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 .
This Office Action is in response to applicant’s submission dated May 28, 2026. Any rejections and/or rejections made in previous actions and not submitted below are hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly conne
c
ted, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to Claim 1, The recitation of, “wherein no filtration step is utilized for increasing protein purity”, raises the issue of new matter not supported by the specification. The cited phraseology clearly signifies a “negative” or “exclusionary” limitation for which the applicants have no support in the original disclosure. Negative limitations in a claim which do not appear in the specification as filed introduce new concepts and violate the description requirement of 35 USC 112, first paragraph, Ex Parte Grasselli, Suresh, and Miller, 231 USPQ 393, 394 (Bd. Pat. App. and Inter. 1983); 783 F. 2d 453.
The insertion of the phraseology as described above positively excludes filtration for increasing protein purity; however, there is no support in the present specification for such exclusions. While the present specification is silent with respect to the use of filtration for increasing protein purity, it is noted that as stated in MPEP § 2173.05(i), the “mere absence of a positive recitation is not the basis for an exclusion.”
Due to their dependency on claim 1, claims 2-29 are also rejected.
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) in view of Talbot et al. (Specialty Oils and Fats in Food and Nutrition - Properties, Processing and Applications).
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, an alkali extraction with an antioxidant and another separation, a pH adjustment with an acid in order to deposit the isolated protein, washing out the protein precipitate, and drying the protein. [Fig. 3] The steps taught in Trass et al., described above, correspond to the steps of washing the milled meal with an acid and separating the wash solution, an alkali extraction resulting in a protein solution, isoelectrically depositing the protein from the solution, and washing out the protein deposit, as recited in claim 1.
Trass et al. teaches that the washing out step comprises a neutralization step, which reads on the neutralization step of the instant claim. [0033] Trass et al. also teaches grinding the material before processing in order to increase yield, [0054] disposing of the wash solution, [0029] heating the extract in order to prevent the formation of undesirable compounds, [0052] and drying in a spray dryer in order to produce a powder. [0064] All these steps read on the steps recited in claim 1 of milling the meal, discarding the wash solution, stabilization by heating, and spray drying, respectively. Trass et al. is silent to the lack of a filtration step for purifying protein.
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”.
Talbot et al. teaches a number of traditional extraction method and subjects of extraction. [5.1.2.2, Title] Additionally, Talbot et al. teaches that some fat extraction methods include a decantation step and no filtration step, [5.1.2.2, Par. 2] and that the benefit of decanting is in the affordability and ease of use. [5.1.2.2, Par. 3]
Trass et al. and Talbot et al. exist within the same field of endeavor, in that they teach methods of extracting oils from seed or nuts. Where Trass et al. teaches a detailed account of modern practices, Talbot et al. teaches more traditional methods, explaining there is a cost efficiency and access to more traditional methods.
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 Talbot 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, wherein there is no filtration step for increasing the purity of the proteins, thereby rendering claim 1 obvious.
With respect to Claim 2-4, Trass et al. teaches the acidic extraction stage 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 Talbot et al. (Specialty Oils and Fats in Food and Nutrition - Properties, Processing and Applications), as applied to claim 1, further 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 Talbot et al. (Specialty Oils and Fats in Food and Nutrition - Properties, Processing and Applications), as applied to claim 1, in further 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.
Response to Arguments
Applicant's arguments filed May 28, 2026 have been fully considered but they are not persuasive.
Applicant asserts on Page 8, Par. 6, that “the acid washing step of Trass is a protein extraction step, while the acid washing step claimed is provided for the removal of unwanted compounds and the resulting solution is discarded”. MPEP 2112 II states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference”. The acid wash step of Trass et al. is identical to the step recited, and therefore would possess the same properties, such as removing phenolic compounds including chlorogenic acid.
For this reason, applicant’s assertion is found to be unpersuasive.
Applicant asserts on Page 9, Par. 3, that, “the reference provides that the addition of the antioxidant is indeed optional and is limited to the alkali extraction step. Trass never contemplates the addition of an antioxidant during the washing step. Applicant is directed 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”. Applicant’s assertion fails to disclose the criticality of the order of performing the steps recited, and Trass et al. does not explicitly teach away from the addition of the antioxidant at other steps of the process. Therefore, it would have been obvious to add the antioxidant to the method of Trass et al. at any step.
For this reason, applicant’s assertion is found to be unpersuasive.
Applicant asserts on Page 10, Par. 3, that “all of claims 2-29 depend from and take all limitations from claim 1 and are believed to be similarly allowable”. The rejection of claim 1 has been maintained. Therefore, applicant’s assertion is found to be unpersuasive.
Applicant asserts on Page 11, Par. 4, that “the secondary reference Mai is not believe to be analogous art”. Trass et al. and Mai et al. exist within the same field of endeavor in that they teach methods of protein isolation. Because Trass and Mai are in the same field of endeavor, and that of the instant application, Mai is an analogous art.
For this reason, and those enumerated above, applicant’s assertions are found to be unpersuasive and the rejections of claim 1-29 are maintained.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CULLEN MERCHLINSKY whose telephone number is (571)272-2260. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michele L Jacobson/Primary Examiner, Art Unit 1793
/J.C.M./Examiner, Art Unit 1791
Prosecution Insights