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 9/23/2025, 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Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.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 1-17 are pending in this application.
Claims 1 is amended.
Claims 10-17 are new.
Claims 1-17 have been rejected.
Claim Objections
4. It is also to be noted that at claim 2 recites first time, the abbreviation form DS. It is advised to write Dry substance (DS) supported by applicant’s specification (in PGPUB [0049]) at least for claim 2 in order to explain what DS stands for. Appropriate correction is required.
Claims 5, 15 and 16 recite the phrase “so much organic solvent”. Applicants are advised to amend the claims with better phrase to explain that the amount of organic solvent to be added is considered which will provide DS content of at most 6 wt.% results in the mixture.
Claim Rejections - 35 USC § 112
5. 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.
6. 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.
Claim 4 recites “The process according to claim 5”. It is unclear how claim 4
depends on claim 5. Claim 4 also recites “wherein at least part of the liquid phase from step b.2 is fed as an aqueous solution to step (a)”. There is no step b.2 in claim 5. Ideally, it should depend on claim 3. Applicants are advised to amend claim 4 to overcome 112 second paragraph rejection.
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 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.
9. 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.
10. Claim(s) 1-6, 9-16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark et al. (PN 2524718) in view of Ratanapariyanuch et al. (J Agric. Food Chem. 64, 9488-9496, 2016) and further in view of Stark et al. USPN 2524718 and as evidenced by NPL
11. Regarding claim 1, Stark et al. discloses the method of making food product from thin stillage (at least in col 1 lines 30-33) which contains protein ( at least in col 2 lines 1-2) and that the flavor quality etc. of the protein can be improved by further solvent extraction method (page 1 col 1 lines 25-30, 38-40). Therefore, it meets “A process for producing a protein product from thin stillage” as claimed in independent claim 1. Stark et al. also discloses that solvent extraction is performed using combinations of as water, methanol, ethanol, ether etc. as solvent (col 2 lines 12-16) in order to remove the substances which renders the product unpalatable (col 2 lines 15-20) and, generally the extraction can be performed about 90-110 -degree F (col 2 lines 32-34), which is a temperature lower than the boiling temperature of solvent e.g. ether and the quantity of solvent can be two to four times the quantity of solubles treated on a weight basis (col 2 lines 38-42). Therefore, it meets claim limitation of “wherein the temperature during the process does not exceed 49-degree C” as claimed in amended claim 1. It is to be noted that the boiling point of solvent varies. For example, boiling point of ether is 34.9 degree C as evidenced by NPL solvent boiling point (Table 1).
Therefore, one of ordinary skill can select the solvent e.g. ether as disclosed by Stark et al. in order to carry out extraction with minimal or no contamination of solvent by treating at the or near the boiling point of solvent e.g. ether having 34.9 degree C which is less than claimed treatment of 49 -degree C. in order to reduce the cost -effective benefit e.g. energy consumption as evidenced by applicant’s specification (in PGPUB [0015]).
It is also to be noted that Shark et al. also discloses the step of separating the residue from the solvent and then heating the residue above the boiling point (col 4 lines 5-7). Therefore, whatever the boiling point of the solvent is, it is up to the separation step where temperature may remain at the extraction temperature of 90-110- degree F (col 2 lines 33-35). Also, during drying step, which is after the step of separation, residual solvent may be evaporated, if any present after the steps of dilution and washing to remove contaminants including solvent. This is applicable for the solvents having boiling point more than 49 degree C e.g. methanol, ethanol etc. as evidenced by NPL solvent boiling point (Table 1). Therefore, Shark et al. is proper primary prior art.
However, more specifically, Stark et al. is silent about the claimed repeated washing steps of extraction followed by separating and removing contaminants including solvent (e.g. ethanol etc.) by centrifugation by performing multiple solid-liquid separation steps at the steps of extraction below 49 degree C as claimed in amended claim 1.
Ratanapariyanuch et al. discloses a method of making protein concentrate from thin stillage (TS) ( Title, Fig 1). Ratanapariyanuch et al. discloses that two stage fermentation (TSF) product can be processed at 25 degree C to make slurry I and liquid I for further process (page 9489, col 1 Under Materials and Method) and Fig 1). Slurry I was centrifuged using a centrifuge to make solid I and Liquid II (page 9489, col 2, fig 1, first paragraph under Fig 1) . This reads on claim 1 step (b). It is to be noted that the claimed solid phase at the steps (b)-(d) contain some residual alcohol originated from fermented ethanol product (Under Introduction, line 1). It is also to be noted that the disclosed water addition at the respective steps read on claimed “first aqueous solution” and claimed “second aqueous solution” as claimed in claim 1. In brief, it is the disclosed few steps of washing by which the final solid IV is free of organic solvent and having enriched protein concentrate (PC) (page 9489 col 2 Fig 1 and paragraph under Fig 1) which meets claim limitation of “ wherein the solid phase comprises or includes the protein product” and the temperature during the process does not exceed 49 degree C” as claimed in claim 1(d).
One of ordinary skill in the art before the effective filling date of the claimed invention , would have been motivated to consider disclosed multi-step washing with the teaching of Ratanapariyanuch et al. to dilute and wash with large amount of solvent, with centrifugation step, thereby removing the solvent concentration in the final concentrated product.
12. Regarding claims 2, 5, 10-16, it is known and as evidence by applicant’s specification that DS is dry substance (in PGPUB [0058]). It is within the skill of one of ordinary skill in the art to optimize by routine experiments to use sufficient solvent to effectively and efficiently achieve the desired effect, i.e., desired dilution to provide sufficient solvent for effective extraction to remove contaminants to wash out the non-protein material.
One of ordinary skill in the art would have had a with a reasonable expectation to remove contaminants which impart unpalatability to the final protein product.
It is to be noted that for claims 2 and 10-15, the amount of DS content is optimizable.
Regarding claims 5, 16, Stark et al. discloses that the quantity of solvent employed may be in a range from two to four times , preferred ratio can be three to one by weight (col 2 lines 38-42). It is to be noted that the reason for dilution is to have better separation and removal of contaminants including solvent used for extraction. Therefore, it is also within the skill of one of ordinary skill in the art to consider the dilution including the disclosed four times solvent in order to have desired dilution which is measured by measuring the DS content as claimed in claimed invention.
Therefore, claims 2, 5, 10-16 are optimizable.
Absent showing of unexpected results, the specific amount of dilution with the solvent is not considered to confer patentability to the claims. As the DS content is variables that can be modified, among others, by adjusting the amount of dilution with the solvent, the precise amount 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 dilution with the solvent to reach desired claimed DS content at the claimed steps as claimed in claims 5, 14-16 of in Stark et al. in view of Ratanapariyanuch et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired DS content which gives an idea of proper dilution at the extraction steps in order to in order to remove sufficient contaminants including solvents also (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).
13. Regarding claims 3, 4, Claim 3 can be interpreted as claim 3 claims further dilution by adding more aqueous solution followed by separation step.
Stark et al. in view of Ratanapariyanuch et al. disclose the step of separating a solid phase from first mixture by centrifugation (Fig 1 of Ratanapariyanuch et al.) and further comprises adding an aqueous solution to the solid phase of step (b) which is step b.2 as claimed in claim 3. Ratanapariyanuch et al. also discloses “separating a further solid phase by means of solid-liquid separation” followed by “separating a further solid phase by means of solid-liquid separation is fed to step (c) reads on claim 3.
Even if Stark et al. in view of Ratanapariyanuch et al. do not specifically mention step of claim 3, however, It would have been obvious and it is within the skill of one of ordinary skill in the art to include the teachings of Stark et al. in view of Ratanapariyanuch et al. by considering the disclosed steps in at least in Fig 1 of Ratanapariyanuch et al. with reasonable expectation of success to perform the process steps with multiple washing and dilution with extract by adding further an aqueous solution in order to achieve best quality palatable protein being separated from most of the contaminants including organic solvent(s) to make protein product from thin stillage to be used for animal and human consumption.
14. Regarding claim 4, the rejection made for claim 3 is applicable for claim 4 also. In addition, Stark et al. discloses that solvent combines aqueous water also (col 2 lines 11-13). Stark et al. also discloses that the solvent is collected, distilled and reused (at least in col 2 lines 46-48). This meets claim limitation of “wherein at least part of the liquid phase from step b.2 is fed as an aqueous solution to step (a)” as claimed in claim 4. It is to be noted that claim 4 has 112 second paragraph rejection as discussed above.
15. Regarding claim 6, Stark et al. discloses further the step of heating after extraction step in order to make an improved flavorful dry final product suitable for human consumption (col 3 lines 3-6 and lines 18-20). Ratanapariyanuch et al. discloses the step of drying in order to produce dried PC (at least page 9489 col 1 last two lines under “Materials and Methods). It is to be noted that Ratanapariyanuch et al. discloses the step of drying to produce dried PC (at least page 9489 col 1 last two lines under “Materials and Methods) which is after step (d) of claim 1. Therefore, even if drying step has temperature greater than 49 degree C, it meets claim 1 because claim 1 claims the temperature up to the step of claim 1 (d) which is prior to claimed drying step ( e) as claimed at least in dependent claim 6.
16. Regarding claim 9, Ratanapariyanuch et al. discloses that the processing steps can include “filtration apparatus” (at least on page 9489, col 1 under “Materials and Method” , second paragraph).
17. Regarding claim 17, Ratanapariyanuch et al. discloses that the amount of protein content of solids is 63-64% (w/w) (at least on page 9492, col 1 under “Production of wet Protein content (PC)” and Fig 1). However, it is to be noted that it is within the skill of one of ordinary skill in the art to dry further to make higher protein content which is optimizable.
Absent showing of unexpected results, the specific amount of drying is not considered to confer patentability to the claims. As the DS content is variables that can be modified, among others, by adjusting the amount of drying, the precise amount 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 drying to reach desired DS content of at least 90% by weight in Ratanapariyanuch et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired at least 90 wt.% DS content containing final dried 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).
18. Claims 7,8 are rejected under 35 U.S.C. 103 as being unpatentable over Stark et al. (PN 2524718) in view of Ratanapariyanuch et al. as applied to claim 1 and further in view of Cantrell et al. US 2006/0041153 A1.
19. Regarding claims 7,8, Stark et al. in view of Ratanapariyanuch et al. discloses that the diluted TSF containing 86-87% water can be concentrated to make prevent spoilage and shipping cost (page 9489, col 1 first paragraph).
Ratanapariyanuch et al. is silent about the claim limitation of “evaporation” of thin stillage prior to step (a) as claimed in claim 7 and also silent about “oil separation from the thin stillage concentrate” as claimed in claim 8.
Cantrell et al. discloses that thin stillage is concentrated and oil is recovered from concentrated thin stillage (at least in Abstract and [0023], [0024]) because oil can be recovered from the thin stillage concentrate using disk stack centrifuge under conditions
having moisture content of concentrated thin stillage specifically from 15% to 90% (at least in Abstract and [0018], [0023], [0024]) and the concentrated syrup can further be used ([0025]).
Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Ratanapariyanuch et al. to include the teaching of Cantrell et al. to perform concentrating thin stillage in order to have desired moisture content suitable for the separation of at least a portion of oil ([0018]) by using disk stack centrifuge and separated oil (Abstract, [0018], 0023]-[0025]) will provide to collect oil separately prior to further processing to recover protein from thin stillage.
One of ordinary skill in the art would have been motivated with reasonable expectation of success to perform the evaporation step (Abstract, [0018], 0023]- [0025]) prior to the preparation of mixture (a) which starts the step of recovering protein as claimed in claim 7 to evaporate thin stillage in order to have optimum moisture content suitable for extraction oil (Abstract, [0018], 0023]- [0025]) which is also prior to the preparation of mixture (a) as claimed in claim 8.
Response to arguments
20. Applicant’s arguments and amendments overcome the rejections of record. Examiner did not use any prior art other than prior used secondary prior art by Stark et al. in this office action. Therefore, examiner has responded the arguments made for Stark et al. and the arguments made for other prior arts are considered as moot.
21. Examiner found ( google scholar search report) that NPL Ratanapariyanuch et al. ( Entitled “ Protein Concentrate Production from Thin Stillage” in J Agric. Food Chem. Vol 64, pages 9488-9496, 2016). Ratanapariyanuch et al. discloses a method of making protein concentrate from thin stillage (TS) using dilution with aqueous solvent and the steps can be processed at 25 degree C to make slurry I and liquid I for further process (page 9489, col 1 Under Materials and Method) and Fig 1). However, Ratanapariyanuch et al. does not specifically teach “ the first mixture and/or the second mixture must contain an organic solvent” as claimed in amended independent claim 1 (c ). teach the claim limitation of “ organic solvent is added “ as claimed in claims 5, 16. However, claim 1 is broad and the addition of organic solvent in independent claim 1 can be in combination with water also. Stark et al. discloses that combinations of water and organic solvent can be used and extraction can be performed from 90-110 degree F (col 2 lines 35-45) and discussed in detail below. Therefore, claim 1 is addressed using Stark et al. in view of Ratanapariyanuch et al. Also, during drying step, which is after the step of separation, residual solvent may be evaporated, if any present after the steps of dilution and washing to remove contaminants including solvent. This is applicable for the solvents having boiling point more than 49 degree C e.g. methanol, ethanol etc. as evidenced by NPL solvent boiling point (Table 1). Therefore, Shark et al. is proper primary prior art.
However, more specifically, Stark et al. is silent about the claimed repeated
Stark et al.:
22. Applicants argued in Remarks section, page 4, last paragraph that “Similarly, Stark requires "heating the residue at a temperature above the boiling point of the solvent" for solvent removal. Since organic solvents such as ethanol have boiling points well above 49°C (e.g., ethanol boils at 78°C), Stark necessarily operates at temperatures exceeding the claimed limitation. Therefore, the Examiner's combination not only fails to teach or suggest the low temperature limitation, but both references specifically require higher temperatures for their respective processes to function effectively”.
In response, it is to be noted that and as in detail in the office action above that Stark et al. discloses that thin stillage can be solvent extracted ( page 1 col 1 lines 25-30, 38-40) , with solvent combinations such as water, methanol, ethanol, ether etc. (col 2 lines 12-16) in order to remove the substances which renders the product unpalatable (col 2 lines 15-20) and, generally the extraction can be performed about 90-110 degree F (col 2 lines 32-34), which is a temperature lower than the boiling temperature of solvent e.g. ether (col 2 lines 38-42). It is also to be noted that the boiling point of solvent varies. For example, boiling point of ether is 34.9 degree C as evidenced by NPL solvent boiling point (Table 1). Also, it is understood that the benefit of having multiple extraction steps with washing and dilution, solvents are removed. In addition, also during drying step, which is after the step of separation, residual solvent may be evaporated, if any present after the steps of dilution and washing step. This includes any solvent including the solvents having boiling point more than 49 degree C (e.g. methanol, ethanol etc. as evidenced by NPL solvent boiling point -in Table 1). Therefore, Shark et al. is proper primary prior art.
Therefore, it meets claim limitation of “wherein the temperature during the process does not exceed 49-degree C” as claimed in amended claim 1.
Conclusion
23. 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