DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 11/20/2025 have been received and entered into the case. Claims 2-3, 18-19 and 22-30 have been canceled. Claims 1, 4-17 and 20-21 are pending, Claims 4, 7-11 and 16 have been withdrawn, and Claims 1, 5-6, 12-15, 17, and 20-21 have been considered on the merits, insofar as they read on the elected species of xylanase, 500-2000 ppm, between 35 minutes and 12 hours, between 39 and 55℃, and sodium metabisulfite. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 2-3 under 35 U.S.C. 103 as being unpatentable over He et al (US 2014/0127760 A1; 5/8/2014.) in view of Ferrer et al (WO 2018/053220 A1; 3/22/2018. Cited on IDS) and Johnston et al (WO 01/94608 A1; 12/13/2001.) are withdrawn in view of applicant’s amendments – Claims 2-3 have been canceled.
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 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 of this title, 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.
Claims 1, 5-6, 12-15, 17, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over He et al (US 2014/0127760 A1; 5/8/2014.) in view of Ferrer et al (WO 2018/053220 A1; 3/22/2018. Cited on IDS) and Johnston et al (WO 01/94608 A1; 12/13/2001.).
The instant claims recite a wet milling process, comprising the steps of: a) soaking corn kernels in water to produce soaked kernels; b) grinding the soaked kernels to produce ground kernels; c) separating germs from the ground kernels to produce a corn kernel mass comprising fiber, starch and gluten; d) subjecting the resultant corn kernel mass comprising fiber to a fiber washing procedure, thereby separating starch, gluten, and fiber; wherein step d) further comprises contacting a fiber rich fraction of ground corn kernels with one or more hydrolytic enzymes selected from a xylanase, a cellulase, or a xylanase and a cellulase and at least 500 ppm of SO2 during step d), and wherein the amount of starch, gluten or both starch and gluten released from fiber during the wet milling process is increased compared to a process where no SO2 is added during step d).
He teaches a method of producing corn starch comprising soaking the corn, fine grinding, washing fiber, and adding enzyme preparation, wherein the enzyme preparation is xylanase, additive amount of the enzyme preparation is from 0.001% to 0.08% by weight of the corn (para 0008), adding the enzyme preparation is in the step of washing the fiber (para 0010), and xylanase is purified (para 0048). When soaking the corn, about 0.15%-0.2% of sulfur dioxide is added, the sulfur dioxide is absorbed by the corn, and in the soaking solution discharged eventually, the content of sulfur dioxide is about 0.01%-0.02% (para 0060), which indicate that an amount of sulfur dioxide remains in the soaked corn.
He does not teach separating germs from the ground kernels to produce a corn kernel mass, subjecting the resultant corn kernel mass comprising fiber to a fiber washing procedure (claim 1), wherein the fiber fraction is a fiber rich fraction (claims 1 and 20), the xylanase is a GH10 xylanase (claim 6), the fiber washing procedure comprises a fiber washing system comprising a space (claims 12-14), and the one or more hydrolytic enzymes is in an amount between 0.005-0.5 kg enzyme protein/metric tonne corn kernels (claim 20).
Ferrer teaches a method of improving starch yield and/or gluten yield from corn kernels in a wet milling process, comprising a) soaking corn kernels in water to produce soaked kernels, b) grinding the soaked kernels to produce ground kernels, c) separating germs from the ground kernels to produce a corn kernel mass comprising fiber, starch and gluten, and d) subjecting the resultant corn kernel mass to a fiber washing procedure (thereby separating starch, gluten, and fiber), wherein during step d) one or more fractions of the corn kernel mass is contacted with one or more hydrolytic enzymes (p.4 line 1-10, p.25 line 25-33). Ferrer teaches a fiber washing system comprising two fractions, wherein a second fraction containing a higher amount measured in wt% fiber than a first fraction (a fiber rich fraction) (p.3 line 1-5), preferably, all of the second fraction is in contact with the one or more hydrolytic enzymes through the fiber washing procedure (p.27 line 13-15), and the one or more hydrolytic enzymes comprise a GH10 xylanase (p.30 line 29). Ferrer teaches a total retention time is between 35 minutes and 5 hours (p.18 line 29-30, p.19 line 12-13), an incubation time is in the range of 1-3 hours (p.19 line 32-33), and an incubation temperature is in the range of 45-49℃ (p.24 line 23-25). The amount of one or more hydrolytic enzymes contacted with one or more fractions of the corn kernel mass is between 0.01-0.5 kg/MT corn kernel mass (p.32 line 4-5).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to increase starch yield and/or gluten yield from corn kernels in a wet milling process using a fiber rich fraction under the claimed conditions, since claimed steps and conditions used for increasing starch yield and/or gluten yield from corn kernels in a wet milling process using a fiber rich fraction are well-known and routinely practiced in the art, as evidenced by Ferrer. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to increase starch yield and/or gluten yield from corn kernels in a wet milling process using a fiber rich fraction under the claimed conditions with a reasonable expectation of success.
References cited above do not teach the claimed amount of SO2, wherein the amount of starch, gluten or both starch and gluten released from fiber during the wet milling process is increased compared to a process where no SO2 is added (claims 1 and 5), the SO2 present or added during fiber wash results in the same extraction yield of starch and gluten while reducing the required contact time between the one or more hydrolytic enzymes and the corn kernel mass compared to a method where SO2 levels are below 400 ppm (claim 15), and the source of SO is sodium metabisulfite (Na2S2O5) (claim 21).
Johnston teaches the effect of sulfur dioxide on enzyme treatment, wherein sulfur dioxide is used in corn wet-milling plants to control microbial growth, sample treated with 600 ppm sulfur dioxide alone showed a small increase in starch yields compared to buffer controls (p.11 para 4), and sodium metabisulfite is added to a sample to give a sulfur dioxide equivalent concentration of 600 or 2000 ppm (p.9 para 4). It is noted that the limitation of “the SO2 present or added during fiber wash results in the same extraction yield of starch and gluten while reducing the required contact time between the one or more hydrolytic enzymes and the corn kernel mass compared to a method where SO2 levels are below 400 ppm” only recites an outcome instead of an active method step. Furthermore, Johnston teaches sample treated with 600 ppm sulfur dioxide alone showed a small increase in starch yields compared to buffer controls, at the 200 ppm level there is no additional improvement when both enzyme and sulfur dioxide are added (p.11 para 4).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an optimized amount of SO2, since Johnston discloses that sulfur dioxide is used in corn wet-milling plants to control microbial growth, and that sample treated with 600 ppm sulfur dioxide alone showed a small increase in starch yields compared to buffer controls. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate an optimized amount of SO2, with a reasonable expectation for successfully producing corn starch.
Response to Arguments
Applicant argues that no combination of He, Ferrer and Johnston discloses or suggests contacting a fiber-rich fraction with SO₂ and enzymes during fiber washing, nor maintaining SO₂ at greater than or equal to 500 ppm at this stage of a corn wet milling process, and that He and Ferrer teach away from contacting a fiber-rich fraction of ground corn kernels with hydrolytic enzymes and 500 ppm SO₂ during fiber washing.
These arguments are not found persuasive because He does teach the method comprises adding enzyme and SO₂ during fiber washing, Ferrer does teach a wet milling process comprises a fiber washing procedure comprises a fiber washing system, wherein the fiber washing system comprises a fiber rich second fraction, wherein preferably all of the fiber rich second fraction is in contact with one or more hydrolytic enzymes through the fiber washing procedure, and Johnston does teach SO₂ is used in corn wet-milling plants, wherein sample treated with 600 ppm sulfur dioxide alone showed a small increase in starch yields compared to buffer controls, addition of both enzyme and SO₂ showed a further improvement in starch yields compared to the controls at the 600 ppm level, however, at the 200 ppm level there is no additional improvement when both enzyme and sulfur dioxide are added (p.11 last para), exactly as claimed. In addition, “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (MPEP 2123) Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (MPEP 2141.02) In the instant case, applicants have not pointed to the specific teachings of He and Ferrer references to show that said references actually “criticize, discredit or otherwise discourage” contacting a fiber-rich fraction of ground corn kernels with a xylanase and/or a cellulase and at least 500 ppm SO₂ during fiber washing.
Applicant argues that Example 2 unexpectedly demonstrates that the presently claimed combination of hydrolytic enzymes and SO₂ present or added in fiber washing achieves significant CGM increases-up to 0.42% over control-while reducing enzyme contact time.
These arguments are not found persuasive because evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. In the instant case, there was no comparison of the claimed invention with the closest prior art, and thereby lack of basis for judging the practical significance of data with regard to the disclosed unexpected results. Furthermore, results in Example 2 are not statistically significant. In addition, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. (MPEP 716.02)
Conclusion
No claims are allowed.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759