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 .
DETAILED ACTION
Continued Examination under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/15/2026 has been entered.
Status of the application
3. Claims 1-4, 6-9, 11 are pending in this application.
Claims 5, 10 have been cancelled.
Claims 1-4, 6-9, 11 have been rejected.
Claim Rejections - 35 USC § 103
4. 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.
5. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claim(s) 1- 4, 6-9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Jian et al. (Application CN201811434843A·2018-11-28; Publication CN109369501B·2019-02-22) in view of Hee et al. (KR 10-2019-0111835A·2019-10-02) further in view of Gehant et al. (US 2004/0049012 A.
8. Claim 1 claims “A method for preparing amino acid granules, which comprises:
(a) a fermented broth comprising an amino acid and
(b) adding a calcium source to a fermentation broth containing an amino acid
( c) at a molar ratio of calcium to amino acid 0.05 to 0.60” as claimed in independent claim 1.
Regarding the steps of claim 1 (a)-(c), and claim 8, Jian et al. discloses a process for purifying tryptophan from fermentation broth comprising the steps of adding calcium chloride in an amount of 1.5-3.5g/L to the fermentation broth having tryptophan amino acid content 20-30 g/L and followed by concentrating to make dried product (at least in Abstract; page 2, under “Summary of the Invention”). It is to be noted that if we consider the above range amounts of calcium chloride and tryptophan, it meets the claimed range molar ratio of 0.052 to 0.62.
For example, for 1.5g/ L calcium chloride, it is mass/molar mass (MW) = 1.5g/L/110.984 g/mol= 0.0135 mol/L. Likewise, for 3.5 g/L calcium chloride it will be 3.5g/L/ 110.98 g/mol =0.0315 mol/L.
For tryptophan, for 20 g/L, it will be 20 g/L/204. 23 g/mol= 0.0979 mol/L and for 30 g/L, it will be 0.146 mol/L.
Therefore, if we do ratio, four points will be, 0.0135 mol/L/ 0.146 mol/L= .092 [Lowest] and 0. 0135/0.0979= 0.137 and 0.0315/0.0979= 0.321 [Highest] and 0.0315/0.146= 0.215. Therefore, the range ratio of calcium chloride : amino acid will be from 0.092-0.32. Therefore, it overlaps with the claimed range amount of 0.052 to 0.60 as claimed in claim 1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
However, it is to be noted that the amounts and ratio depend on type of amino acid, concentration of amino acid in the fermentation broth, type, solubility of the calcium source to be used. Also, the molar ratio with respect to solubility etc. is considered as technical matter and is optimizable. It is within the skill of one of ordinary skill in the art to optimize the amount of calcium source necessary from within the disclosed range concentration of calcium source in order to add to the fermentation broth containing amino acid before or after concentration step. One of ordinary skill in the art can consider the characteristics property of the type of calcium source, type of amino acid, its concentration in the fermentation broth and using the disclosed guidelines as disclosed for a disclosed range amounts of calcium chloride used to add to the disclosed range amounts of tryptophan containing fermentation broth as disclosed by Jian et al. to optimize the range molar ratio of calcium source and amino acid in the fermentation broth. Therefore, it is optimizable.
Absent showing of unexpected results, the specific amount of molar ratio is not considered to confer patentability to the claims. As the type of calcium source, its solubility, and amino acid concentration in the broth are variables that can be modified, among others, by adjusting the amount of calcium, for a desired concentration range of the amino acid in the fermentation broth, the precise molar ratio would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of calcium in Jian et al. et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired molar ratio which is effective to have best yield of amino acid in final product (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding the claim limitation “solubility of amino acid in the fermentation broth is increased and the degree of concentration is increased by adding a calcium source to a fermentation broth containing the amino acid” is considered as physical property of the calcium salt (e.g. calcium chloride). Therefore, as the structure of the ingredients e.g. calcium source and a specific amino acid are identical to the claimed calcium source and the claimed specific amino acid, and also the disclosed molar ratio range meet the claimed molar range ratio, therefore, the disclosed range ratio will have an inherent claimed property of an increased solubility of amino acid in the fermentation broth with the increase of the degree of concentration by adding a calcium source to a fermentation broth containing the amino acid”.
However, additionally, Gehant et al. discloses that calcium chloride (10 mM to 150 mM) ([0038]) can be used as solubility enhancer to solubilize protein in solution ([0035], [0036]) which enhances the solubility of the homogenate or whole cell solution containing protein or related product ([0037]).
It is to be noted that 10 mM is 0.01 moles/L and 100 mM is 0.1 moles/L. Therefore, the range of Gehant et al. encloses the addition of calcium chloride in an amount of 1.5-3.5g/L (i.e. 0.0135 moles/L-0.0315 moles /L) to the fermentation broth as disclosed by Jian et al. (at least in Abstract; page 2, under “Summary of the Invention”) as discussed above. Therefore, the disclosed range amount of calcium chloride as disclosed by Jian et al., is effective to serve as ‘solubility enhancer’ to increase the solubility of amino acid in the fermentation broth which meets the claim limitation of “solubility of amino acid in the fermentation broth is increased and the degree of concentration is increased by adding a calcium source to a fermentation broth containing the amino acid” as claimed in claim 1.
Regarding the step of granulating the product as claimed in claim 1,
Jian et al. discloses concentration step to make dried powder (At least in Abstract). However, Jian et al. does not specifically teach the step of “granulation” as claimed in claim 1.
Therefore, more specifically, Hee et al. is used as an additional secondary prior art to address the step of granulation as claimed in independent claim 1 and claim 8.
Hee et al. discloses granulation step by mixing with seeds (at least, [0052], claim 1 of Hee et al.) which comprises the steps of concentrating the amino acid containing fermentation broth ([0015]) and followed by granulation because granule form has demand because it is convenient to store, carry and consume ([0005]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Jian et al. to include the teaching of Hee et al. who discloses the step of granulation by mixing with seeds (at least, [0052], claim 1 of Hee et al.) which comprises the steps of concentrating the amino acid containing fermentation broth ([0015]) and forming granules which has demand because it is convenient to store, carry and consume ([0005]).
9. Regarding claim 2, Jian et al discloses a process for purifying tryptophan from fermentation broth comprising the steps of adding calcium chloride in an amount of 1.5-3.5g/L to the fermentation broth having tryptophan amino acid content 20-30 g/L and followed by concentrating to make dried product (at least in Abstract; page 2, under “Summary of the Invention”).
Even if Jiang et al. discloses the addition of calcium salt to the fermentation broth, it is to be noted that the claim limitation of “a step of performing concentration before the step of adding the calcium source” is merely a selection because the enhancement of solubility is applicable under both the condition because it is a matter of different concentration of the amino acid in the fermentation broth. The reasons are discussed below.
It is within the skill of one of ordinary skill in the art to optimize the amount of calcium source necessary from within the disclosed range concentration of calcium source in order to add to the fermentation broth containing amino acid after concentration step.
It is known that concentrated liquid has less volume with maximally enriched amino acid concentration and the known amount of amino acid concentrate after the concentration step. Therefore, one of ordinary skill in the art may consider to use disclosed calcium chloride after the concentration step with reasonable expectation of success because, (i) it is easy to handle less volume of liquid and (ii) application of calcium agent after concentration will further enhance solubility and the yield of the already concentrated amino acid further for better yield in the final product. Therefore, it meets the claim limitation of “ a step performing concentration before the step of adding the calcium source” as claimed in claim 2.
Jiang et al. does not specifically disclose the step of claim 2. However, Jiang et al. teach substantially the same product produced by substantially the same method as instantly claimed by applicant; where the claimed and prior art products are produced by substantially identical processes, a prima facie case of obviousness has been established. To switch the order of performing process steps, i.e. the order of the addition of the ingredients into the final mixture, would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results". Therefore, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to add the calcium source as calcium chloride in the amino acid containing solution (fermentation broth) after the concentration step.
10. Regarding claims 3, 6, Jian et al. discloses the step of concentrating, by evaporation (at least page 3 line 2 , step 5) . Hee et al. also discloses granulation step by mixing with seeds (at least, [0052], claim 1 of Hee et al.) which comprises the steps of concentrating the amino acid containing fermentation broth ([0015]). It is within the skill of one of ordinary skill in the art to optimize the concentration step in order to have desired percent moisture containing broth with calcium amino acid complex solid content product which provides the desired disclosed amount of moisture content (in Hee et al. [0024]) before granulation step as claimed in claim 6. This is optimizable. Therefore, the disclosed moisture (i.e. considering 40-80% solid, rest is moisture [0024]) overlaps the claimed range amount of moisture content.
Absent showing of unexpected results, the specific amount of moisture content is not considered to confer patentability to the claims. As the concentration as claimed in claim 2, degree of concentration as claimed in claim 3 and moisture content necessary before granulation step are variables that can be modified, among others, by adjusting the conditions and moisture content before granulation step, the precise degree of concentration and have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the degree of concentration and moisture content before granulation step in Jian et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired yield of amino acid in final product. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
11. Regarding claim 4, Jian discloses the fermentation broth containing Tryptophan (Abstract of Jian et al.). Claim 4 depends on claim 1. Claim 1 has amino acids including tryptophan. The solubility of an amino acid is considered as the physical property of an individual amino acid. Therefore, as the disclosed amino acid e.g. Tryptophan (Jian et al. , in Abstract) and as claim 4 depends on claim 1 which claims tryptophan, therefore, the claimed physical property of an amino acid as claimed in claim 4 is applicable for the claimed amino acid of claim 1 including tryptophan also as claim 4 depends on claim 1. It is also to be noted that claim 4 corresponds to a scope that could be derived through experiments by a person skilled in the art, considering the feature in Jian et al. wherein the amino acid is tryptophan ( Abstract of Jian et al.).
12. Regarding claim 7, Jian et al. discloses the step of processing includes sequential steps of grinding (i.e. pulverizing) and granulation steps ([0023], [0024]) in order to have fine small particle size which is suitable for dietary feed composition and may increase the palatability, digestibility of the feed composition ([0025]) to meet claim 7.
13. Regarding claim 9, it is considered as the physical property of amino acid granules product of claim 8. Therefore, as the disclosed amino acid granule is identical to the claimed amino acid granule of claim 8 from which claim 9 depends, therefore, the physical property of the disclosed product will have identical physical property of the claimed product including “a moisture absorption of 7% or less” under claimed condition of claim 9.
14. Regarding claim 11, Jian et al. discloses that tryptophan is an essential amino acid which has its broad application as nutritional component including in feed composition ( Under Inventive-Title, Under “Background Technology). Even if it is under background Technology, however, it is commonly known valuable nutritional component in feed composition, therefore, appropriate.
15. Claim(s) 1-4, 6- 9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hee et al. (KR 10-2019-0111835A·2019-10-02) in view of Gehant et al. (US 2004/0049012 A) in view of Jian et al. (Application CN201811434843A·2018-11-28; Publication CN109369501B·2019-02-22)
16. Regarding claims 1, 8, Hee et al. discloses a method of preparing L-amino acid e.g. L-threonine from fermentation broth which is used as feed additives for animal food, nutrition etc. (Under Description [0003]). Hee also discloses (a) preparing a fermentation broth of L-threonine (fermentation broth preparation step); (b) removing the water in the fermentation broth with a fermentation broth of L-threonine at a solid content of 40-80% (concentration step); (c) mixing the concentrated fermentation broth of L-threonine with seeds to form granule particles having a water content of 5 to 20% (granulation step); (d) drying the granulated particles formed in the step (c) (drying step); (e) sifting the granulated particles dried in the step (d) (sieving step); And (f) pulverizing or circulating the remaining particles in step (e) to reuse the seed in step (c) (seed circulation step), a method for producing L-threonine granules.
Hee et al. also discloses that the fermentation broth was concentrated to a solid content of 60.1% and the solid and mother liquor were separated thereafter (at least second paragraph under example 4).
Hee is silent about (i) the amount of calcium chloride and molar ratio as claimed in independent claim 1 and (ii) a step of performing concentration before adding the calcium source.
Regarding the claim limitation “solubility of amino acid in the fermentation broth is increased and the degree of concentration is increased by adding a calcium source to a fermentation broth containing the amino acid” is considered as physical property of the calcium salt (e.g. calcium chloride). Therefore, as the structure of the ingredients e.g. calcium source and a specific amino acid are identical to the claimed calcium source and the claimed specific amino acid, and also the disclosed molar ratio range meet the claimed molar range ratio, therefore, the disclosed range ratio will have an inherent claimed property of an increased solubility of amino acid in the fermentation broth with the increase of the degree of concentration by adding a calcium source to a fermentation broth containing the amino acid”.
Gehant et al. discloses that calcium chloride (10 mM to 150 mM) ([0038]) can be used as solubility enhancer to solubilize protein in whole cell solution ([0035], [0036]) which enhances the solubility of the homogenate or whole cell solution containing protein or related product ([0037]). Gehant’s teaching provides additional guideline to one of ordinary skill in the art to understand the range amount of concentration suitable to perform as solubility enhancer.
Hee discloses that threonine amino acid can be 174.7g/L ([0089]).
Calcium chloride 10 mM-100 mM is 0.010 mmol/L and 0.10mol/L.
Amino acid is L-threonine, L-threonine has MW 119.12g/mol. Therefore, considering 174.7 g/L (as one example, however, it varies), it will be 174.7g/L/119.12 g/mole = 1.466 mole/L. Therefore, 0.01/1.466= 0.006 and 0.10/1.466=0.06.
It is to be noted that even if Gehant et al. does not mention “fermentation broth”, however, Gehant et al. is secondary prior art who teaches similar very close match concept of the property of calcium chloride to be used any protein solution which can be fermentation broth comprising protein, amino acids also.
According to MPEP 2143.01, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis). Axonics, Inc. v. Medtronic, Inc., 73 F.4th 950, 957-58, 2023 USPQ2d 795 (Fed. Cir. 2023)”.
However, as discussed above, “solubility enhancer” is considered as inherent property. Gehant’s teaching provides additional guideline to one of ordinary skill in the art to understand the range amount of concentration suitable to perform as solubility enhancer. Therefore, Gehant et al. is proper.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Hee et al. to include the teaching of Gehant et al. to include calcium chloride (10mM-150 mM) as a solubility enhancer in the fermented broth (i.e. whole cell solution) ([0035], [0036]) with a reasonable expectation of success to enhance the solubility of the respective similar protein containing composition which includes amino acid present in protein present in the homogenate or whole cell solution containing protein or related product ([0037]) because enhanced solubility will enhance the yield of the amino acid after further drying step.
(Additionally), to be more specific, as because Gehant et al. does not mention calcium salt is added to the “fermentation broth”, examiner used Jiang et al. as a secondary prior art to teach that this disclosed concentration of calcium chloride as disclosed by Gehant’s (10mM-100 mM) can be considered to be used in the fermentation broth.
Hee and Gehant et al. meets claimed range amount of molar ratio between calvium source: amino acid as discussed above.
Additionally, examiner is presenting this using another amino acid tryptophan as disclosed by Jian et al.
Jian et al. discloses a process for purifying tryptophan from fermentation broth comprising the steps of adding calcium chloride in an amount of 1.5-3.5g/L to the fermentation broth having tryptophan amino acid content 20-30 g/L and followed by concentrating to make dried product (at least in Abstract; page 2, under “Summary of the Invention”). It is to be noted that if we consider the above range amounts of calcium chloride and amino acid tryptophan, the calculation shown below.
For example, for 1.5g/ L calcium chloride, it is mass/molar mass (MW) = 1.5g/L/110.984 g/mol= 0.0135 mol/L. Likewise, for 3.5 g/L calcium chloride it will be 3.5g/L/ 110.98 g/mol =0.0315 mol/L.
For tryptophan, for 20 g/L, it will be 20 g/L/204. 23 g/mol= 0.0979 mol/L and for 30 g/L, it will be 0.146 mol/L.
Therefore, if we do ratio, four points will be, 0.0135 mol/L/ 0.146 mol/L= .092 [Lowest] and 0. 0135/0.0979= 0.137 and 0.0315/0.0979= 0.321 [Highest] and 0.0315/0.146= 0.215. Therefore, the range ratio of calcium chloride : amino acid will be from 0.092-0.32. Therefore, it overlaps with the claimed range amount of 0.052 to 0.60 as claimed in claim 1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It is to be noted that Jian’s disclosed 1.5-3.5 g/L calcium chloride is 0.0135 mol/L (i.e. 13.5 mM) -0.0315 mol/L (i.e. 31.5 mM) which is within the disclosed range value of 10 mM-100 mM calcium chloride which serves as solubility enhancer as disclosed by Gehant et al. as discussed above ( [0038]).
It is also to be noted that examiner has performed a detail calculation considering L-threonine of Hee and Tryptophan of Jiang et al. and the disclosed calcium chloride.
However, it is to be noted that and as it is understood from above discussion that the amounts and ratio depend on type of amino acid, concentration of amino acid in the broth, type, solubility of the calcium source to be used. It is within the skill of one of ordinary skill in the art to optimize the amount of calcium source necessary from within the disclosed range concentration of calcium source in order to add to the fermentation broth containing amino acid before or after concentration step. Also, the molar ratio with respect to solubility etc. is considered as technical matter and is optimizable. One of ordinary skill in the art can consider the characteristics property of the type of calcium source, type of amino acid, its concentration in the fermentation broth and using the disclosed guidelines as disclosed for a disclosed range amounts of calcium chloride used to add to the disclosed range amounts of tryptophan containing fermentation broth as disclosed by Hee et al. in view of Gehant et al. to optimize the range molar ratio of calcium source and amino acid in the fermentation broth. Therefore, it is optimizable.
Absent showing of unexpected results, the specific amount of molar ratio is not considered to confer patentability to the claims. As the type of calcium source, its solubility, and amino acid concentration in the broth are variables that can be modified, among others, by adjusting the amount of calcium, for a desired concentration range of the amino acid in the fermentation broth, the precise molar ratio would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of calcium in Hee et al. et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired molar ratio which is effective to have best yield of amino acid in final product (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
17. Regarding claim 2, Hee et al. does not specifically disclose the step of claim 2. It is to be noted that the claim limitation of “a step of performing concentration before the step of adding the calcium source” is merely a selection because the enhancement of solubility is applicable under both the condition.
It is known that concentrated liquid has less volume with maximally enriched amino acid concentration after concentration step. Therefore, one of ordinary skill in the art may consider to use disclosed calcium chloride and the known amount of amino acid concentrate after the concentration step with reasonable expectation of success because, (i) it is easy to handle less volume of liquid and (ii) application of calcium agent after concentration will further enhance solubility and the yield of the already concentrated amino acid further for better yield in the final product. Therefore, it meets the claim limitation of “ a step performing concentration before the step of adding the calcium source” as claimed in claim 2.
It is within the skill of one of ordinary skill in the art to calculate the amount of calcium source necessary from within the disclosed range concentration of calcium source in order to add to the fermentation broth containing amino acid after concentration step
However, Hee et al. teach substantially the same product produced by substantially the same method as instantly claimed by applicant; where the claimed and prior art products are produced by substantially identical processes, a prima facie case of obviousness has been established. To switch the order of performing process steps, i.e. the order of the addition of the ingredients into the final mixture, would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results". Therefore, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to add the calcium source as calcium chloride in the amino acid containing solution (fermentation broth) after the concentration step.
18. Regarding claims 3 and 6, Hee et al. discloses the steps of concentrating the amino acid containing fermentation broth ([0015]). Hee et al. also discloses that large amount of moisture is evaporated to a solid content of 40-55% and water 45-60% ([0007]) prior to drying step ([0009], [0018]). Hee et al. also discloses that the concentration step ([0015]) is prior to granulation step ([0016]). It is within the skill of one of ordinary skill in the art to optimize the concentration step in order to have desired percent moisture containing broth with calcium amino acid complex solid content product which provides the desired disclosed amount of moisture content (in Hee et al. [0024]) before granulation step as claimed in claim 6. This is optimizable. Therefore, the disclosed moisture (i.e. considering 40-80% solid, rest is moisture [0024]) overlaps the claimed range amount of moisture content.
Absent showing of unexpected results, the specific amount of moisture content is not considered to confer patentability to the claims. As the concentration as claimed in claim 2, degree of concentration as claimed in claim 3 and moisture content necessary before granulation step are variables that can be modified, among others, by adjusting the conditions and moisture content before granulation step, the precise degree of concentration and have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the degree of concentration and moisture content before granulation step in Jian et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired yield of amino acid in final product. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
19. Regarding claim 4, claim 4 depends on claim 1. Claim 1 has amino acids including threonine. The solubility of an amino acid is considered as the physical property of an individual amino acid. Therefore, as the disclosed amino acid e.g. Threonine (Hee et al. , in Abstract) and as claim 4 depends on claim 1 which claims threonine, therefore, the claimed physical property of an amino acid as claimed in claim 4 is applicable for the claimed amino acid of claim 1 including tryptophan also as claim 4 depends on claim 1. It is also to be noted that claim 4 corresponds to a scope that could be derived through experiments by a person skilled in the art, considering the feature in Jian et al. wherein the amino acid is threonine ( Abstract of Hee et al.).
20. Regarding claim 7, Hee et al. discloses mixing step followed by granulation step (Abstract). However, Hee et al. is specifically silent about the pulverizing step prior to granulation step.
Jian et al. discloses the step of processing which includes sequential steps of grinding (i.e. pulverizing) and granulation steps ([0023], [0024]), i.e. pulverizing before granulation step, in order to have fine small particle size which is suitable for dietary feed composition and may increase the palatability, digestibility of the feed composition ([0025]) to meet claim 7.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Hee et al. in view of Gehand et al. with the teaching of Jian et al. who discloses the step of processing which includes sequential steps of grinding (i.e. pulverizing) and granulation steps ([0023], [0024]), i.e. pulverizing before granulation step, in order to have granules with fine uniform small particle size which is suitable for dietary feed composition and may increase the palatability, digestibility of the feed composition ([0025]).
21. Regarding claim 9, it is considered as the physical property of amino acid granules product of claim 8. Therefore, as the disclosed amino acid granule is identical to the claimed amino acid granule of claim 8 from which claim 9 depends, therefore, the physical property of the disclosed product will have identical physical property of the claimed product including “a moisture absorption of 7% or less” under claimed condition of claim 9.
22. Regarding claim 11, Hee et al. a method of preparing L-amino acid e.g. L-threonine from fermentation broth which is used as an important material as food, feed additives for animal food, nutrition etc. (Under Description [0003]) . Therefore, it meets claim 11.
Response to arguments
23. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome the rejections of record. Examiner has considered a new ground of rejection using a new primary prior art by Jian et al. in one set of rejection and also another new secondary prior art by Gehant et al. in another set of rejection. However, examiner used prior secondary prior art by Hee et al. and used Jian et al. in view of Hee et al. to reject amended independent claim 1.
Examiner also made another set of rejection using Hee et al. in view of Gehant et al. in order to address claim 2 and discussed in detail in the office action above.
As examiner did not use any other prior art from prior rejection, therefore, arguments made for primary prior art by Wan et al. and secondary prior arts by Kenyon et al. and Hatch et al. are considered as moot. However, examiner is responding the arguments made for prior secondary prior art by Hee et al. as presented below.
23. Applicants argued in remarks, last but one paragraph that “none of the references including Hee et al. discloses that “adding a calcium source to a fermentation broth”.
In response, it is agreed. However, Hee is not used to address this claim limitation of “adding a calcium source to a fermentation broth”. It is addressed using new primary prior art by Jian et al. Hee et al. is used to teach granulation step by mixing with seeds (at least, [0052], claim 1 of Hee et al.) which comprises the steps of concentrating the amino acid containing fermentation broth ([0015]) . Further, Jian et al. is modified by Hee et al. with the motivation that granule form has demand because it is convenient to store, carry and consume (in Hee et al., [0005]).
The rejection is made as non-final.
Conclusion
24. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792