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.
This office action is a response to applicant’s communication submitted April 18, 2024, wherein claims 1, 3-7, 9-10, and 12-21 were preliminarily amended, and claims 2, 8, 11, and 22-23 were canceled.
Claims 1, 3-7, 9-10, and 12-21 are pending in this application.
Priority
This application is a 371 of PCT/US2022/046217 filed 10/11/2022 PCT/US2022/046217 and claims benefit of provisional application 63/271,329 filed 10/25/2021.
Specification
The disclosure is objected to because of the following informalities:
The use of the term Brabender® (pg.16, para. 0057). which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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, 3-7, 9-10, 12-17, 19, 21 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 1, 3-7, 9-10, 12-17, 19, 21: The term “hot aqueous fluid” in the claims is a relative term which renders the claim indefinite. The term “hot” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant specification states, “In some embodiments the hot fluid is applied as water or aqueous liquid having temperature near to or at the boiling point of water. In at least some embodiments of the method disclosed in this specification a hot aqueous liquid has a temperature from about 70° C….” (pg. 3, para. 0010). However, exemplification is not an explicit definition. For example would 1 degree above room temperature be considered hot?. Thus what constitutes a hot aqueous liquid is unclear.
Regarding claim 7: Claim 7 recites “wherein preferably, the modification is thermal inhibition”. The phrase “wherein preferably” renders the claim indefinite because there is a question or doubt as to whether the feature introduced by the phrase is merely exemplary of the remainder of the claim, and therefore not required, or is a required feature of the claim.
Regarding claims 16-17: Claims 16-17 recites inter alia, “wherein the starch is agglomerated or pregelatinized”. However, given that claim 1, of which claim 16-17 depends, recites the product starch is pregelatinized. It is unclear whether the agglomeration or pregelatinized is referring to the starting material starch or the product produced by the method. Thus a person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16-17 and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 16-17 recite “wherein the starch is agglomerated or pregelatinized”. However, claim 1 of which claims 16-17 require that the starch is pregelatinized. Thus claim 16-17 by making pregelatinized an alternative limitation instead of a necessary one, fails to include all the limitations of claim 1.
Claim 21 recites “A pregelatinized thermally inhibited starch made according to the process as described in claim 1.”. However, claim 21 is not a proper dependent claim because the product can be made by a method other than that recited in the base method claim, and thus, does not include the limitations of the base claim. Specifically, claim 1 is directed towards a process for processing starch comprising applying a hot aqueous fluid to the starch in an amount up to 45% such that the starch is pregelatinized and does not exhibit a Maltese cross diffraction pattern when viewed under polarized light. According to the instant specification drum drying can be utilized to prepare a pregelatinized starch which uses 93% juice (i.e. aqueous liquid) to cook the starch and does not exhibit a maltese diffraction pattern (pgs. 22-23, para. 0093-0094). Thus, the starch prepared by the process of claim 1 can be prepared by another method (i.e. higher aqueous liquid concentration).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 5-7, 17-18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schopmeyer (US 2,427,328, cited on PTO-892) as evidenced by Xiao (J. Food Composition and Analysis, 2020, cited on PTO-892).
Regarding claims 1, 3, 5-7, 17-18, and 21: Schopmeyer teaches a method of a preparing a pregelatinized waxy starch (col. 1, lines 44-50). The method comprises spraying steam to a wet waxy maize starch having initial moisture content of about 30% such that the water is increased by about 2 to 5% with each spray up to about 38-45% moisture content (col. 3, lines 1-12). As the starch passes through the conveyor there is a progressive increase of the temperature up to the maximum, which is about 160 F to 180 F, and preferably about 170 F (i.e. approx. 77 C, col. 3, lines 12-17). The temperature is maintained for a short period of time say about one fourth to one minute (col. 3, lines 16-18). The pregelatinized material is delivered from discharge opening to a flash drier (i.e. different reactor) and mill combined (col. 3, lines 26-29). Schopmeyer teaches the method can be applied to a starch that has been initially modified by a chemical treatment (i.e. modified starch, col. 3, lines 50-55). According to Xiao (J. Food Composition and Analysis, 2020, cited on PTO-892), complete gelatinization results in disappearance of maltese cross (pg. 3, col. 2, last para.). Wherein the process of claim 1 is anticipated the resulting starch is necessarily produced as recited by instant claim 21.
Claims 1, 3, 5-6, 15, 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bahrani (Chemical Engineering and Processing, 2014, IDS filed April 18, 2024) as evidenced by Xiao (J. Food Composition and Analysis, 2020, cited on PTO-892).
Regarding claims 1, 3, 5-6, 15, 19-21: Bahrani teaches hydrothermal processes, such as RP-HMT process for Reduced Pressurized-Heat Moisture Treatment and the second is the DV-HMT process for Direct Vapor-Heat Moisture Treatment for treatment of starchy material (abstract). Bahrani teaches a method for processing starch comprising treating a corn starch having 14% moisture with saturated steam at 120 C for 20 minutes (pg. 217, col. 2, section 2.1, pg. 218, col. 1, section. 2.3). Bahrani teaches the water content reaches 20 and 24% after 1800s (pg. 222, col. 2, para. 1). Bahrani teaches pregelatinized starch is used as a viscosity enhancer (pg. 216, col. 1, para. 1). Bahrani teaches starch can be physically transformed by intermediacy of hydrothermal process using temperature and pressure (pg. 216, col. 1, para. 1). Bahrani teaches the starch is placed into a hollow reaction chamber, which is tubular in shape (pg. 218, figure 1, col. 1, para. 4). According to Xiao (J. Food Composition and Analysis, 2020, cited on PTO-892), complete gelatinization results in disappearance of maltese cross (pg. 3, col. 2, last para.). Wherein the process of claim 1 is anticipated the resulting starch is necessarily produced as recited by instant claim 21.
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.
Claims 4, 10, 12, 14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Schopmeyer (US 2,427,328, cited on PTO-892) and Xiao (J. Food Composition and Analysis, 2020, cited on PTO-892) as applied to claims 1, 3, 5-7, 17-18, and 21 above in view of Shah (US Patent 5,718,770, IDS filed April 18, 2024) and Essers (US 2016/0053027, cited on PTO-892).
Regarding claims 4, 10, 12, 14: As discussed above, Schopmeyer teaches the method of claims 1, 3, 5-7, 17-18.
Schopmeyer does not teach wherein the hot aqueous fluid is applied to a thermally inhibited starch having a moisture content of less than about 2%, wherein the starch is dried to have a moisture content of up to about 15 %. Schopmeyer does not teach wherein the starch has a peak hot viscosity of less than about 2000 mPa*s.
However, Shah teaches a thermally-inhibited pregelatinized starch (col. 2, lines 1-5). The starches may be thermally inhibited first and subsequently pregelatinized (col. 2, lines 15-17). Shah teaches thermal inhibition results in improved texture and flavor (col. 1, lines 62-67, col. 2, lines 9-14). Shah teaches the thermal inhibition process comprises optionally pH adjusting the starch to a pH of about 7.0 or above, dehydrating to substantially anhydrous (i.e. less than 1% moisture by weight), and heat treating for a period of time sufficient to inhibit the starch (col. 2, lines 18-26). If the starch or flour is to be pH adjusted, thermally inhibited, and then pregelatinized, the granular starch or flour is slurried in water, the pH is adjusted to neutral or greater by the addition of a base, and the starch or flour is dried to about 2-15% moisture (col. 2, lines 39-43). Shah teaches measuring of the peak viscosity in Brabender units at 95 C (i.e. hot peak viscosity) using a viscoamylograph (col. 9, lines 10-24, 34-40) The peak viscosity for gelatinized samples for both high and low viscosity were less than 2000 units (col. 9, example 1, lines 20-65). According to the instant specification, Brabender visco-amylographs or micro-visco-amylographs commonly can report viscosity measurements using Brabender units (BU) mPA *s, or cmg (pg. 16, para. 0056). The instant specification states that, Reference to a "micro-visco-amylograph test" within this specification means the following test. Obtain aqueous slurry of starch by mixing 6% (wt.%) starch with aqueous solution that was buffered, and pH adjusted to pH 6. Heat and stir the slurry using Brabender viscoamylograph or micro-visco-amylograph machine rotating at a rate of 75 rpm at a rate of 6° C per minute from a temperature of about 50° C to about 95° C and hold the slurry at 95° C for 15 minutes. Combined, the heating from 50° to 95° and holding at 95° are referred to in this specification as the "heating phase" of the micro-visco-amylograph test.” (pg. 16, para. 0057). Additionally Essers teaches A process for producing thermally inhibited starch is described resulting in a visco-stable starch product with improved whiteness. The process comprises pretreating a dry starch with an alkaline solution in a water-miscible solvent, adjusting the water content of the starch to below 12 wt.%, heating the starch at a temperature between 140 and 190° C., preferably between 140 and 180° C (abstract). Essers teaches where native waxy maize starch has a peak viscosity of 600 mPas, and a final viscosity of 480 mPas, as measured in gelatinization (pasting) test using the standard Brabender Micro Visco-AmyloGraph at 5.8 wt.% starch in water (90° C., 25° C.), the final viscosity of the modified starches of the invention is at least 840 mPas, preferably at least 900 mPas, more preferably at least 960 mPas (pgs. 2-3, para. 0027).
Taken together it would have been prima facie obvious to modify the method of Schopmeyer such that then the hot aqueous fluid is applied to a thermally inhibited starch having a moisture content of less than about 2%, wherein the starch is dried to have a moisture content of up to about 15 % as taught by Shah and Essers. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success in order to improve the flavor and texture of the resulting starch product and drying to low levels is a routine practice in the art of preparing pregelatinized starches. Although the prior art does not explicitly state wherein the starch has a peak hot viscosity of less than about 2000 mPa*s. The art recognizes that viscosity is a result effective variable that can be manipulated depending on conditions treated. Additionally, arriving at the viscosity of less than 2000 mPa*s would flow naturally following suggestions in the prior art, absent evidence to the contrary.
Regarding claim 21: Even if assuming for the sake of argument that Schopmeyer does not teach a thermally inhibited starch as recited by instant claim 21. By following the above process of treating a thermally inhibited starch, the resulting starch is necessarily a pregelatinized thermally inhibited starch as claimed, absent evidence to the contrary.
Claims 9, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Schopmeyer (US 2,427,328, cited on PTO-892), Xiao (J. Food Composition and Analysis, 2020, cited on PTO-892), Shah (US Patent 5,718,770, IDS filed April 18, 2024), and Essers (US 2016/0053027, cited on PTO-892) as applied to claims 1, 3-7, 10, 12, 14, 17-18, and 21 above in view of Lane (EP 3345932, IDS filed April 18, 2024).
Regarding claims 9, 13: As discussed above, the prior art renders obvious all as taught above, except they do not teach wherein the starch is a thermally inhibited agglomerated starch, the method further comprises prior to the applying step of claim 1, applying a hot aqueous fluid to a native starch in an amount of 10% to about 20% with a buffering agent and acid or base to agglomerate the starch, pH is adjusted to pH between 4.5 and 9.5, dehydrating the starch to less than 2% starch, and heating to a temperature of about 100 C to about 200 C for up to 20 hours, thereby thermally inhibiting the starch agglomerates to obtain a thermally inhibited agglomerated starch that is then subjected to the procedure of claim 1. The prior art do not teach forming an agglomeration of thermally inhibited starch by applying aqueous fluid to a thermally inhibited to starch in a first amount up to 45% of the starch and then pregelatinizing the agglomerated thermally inhibited starch by applying the hot aqueous fluid to the thermally inhibited agglomerated starch in a second amount which is greater than the first amount but is within the up to 45% of hot aqueous fluid.
However, Shah teaches buffers such as a base can be used to maintain the pH of at least 7 during thermal dehydration and heat treatment (col. 5, lines 14-27). Lane a teaches method of improving the viscosity of thermally inhibited, starch-based texturizers and application of those texturizers in food products (pg. 2, para. 0001). Lane teaches agglomerated starch-based products disperse easily and develops its full viscosity instantaneously (pg. 3, para. 0017). Lane teaches heat hydrothermal treatments are used to modify the physiochemical properties and gelatinization can be controlled by controlling both temperature and moisture in a sample (pg. 2, para. 0006). Lane teaches that heat-moisture treatment comprising heating with limited moisture of about 10 wt% to about 30% without gelatinizing (pg. 2, para. 0006).. Lane teaches the thermally inhibited starch agglomerate is prepared by mixing a starch binding agent and starch granules together to form starch agglomerates which are dehydrated to anhydrous or substantially anhydrous (pgs. 3-4, para. 0018). These thermally inhibited starch agglomerates have a higher viscosity than that of non-agglomerated thermally inhibited starch granules derived from the same native starch as the starch granules present in the starch agglomerates (pgs. 3-4, para. 0018). In one embodiment, this starch-based binding agent can be either a physically modified or fully cooked starch which has not been subjected to any chemical modifications, resulting in a final agglomerated product that is still considered an ’unmodified’ (i.e., not chemically modified) starch for regulatory purposes and accordingly given a clean label designation (pg. 6, para. 0041). These unmodified starch-based binding agents can be rendered cold water soluble or swellable by, for example, simultaneously cooking and drying the starch on hot drums or in spray driers (pg. 6, para. 0041). Lane teaches agglomeration can be carried out by mixing wet starch granules with a starch binding agent, wherein a slurry (comprising about 15.0 to about 90.0% moisture) of the starch granules and an appropriate amount of the starch binding agent may be prepared using an appropriate mixing device (pg. 7, para. 0053). Lane teaches agglomeration may be conducted with or without buffering to maintain a certain pH (pg. 7, para. 0054).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the method further by ,prior to the applying the hot aqueous fluid step, applying a hot aqueous fluid to a native starch in an amount of 10% to about 20% with a buffering agent and acid or base to agglomerate the starch, pH is adjusted to pH between 4.5 and 9.5, dehydrating the starch to less than 2% starch, and heating to a temperature of about 100 C to about 200 C for up to 20 hours, thereby thermally inhibiting the starch agglomerates to obtain a thermally inhibited agglomerated starch that is then subjected to the pregelatinization procedure as suggested by Lane and Shah. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success in order to improve the viscosity properties of the starch and the claimed parameters are within typical conditions utilized in the art to thermally inhibit, dehydrate, and agglomerate the starch. Additionally, it would also have been prima facie obvious to a person of ordinary skill in the art to modify the method such that the agglomeration of thermally inhibited starch by applying aqueous fluid to a thermally inhibited to starch in a first amount up to 45% of the starch and then pregelatinizing the agglomerated thermally inhibited starch by applying the hot aqueous fluid to the thermally inhibited agglomerated starch in a second amount which is greater than the first amount but is within the up to 45% of hot aqueous fluid as taught by Lane and Shah. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success in order to streamline the process as the art recognizes that controlling heat and moisture content can alter when gelatinization occurs but can still result in agglomeration and thermally inhibiting the starch. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (See MPEP 2144.05 (II)). Wherein the art establishes moisture levels and temperature in conjunction can affect the properties of the resultant starch they are established result-effective variables.
Regarding claim 16: As discussed above, the prior art renders obvious all as taught above, except they do not teach
Schopmeyer does not teach wherein the starch is pregelatinized and dried at the same time.
However, Lane teaches dehydration and heat treatment can be performed in the same equipment (pg. 7, para. 0056). Heat treatment may be accomplished in the same equipment in which dehydration occurs, and most conveniently is continuous with the dehydrating step (pg. 7, para. 0056).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art such that the heat treatment (i.e. mixing) and dehydration (i.e. drying) occur in the same reactor as suggested by Lane. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art recognizes they can be carried out in the same equipment in order to make the process continuous and thus more convenient.
Conclusion
No claims area allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL L GALSTER/ Examiner, Art Unit 1693
