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 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 14, 20 and 67 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.
Regarding Claims 14 and 20, the use of parentheses in the claims render the claims indefinite as it is unclear whether the limitation in parentheses is exemplary or required.
Claim 67 recites the limitation "the canola seed protein isolate" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim as Claim 67 depends from Claim 17 which recites “An oil seed protein isolate” and where the oil seed protein isolate can be canola is only recited in Claim 20.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 17, 20, 67, 71, 78 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhang (2020), made of record by Applicant, and as evidenced by NC State Extension “Brassica napus Oleifera Group”.
Regarding amended Claims 17, 20, 67, 71, 78, Zhang teaches rapeseed (Brassica napus spp. oleifera) protein isolates made with alkaline extraction and acid precipitation methods, which are made into an emulsion gel comprising the oil seed protein isolate/canola seed protein isolates/rapeseed protein isolates (Page 1, Column 1, Paragraph 1, Page 2, Column 1, Paragraph 1, Page 3, Column 2, Paragraph 1, (Section 2.9.2, preparation of rapeseed protein emulsion gel). The emulsion gel comprising the oil seed protein isolate is deemed a food in light of its edible nature. The seed protein isolates made from Brassica napus spp. oleifera are seen to be equivalent to canola seed protein isolates as well, in light of the evidentiary reference to NC State Extension, Page 1, Paragraphs 1-3).
Applicants' Claims 17, 20, 67, 71 and 78 are written in a product-by-process format and as such, it is the novelty of the instantly claimed product that needs to be established and not that of the recited process steps. In re Brown, 173 USPQ 685 (CCPA 1972); In re Wertheim, 191 USPQ (CCPA 1976). Regarding Claims 17, 67 and 71, since the product shown by this reference is a canola seed protein isolate/oil seed protein isolate that is a gel or emulsion and therefore a food comprising the oil seed protein isolate, the product is met.
Claims 17-20 and 78 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lusas (1985), made of record by Applicant.
Regarding amended Claims 17-20, 78, Lusas teaches of oilseed protein isolates, such as sunflower seed protein isolates made from aqueous alkali salt solubilization and acid precipitation methods that contain 90% protein and are substantially in native form as no denaturation steps are disclosed, and which are disclosed as sunflower seed food protein ingredients (Page 417, Figure 5). Therefore, Lusas teaches using the sunflower seed protein isolates in foods and beverages.
Applicants' Claims17, 18, 19, 20, 78 are written in a product-by-process format and as such, it is the novelty of the instantly claimed product that needs to be established and not that of the recited process steps. In re Brown, 173 USPQ 685 (CCPA 1972); In re Wertheim, 191 USPQ (CCPA 1976). Regarding amended Claims 17, 18, 19, 20, 78, since the product shown by this reference is an oil seed protein isolate and a food or beverage comprising the oil seed protein isolate, the product is met.
Claim Rejections - 35 USC § 103
Claims 1, 2, 5, 7, 8, 13, 14, 17-20, and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Eisner (USPA 2022/0007679) in view of Zhifu (CN 101326951), both made of record by Applicant.
A machine translation of the CN document is used in the following rejection and has been made of record by the Examiner.
Regarding amended Claims 1, 2, 5, 14, 17, 18, 20, Eiser teaches an oilseed protein isolate extraction process, and the oilseed protein isolate itself with a protein content of greater than 90% (Paragraph 36) comprising:
Step a. separating hulls if present from desolvented and de-oiled seed flour, as Eiser teaches providing a protein-containing flour which has been obtained from dehulled and de-oiled sunflower seeds and then is desolvented (Paragraphs 15-19), where the oil content is less than 2% by mass (Paragraph 15).
Step b. as Eiser teaches alkaline hydration of hull free, desolvented, de-oiled oil seed flour with an aqueous solution (Paragraph 21) and teaches preferable pH range below 8, and/or by the use of antioxidants or reducing agents such as sodium sulfite (Paragraph 23), therefore rendering obvious to one of ordinary skill in the art the claimed pH range and teaching of a sodium salt. Eisner teaches temperature for the aqueous extraction above 20̊C or above 40̊C (Paragraph 59), therefore overlapping with the claimed temperature range.
Step c. and d. separation of solids form the solution, producing a liquid fraction (Paragraph 63), precipitation and separation of protein from liquid fraction at pH between 5.5 and 7 (Paragraphs 64 and 65), therefore overlapping with the claimed pH range for the precipitation and separation step. Eisner teaches the protein precipitation step occurs at room temperature (20̊C).
Step e. dilution of the protein to produce a slurry as Eiser teaches multiple extraction with water prior to drying of the slurry (Paragraphs 70-73).
Step g. Eisner teaches drying the protein (Paragraph 73).
Eisner does not specifically teach step f. homogenizing and sterilizing the protein slurry.
Zhifu teaches a process of extracting sunflower seed protein with aqueous separation (Paragraph 1 of the machine translation) using dehulled sunflower seeds (Paragraph 11), followed by aqueous extraction with pH value of 3-8 in a tank with a prepared alkali solution in temperatures similar to what is taught by Eisner of about 30-80 ̊C (Paragraph 13). Zhifu teaches centrifugal separation, oil separation and protein processing to form a protein slurry with pH in the range of 3-7, protein separation, followed by sterilization and homogenization of the liquid, followed by drying (Paragraph 16). Therefore, the additional steps of homogenization and sterilization of the protein slurry, prior to drying, would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the teachings of Zhifu.
Regarding amended Claims 7 and 8, and the limitation of the solids concentration in step b being in the range of 10-20%, Eisner in view of Zhifu teaches the aqueous extraction is carried out with the flour and a defined quantity of water in excess (e.g. a ratio of water to flour greater than 3:1), kept in suspension for a period of 10 to 60 minutes (Eisner, Paragraph 21), where the limitation of wherein alkaline hydration step being carried out for 30-60 minutes is met by the teachings of Eiser. While Eisner does not specifically teach the claimed solids content in the alkaline hydration step, since Eisner teaches water in excess during the alkaline hydration of the flour and extraction step. Therefore, it would have been well within the skill of one of ordinary skill in the art to determine the optimal solids concentration during the alkaline hydration step in order to maximize the efficiency of the hydration step, thereby providing a high quality sunflower seed protein component. In addition, where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in the solids concentration involves only routine skill in the art. MPEP 2144.05 II.
Regarding amended Claim 13, Eisner in view of Zhifu teach multiple dilution or aqueous extraction operations with water at pH around 7 (Paragraphs 62-64).
Regarding amended Claim 19, since Eisner in view of Zhifu do not teach any processes that result in denaturation of the protein, the prior art is understood to teach wherein the protein is substantially maintained in its native form.
Regarding amended Claim 78, Eisner in view of Zhifu teach using the protein components made in human foodstuffs (Eisner, Paragraph 12).
Claims 6, 9, 63 and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Eisner (USPA 2022/0007679) in view of Zhifu (CN 101326951), and further in view of Lusas (1985), all made of record by Applicant.
Regarding amended Claims 6, 9, 63 and 71, Eisner in view of Zhifu are taken as cited above in the process of Claim 1 and the product of Claim 17.
Regarding amended Claims 6 and 9, Eisner in view of Zhifu teach a salt such as sodium sulfite used in the aqueous hydration step, but not specifically sodium hexametaphosphate and in an amount in the claimed range.
Lusas teaches of oilseed protein isolates, such as sunflower seed protein isolates made from aqueous alkali salt solubilization and acid precipitation methods that contain 90% protein and are substantially in native form as no denaturation steps are disclosed, and which are disclosed as sunflower seed food protein ingredients (Page 417, Figure 5). Lusas teaches in terms of maximizing protein solubility, it has been found that 2% sodium hexametaphosphate approximately doubled the solubility of sunflower concentrate and isolate in the pH range of 4-8 (Page 423). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used an amount of the claimed sodium salt in the claimed range in order to increase the solubility of the protein, thereby providing a sunflower protein isolate with maximum protein content.
Regarding amended Claims 63 and 71, Eisner in view of Zhifu teach the claimed sunflower seed protein isolate but not specifically a foam or an emulsion comprising the protein isolate.
Lusas discusses the use of the sunflower protein isolates in various food applications, and teaches the protein isolates have good emulsifying properties and can be added to wieners (Page 424). Lusas also teaches the sunflower protein isolates exhibit good whippability and foaming compared to their soybean counterparts (Page 425). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the sunflower seed protein isolates of Eisner in view of Zhifu to be made into emulsions comprising the protein isolates and foams comprising the protein isolates, in light of the teachings of Lusas and the known functionality of sunflower protein isolates in terms of its emulsification and whippability properties.
Claims 63 and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Lusas (1985), made of record by Applicant.
Regarding amended Claims 63 and 71, Lusas is taken as cited above in the rejection of Claim 17 and discusses the use of the sunflower protein isolates in various food applications, and teaches the protein isolates have good emulsifying properties and can be added to wieners (Page 424). Lusas also teaches the sunflower protein isolates exhibit good whippability and foaming compared to their soybean counterparts (Page 425). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the sunflower seed protein isolates to be made into emulsions comprising the protein isolates and foams comprising the protein isolates, in light of the teachings of Lusas and the known functionality of sunflower protein isolates in terms of its emulsification and whippability properties.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA A WATTS whose telephone number is (571)270-7368. The examiner can normally be reached Monday-Friday. 9am-4:30pm.
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JENNA A. WATTS
Primary Examiner
Art Unit 1791
/JENNA A WATTS/Primary Examiner, Art Unit 1791 9/29/2026
