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
2. Applicants’ arguments and amendments filed on 6/03/2026, overcomes the rejections of record, however, the new grounds of rejection as set forth below are necessitated by applicants’ amendment and therefore, the following action is Final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-4, 6-9 and 11 are pending in this office action.
Claim 1 and 8 are amended.
Claims 5 and 10 have been cancelled.
Claims 1-4, 6-9 and 11 have been rejected.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claim 3 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance, claim 3 claims “more than 0% (w/w) and 70% (w/w) or less. Claim 3 depends ultimately on independent claim 1 which claims “a degree of concentration at least 5% (w/w)”. Therefore, claim 3 is failing to further limit the subject matter of the amended independent claim 1 upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. 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.
9. 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).
10. 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.
11. 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 considering the above range amounts of calcium chloride and tryptophan, it meets the claimed range molar ratio of 0.05 to 0.6.
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”.
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]).
12. Regarding the amended claim limitation of “wherein a product obtained in the concentration step is prepared at a degree of concentration of 5% (w/w) or more when the amino acid is tryptophan”, claims 1, 8, claim broadly “the concentration step” which can be interpreted as after the step of addition of calcium source. Amended claims 1, 8 do not specifically claim the step of performing the addition of calcium source after the preparation of concentration step at a degree of concentration of 5% (w/w) or more when the amino acid is tryptophan”. As discussed above, 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 a 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”).
Also, the amended claims 1, 8 broadly claims “at a concentration of 5% (w/w) or more can read on pure dry form also which is addressed by the primary prior art and discussed in the office action. Therefore, the teachings of Jian et al. to teach ‘concentrating to make dried product’ (at least in Abstract; page 2, under “Summary of the Invention”) can read on pure dried (i.e. greater than 5% (w/w) ] product to meet claim limitation of amended claims 1, 8.
13. 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.
Jian 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.
14. 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).
15. 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.).
16. 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.
17. 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.
18. 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.
Response to arguments
19. Applicant’s amendment of claims 1, 8 overcome the rejections of record.
20. It is to be noted that claim 3 claims “more than 0% (w/w) and 70% (w/w) or less. Claim 3 depends ultimately on independent claim 1 which claims “a degree of concentration at least 5% (w/w)”. Therefore, claim 3 has 112 fourth paragraph rejection due to an amendment of claim 1 and discussed in the office action above.
It is also to be noted that claims 1, 8 claim broadly “the concentration step” which can be interpreted as after the step of addition of calcium source also. Also, the amended claims 1, 8 broadly claims “at a concentration of 5% (w/w) or more can read on pure dry form also which is addressed by the primary prior art and discussed in the office action.
21. Applicant’s arguments and amendment of claims 1, 8 overcome the rejection made using “Gehant et al. It is to be noted that Gehant et al. is an additional secondary prior art which is used to teach the range amount of calcium source to address the claimed molar ratio between calcium source and an amino acid present in the fermentation broth. However, as discussed in the office action above (item # 11 above), the claimed molar ratio can still be, and was previously addressed using Jian et al. and without Gehant et al. Therefore, the rejection regarding the molar ratio remains the same with the exception of the removal of the Gehant reference. As such it is merely relying on fewer than all references in support of a 35 U.S.C. 103 rejection but relying on the same teachings and as such is not a new grounds of rejection and the action is therefore final [in MPEP 1207.03 a II 3, [In re Kronig, 539 F.2d 1300, 1302, 190 USPQ 425, 427 (CCPA 1976), Kronig, 539 F.2d at 1303, 190 USPQ at 427 . See also In re Bush, 296 F.2d 491, 495–96, 131 USPQ 263, 266-67 (CCPA 1961).
Therefore, even if without Gehant et al., the rejection is maintained as final.
Conclusion
22. 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 extension fee 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 date of this final action.
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
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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