly efficient production of an enantiomerically pure lactate salt, particularly an L-lactate salt, by combined recycling of organic waste and PLA waste. More particularly, the method of Shapira integrates production of L-lactate monomers by lactic acid fermentation of organic waste with chemical hydrolysis of PLA to its constituting monomers (L- and optionally D- lactate monomers). As disclosed herein, L-lactate monomers produced by fermentation and lactate monomers produced by chemical hydrolysis of PLA are combined and purified together in a single downstream purification and recovery process to obtain a pure L-lactate salt. (pp. 6, ln 7 – 15).
As disclosed in Shapira, lactic acid fermentation is carried out in the presence of an alkaline compound that adjusts the pH during fermentation, resulting in a fermentation broth comprising L-lactate monomers and a counterion. The PLA hydrolysis is carried out using a metal oxide or a hydroxide, resulting in a hydrolysis slurry comprising lactate monomers (L- and optionally D-) and a counterion. The alkaline compound used during fermentation and the metal oxide or the hydroxide used for PLA hydrolysis according to the present invention produce L-lactate monomers and a counterion which may be the same or different with each possibility representing a separate embodiment. When using the same counterion, the L-lactate monomers and the counterions can be combined and purified together to obtain a pure lactate salt. When using a different counterion, at least one of the counterions can be exchanged thereby resulting in the same counterion which together with the L-lactate monomers can be subjected to subsequent combined purification. (pp. 6, ln 23 to pp. 7, ln 3).
Further, in other embodiments, the compounds are different, but one of the counterions is exchanged to produce the same counterion as the other for subsequent purification. For example, sodium hydroxide can be used as a hydroxide for PLA hydrolysis, and magnesium hydroxide can be used as an alkaline compound for pH adjustment during fermentation. The sodium ions in the hydrolysis slurry can then be exchanged with magnesium ions thereby resulting in lactate monomers and magnesium ions in both the hydrolysis slurry and the fermentation broth, which can be recovered as magnesium lactate salt. In further embodiments, both counterions are exchanged to produce the same counterion for subsequent purification. (pp. 7, ln 14 – 22).
The alkaline compound of Shapira can be at least one of NaOH, KOH, NH4OH, Ca(OH)2, Mg(OH)2, and a mixture or combination thereof. (pp. 19, ln 11 – 13 & pp. 22, ln 27 – 30).
Figure 3 illustrates a process in which NH4OH is used as the PLA alkaline hydrolysis agent and as the pH adjusting alkaline compound in lactic acid fermentation. and in which ion exchange is carried out in order to obtain Mg(LA)2 that can be recovered and purified. PLA waste undergoes chemical degradation using NH4OH, to obtain NH4LA. Organic waste undergoes fermentation by an L-lactic acid-producing microorganism in the presence of NH4OH for pH neutralization, resulting in NH4(L-LA). NH4LA obtained from PLA hydrolysis and NH4LA produced by fermentation are combined and subjected to ion exchange with Mg(OH)2, to obtain Mg(LA)2 and NH4OH. The Mg(LA)2 can be recovered, purified and acidified to obtain LAH, that can be used in the synthesis of new PLA. The NH4OH can be re-used for pH adjustment and/or PLA hydrolysis in further lactic acid fermentation and PLA hydrolysis processes. (pp. 16, ln 19 – 30).
Also, in Shapira magnesium salts are added to the PLA hydrolysis slurry to thereby precipitate magnesium L-lactate salt. (pp. 12, ln 1 – 2).
The difference between Shapira and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. §2131: "[t]he identical invention must be shown in as complete detail as is contained in the ...claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).).
However, based on the above, Shapira teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. (see M.P.E.P. § 2143).
The remaining differences between Shapira and the claimed invention is as follows: the NH4OH is obtained by gas stripping; and wherein the magnesium salt in step (c) is derived from acidification, methylation or acetylation of magnesium L-lactate of a previous batch of lactic acid fermentation.
However, with regard to the NH4OH is obtained by gas stripping the Examiner turns to the teaching of Shapira Figure 3, where it is discloses that NH4OH is recycled for reuse. It would have been obvious to one having ordinary skill in the art at the time of the instantly claimed invention use any known means to separate out the NH4OH for recycling back into the reaction process. This limitation is deemed to be obvious absent a showing of unexpected results.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35USC 103.
Regarding wherein the magnesium salt in step (c) is derived from acidification, methylation or acetylation of magnesium L-lactate of a previous batch of lactic acid fermentation, the Examiner turns to the teaching of Example 2 of Shapira. In Example 2, the solution was neutralized with concentrated H2SO4, then 280 ml of magnesium sulfate heptahydrate solution (300 g/L) were added dropwise while stirring. The MgLa₂·2H₂O precipitate that formed was filtered. The magnesium lactate precipitate is added into a lactic acid fermentation broth and subsequently subjected to a downstream processing (DSP) procedure to produce pure magnesium L-lactate crystals. (pp. 30. ln 32 – pp. 31, ln 9). This limitation is deemed to be obvious absent a showing of unexpected results.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35USC 103.
Conclusion
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/YATE' K CUTLIFF/Primary Examiner, Art Unit 1692
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