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 1-18 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 Claim 1, Claim 1 recites the limitation of “removing starch-and/or fiber-enriched fractions to form a liquid protein fraction”. However, it is unclear whether the starch and fiber enriched fractions are removed from the previously recited suspension of legume flour, or from another source.
Claims 2-16 depend from independent Claim 1 and are therefore also rejected.
Regarding Claim 3, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding Claims 11, 13, and 14, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 11 recites the broad recitation of 4-20%, and the Claim also recites 5-15%, which is the narrower statement of the range/limitation. Claim 13 recites the broad recitation of less than 15%, and the Claim also recites the narrower ranges of less than 10%, less than 6% and between 3% and 5%. Claim 14 recites the broad recitation of 0.1-3%, and the Claim also recites the narrower range of 0.2% to 1%. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding Claims 16 and 18, the phrase "most preferentially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 recites “a use of” an enzyme. Since no active method step is recited, the claim is indefinite. See MPEP 2173.05(q).
Claim 18 depends from independent Claim 17 and is therefore also rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because no active positive method step is recited. See MPEP 2173.05 Q.
Claim 18 depends from independent Claim 17 and is therefore also rejected.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 5-6, 8-13, 15, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Calmon (US 20220312794 A1) in view of Simell (WO 90/08476)
Regarding Claims 1, 5, and 6, Calmon teaches a method for producing plant proteins, including leguminous proteins (Abstract) such as soy [0027]. The method comprises separating the starch and polysaccharide components from the protein components in aqueous suspension [0039]. Calmon teaches that this produces a liquid fraction with concentrated protein [0039]. Calmon teaches further concentration of the protein fraction via, e.g. protein precipitation [0041].
Calmon does not address treating the liquid protein fraction with a phytic acid degrading enzyme.
Simell teaches that phytic acid (or phytate, Page 1, Lines 17-19) is common in plant seeds such as soy beans and interferes with assimilation of nutrients (Page 1, Line 25-Page 2, Line 2). Simell teaches that phytate may be removed by treating a plant protein isolate with a phytate degrading enzyme. Note that Simell teaches treatment of the plant protein in an aqueous suspension (Page 9, Line 32- Page 10, Line 6), which is a “liquid protein”. Simell additionally teaches re-suspending a protein product in aqueous suspension, and treating the aqueous suspension with a phytate degrading enzyme (Page 9, Lines 13-18). Simell therefore teaches the treatment of a “liquid protein fraction” and a “protein-enriched protein fraction” as claimed in Claim(s) 5 and 6.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to utilize a phytate degrading enzyme as taught by Simell in the protein isolate product(s) of Calmon. One would have been motivated to make such a modification since Simell teaches that phytate is common in plant seeds, and the treatment of a plant protein isolate with a phytate degrading enzyme removes phytate.
Regarding Claim 2, note that the instant Claim recites that the step “may comprise”, and the limitations of a precipitation stage and a separation stage are therefore optional. Regardless, Calmon teaches that the protein is precipitated and separated [0042 and 0045].
Regarding Claim 3, Calmon teaches that the protein is coagulated at pH 4-6 [0042].
Regarding Claim 8, Calmon does not address a proteolysis step. Absent evidence to the contrary, Calmon is interpreted to teach an extraction process that does not comprise proteolysis of the protein-enriched protein fraction, as claimed.
Regarding Claim 9, Simell teaches the use of phytase (Page 13, Lines 6-7).
Regarding Claim 10, Simell teaches that the protein is heated after treatment with the enzyme (Page 9, Lines 19-21 and Page 10, Lines 7-9).
Regarding Claim 11, Simell teaches the treatment of a protein fraction which is e.g. 10 grams of a protein fraction in 100 mL of water, which is 10% (Page 19, Example 4). Note that the “dry matter of the protein fraction” is interpreted to mean the amount of dry matter, encompassing both protein and other components, in a “protein fraction”.
Regarding Claim 12, Simell teaches that the phytic acid is reduced to below 1% (Page 18, Table 1).
Regarding Claim 13, Calmon does not teach an active hydrolysis step; absent evidence to the contrary, the protein of Calmon is interpreted to be unhydrolyzed, which is a degree of hydrolysis of “less than 6%” as claimed.
Regarding Claim 15, Calmon teaches drying of the protein [0048].
Regarding Claims 16 and 18, Calmon teaches the treatment of plant proteins including beans, peas, and faba bean [0027]. Additionally, note that where Simell teaches that phytate is common in plant seeds (which encompasses beans), it would have been obvious to modify Calmon to utilize the method of Simell for any plant seed, including peas and faba beans as claimed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Calmon in view of Simell as applied to Claim 1 above, and further in view of Goodnight (US 3995071 A, November 1976).
Regarding Claim 4, modified Calmon teaches the method of Claim 1 as discussed above. Calmon teaches that the extraction of proteins may be performed by “any type of suitable method” [0041] but does not address the use of membrane filtration.
Goodnight teaches a method for obtaining purified plant protein (Column 1, Line 1). Goodnight teaches that ultrafiltration via a semi-permeable membrane (Column 3, Lines 11-15) effectively retains high molecular weight proteins, and is cheaper to operate than other filtration types (Column 3, Lines 20-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to utilize membrane filtration in the process of Calmon. One would have been motivated to make such a modification since Calmon teaches the use of any suitable method for protein isolation, and Goodnight teaches that membrane filtration is an effective method for protein isolation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Calmon in view of Simell as applied to Claim 1 above, and further in view of Kim (“Functional Properties of Proteolytic Enzyme Modified Soy Protein Isolate”, DOI: https://pubs.acs.org/doi/pdf/10.1021/jf00093a014, March 1990).
Regarding Claim 7, modified Calmon teaches the method of Claim 1 as discussed above but does not discuss a proteolysis step of the protein-enriched fraction.
Kim teaches that proteolysis of soy proteins improves solubility of the protein (Page 651, Column 1, Paragraph 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to incorporate a proteolysis step in the method of modified Calmon. One would have been motivated to make such a modification to improve the solubility of the soy proteins.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Calmon in view of Simell, taken with evidentiary reference of Teskeredzic (“Assessment of undephytinized and dephytinized rapeseed protein concentrate as sources of dietary protein for juvenile rainbow trout (Oncorhynchus mykiss)” DOI: 10.1016/0044-8486(94)00334-K, April 1995)
Regarding Claim 14, Simell teaches the addition of a Finase enzyme at e.g. 150 PU (phytate-degrading units) per gram of substrate (Page 18, Table 1). A typical Finase product has an activity of 5,000 PU/gram (see evidentiary reference of Teskeredzic, Page 266, last line). Simell therefore teaches the addition of 150/5,000 = 3% of enzyme per weight of substrate, which touches the claimed range.
With a view towards compact prosecution, Examiner notes that the mass of an enzyme is generally unrelated to the activity of the enzyme. The instant Claim, which is directed towards a mass ratio of enzyme to substrate, encompasses a wide range of possible enzyme activities. One of ordinary skill would have recognized that the amount of enzyme could be adjusted based on the desired amount of enzymatic activity and the conditions under which the reaction was occurring, and therefore arriving at the claimed amount is considered to require no more than routine experimentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH LIU whose telephone number is (571)270-5685. The examiner can normally be reached 12-8 Eastern Time.
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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.
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/D.L./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791