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
Status of the application
2. Claims 1-11 are pending in this application.
Claims 1-11 are rejected.
Double Patenting (ODP)
3. The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321 (d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321 (b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
Claims 1-3, 6,7,8 and 11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 2 4, 8, 11 of U.S. Patent Application No.18/013059. The method steps of present claims 1-3, 6,7,8 and 11 would have been obvious over the method steps of independent claim 1 of pending application 18/013059. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-3, 6,7,8 and 11, are directed to “A method of preparing an amino acid granule” include steps to prepare amino acid granule from fermentation broth containing amino acid by adding calcium chloride having molar ratio of calcium source to the amino acid which is 0.02 to 2,0 as claimed in claims 8, 11 which encompasses the molar ratio of calcium source to the amino acid which is 0.05 to 0.6 as claimed in independent claim 1 of pending U.S. Patent Application No. 18/013059.
It is to be noted that even if the independent claims are not identical, however, the claims 1,3,6, 7, 8, 11 have the claim limitations of independent claim 1 of pending application 18/013059. It is also to be noted that the claimed amino acids as claimed in claim 3 is identical to the amino acids of independent claim 1 of pending application 18/013059. Also claimed solubility property as claimed in claim 2 is identical to the solubility of claim 4 of pending application 18/013059.
Therefore, although the conflicting claims are not identical, they are not patentably distinct.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
4. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claim 4 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
6. Claim 4 claims “wherein the first step comprises concentrating the fermentation filtrate”. Claim 4 depends on claim 1. Claim 1 claims first step of preparing a fermentation filtrate” . Therefore, If the first step ‘is preparing a fermentation filtrate’, it is unclear how a first step could then be concentrating the fermentation filtrate. Applicants are advised to amend the claim 4 to read “wherein after the first step concentrating the fermentation filtrate before the second step”.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. 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.
10. Claim(s) 1-4, 10 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).
11. Regarding claim 1, Jian et al. discloses the method of purifying amino acid tryptophan from fermentation broth comprising the steps of filtration, evaporation and concentration [at least in Abstract and on page 3, under Summary of the Invention, e.g. processing steps 1-5 (1)].
It is to be noted that claim 1 merely states that cells are removed. Claim 1 does not set any limit as to how many cells are removed.
It is also to be noted that Jian et al. discloses the purity levels of the amino acid tryptophan is 98.1-99.2% (Examples 1-3). Therefore, it would have been obvious to one of ordinary skill in the art to consider the majority of the cells would have been removed during the process of Jian et al. in order to obtain disclosed purity levels of the product tryptophan from 98.1-99.2% (Examples 1-3).
It would have been obvious and it is understood that the filtration step to prepare fermentation filtrate removes cells from a fermentation broth as claimed in first step of 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 the claimed second step of granulation as claimed in independent 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.
Hee et al. discloses granulation step by mixing with seeds to form granule particles followed by pulverizing to have desired particle size of the granules (at least, [0052], claim 1 of Hee et al.) which comprises the steps of concentrating the amino acid containing fermentation broth ([0015], [0030]) 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 claims 2, 3, Jian et al. in view of Hee et al. disclose that the amino acid is tryptophan which meets claim 3 (at least in Abstract). It is evidenced by applicant’s specification and also as claimed in claim 3 that amino acid can be tryptophan which would have an inherent water solubility property of less than or equal to 20 g/100 g at 25 degree C to meet claim 2.
13. Regarding claim 4, Jian et al. in view of Hee et al. disclose the step of concentrating the fermentation filtrate [in Jian et al. at least Under Summary of the invention, step (5)].
14. Regarding claim 10, Jian et al. discloses that the yield is 67. 5%-81.7% (i.e. amino acid content) and the purity is 98.1%-99.2% (at least in Examples 1-3). However, if we consider granule form, Hee et al. discloses the step of granulation by mixing with seeds (at least, [0052], claim 1 of Hee et al.). Therefore, seed crystals are crystals of amino acid which is formed due to reasons including one reason is supersaturation. Therefore, it is pure form also. If we consider the claimed content is greater than 50% , therefore, it meets the claim limitation of “amino acid granules having an amino acid content of 50% or more”.
Regarding the claim limitation “ and no cells” as claimed in claim 10, it is to be noted that the disclosed purity of 98.1%-99.2% (at least in Examples 1- 3), may account for residual 1.9% - 0.8% is not the amino acid tryptophan. In this instance, it is not contributed by the cells. During purification, fermentation broth was heated, the cells were destroyed and crystallization method removes all other contaminants from tryptophan. However, further processing step to dry the crystallized product leaves minimal residual water content which accounts for this residual 1.9%-0.8%.
15. Claims 5,9 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) as applied to claim 1 and further in view of Takeda et al. EP 1438901 A1 ).
16. Regarding claim 5, Jian in view of Hee are specifically silent about “separating amino acid crystals from the fermentation broth”.
Hee et al. discloses that amino acids are belonging to two groups, highly soluble e.g. lysine which do not form crystals due to high solubility([0007]) but low soluble amino acids like threonine , tryptophan etc. ([0032]) produces crystals even at low concentration ([0007]). Therefore, the crystal formed amino acids are to be separated as claimed in claim 5 and/or further dissolved in order to make more soluble amino acids in the broth for further processing as claimed in claim 6. Claim 6 is addressed above.
Takeda et al. discloses that if mother liquid, whereupon said amino acid has crystallized out and said amino acid crystals have been separated from the broth by a solid-liquid separation procedure (at least page 4, paragraph 7 of Takeda et al.).
It is to be noted that even if Takeda et al. discloses that crystals of amino acids including tryptophan or the like are separated due to isoelectric pH (PI), or due to salting out ( at least page 4, paragraph 7 of Takeda et al.), however, this separation step of amino acid crystal from the fermentation broth is applicable for any amino acid crystal formation including the amino acid crystal formed due to low solubility of the amino acid.
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)”.
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. in view of Hee et al., to include the teaching of Takeda et al. in order to separate amino acid crystal which can be used separately as seed crystal at the step of making granules as disclosed by Takeda 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]).
17. Claims 6-8, 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) as applied to claim 1 and further in view of Gehant et al. US 2004/0049012 A.
18. Regarding claims 6-7, Jian et al. discloses that the process generates amino acid in crystal form and the fermentation liquid is diluted with the addition of calcium chloride to dissolve it in order to have more dissolved amino acid in the filtered liquid (at least on page 3 last two paragraphs in step 5 (1) under “summary of the invention).
It is to be noted that Hee et al. discloses that amino acids are belonging to two groups, highly soluble e.g. lysine which do not form crystals due to high solubility([0007]) but low soluble amino acids like threonine , tryptophan etc. ([0032]) produces crystals even at low concentration ([0007]). Therefore, the crystal formed amino acids can be dissolved in order to make more soluble amino acids in the broth for further processing as claimed in claim 6 and is addressed here.
As discussed above, Jian et al. discloses the dilution and addition of calcium chloride to the diluted fermentation broth at this step as discussed above (at least on page 3 last two paragraphs in step 5 (1) under “summary of the invention).
The reason for adding calcium chloride is because it serves as a solubility enhancer to enhance the solubility of the homogenate or whole cell solution , protein in solution as disclosed by Gehant et al. (at least in [0035], [0036], [0037], [0038], [0039]).
Gehant et al. is used because Gehant’s teaching motivates one of ordinary skill in the art to consider calcium chloride addition to dilute fermentation liquid with a reasonable expectation of success to dissolve amino acid crystals in order to have more dissolved amino acid in the filtered liquid as disclosed by Jian et al. (at least in step 5 (1) under “summary of the invention) and Gehant et al. ([0038], [0039]). Also. Gehant et al. is appropriate to address that the molar ratio of calcium source and amino acid as claimed in claims 8, 11 are optimizable as discussed below. However, the ratio is met by the prior arts of record.
19. Regarding claims 7, 8, and 11, 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 molar ratio of 0.02 to 2.0 as claimed in claims 8 and 11. 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.
As discussed above, the teaching of Gehant et al. provides guidance to one of ordinary skill in the art to consider calcium source as a solubility enhancer which is optimizable and depends on the type of amino acid as the solubility varies for individual amino acids containing 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).
Conclusion
20. 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