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 .
Status of the Application
Claims 1-20 filed in a preliminary amendment on 2/12/2024 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/12/2024 was filed before the first Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 5, 8,13 and dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 5 recites an amino acid selected from the group consisting of lysine, arginine, methionine, serine, histidine and mixtures thereof. However, independent claim 1 requires that the amino acid comprises more than one nitrogen-containing functionality. Methionine and serine do not have the claimed more than one nitrogen-containing functionality. The scope of the claim is unclear.
Claim 8 recites a listing with organic solvent and ethanolamine. However, ethanolamine is an organic solvent. A broad and narrower recitation of organic solvent and ethanolamine respectively, in the same claim, renders the claim indefinite.
Claim 13 recites “wherein the plant is cotton, okra, soybean and sunflower” limiting “where the plant is one that produces gossypol”. However, soybean and sunflower plants do not produce gossypol. The scope of the claim is unclear.
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.
Claims 1-20 are rejected under 35 USC 103 as being unpatentable over Hron et al (US5112637A), cited in an IDS in view of known binding of gossypol to amino acids disclosed in Conkerton et al. (Arch. Biochem. Biophys. 81:130-134 (1959)
Regarding claims 1, 2 and 16, Hron (column 3 lines 5-20) discloses a method of removing gossypol from one or more plant parts (cottonseed meal) comprising:
(a) contacting cottonseed with a solvent solution comprised of: (i) a water miscible organic solvent; (ii) water; and (iii) an acid which is characterized as being strong enough to prevent binding of the gossypol to the cottonseed protein but not so strong that it will hydrolyze a substantial portion of the cottonseed protein; under conditions providing extraction of gossypol from said cottonseed by said solvent solution, thereby producing cottonseed meal of reduced gossypol content and solvent solution having gossypol therein; and(b) separating said cottonseed meal of reduced gossypol content from said solvent solution having gossypol therein (which by definition includes known separation methods as claimed in claim 16) . Hron therefore broadly discloses an acidified solution in removing gossypol, (column 3 lines 8-10) containing an organic solvent as in claim 2.
Hron does not disclose “amino acid solution.” However, Hron discloses removing gossypol from cottonseed derived plant material by contacting the material with an acidified aqueous medium , explaining that controlled acidic conditions disrupt binding between gossypol and protein amino groups and thereby facilitate removal of gossypol without hydrolyzing protein (col 6 lines 3-7). Conkerton discloses that gossypol reacts with free [Symbol font/0x65]-amino groups of lysine in proteins, identifying lysine amino groups, for example, as primary reactive sites for gossypol (introduction paragraph 3, Table 1).
In view of these findings, a person of ordinary skill in the art would have been motivated to modify the acidified solvent removal method of Hron to include free lysine in the extraction medium, such that lysine amino groups in solution would competitively interact with gossypol released under acidic conditions , thereby facilitating its removal from the plant part.
This modification represents a predictable application of known chemistry that one of ordinary skill in the art would have practiced with a reasonable expectation of success.
Regarding claim 3, Hron discloses organic and inorganic acids as claimed (column 4 lines 14-19).
Regarding claim 4, Hron discloses an acid concentration in the claimed range (exemplary 0.1-0.4 molar, column 4 line 21) which falls within the claimed range.
Regarding claims 5 and 6 Conkerton discloses amino group of lysine binding gossypol (introduction paragraph 3). As mentioned in applicant’s background art, arginine with a guanido group, and histidine were known to bind gossypol, motivating one of ordinary skill in the art to have included one of these amino acids in an extraction solution for gossypol in modified Hron, with a reasonable expectation of success.
Regarding claim 7, Conkerton discloses an amino acid concentration with respect to gossypol on mole to mole basis (page 132 last paragraph) which is expected to be in the claimed broad range.
Regarding claim 8 and 9, Hron discloses organic solvents as claimed, water and mixtures (column 4 lines 25-31).
Regarding claim 10, Hron discloses 70-98% organic solvent, which falls within the claimed range (column 4 lines 45-50).
Regarding claims 11-13, Hron discloses cottonseed meal and the cotton plant produces gossypol (abstract, column 3 lines 5-7).
Regarding claims 14 and 15, Hron discloses that the contacting at 50-90 deg C (column 5 line 4) and that determination of residence times determinations of residence times etc. are within the ordinary skill of those in the art (column 5 lines 20 and 21). One of ordinary skill in the art would suitably select a time depending on the nature of the plant part and the incubation temperature, in modified Hron.
Claims 17-20 are rejected under 35USC 103 as being unpatentable over Li et al. (WO2021/174226A1) cited in an IDS.
Regarding claim 17 Li discloses a protein product (Example 9) with less than 1 ppm free gossypol.
Claim 18 is a product-by-process claim. A product-by-process claim is not limited by manipulations of process steps, only by the structure implied by the steps, which is a gossypol reduced protein isolate. Li discloses a cottonseed protein isolate with less than 1ppm free gossypol (Example 9).
Regarding claim 19 and 20, Li discloses that the cottonseed contained higher than 450ppm of free gossypol which was reduced to less than 1ppm (Examples 5 and 9), that is pure protein isolate after gossypol removal, and therefore expected to have a protein content of more than 90%.
Claims 1-20 are therefore prima facie obvious in view of the art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUBBALAKSHMI PRAKASH/ Primary Examiner, Art Unit 1793
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