Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/182413 (Jo) in view of US 2013/0302470 (Becker) and SU 1428397 (Anokhin).
Jo discloses the method for preparing L-amino acid granules according to the present disclosure may include the following steps:
(a) a step of preparing a fermentation liquid of an L-amino acid (a fermentation liquid preparation step); (considered to meet the claimed first step)
(b) a step of removing moisture from the fermentation liquid of the L-amino acid such that the solid content of the fermentation liquid of the L-amino acid is in a range of 40% to 80% (a concentration step);
(c) a step of forming granulated particles with a moisture content of 5% to 20% by mixing the concentrated fermentation liquid of the L-amino acid with a seed (a granule forming step);
(d) a step of drying the granulated particles formed in step (c) (a drying step); (meeting the third step)
(e) a step of sieving the granulated particles dried in step (d) (a sieving step); and
(f) a step of pulverizing and/or circulating the particles left in step (e) to be reused as the seed in step (c) (a seed circulating step).
Jo discloses evaporating and removing moisture from the fermentation broth followed by concentrating or drying the fermentation broth. The content of solids in the slurry of the fermentation broth may be as high as 90% (v/v) and Jo explains that if the solid content is less than the above range, overload may occur during granulation and if the solids content is above the range, there may be difficulty in transferring the slurry due to high viscosity. Jo states that the removal of water from the fermentation broth may be carried out by methods known in the art and that concentration may be performed together with reducing the pressure. Jo states that the method of removing water is a facility (apparatus) capable of evaporating fermentation broth and a forced circulation concentrator, paddle dryer or slurry drying facility (apparatus) may be used.
Jo further discloses mixing the concentrated fermentation broth with seeds to form granule particles having a water content of 5-20% (wet granules) and further discloses drying the granulated particles (third step). A water content of 5-20wt% with the wet granules corresponds to a solid concentration of 80-95wt%.
Jo does not teach the claimed second step of stirring the mixed solution to form a thin film, and drying and pulverizing to prepare wet granules. Applicant states that in the wet granules, “granule” is a macroscopic particle and may refer to granules that are in granular form but in a state containing water [0024]. Applicant states that at least part of the water in the amino acid mixed solution may be evaporated and removed and the solid concentration may increase while it is dried, thereby providing wet granules [0023].
Becker teaches forming granules containing L-amino acids from a fermentation broth. Becker teaches using a thin-film evaporator, rotary evaporator, or falling film evaporator to thicken or concentrate the broth. Use of a thin-film evaporator or rotary evaporator is expected to form a thin film having granules from stirring, drying and pulverizing in the same manner as claimed. The instant specification describes that each of the stirring, drying and pulverizing is performed by the thin film drying apparatus to prepare wet granules but the claims are not so limited. The pulverization is not claimed as obtaining a particular particle size or using a particular structure, thus pulverizing is seen as part of the formation of the wet granules but is not limited to a particular structure or grain size. As noted above, wet granules are described in the instant specification as in the state of containing water. The instant specification describes stirring as accomplished by a stirring unit that pushes the solution toward the inner wall to form a thin film [0052]. Becker does not give an example of a thin film or rotary evaporator.
Anokhin teaches a rotary film apparatus to obtain fine dry product from solution and includes scrapers and blades and application of heat (evaporation) wherein the solution is formed onto the walls (heated surface) and solid product particles are formed. Knives remove the dry substances (particles) from the surface. This structure is seen to perform the claimed stirring (pushing solution to a surface to form a thin film), drying (evaporation) and pulverizing (forming particles). Note that applicant’s specification indicates that the blades in a stirring unit of a thin film drying apparatus may be used to separate the dried thin film from the inner wall and pulverize the dried thin film to form wet granules (page 12). Similarly, Anokhin’s rotary thin film apparatus removes the thin film using knives.
Jo describes removing moisture from the fermentation broth to increase the solids content and states that this may be accomplished by methods known in the art. Becker describes a similar process and discloses thin film and rotary evaporators may be used to remove moisture and increase solids content. It would have been obvious to use a thin-film evaporator or rotary evaporator in the process of Jo to remove moisture from the fermentation broth and increase the solids content as suggested by Becker with a reasonable expectation of achieving both outcomes since Becker teaches that these structures are useful for concentrating the fermentation broth. Further, while Becker does not give a specific example of these structures, Anokhin teaches a known rotary film apparatus which performs in a manner similar to applicant’s disclosure by providing a heated surface where the solution is pushed onto the heated surface, thereby forming a film, and the film is removed via blades which when performed to the extent suggested of solids content in Jo would result in wet granules. It would have been obvious to use an evaporator such as that of Anokhin with a reasonable expectation of providing wet granules as part of the process of Jo as the type of structure is suggested by Becker and Anokhin teaches a similar use.
Regarding claim 2, Jo teaches mixing the concentrated fermentation broth with seeds to form the granule particles and teaches the use of a mixed-type granulator to perform granulation after step (c) above (Example 1-2).
Regarding claim 3, it would have been obvious to one of ordinary skill to adjust the formation of the wet granules depending upon the material used which would include the amino acids. Jo discloses that step (b) involves adjusting the solid content and that even if the amino acid is low solubility, by adjusting the content of solids contained in the slurry to 40 ~ 80% to reduce the amount of steam used by evaporating a large amount of water during the concentration of the overall manufacturing process It is characterized by increasing productivity and production efficiency. This suggests that one of ordinary skill would consider the solubility of the amino acid and make adjustments as needed to obtain the desired solid content.
Regarding claim 4, Jo discloses L-threonine (examples).
Regarding claim 5, Jo discloses Corynebacterium sp.
Regarding claim 8, Jo discloses drying wet granules using a fluidized bed dryer (Example 1-2).
Regarding claim 9, Jo discloses two concentration steps (Example 4) where the fermentation broth is concentrated and then concentrated again to a to prepare a mother liquor slurry.
Claims 6 and 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/182413 (Jo) in view of US 2013/0302470 (Becker) and SU 1428397 (Anokhin) as applied to claim 1 above and further in view of WO 2022/128692 (Mueller) (relying on provisional filing date and foreign priority claimed in the instant application has not been perfected).
Jo discloses performing the step of removing water may be performed together with the step of reducing pressure but does not disclose the pressure reduction range. Mueller discloses forming solid particles from a slurry including the step of removing water (step d) which may be performed in a cylindrical drying apparatus at a reduced pressure of 50.6-607 mbar (0.05-6 atm). Mueller also discloses the rotation speed of the stirring element results in a tip velocity of 0.8-20 m/s. Mueller teaches parameters for use in an evaporator for removal of water for removing water from a slurry to form a granule. One of ordinary skill would have found it obvious to use similar parameters for water removal in Jo as modified above with a reasonable expectation of successfully removing water from the slurry to form granules. One of ordinary skill would also reasonably optimize the pressure and stir speed in the evaporator depending upon the material used, the starting water content, the speed with which the water is desired to be removed and the desired final water content, amongst other parameters.
Claims 1 and 14 (new claim) are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0302470 (Becker) in view of WO 2019/182413 (Jo) and SU 1428397 (Anokhin).
Becker teaches forming granules containing L-amino acids from a fermentation broth. Becker teaches the steps of providing an amino acid solution, concentrating the fermentation broth, and drying (removing water) to give granules [0074-0079). Becker teaches using a thin-film evaporator, rotary evaporator, or falling film evaporator to thicken or concentrate the broth. Use of a thin-film evaporator or rotary evaporator is expected to form a thin film having granules from stirring, drying and pulverizing in the same manner as claimed. The instant specification describes that each of the stirring, drying and pulverizing is performed by the thin film drying apparatus to prepare wet granules but the claims are not so limited. The pulverization is not claimed as obtaining a particular particle size or using a particular structure, thus pulverizing is seen as part of the formation of the wet granules but is not limited to a particular structure or grain size. As noted above, wet granules are described in the instant specification as in the state of containing water. The instant specification describes stirring as accomplished by a stirring unit that pushes the solution toward the inner wall to form a thin film [0052]. Regarding claim 14, Becker does not disclose the use of seed.
Becker does not give an example of a thin film or rotary evaporator.
Becker also does not disclose the degree to which the fermentation broth is concentrated (solids content).
Jo discloses the method for preparing L-amino acid granules according to the present disclosure may include the following steps:
(a) a step of preparing a fermentation liquid of an L-amino acid (a fermentation liquid preparation step); (considered to meet the claimed first step)
(b) a step of removing moisture from the fermentation liquid of the L-amino acid such that the solid content of the fermentation liquid of the L-amino acid is in a range of 40% to 80% (a concentration step);
Jo discloses evaporating and removing moisture from the fermentation broth followed by concentrating or drying the fermentation broth. The content of solids in the slurry of the fermentation broth may be as high as 90% (v/v) and Jo explains that if the solid content is less than the above range, overload may occur during granulation and if the solids content is above the range, there may be difficulty in transferring the slurry due to high viscosity. Jo states that the removal of water from the fermentation broth may be carried out by methods known in the art and that concentration may be performed together with reducing the pressure. Jo states that the method of removing water is a facility (apparatus) capable of evaporating fermentation broth and a forced circulation concentrator, paddle dryer or slurry drying facility (apparatus) may be used.
Jo further discloses mixing the concentrated fermentation broth with seeds to form granule particles having a water content of 5-20% (wet granules) and further discloses drying the granulated particles (third step). A water content of 5-20wt% with the wet granules corresponds to a solid concentration of 80-95wt%.
It would have been obvious to one of ordinary skill to concentrate the fermentation broth of Becker to the degree disclosed by Jo as the solids content of Jo is described as reducing the amount of steam needed for concentration and drying process and increases productivity.
Anokhin teaches a rotary film apparatus to obtain fine dry product from solution and includes scrapers and blades and application of heat (evaporation) wherein the solution is formed onto the walls (heated surface) and solid product particles are formed. Knives remove the dry substances (particles) from the surface. This structure is seen to perform the claimed stirring (pushing solution to a surface to form a thin film), drying (evaporation) and pulverizing (forming particles). Note that applicant’s specification indicates that the blades in a stirring unit of a thin film drying apparatus may be used to separate the dried thin film from the inner wall and pulverize the dried thin film to form wet granules (page 12). Similarly, Anokhin’s rotary thin film apparatus removes the thin film using knives. While Becker does not give a specific example of these structures, Anokhin teaches a known rotary film apparatus which performs in a manner similar to applicant’s disclosure by providing a heated surface where the solution is pushed onto the heated surface, thereby forming a film, and the film is removed via blades which when performed to the extent suggested of solids content in Jo would result in wet granules. It would have been obvious to use an evaporator such as that of Anokhin with a reasonable expectation of providing wet granules as part of the process of Becker as the type of structure is suggested by Becker and Anokhin teaches a similar use.
Response to Arguments
Applicant’s amendment to claim 1 has overcome the 112(b) rejection, thus the rejection is withdrawn.
Applicant's arguments filed 03/03/2026 regarding the 103 rejection over Jo in view of Becker and Anokhin have been fully considered but they are not persuasive.
Applicant argues that Becker fails to disclose the claimed “thin film drying apparatus” because the thin-film evaporator is merely a device for removing moisture and cannot perform drying and granulation.
At the outset, claim 1 requires “a second step of stirring the amino acid mixed solution to form a thin film, and drying and pulverizing the formed thin film to prepare wet granules, using a thin film drying apparatus”. The recitation of a thin film drying apparatus is not required to perform the pulverizing step as the claim requires that the step use a thin film drying apparatus, but does not limit the step to being performed solely by a thin film drying apparatus. In other words, as currently worded, the second step may use more than one apparatus but must include a thin film drying apparatus to perform at least part of the step. In Becker a thin-film evaporator is used and the concentrated broth formed therein can be processed by freeze-drying, spray-drying and spray granulation [0072, 0094]. The claims do not require a single structure that performs both the thin-film formation and pulverizing (granulation).
Additionally, the art of Anokhin teaches a rotary thin-film apparatus designed to obtain a fine dry product from solutions and combines evaporation and drying in a single package. Given that Becker discloses formation of a thin film in order to concentrate the amino acid solution and then granulates the material formed in the thin-film evaporator, one of ordinary skill would reasonably look to known thin-film apparatus to determine the structure needed. Here, Anokhim discloses a combined apparatus that will accomplish both the thin film formation and the granulation. One of ordinary skill would have found it obvious to use the apparatus of Anohim to form the thin film and granules as disclosed in Becker.
Applicant argues that Anokhin is not analogous to the claimed invention as it is not within the same field of amino acid production and has a different purpose of intensifying the heat exchange process by completely cleaning the surface of solids and increasing residence time of the product in the apparatus.
This argument is not persuasive. The instant claims are directed to amino acid production, but that production includes a thin-film drying apparatus. In other words, the claims encompass the necessary function of a thin-film drying apparatus. Such an apparatus may be used in a multitude of settings and one of ordinary skill must look to the general art of thin-film drying apparatus for their necessary function as utilized in the claim. In other words, analogous art isn’t limited to only an apparatus that is used for amino acid production. Analogous art depends upon the necessary essential function or utility of the subject matter covered by the claims which in this case include amino acid production but also the structure and function of a thin-film drying apparatus. As explained in MPEP 904.01(c), a tea mixer and a concrete mixer may both be regarded as relating to the mixing art, this being the necessary function of each. Here, the thin-film drying apparatus of Anokhin is considered analogous regardless of whether it is expressly used in the production of amino acid products. The argument regarding the heat exchange is not seen to preclude the disclosure of Anokhin that the structure forms a thin-film and particulate in a similar manner disclosed by applicant.
Applicant argues unexpected results based upon the claimed concentration of 80-92wt% solids. Applicant argues that granules are not formed when the solid content in wet granules recovered from the thin film drying apparatus was less than 80% and as the solid content in wet granules increased, the formation of granules became more difficult and additional formulation process was required. When the solid formation was above 94wt%, granules were not formed and this is unexpected because Jo does not use a thin film drying apparatus at all, Becker mentions evaporators that merely seem to resemble the claimed thin film apparatus with no details of the solid content, and Anokhin is not analogous art.
These arguments are not persuasive. As stated above, Jo discloses 80-95wt% which overlaps the claimed range. Jo expressly discloses concentration of the fermentation broth thereby producing a concentrate and mixing with an amino acid seed to form wet granules with a water content of 5-20wt% which is considered 80-95wt% solids. This is considered to correspond to the second step of the instant claims. Jo discloses that a large amount of water is evaporated during concentration, so that even when the fermentation broth has a high solid content, granulation can be easily performed, thereby reducing the consumption of steam and increasing the production efficiency of granules. The range disclosed by Jo is 80-95wt% solids as compared to applicant’s claims of 80-92wt% and the example of 94wt% where granulation did not occur. The disclosure by Jo of an almost identical range for the concentration of the granules formed in the second step and Jo also recognizes benefits of this range and the workability of forming granules with this range. Thus, the arguments of unexpected results are not found persuasive. Additionally, the data relied upon is not considered commensurate in scope. Table 1 of the instant specification provides examples but they are limited to the amino acid L-tryptophan and L-leucine. Also, in the explanation of Example 1A on page 15, the solid content is noted as 99% but in Table 1 the solid content of Example 1A is 92%. Comparative Examples 1A and 1B have 75% and 96% solids, respectively, which are outside the range of Jo (80-95%) and thus is not demonstrative of anything in the range of Jo not being workable. Table 14 does use L-leucine and notes that for Comparative Example 5B, 95% solids resulted in formation of granules since there is a notation for the size of 200-300 microns for the size formed (note that this data is confusing since there is an “X” indicating no formation of granules, but then gives a size of the granules. The instant claims do not require any particular size of wet granules are formed. Thus, there is a gap between 92% and 96% where Jo discloses that the wet granules having solid concentrations of up to 95% will result in granulation. Indeed, Table 2 discloses 95% solids in example 1G appears to be a workable solids range.
Regarding new claim 14, a new ground of rejection is set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
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