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 . 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.
Claims Status
Claims 5 and 10 are pending.
Claim 5 has been amended.
Withdrawn Rejections
The rejection of claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertain differentiation between ultrafiltration and concentration is hereby withdrawn due to amendment.
The rejection of claims 5, 8, and 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to how the emulsifying ability is measured is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(a)
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 connected, 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 5, 8, and 10 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.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure(MPEP 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure and (d) representative number of samples.
The issue is if the method described by the claims will reliably yield a product as claimed.
(a and b) actual reduction to practice and disclosure of drawings or structural chemical formulas: Applicants describe a separation using a specific cation exchange resin (glycidyl methacrylate copolymer with propylsulfonic acid groups, p12, 2nd paragraph), separated using a three step solvent procedure varying the pH and ionic strength, yielding three peaks (p12, 2nd paragraph).
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure: applicants are claiming a method of isolating wheat proteins, comprising extraction of the wheat and cation exchange chromatography. Yet the claims do not provide sufficient detail of the experiment that embodiments will necessarily yield samples that meet the functional claim limitations, such as three peaks.
The Sigma Aldrich ion exchange troubleshooting document (downloaded 12 March, 2025) discusses ionic and hydrophobic interactions between the protein and the matrix (6th page, “Protein elutes later than expected or not at all”). This indicates that changing the matrix will affect binding of the various proteins – note that this is the basis of hydrophobic interaction chromatography. This means that a different matrix will give a different separation. Note that the recommended solution is to manipulate the pH and ionic strength. However, this will also affect the resolution (p4, “Peak of interest is poorly resolved from other major peaks”, continues to p5 – note “incorrect buffer pH and/or ionic strength” and “Sub-optimal elution conditions e.g. incorrect pH, gradient too steep, flow rate too high”). It is clear that a proper separation requires optimization of the elution for a given column material.
Merlino et al (Theor. Appl. Genet. (2009) 118 p1321-1337) teaches that there are well over 2000 albumin proteins in a given flour; the exact number and species dependent on the cultivar (abstract). Even a much cruder separation gives around a dozen relatively poorly resolved albumin proteins (Ewart, J. Sci. Fd. Agric. (1969) 20 p730-733, fig 1, p731, bottom of page). Presumably, a more sensitive detector and/or better resolution would produce more than the 3 peaks that applicants saw in their separation (p12, 2nd paragraph).
Ayers (J. Chem. Phys. (2005) 112(141102)) discusses the hard/soft acids and bases (title). Hard acids bind better to hard bases and vice versa (abstract). This suggests that the retention and even the elution order will change as the column binding material is changed from, for example, carboxymethyl (a hard anion) to the sidechain of selenocysteine (a soft anion).
(d) representative number of samples: Applicants provide one example that gives three peaks, only two of which meet the claim limitations of the independent claim. It is clear that modifying the separation conditions within the limitations of the claims will change the separation in ways that will change the peaks isolated. Nor is it possible to a priori determine which of these potentially isolated peaks will meet the functional limitations of the claim. Thus, the claims lack written description.
response to applicant’s arguments
Applicants state that they have amended around the rejection.
Applicant's arguments filed 16 Oct, 2025 have been fully considered but they are not persuasive.
Applicants have removed the emulsifying ability requirement, but the claims still require that the material be resolved into 3 peaks, a functional limitation. But the claim limitations are not sufficient to give the identical separation that applicants achieved. As noted in the rejection, there are thousands of proteins in wheat. This means that the peaks that applicants have obtained are not pure compounds, but rather mixtures, and that a different plate count in the separation will give a different number of peaks. Different wheat varieties have different protein profiles, so if a different variety of wheat than applicants used (not a claim limitation), it would not be surprising to get a different result. The separation medium is not limited to the medium of the claims (“comprising”), and the loading of propylsulfonic groups is not specified. Nor is the column length, flow rate, particle size, loading as a function of column diameter, or other parameters that will affect the resolution specified by the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658