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 .
Priority
This application is a 371 of PCT/IL2022/050081 which claims the benefit of US Provisional Applications 63/280,150 and 63/139,894 with an effective filing date of 21 January 2021 as reflected in the filing receipt mailed on 04 June 2024.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections
Claims 51 and 69 are objected to because of the following informalities:
Claims 51 and 69 recite the limitation “the application of a vacuum to a pressure of about 80 to about 300 mbar”, which appears to include grammatical and/or typographical mistakes. The limitation in claims 51 and 69 is interpreted to state “with the application of a vacuum to a pressure of about 80 to about 300 mbar”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 51-70 are rejected 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.
If the language of the claim is such that a person of ordinary skill in the art could
not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 USC 112(b) is appropriate, see MPEP 2173.02.
Claims 51 and 69 are drawn to the formation of magnesium lactate crystals. Claims 51 and 69 steps (a) and (b) state “a lactate salt”. The lactate salt of steps (a) and (b) lack clarity. In order for magnesium lactate crystals to form upon the mixing in step (c), the lactate salt of step (a) and step (b) must contain magnesium or the clarified dispersion in step (a) must contain lactate and magnesium. Herein, a lactate salt in steps (a) and (b) is interpreted as “a magnesium lactate salt”.
Claims 51 and 69 recite step (d) where water is in the suspension of step (c); however, water is not detailed as a component in steps (a)-(c). Step (a) in claims 51 and 69 is interpreted with the clarified dispersion also comprising water.
Regarding claim 55, herein, a lactate salt is interpreted as “a magnesium lactate salt”.
Claims 52-68 and 71 depend from base claims 51 and 69 and are included in this rejection as they do not correct the informalities identified in base claims 51 and 69.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 68 is rejected 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).
The applied reference Shapira may have a common assignee with the instant application; however, a certificate of name change is not record. Based upon the earlier effectively filed date of 25 November 2019 of Shapira, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 102 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding instant application claim 68, Shapira discloses a process for the formation of high purity magnesium lactate crystals, where the magnesium lactate is L-lactate, see Pg. 12, Ln. 14-Pg. 13, Ln. 13, where the obtained magnesium lactate crystals are combined with the additional obtained magnesium lactate crystals, thus forming combined magnesium lactate crystals, see Pg. 8, Lns. 12-17, meeting the plurality of crystals in instant application claim 68.
In regard to “crystals obtained by the process of claim 51”, see MPEP 2113(I) stating “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)”. Shapira discloses a plurality of magnesium L-lactate crystals; therefore, the process of production is not given patentable weight.
Claim 68 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baets et al. (US20170218408, published 03 August 2017, hereinafter Baets).
Regarding instant application claim 68, Baets discloses a process for the high recovery of magnesium lactate crystals, where the magnesium lactate is L-lactate, see Abstract; Paras. [0082]-[0087], meeting the plurality of crystals in instant application claim 68.
In regard to “crystals obtained by the process of claim 51”, see MPEP 2113(I) stating “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)”. Baets discloses a plurality of magnesium L-lactate crystals; therefore, the process of production is not given patentable weight.
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 51-57, 59-61, 63, 67, 69, and 70 are rejected 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).
The applied reference Shapira may have a common assignee with the instant application; however, a certificate of name change is not record. Based upon the earlier effectively filed date of 25 November 2019 of Shapira, it constitutes prior art under 35 U.S.C. 102(a)(2).
The below Shapira rejections under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Shapira is in the known prior art field of the efficient purification of magnesium lactate from fermentation broths derived from non-homogeneous feedstocks that contain soluble and insoluble impurities, see Abstract and Fig. 1.
Regarding instant application claims 51 and 69, Shapira teaches a process for the formation of high purity magnesium lactate crystals, where the magnesium lactate is L-lactate or a mixture of D- and L-lactate, see Pg. 12, Ln. 14-Pg. 13, Ln. 13. The process comprises clarifying 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 insoluble impurities have been removed comprising magnesium lactate in a soluble form as the result of a fermentation process, the fermentation broth is at a temperature of about 45 °C to about 75 °C, see Pg. 12, Ln. 14-Pg. 13, Ln. 26. The magnesium lactate in step (a) comprises an initial concentration of about 50 to about 120 g/L, see Pg. 14, Lns. 20-23, meeting step (a) and within the concentration range in instant application claim 51 and in instant application claim 69.
The broth is concentrated to a concentration of about 150 g/L, see Pg. 18, Ln. 12, where “about” is defined as ± 10%, see Pg. 23, Ln. 1, as calculated by the examiner, 135 g/L to 165 g/L, meeting optional step (b) and within the concentration range in instant application claim 51 and in instant application claim 69.
Water and other solvents are considered impurities and are removed by evaporation of water, optionally under vacuum, and/or concentrating through reverse osmosis (RO) filtration, see Pg. 11, Lns. 13-19; Pg. 18, Lns. 1-5, where the concentration is performed at temperatures of about 45 ◦C to about 75 ◦C and about 5 wt% of magnesium lactate crystals are formed, see Pg. 16, Lns. 1-23, meeting most of step (d) and within the temperature range in instant application claim 51 and in instant application claim 69.
As stated above, an initial broth of Shapira of about 50 g/L having about 70% of the water evaporated, as calculated by the examiner, leads to the about 167 g/L concentrated broth of Shapira, see Pg. 14, Lns. 20-23; Pg. 18, Lns. 1-17, for crystallization to obtain and collect magnesium lactate crystals, where the remaining mother liquor is further concentrated and crystallized, see Pg. 12, Ln. 14-Pg. 13, Ln. 13; Pg. 19, Ln. 6-Pg. 21, Ln. 2, meeting:
Within the range of water removed by concentration in step (d) and collecting the magnesium lactate crystals of step (e) in instant application claim 51 and in instant application claim 69.
Regarding instant application claims 52-54, Shapira teaches the impurities are removed from the decomposed organic waste fermentation broth of food, municipal, domestic, agricultural, industrial, commercial, and hospital waste, or combinations thereof, by filtration, centrifugation, flotation, sedimentation, flocculation and decantation, see Pg. 13, Lns. 14-26; Pg. 17, Lns. 10-22, 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 claim 55, as stated above, Shapira teaches the broth is concentrated to a concentration of about 150 g/L, see Pg. 18, Ln. 12, where “about” is defined as ± 10%, see Pg. 23, Ln. 1, as calculated by the examiner, 135 g/L to 165 g/L. Instant specification, Pg. 21, Ln. 7, defines “about” as ± 10%, i.e., instantly claimed “about 130 g/L” +10%, as calculated by the examiner, equates to 143 g/L; therefore, the 135 g/L to 165 g/L teaching of Shapira meets within the concentration range of about 130 g/L in instant application claim 55.
Regarding instant application claim 57, as stated above, Shapira teaches the concentration is performed at temperatures of about 45 ◦C to about 75 ◦C, see Pg. 16, Lns. 1-23, meeting within the temperature range in instant application claim 57.
Regarding instant application claim 59, Shapira teaches the obtained magnesium lactate crystals are collected and separated from the remaining mother liquor by microfiltration, nanofiltration, or another method known in the art, see Pg. 20, Lns. 1-6, meeting the filtration collection in instant application claim 59.
Regarding instant application claims 60 and 61, Shapira teaches the process of the present invention further comprises a washing and/or purifying step, comprising washing and/or purifying the obtained magnesium lactate crystals or the combined magnesium lactate crystals in a solvent, such as water, ethanol, propanol, isobutanol, cyclohexane, acetone, ethyl acetate and combinations thereof, see Pg. 21, Lns. 3-11, meeting the washing and specific solvent in instant application claim 60 and in instant application claim 61.
Regarding instant application claim 63, as stated above, Shapira teaches after the process is performed, the remaining mother liquor is further recycled to the fermentation broth, concentrated, and crystallized multiple times, see Pg. 20, Ln. 1-Pg. 21, Ln. 2, meeting the recrystallized and solubilized in instant application claim 63.
Regarding instant application claims 67 and 70, Shapira teaches the magnesium lactate is L-lactate, see Pg. 13, Lns. 6-13, with a purity of about 99 wt%, see Pg. 21, Lns. 20-24, i.e., less than about 1 wt% D-lactate, meeting and within the range in instant application claim 67 and in instant application claim 70.
Shapira 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; and, wherein the application of a vacuum to a pressure of about 80 to about 300 mbar; and,
The limitations of instant application claim 56.
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 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], and the pressure is maintained below 1 bar, such as 6.5 mbar and 100 mbar, see Paras. [0063]-[0070], meeting step (c), within the range of water removal in step (d), and within the pressure range in instant application claim 51 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 Shapira 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 Shapira 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 Shapira 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 Shapira 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 Shapira, Pg. 8, Ln. 32-Pg. 9, Ln. 17; Pg. 13, Lns. 6-13; Pg. 23, Lns. 9-13; Pg. 32, Ln. 30-Pg. 33, Ln. 8.
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, 65, and 66 are rejected 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).
Shapira teaches the known prior art of the concentration at step (b) is performed by evaporation of water under vacuum aka reduced pressure, see Pg. 11, Lns. 13-19; Pg. 18, Lns. 1-7, and the size of the crystals increase during crystallization, where combinations of crystals may be formed, see Pg. 8, Lns. 12-17; Pg. 27, Ln. 25-Pg. 29, Ln. 13.
Shapira does not teach the limitations of instant application claims 58, 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 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 Shapira 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 Shapira 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 Shapira 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 is rejected 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).
Regarding instant application claim 62, Shapira teaches a process for the formation of high purity magnesium lactate crystals, where the magnesium lactate is L-lactate, see Pg. 12, Ln. 14-Pg. 13, Ln. 13, and the obtained crystals are dried at 70 ◦C, Pg. 27, Ln. 25-Pg. 29, Ln. 13, meeting within the drying temperature range in instant application claim 62.
Shapira does not teach the instant application claim 62 loss on drying.
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 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 Shapira 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 Shapira 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 Shapira 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.
Claim 64 is rejected 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).
Shapira teaches the known prior art of collecting magnesium L-lactate crystals, where the remaining mother liquor is further concentrated and crystallized, see Pg. 12, Ln. 14-Pg. 13, Ln. 13; Pg. 19, Lns. 6-Pg. 21, Ln. 2.
Shapira does not teach the instant application 64 recovery %.
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 Paras. [0030];[0082]-[0087], and is applied to solve the problem of crystallization and recovery of magnesium lactate crystals.
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.
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 the crystallization of Shapira to recovery high amounts of magnesium lactate as taught by Baets with a reasonable predictability of success for the purpose of efficiently recovering magnesium L-lactate crystals from a fermentation broth by use of recycling in order to recover the lactate in high yield, see Baets, Paras. [0024];[0030];[0082]-[0087].
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 Shapira and Baets teach vacuum crystallization of supersaturated aqueous solutions to obtain magnesium L-lactate crystals, a person of ordinary skill in the art has good reason to modify the crystallization of Shapira by relying upon Baets 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 recovering magnesium L-lactate crystals from a fermentation broth by use of recycling in order to recover the lactate in high yield, see Baets, Paras. [0024];[0030];[0082]-[0087] 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 % lactate recovered, “is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), see MPEP 2144.05.
Claims 51-54, 56, 57, 59, 60, 63, 64, and 69 are 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).
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]. 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 are 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 is 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,
PNG
media_image1.png
461
1011
media_image1.png
Greyscale
, 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 are 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.
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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699