DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 23 is objected to because of the following informalities: “a sodium hydroxide” on lines 1-2 does not require the article “a” before sodium hydroxide, and should therefore be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-29 are 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.
With respect to Claim 1, step (b) recites “washing out the milled mill using an acid followed by separating a solvent,”. It is not clear if the acid is the solvent that is separated, or if there is an additional solvent used in the washing. Further, is the solvent separated from the washed, milled meal? If so, this should be explicitly stated. Then in claim 1, steps (c) and (f) recite the limitation “the produced product” in line 1, there is no antecedent basis for “the produced product”. Is the “produced product” in step (c) the washed, milled meal of step (c)? Steps (d) and (e) recite the limitation “the acid” in line 1, but does not clarify whether the acid recited is the acid recovered from step (b) or simply the same type of acid from step (b). Step (e) additionally recites the limitation “a produced deposit” on line 1, but does not explicitly point out what the deposit is. Step (f) recites the limitation “a suspension of the produced product” in line 1, but the preceding claim recites “washing a produced deposit” and “separating the solvent”. It is unclear which suspension is recited in step (f).
For the purposes of interpretation, “the produced product” will be interpreted as the washed, milled meal in step (c) and the deposited protein in step (f). “the acid” in steps (d) and (e) will be interpreted as the same type of acid recited in step (b), and “the suspension” recited in step (f) will be interpreted as the washed solution comprising the protein deposit. Claim 1 should be amended so that the product, starting with the milled meal, can be followed through each step of the process.
Due to their dependency on claim 1, claims 2-29 are rejected.
With respect to Claim 2, the recitation of “sunflower meal:water ratio” is unclear due to the lack of clarification of the units of the ratio. For the purposes of examination, the ratio will be interpreted to mean weight:weight.
With respect to Claim 5, the recitation of “wherein deposition at stage (b)” in line 1, lacks antecedent basis in step (b) of claim 1. For the purposes of examination, the limitation will be interpreted as reciting “wherein separating at stage (b)”.
With respect to Claim 7, the recitation of “the protein produced at stage (b)” in line 1, lacks antecedent basis in step (b) of claim 1. For the purposes of examination, the limitation will be interpreted as reciting “wherein extracting at stage (c)”.
With respect to Claims 8 and 9, the recitation of “protein extracting at stage (c)” in line 1, lacks antecedent basis in step (c) of claim 1, which recites the limitations “alkali extracting” and “separating a protein solution”. For the purposes of examination, the limitation will be interpreted as reciting “alkali extracting at stage (c)”.
With respect to Claim 10, the recitation of “an insoluble residue” in line 1, lacks antecedent basis in step (c) of claim 1. For the purposes of examination, the limitation will be interpreted as reciting “the protein solution”.
With respect to Claim 20, the recitation of “the protein at stage (e) is deposited” in line 1, lacks antecedent basis in step (e) of claim 1. For the purposes of examination, the limitation will be interpreted as reciting “the solvent at stage (e) is separated”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Trass et al. (US 2011/0177582 A1).
With respect to Claim 1, Trass et al. teaches a process for isolating proteins from a defatted sunflower seed meal. [0017] The process comprises an acid extraction followed by a separation, as recited in step (b), an alkali extraction with an antioxidant and another separation, as recited in step (c), a pH adjustment with an acid in order to deposit the isolated protein, as recited in step (d), washing out the protein precipitate, as recited in step (e), and drying the protein. [Fig. 3] Trass et al. teaches that the washing out step comprises a neutralization step, [0033] as recited in step (f). Trass et al. also teaches grinding the material before processing in order to increase yield, [0054] as recited in step (a), heating the extract in order to prevent the formation of undesirable compounds, [0052] as recited in step (g), and drying in a spray dryer in order to produce a powder, [0064] as recited in step (h).
Trass et al. teaches milling the material, washing with acid and separating the solvent, washing with alkaline and separating the protein solution, isoelectrically depositing the protein through the use of acid, washing out with water and separating the solvent, neutralizing the suspension, stabilizing the suspension by heating, and spray drying the suspension to produce the isolate, but does not teach the steps in the exact order recited. According to MPEP 2144.04 IV C., “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. in order to develop a method of isolating protein from sunflower meal through the steps of milling the meal, an acid wash, an alkali wash, isoelectrically depositing the protein with an acid, another washing out with acid, neutralizing the substance, stabilizing the substance with heat, and spray drying the substance, thereby rendering claim 1 obvious.
With respect to Claim 2-4, Trass et al. teaches the acidic extraction stage (i.e., claimed stage (b)) may be carried out with a water to meal ratio of 8-10:1, a pH between 4.5-5, for about 15-60 minutes, [0019]and between 30-60°C. [0019] The ranges taught by Trass et al. overlap with the values recited in claim 2-4. According to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”.
Additionally, Trass et al. teaches the use of hydrochloric acid as a suitable acid for the acid wash, [0019] but does not teach a specific concentration of HCl. It would have been obvious to one of ordinary skill in the art to have optimized the concentration of HCl added to the solution in order to achieve a pH of 4.5. According to MPEP 2144.05 II, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to produce a method of protein isolation wherein the acid extraction step is performed with 10% hydrochloric acid, at a pH of between 4.0-4.9, for 15-45 min, at 45-70°C, and the sunflower meal:water ratio is between 8-9:1, thereby rendering claims 2-4 obvious.
With respect to Claim 5 and 10, Trass et al. teaches a variety of methods of separating the precipitate from the solution, including a decanting centrifuge after the alkaline extraction. [0066] The use of a decanter centrifuge reads on decanting a liquid. Additionally, according to MPEP 2144.04 IV C., “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”. It would have been obvious to one of ordinary skill to use the same decanter centrifuge in the separation stage of the acid extraction. Therefore, it would have been obvious from one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to use a method of decanting in order to separate the liquid and solid phases in the acid and alkaline extraction steps, thereby rendering claims 5 and 10 obvious.
With respect to Claim 6 and 11, Trass et al. teaches the use of sodium sulfite as an antioxidant during the alkaline extraction step. Additionally, MPEP 2144.04 IV C. states, “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”. It would have been obvious to one of ordinary skill to have used the sodium sulfite in the acid step as well. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to add the antioxidant to the acid of alkali extraction, thereby rendering claims 6 and 11 obvious.
With respect to Claims 7 and 8, Trass et al. teaches the alkaline extraction step that is performed between a pH of 9-12, for 30-60 minutes, [0023] at about 50°C. [0052] These values overlap with the values recited in claims 7 and 8. According to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore Trass et al. renders claims 7 and 8 obvious.
With respect to Claim 9, Trass et al. teaches the alkaline extraction step is performed at about 50°C. [0052] This value is close to the value recited in claim 9 and teaches the general principle of performing the extraction at an elevated temperature. According to MPEP 2144.05 II, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention to have used the teaching of Trass et al. to perform the alkaline extraction step at 55°C, thereby rendering claim 9 obvious.
With respect to Claims 12 and 13, Trass et al. teaches precipitating the protein in the solution at a pH of 4.5. [0069] Therefore Trass et al. renders claims 12 and 13 obvious.
With respect to Claims 14-16, Trass et al. teaches using hydrochloric acid in order to cause the precipitation, [0063] and maintaining the pH for between 5 and 30 minutes. [0032] Additionally, Trass et al. teaches the entire process may be carried out at an elevated temperature of at least 40°C. [Example 1] The elevated temperature and concentration of hydrochloric acid would have been modified by one of ordinary skill in the art in order to achieve the most efficient protein isolation method. According to MPEP 2144.05 II, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. in order to develop a method of precipitating sunflower meal proteins, wherein the isoelectric precipitation step comprises the use of 10% HCl for 15-45 min, at a temperature of 45-70°C, thereby rendering claims 14-16 obvious.
With respect to Claims 17 and 20, Trass et al. teaches using a centrifuge in order to separate out the proteins in the precipitation and washing out stage, [0063] and teaches that the centrifuge may be operated at about 9000g. [0067] According to MPEP 2144.05 II, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. The amount of g forces applied would have been modified to determine the best separation parameters. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to use centrifugation in precipitating and washing the protein isolate at 17,000g, thereby rendering claims 17 and 20 obvious.
With respect to Claims 18 and 19, Trass et al. teaches a washing out stage after the alkali extraction that involves the use of water [0061] and teaches lowering the pH of the alkali wash solution. [0062] Trass et al. does not explicitly teach the pH of the acid used, the amount of time, or temperature at which the washing out stage occurs. Trass et al. does teach carrying out the whole precipitation process at temperatures that range from 40°C [Example 1] to 50°C. [Example 3] Additionally, the pH changing steps of acidification and alkalization occur for between 5 and 30 minutes, [0032] and 30-60 minutes, [0023] respectively. Additionally, the exact pH, time, and temperature recited in claims 18 and 19 are simply the results of routine optimization, and MPEP 2144.05 II states, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to develop a method of isolating a protein from sunflower meal, wherein the washing out step comprises the use of water, then an acid at a pH of between 4.5-5, for 10 minutes, at a temperature between 50-60°C, thereby rendering claims 18 and 19 obvious.
With respect to Claims 21-24, Trass et al. teaches a washing out stage that comprises suspending in water and neutralization, [0033] specifically through the use of sodium hydroxide. [0064] Trass does not teach the specific concentration of NaOH, but it would have been obvious to one of ordinary skill in the art, to have optimized the concentration in order to achieve a pH of 7 during neutralization. According to MPEP 2144.05 II, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to neutralize the proteins during the washing step with 8% sodium hydroxide, thereby rendering claims 21-24 obvious.
With respect to Claim 25 and 26, Trass et al. is silent to the exact temperature and time required to neutralize the pH of the protein isolate, but does teach carrying out the whole precipitation process at temperatures that range from 40°C [Example 1] to 50°C. [Example 3] Additionally, the pH changing steps of acidification and alkalization occur for between 5 and 30 minutes, [0032] and 30-60 minutes, [0023] respectively. The time and temperature recited in claims 25 and 26 are the results of routine optimization, and according to MPEP 2144.05 II, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. to have developed a method of producing a protein isolate, wherein the neutralization step is carried out for 30 minutes at between 45-70°C, thereby rendering claims 25 and 26 obvious.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Trass et al. (US 2011/0177582 A1) in view of Mai et al. (US 2007/0014909 A1).
With respect to Claims 27 and 28, Trass et al. teaches the invention as recited in claim 1, as described above, but does not teach an elevated temperature for the protein suspension before spray-drying.
Mai et al. teaches producing a protein extract with an acid form that is neutralized, then heated to between 85-95°C for 30 seconds to 50 minutes. [0014] Additionally, the protein product taught by Mai et al. is more stable in acidic drinks and has a greater solubility in products comprising the protein. [0121]
Trass et al. and Mai et al. exist within the same field of endeavor in that they teach methods of protein isolation. Where Trass et al. teaches a generalized method for use with sunflower seed meal, Mai et al. teaches that the protein isolate may be treated with elevated temperatures to produce desirable properties and sterilization.
The time and temperature taught by Mai et al. overlap with the temperature recited in claims 27 and 28, and according to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. in view of Mai et al. in order to produce a protein isolate according to the method recited in claim 1, wherein there is a sterilization step before spray-drying at a temperature between 70-95°C for 15-60 seconds, thereby rendering claims 27 and 28 obvious.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Trass et al. (US 2011/0177582 A1) in view of Petit et al. (US 4174313).
With respect to Claim 29, Trass et al. teaches the invention according to claim 1, as described above, including the use of spray-drying to produce a powder, but is silent to the exact temperature at which the spray-drying occurs.
Petit et al. teaches the purification of proteins from sunflower seeds, [Col. 1, Ln. 7-10] wherein the proteins are dried by atomization, [Col. 1, Ln. 43-44] which is also known as spray-drying. Petit et al. teaches the temperature at which the proteins can be atomized is between 150-300°C. [Col. 4, Ln. 26-27] Additionally, Petit et al. teaches that it is advantageous to isolate protein sources, such as sunflower seed proteins, in order to remedy diseases such as malnutrition. [Col. 1, Ln. 11-15]
Trass et al. and Petit et al. exist within the same field of endeavor in that they teach methods of isolating sunflower proteins. Where Trass et al. teaches a generalized method for use with sunflower seed meal, Petit et al. teaches specific temperatures at which the sunflower protein can be spray-dried.
The temperature recited in Petit et al. overlaps with the temperature recited in claim 29, and according to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Trass et al. in view of Petit et al. to develop a method according to claim 1, wherein the temperature of the spray-drying step is between 80-180°C, thereby rendering claim 29 obvious.
Conclusion
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791