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 the Claims
Claims 51-67, 69 and 70 are pending.
Claims 51, 55, and 69 are currently amended.
Claim 68 is currently cancelled.
Claims 1-50 were previously cancelled.
Response to Amendments
Applicant’s amendments filed on 12 June 2026 are acknowledged.
Claim Objections
Applicant’s amendments to claims 51 and 69 are sufficient to overcome the
objections of the claims. The claims have been amended for clarity. The objections are withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s amendments to claims 51, 55, and 69 are sufficient to overcome the rejections of claims 51-70 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 51, 55, and 69 have been amended to clarify the specific lactate salt. The rejections are withdrawn.
Applicant’s amendments to claims 51 and 69 are sufficient to overcome the rejection of claims 51-70 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 51 and 69 have been amended to clarify the antecedent basis issue regarding the water in step (d). The rejection is withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s cancellation of claim 68 is sufficient to overcome the rejections of:
Claim 68 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Shapira (WO2020110108, published 04 June 2020, effectively filed date 25 November 2019); and,
Claim 68 under 35 U.S.C. 102(a)(1) as being anticipated by Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets).
Response to Arguments
Applicant’s 35 U.S.C. § 102(b)(2)(C) Response
The declaration filed on 12 June 2026 regarding the name change of TripleW Ltd. to 3PLW Ltd. is acknowledged.
Applicant’s statements on page 7 of the remarks filed on 12 June 2026 that “Shapira is disqualified as prior art under 35 U.S.C. § 102(b)(2)(C) as it was not later than January 21, 2021, owned by, or subject to an obligation of assignment to, the same legal entity, namely the company then known as 3PLW Ltd. and now known as TripleW Ltd. In support, a Declaration under 35 U.S.C. § 102(b)(2)(C) of Tal Shapira, the CEO and co-founder of TripleW Ltd. is submitted herewith”, is sufficient to overcome the rejections of:
Claims 51-57, 59-61, 63, 67, 69, and 70 under 35 U.S.C. 103 as being obvious over Shapira (WO2020110108, published 04 June 2020, effectively filed date 25 November 2019) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel);
Claims 58, 65, and 66 under 35 U.S.C. 103 as being obvious over Shapira (WO2020110108, published 04 June 2020, effectively filed date 25 November 2019) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-57, 59-61, 63, 67, 69, and 70, in further view of Boit et al. (US20150218071, published 06 August 2015, hereinafter Boit);
Claim 62 under 35 U.S.C. 103 as being obvious over Shapira (WO2020110108, published 04 June 2020, effectively filed date 25 November 2019) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-57, 59-61, 63, 67, 69, and 70, in further view of Zhiyong (CN106083565, published 09 November 2016, see machine translation); and,
Claim 64 under 35 U.S.C. 103 as being obvious over Shapira (WO2020110108, published 04 June 2020, effectively filed date 25 November 2019) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-57, 59-61, 63, 67, 69, and 70, in further view of Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets).
Due to applicant’s clear and conspicuous statement that the claimed invention of the application under examination and the subject matter disclosed in WO2020110108 to Shapira applied as prior art were owned by the same person or subject to an obligation of assignment to the same person, namely the company then known as 3PLW Ltd. and now known as TripleW Ltd., not later than the effective filing date of the claimed invention, the above rejections are withdrawn, see MPEP 2154.02(c).
Applicant’s arguments filed on 12 June 2026 have been fully considered but they are not persuasive.
Applicant’s argue that Baets, Stiefel, Boit, Zhiyong, and Horiguchi do not disclose the limitations as recited in the claims. These arguments have been considered but are not persuasive for the reasons set forth in the maintained and modified grounds of rejection below and the response to arguments below.
In response to Applicant’s arguments on page 8 of the remarks filed on 12 June 2026 that “the pending claims require a coordinated sequence of process steps, including, inter alia, mixing a clarified dispersion of decomposed organic waste to obtain a seeded suspension and removing from about 70% to about 90% of water from the suspension, performed under elevated temperature and reduced pressure conditions”, on pages 11-12 of the remarks that “the claimed processes employ evaporative crystallization performed outside a fluidized bed dryer, requiring controlled removal of solvent from a bulk liquid phase to induce crystallization from solution”, and throughout the remarks that “the claimed processes provide selective crystallization and enrichment of enantiomeric purity of magnesium L-lactate directly from a D- and L-lactate mixture containing endogenous D-lactic acid/lactate of up to 10wt.%, without resorting to postproduction chiral separation or stereochemical purification steps”.
It is noted the instant claims do not specifically claim a sequence of adding/mixing/removing ingredients, the instant claims incorporate optional steps, the instant claims make no mention of a specific type of evaporative crystallization without the use of a fluidized dryer, and the instant claims make no mention of zero postproduction chiral separation or stereochemical purification steps.
MPEP 2145 VI. states “[a]lthough the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993)”. Therefore, merely discovering and claiming a new benefit of an old process cannot render the process again patentable, for example reversing the order of the prior art process steps, selection of any order of performing process steps, and selection of any order of mixing ingredients are all prima facie obvious in the absence of new or unexpected results, see MPEP 2144.04 IV.C. and In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). In addition, the instant claims are drawn to the transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps”, see MPEP 2111.03 I. Additional steps, such as separating the isomers may occur at any point between and amongst the instantly claimed steps.
For the reasons indicated above, applicants above arguments are not persuasive.
In response to applicant's arguments throughout the remarks filed on 12 June 2026 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) and MPEP 2145 IV.
In response to Applicant’s arguments on pages 8-10 of the remarks filed on 12 June 2026 that “[s]urprisingly, the claimed processes provide selective crystallization and enrichment of enantiomeric purity of magnesium L-lactate directly from a D- and L-lactate mixture containing endogenous D-lactic acid/lactate of up to 10wt.%, without resorting to postproduction chiral separation or stereochemical purification steps”. “As a result, an economical process for producing magnesium L-lactate salt with enantiomeric purity greater than 99% is provided, while avoiding additional complex and costly isomer-separation steps.”
The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious, see Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition, “[t]o establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range” In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960), see MPEP 716.02(d).
In this case, Applicant’s have not provided a proper comparison to the closest prior art and have not established test points inside and outside any claimed range in order to support the argument of surprising and unexpected results, see MPEP 716.02(e). For the reasons indicated above, applicants above arguments are not persuasive.
In response to Applicant’s arguments throughout the remarks filed on 12 June 2026 that Baets, Stiefel, Boit, Zhiyong, and Horiguchi do not individually teach each and every limitation of the instant claims. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art, see In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981) and MPEP 2145. For the reasons indicated above, applicants above arguments are not persuasive.
In this case, in response to applicants arguments throughout the remarks that Baets is directed to a differing process, a different fermentation material, “does not describe the stereochemical or enantiomeric composition of lactate derived from the starting materials”, there is “no description of any result relating to enrichment or modification of enantiomeric composition”, and “neither Baets nor Stiefel teaches or suggests enantiomeric enrichment by crystallization, nor do they address selective crystallization of one enantiomer from an enantiomeric mixture”.
As stated above, the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art and , “[a] reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention)”, see MPEP 2141.01(a).
As stated on pages 26-28 of the previous office action dated 17 February 2026 (hereinafter POA), “Baets is in the known prior art field of processes for vacuum crystallization of magnesium L-lactate supersaturated aqueous solutions to cause in situ seed crystals to form, see Abstract; Paras. [0030];[0036]-[0038];[0082]-[0087]”, and is applied to teach the same. To clarify, Baets teaches the enantiomeric separation of “magnesium L-lactate” from an aqueous “organic waste feedstock”, such as food and agricultural waste, fermentation broth “from which dissolved magnesium lactate is isolated from a fermentation broth” , see Paras. [0036]-[0038];[0080];[0086], which “includes the production of either a single stereoisomer of lactic acid or lactate or a mixture of both stereoisomers of lactic acid or lactate”, see Para. [0030]. Therefore, Baets is in the same field of endeavor as the instant specification and is drawn to the same problem to be solved of isolating, crystallizing, and purifying a single stereoisomer of magnesium L-lactate from food organic aqueous waste fermentation broths. For the reasons indicated above, applicants above arguments are not persuasive.
As stated on pages 28-29 of the POA, “Stiefel is in the known prior art field of processes for vacuum crystallization of supersaturated aqueous solutions of metal hydrates useful as pharmaceutical ingredients without the use of seed crystals, see Abstract; Figs. 1-2; Paras. [0021]-[0023], and is applied to teach the problem to be solved of crystallization of metal hydrates from unsaturated aqueous solutions.” Applicant’s argue on pages 10-12 of the remarks that “[a] person of ordinary skill in the art would not reasonably view Stiefel as addressing the same technical problem as the present application” and “Stiefel's parameters are disclosed in the context of crystallization perforned in a fluidized bed dryer and are specifically designed for drying and crystallizing discrete solid particles suspended in a gas stream”. To clarify, as stated on pages 28-29 of the POA, Stiefel teaches “feeding a filtered unsaturated solution via spray 5 to a vacuum crystallization vessel 6 equipped with stirrers 7, 8, mixing the solution, and concentrating the solution until seed crystals are formed in situ, see Paras. [0033]-[0034];[0044]-[0049];[0172]-[0176]; Fig. 2”. Stiefel teaches solution based vacuum separation and crystallization and that crystallization is rarely “directly from a gas”, see Para. [0002], a ““fluidized bed dryer” is an apparatus basically comprising a cylindrical vessel with a conical designed bottom part”, see Paras. [0037]-[0041], and the “rotation speed and rotation direction of the stirring paddle was modified during the various stages of drying”, see Para. [0201]. As stated on page 16, lines 20-32 of the instant specification, the instantly claimed evaporation is also performed with rotation in “a rotatory evaporator”. In addition, Baets teaches “[l]actic acid is widely used in the food, pharmaceutical, plastics and textile industries”, see Para. [0002], and the “concentration step ii) may be performed by removal of water under ambient or reduced pressure or by means of evaporative crystallization”, see Paras. [0083]-[0086]. Therefore, Stiefel is in the same field of endeavor as Baets and is directed to the problem to be solved of controlled solution precipitation of a pharmaceutical metal hydrate.
As stated on page 30 of the POA, “[t]he rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Stiefel teach vacuum crystallization of supersaturated aqueous solutions of metal hydrates, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Stiefel before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently crystallizing a metal hydrate of desired size by adjusting the operating conditions, such as mixing conditions, temperature, pressures, supersaturation, etc., by vacuum crystallization of supersaturated aqueous solutions of metal hydrates useful as pharmaceutical ingredients without the use of seed crystals, see Stiefel, Abstract; Figs. 1-2; Paras. [0002]-[0006];[0021]-[0023];[0044]-[0049];[0099] and MPEP 2141.” For the reasons indicated above, applicants above arguments are not persuasive.
As stated on pages 32-33 of the POA, “Boit is in the known prior art field of processes for vacuum crystallization of supersaturated aqueous solutions by stirring to cause in situ seed crystals to form, see Abstract; Paras. [0023]-[0032], and adjusting the evaporation rate, the temperature, and the pressure in order to obtain crystals of the desired physical properties, such as particle size, see Paras. [0001];[0028];[0031];[0045]. Boit is applied to solve the problem of solvent extraction by vacuum crystallization of supersaturated aqueous solutions to obtain crystals of desired particle size.” Boit also teaches “[m]annitol is an acyclic polyol commonly used in particular as an excipient in pharmaceutical formulations such as tablets, granules or powders, or else as a stabilizer in protein compositions”, see Paras. [0002];[0067]. Therefore, Boit is in the same field of endeavor as Baets teaching evaporative crystallization of pharmaceutical products.
As stated on page 34 of the POA, “[t]he rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Boit teach vacuum crystallization of supersaturated aqueous solutions, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Boit before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently obtaining crystals of desired physical properties, such as crystal size, by adjusting the operating conditions, such as evaporation rate, the temperature, and the pressure, by vacuum crystallization of supersaturated aqueous solutions by stirring to cause in situ seed crystals to form, see Boit, Abstract; Paras. [0001];[0023]-[0032];[0045] and MPEP 2141.” For the reasons indicated above, applicants above arguments are not persuasive.
Furthermore, an “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, see MPEP 2145 X.B. Since Baets, Stiefel, and Boit all teach evaporative vacuum solution crystallization of pharmaceutical products, the prior art contains “detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful”, see MPEP 2145 X.B.; therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was made to try the evaporative vacuum solution crystallization methods and techniques of Stiefel and Boit to selectively crystallize the magnesium L-lactate of Baets.
For all of the reasons indicated above, applicants above arguments are not persuasive.
In response to Applicant’s arguments on pages 14-17 of the remarks filed on 12 June 2026 that Zhiyong and Horiguchi do not remedy the insufficiencies identified in the combination of Baets, Stiefel, and Boit.
As stated on page 36 of the POA, “Zhiyong is in the known prior art field of processes for vacuum crystallization of magnesium lactate supersaturated aqueous solutions by stirring to cause in situ seed crystals to form magnesium lactate crystals with the desired physical properties, see Abstract; Paras. [0020];[0032]-[0037]. Zhiyong is applied to solve the problem of crystallization and drying of magnesium lactate crystals.” Zhiyong is not applied to teach instantly claimed steps (a)-(f), Zhiyong is applied to teach the magnesium lactate drying step (g). Baets teaches the “recovered yield of lactic acid in the form of magnesium lactate crystals is usually from 50 wt. % or even from 70 wt. % to 99 wt. %, based on the amount of lactic acid produced during fermentation”, where the methods for recovery “may equally find utility in further purification steps applied to the magnesium lactate”, see Paras. [0082]-[0087].
As stated on pages 37-38 of the POA, “[t]he rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Zhiyong teach vacuum crystallization of supersaturated aqueous solutions to obtain magnesium lactate crystals, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Zhiyong before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently obtaining magnesium lactate crystals of desired physical properties, such as LOD, see Zhiyong, Abstract; Paras. [0020];[0032]-[0037] and MPEP 2141.” For the reasons indicated above, applicants above arguments are not persuasive.
As stated on page 39 of the POA, “Horiguchi is in the known prior art field of lactic acid salt production from a fermentation broth, such as magnesium L-lactate, by reduced pressure crystallization, see Paras. [0002]-[0015];[0056]-[0057].” Applicant’s argue on pages 15-17 of the remarks that “Horiguchi does not teach crystallization of L-lactate salts by reducing the pressure and controlling the temperature to evaporate water from the fermentation broth. Rather, the cited reference clearly teaches that crystallization of lactic acid salts is achieved by cooling the aqueous solution.” Horiguchi is not applied to teach the temperature of the vacuum crystallization. Baets teaches the “concentration step may be performed by evaporation followed by cooling crystallization”, see Para. [0086]. Stiefel teaches the crystallization temperature “is in the range of between −10° C. and +125° C.” depending “from the chemical nature of the substance to be crystallized”, see Paras. [0046];[0063]-[0064]. Horiguchi is applied to teach the concentration of the lactic acid solution after the concentration step (b) and the crystallization of magnesium L-lactate.
As stated on pages 40-41 of the POA, “[t]he rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Horiguchi teach vacuum crystallization of supersaturated aqueous solutions, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Horiguchi before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently crystallizing a lactic acid salt of the optimal isomer with high purity and recovery, see Horiguchi, Paras. [0002];[0006];[0015];[0022];[0056]-[0057] and MPEP 2141.” For the reasons indicated above, applicants above arguments are not persuasive.
For all of the reasons indicated above, applicants above arguments are not persuasive.
In response to Applicant’s arguments on pages 12-14 of the remarks filed on 12 June 2026 that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper, see In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971) and MPEP 2145 X.A. Only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made has been applied to determine obviousness.
For the reasons indicated above, applicant’s above argument is not persuasive.
Therefore, the following rejections are all maintained in modified form:
Claims 51-54, 56, 57, 59, 60, 63, 64, and 69 under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel);
Claims 58, 61, 65, and 66 under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-54, 56, 57, 59, 60, 63, 64, and 69 above, in further view of Boit et al. (US20150218071, published 06 August 2015, hereinafter Boit);
Claim 62 under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-54, 56, 57, 59, 60, 63, 64, and 69 above, in further view of Zhiyong (CN106083565, published 09 November 2016, see machine translation); and,
Claims 55, 67, and 70 under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-54, 56, 57, 59, 60, 63, 64, and 69 above, in further view of Horiguchi et al. (US20140012041, 09 January 2014, hereinafter Horiguchi), as evidenced by Sawai et al. (US20110263811, published 27 October 2011, hereinafter Sawai).
In the Spirit of Compact Prosecution
While the examiner has attempted to identify all objections and clarity issues amongst the claims, applicant is advised that some objections and clarity issues may still remain. Going forward, the examiner respectfully requests applicant to perform a detailed review of the claims regarding clarity, grammar, antecedent basis, word spacing, and spelling issues.
Maintained Rejections Based on the Amendments to the Claims filed on 12 June 2026
For clarity between the maintained and modified rejections, the specific modified rejections below are in italics.
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.
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.
Claims 51-54, 56, 57, 59, 60, 63, 64, and 69 stand rejected in modified form under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel).
Baets is in the known prior art field of processes for vacuum crystallization of magnesium L-lactate supersaturated aqueous solutions to cause in situ seed crystals to form, see Abstract; Paras. [0030];[0082]-[0087].
Regarding instant application claims 51 and 69, Baets teaches a process for the high recovery of magnesium lactate crystals, where the magnesium lactate is L-lactate or a mixture of D- and L-lactate, see Abstract; Paras. [0030];[0082]-[0087]. The process comprises clarifying by solid/liquid separation a fermentation broth obtained from a fermentation process of organic waste feedstocks comprising soluble and insoluble impurities to provide step (a) a clarified fermentation broth from which dissolved magnesium lactate is isolated from a fermentation broth at a temperature of 20 °C to 75 °C, see Paras. [0036]-[0038];[0086], where the fermentation broth is an aqueous fermentation broth, see Paras. [0021];[0064]. The magnesium lactate medium in step (a) remains soluble in the fermentation broth at a concentration of at the most 9.5 wt. % or 95 g/L when measured at a temperature of 80° C, see Para. [0080], meeting step (a) and within the concentration range in instant application claim 51 and in instant application claim 69.
Next, a concentration step is performed to provide magnesium lactate crystals from the magnesium lactate medium by removal of water under reduced pressure or by means of evaporative crystallization, see Para. [0086], meeting optional step (b) and removal of water in step (d) in instant application claim 51 and in instant application claim 69.
The magnesium lactate crystals are then separated, collected, and washed, see Paras. [0086]-[0087], meeting the collection of step (e) in instant application claim 51 and in instant application claim 69.
Regarding instant application claims 52-54, Baets teaches the impurities are removed from the decomposed organic waste fermentation broth of food, municipal, agricultural, industrial, and commercial waste, or combinations thereof, by filtration, centrifugation, flotation, sedimentation, flocculation and decantation, see Paras. [0036]-[0038];[0086], meeting the clarification, specific wastes, and fermentation broth in instant application claim 52, in instant application claim 53, and in instant application claim 54.
Regarding instant application claims 59 and 60, Baets teaches the obtained magnesium lactate crystals are collected, separated by solid/liquid separation, such as filtration or centrifuge, and then washed, see Para. [0086], meeting the filtration or centrifuge collection and washing in instant application claim 59 and in instant application claim 60.
Regarding instant application claim 63, Baets teaches the crystalline solids obtained are further processed, recrystallized, and the mother liquor may be recycled to a biologically mediated transformation process, to the enzymatic hydrolysis and/or the fermentation steps, see Paras. [0082]-[0085], meeting the recrystallized and solubilized in instant application claim 63.
Regarding instant application claim 64, Baets teaches the recovery of magnesium lactate crystals is from 70 wt. % to 99 wt. %, see Para. [0087], meeting within the recovery range in instant application claim 64.
Baets does not teach:
The instant application claims 51 and 69 limitations of c. mixing the clarified dispersion of step (a) or the concentrated clarified dispersion of step (b) to obtain a suspension comprising seed magnesium L-lactate crystals; d. removing from about 70% to about 90% of water from the suspension; and, wherein steps (b) through (d) are performed at elevated temperature in the range of about 50 0C to about 90 0C and the application of a vacuum to a pressure of about 80 to about 300 mbar; and,
The limitations of instant application claims 56 and 57.
Stiefel is in the known prior art field of processes for vacuum crystallization of supersaturated aqueous solutions of metal hydrates useful as pharmaceutical ingredients without the use of seed crystals, see Abstract; Figs. 1-2; Paras. [0021]-[0023], and is applied to teach the problem to be solved of crystallization of metal hydrates from unsaturated aqueous solutions.
Regarding instant application claims 51, 57, and 69, Stiefel teaches feeding a filtered unsaturated solution via spray 5 to a vacuum crystallization vessel 6 equipped with stirrers 7, 8, mixing the solution, and concentrating the solution until seed crystals are formed in situ, see Paras. [0033]-[0034];[0044]-[0049];[0172]-[0176]; Fig. 2, where the water content upon concentration is in the range of between 80%-0%, see Paras. [0070];[0096]-[0097], the pressure is maintained below 1 bar, such as 6.5 mbar and 100 mbar, and the temperature is in the range of between −10° C. and +125° C., see Paras. [0063]-[0070], meeting step (c), within the range of water removal in step (d), within the pressure range, and within the temperature range in instant application claim 51, in instant application claim 57, and in instant application claim 69.
Regarding instant application claim 56, Stiefel teaches the process concentration mixing is conducted within the range of 20 rpm-80 rpm for the paddle stirrer and for the multiple chopper within a range of 200 rpm-400 rpm, see Para. [0099], meeting within the rpm range in instant application claim 56.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Baets to apply the crystallization process as taught by Stiefel with a reasonable predictability of success for the purpose of efficiently crystallizing a metal hydrate of desired size by adjusting the operating conditions, such as mixing conditions, temperature, pressures, supersaturation, etc., by vacuum crystallization of supersaturated aqueous solutions of metal hydrates useful as pharmaceutical ingredients without the use of seed crystals, see Stiefel, Abstract; Figs. 1-2; Paras. [0002]-[0006];[0021]-[0023];[0044]-[0049];[0099].
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Stiefel teach vacuum crystallization of supersaturated aqueous solutions of metal hydrates, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Stiefel before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently crystallizing a metal hydrate of desired size by adjusting the operating conditions, such as mixing conditions, temperature, pressures, supersaturation, etc., by vacuum crystallization of supersaturated aqueous solutions of metal hydrates useful as pharmaceutical ingredients without the use of seed crystals, see Stiefel, Abstract; Figs. 1-2; Paras. [0002]-[0006];[0021]-[0023];[0044]-[0049];[0099] and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“The normal desire of scientists or artisans to improve upon what is
already generally known provides the motivation to determine where in a disclosed set
of percentage ranges”, such as the % water evaporation and % isomer collected, “is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), see MPEP 2144.05.
Selection of a known material, such as a particular fermentation broth or washing solvent, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Since “a prima facie case of obviousness exists” where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” and where the claimed ranges or amounts do not overlap with the prior art but are merely close, see MPEP 2144.05, one of ordinary skill in the art, before the effective filing date of the claimed invention, would be able to modify Baets to predictably determine the % water evaporation, % isomer collected, saturation concentrations, pressure ranges, temperature ranges, mixing rate, and mixing time in order to crystallize magnesium L-lactate crystals from a fermentation broth, see Baets, Paras. [0080];[0161].
In addition, “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions,” such as saturation concentrations, pressure ranges, “or degree” such as temperature ranges, mixing rate, and mixing time, “or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
Claims 58, 61, 65, and 66 stand rejected under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-54, 56, 57, 59, 60, 63, 64, and 69 above, in further view of Boit et al. (US20150218071, published 06 August 2015, hereinafter Boit).
Baets teaches the known prior art field of the concentration is performed by evaporation of water under reduced pressure, see Para. [0086].
Baets does not teach the limitations of instant application claims 58, 61, 65, and 66.
Boit is in the known prior art field of processes for vacuum crystallization of supersaturated aqueous solutions by stirring to cause in situ seed crystals to form, see Abstract; Paras. [0023]-[0032], and adjusting the evaporation rate, the temperature, and the pressure in order to obtain crystals of the desired physical properties, such as particle size, see Paras. [0001];[0028];[0031];[0045]. Boit is applied to solve the problem of solvent extraction by vacuum crystallization of supersaturated aqueous solutions to obtain crystals of desired particle size.
Regarding instant application claim 58, Boit teaches the evaporation rate during constant stirring of the in situ seed crystal formation water evaporation is at an evaporation rate by mass of between 0.08 and 0.5 kg of solvent/h/kg of initial stock solution and during the growth phase an evaporation rate by mass of water between 0.005 and 0.1 kg of solvent/h/kg of initial stock solution, see Paras. [0024];[0030]-[0032], when the stock solution is 50% water and 50% dissolved dry matter a 5 kg initial stock solution has 2.5 kg of water, see Paras. [0023]-[0027];[0054]-[0056], as calculated by the examiner, an evaporation rate of 0.2 wt% to 20 wt% per hour, meeting and within the evaporation rate range in instant application claim 58.
Regarding instant application claim 61, Boit teaches the collected crystals are washed by rinsing with water and ethanol, see Para. [0041], meeting the specific washing solvent in instant application claim 61.
Regarding instant application claims 65 and 66, Boit teaches the crystals have a volume mean diameter D4,3 greater than 20 μm, preferentially a volume mean diameter of between 30 μm and 100 μm and very preferentially between 50 μm and 100 μm, see Para. [0045], meeting the within the crystal sizes in instant application claim 65 and in instant application claim 66.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Baets to apply the crystallization process as taught by Boit with a reasonable predictability of success for the purpose of efficiently obtaining crystals of desired physical properties, such as crystal size, by adjusting the operating conditions, such as evaporation rate, the temperature, and the pressure, by vacuum crystallization of supersaturated aqueous solutions by stirring to cause in situ seed crystals to form, see Boit, Abstract; Paras. [0001];[0023]-[0032];[0045].
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Boit teach vacuum crystallization of supersaturated aqueous solutions, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Boit before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently obtaining crystals of desired physical properties, such as crystal size, by adjusting the operating conditions, such as evaporation rate, the temperature, and the pressure, by vacuum crystallization of supersaturated aqueous solutions by stirring to cause in situ seed crystals to form, see Boit, Abstract; Paras. [0001];[0023]-[0032];[0045] and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“The normal desire of scientists or artisans to improve upon what is
already generally known provides the motivation to determine where in a disclosed set
of percentage ranges”, such as the % water evaporation rate, “is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), see MPEP 2144.05.
In addition, “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions,” such as particle size, “or degree” such as evaporation rate, “or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
Claim 62 stands rejected under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-54, 56, 57, 59, 60, 63, 64, and 69 above, in further view of Zhiyong (CN106083565, published 09 November 2016, see machine translation).
Baets teaches the known prior art of a process for the high recovery of magnesium lactate crystals, where the magnesium lactate is L-lactate, see Abstract; Paras. [0030];[0082]-[0087].
Baets does not teach the limitations of instant application claim 62.
Zhiyong is in the known prior art field of processes for vacuum crystallization of magnesium lactate supersaturated aqueous solutions by stirring to cause in situ seed crystals to form magnesium lactate crystals with the desired physical properties, see Abstract; Paras. [0020];[0032]-[0037]. Zhiyong is applied to solve the problem of crystallization and drying of magnesium lactate crystals.
Regarding instant application claim 62, Zhiyong teaches the obtained crystalized magnesium lactate has a loss on drying tested at 120℃ for 4h of ≤17.0%, dihydrate, see Paras. [0036]-[0037] and below,
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, meeting within the temperature range and the LOD range in instant application claim 62.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Baets to test for and to manufacture a crystal with the LOD as taught by Zhiyong with a reasonable predictability of success for the purpose of efficiently obtaining magnesium lactate crystals of desired physical properties, such as LOD, see Zhiyong, Abstract; Paras. [0020];[0032]-[0037].
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Zhiyong teach vacuum crystallization of supersaturated aqueous solutions to obtain magnesium lactate crystals, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Zhiyong before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently obtaining magnesium lactate crystals of desired physical properties, such as LOD, see Zhiyong, Abstract; Paras. [0020];[0032]-[0037] and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“The normal desire of scientists or artisans to improve upon what is
already generally known provides the motivation to determine where in a disclosed set
of percentage ranges”, such as the % LOD, “is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), see MPEP 2144.05.
In addition, “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form”, such as LOD %, “proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
Claims 55, 67, and 70 stand rejected under 35 U.S.C. 103 as being obvious over Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets) in view of Stiefel et al. (US20130149232, published 13 June 2013, hereinafter Stiefel), as applied in the 35 USC 103 rejection of claims 51-54, 56, 57, 59, 60, 63, 64, and 69 above, in further view of Horiguchi et al. (US20140012041, 09 January 2014, hereinafter Horiguchi), as evidenced by Sawai et al. (US20110263811, published 27 October 2011, hereinafter Sawai).
Baets teaches the known prior art of a process for the high recovery of magnesium lactate crystals by concentration under reduced pressure to evaporate water, where the magnesium lactate is L-lactate, see Abstract; Paras. [0030];[0082]-[0087].
Baets does not teach the limitations of instant application claims 55, 67, and 70.
Horiguchi is in the known prior art field of lactic acid salt production from a fermentation broth, such as magnesium L-lactate, by reduced pressure crystallization, see Paras. [0002]-[0015];[0056]-[0057].
Regarding instant application claim 55, Horiguchi teaches crystallization of L-lactate salts by reducing the pressure and controlling the temperature to evaporate water from the fermentation broth, see Paras. [0007]-[0015];[0032]-[0035];[0056]-[0057]. When the concentration of the lactic acid salt is above 30.0% by weight or 300 g/L, the fermentation broth is evaporated at temperatures of not less than 40° C. to obtain a concentrated solution of the L-lactate salt that is between 10.0 to 30.0% by weight or 100 to 300 g/L, see Paras. [0032]-[0033], meeting within the concentration range in instant application claim 55.
Regarding instant application claims 67 and 70, Horiguchi teaches the lactic acid salt is selectively produced to be an L-isomer by selecting the microorganism for microbial fermentation that produced L-isomers, such as Lactobacillus casei, see Paras. [0002];[0056]-0057]. As evidenced by Sawai, fermentation with the Lactobacillus casei strain produces the L-isomer lactic acid with an optical purity of 95% to 99.9%, see Paras. [0065]-[0066];[0145]; therefore, the Horiguchi produced L-lactate salt may have an L-isomer purity of 95% to 99.9%, , i.e., less than about 0.1% to 5 wt% D-lactate, meeting and within the range in instant application claim 67 and in instant application claim 70.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Baets to apply the crystallization process and selection of isomer as taught by Horiguchi with a reasonable predictability of success for the purpose of efficiently crystallizing a lactic acid salt of the optimal isomer with high purity and recovery, see Horiguchi, Paras. [0002];[0006];[0015];[0022];[0056]-[0057].
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Baets and Horiguchi teach vacuum crystallization of supersaturated aqueous solutions, a person of ordinary skill in the art has good reason to modify the crystallization of Baets by relying upon Horiguchi before the effective filing date of the claimed invention for knowledge generally available within the supersaturation vacuum crystallization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently crystallizing a lactic acid salt of the optimal isomer with high purity and recovery, see Horiguchi, Paras. [0002];[0006];[0015];[0022];[0056]-[0057] and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“The normal desire of scientists or artisans to improve upon what is
already generally known provides the motivation to determine where in a disclosed set
of percentage ranges”, such as the % isomers, “is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), see MPEP 2144.05.
In addition, “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions,” such as concentration for saturation, “or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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