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 Claim
Claims 1, 4, 7, 9-11 and 14-22 are pending and under examination. Any objections or rejections not repeated below have been withdrawn.
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 (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.
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, 4, 7, 9-11 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Veelaert et al. US 20070039612 (cited in IDS dated 08/23/2023) in view of Klemaszewski US 20100278994.
Regarding claim 1, the recitations within the claim of “having a protein content of less than 0.4% w/w with a reactant capable of forming active chlorine, wherein the reactant is used in an amount sufficient to provide greater than 4000 ppm and below 8200 ppm of active chlorine during stabilization reaction” does not limit the claim, but is merely directed towards process steps and ingredients to make the final product instead of the final product itself. See MPEP 2113.I. Therefore, if the product in the product-by-process recitation in claim 1 is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Veelaert teaches a stabilized starch obtained by reacting under alkaline conditions a base starch (reaction performed at pH from 3 to 12, preferably a pH of 8.5 to 10.5; [0014-0020]). Veelaert discloses the base starch has a protein content from 0.2 to 0.4% [0021], which is within the claimed range of less than 0.4%. Veelaert further discloses that the reactant used to treat the base starch during the stabilization reaction is used in an amount sufficient to provide between 100 to 8000 ppm active chlorine ([0014-0019], [0057-0058], Claim 19), which overlaps the claimed range of greater than 4000 ppm and below 8200 ppm of active chlorine during the stabilization reaction. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Veelaert teaches the base starch is a modified waxy starch (starches may be chemically modified before treatment and are waxy starches; [0047-0048]) selected from the group consisting of modified waxy maize, modified waxy rice, modified waxy potato, modified waxy sorghum and modified barley [0047-0048].
Veelaert teaches the base starch can be modified by a chemical reaction [0047] but does not state the starch is modified by a chemical reaction with a succinic anhydride to have a succinic anhydride modified waxy starch.
Klemaszewski teaches a stabilized starch (starch modified for increased stability [0023]) which has undergone a reaction with a reactant of hypochlorite capable of forming active chlorine under alkaline conditions, pH between 7.5 to 11.5, where the starch is a waxy maize starch [0020-0021], [0048-0050]. Klemaszewski teaches that the starch is modified by a chemical with succinic anhydride or is a succinic anhydride modified waxy starch (n-octenyl succinic anhydride (nOSA); Abstract, [0049-0052]), which results in a starch with improved heat and shear stability, as well as a starch that can be used in products as a fat mimetic, or in other words used to replace the fat in food products, resulting in improved nutrition by reducing the fat in the overall product [0018], [0048], [0086].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Veelaert by using succinic anhydride, specifically nOSA, as the chemical to modify the starch, because nOSA modified starch has improved heat and shear stability, and is also a starch that can be used in products as a fat mimetic, or in other words used to replace the fat in food products, resulting in improved nutrition by reducing the fat in the overall product, as recognized by Klemaszewski.
Veelaert teaches the chemically modified waxy starch may or may not be a protease-treated starch ([0047], [0028], Claim 26). Veelaert states that the modified waxy starch undergoes a process step “a) treating starch with an amount of reactant…” but their reactant is selected from a group consisting of proteases, lipases, alkaline solution, and other reactants ([0019], [0028], Claim 18, Claim 26). However, a person of ordinary skill in the art can choose any of the reactants selected from the group, including an alkaline solution, and does not need to use the protease reactant. Therefore, modified Veelaert does teach the succinic anhydride modified waxy starch is not a protease-treated starch.
Regarding the recitation, wherein the stabilized starch exhibits a viscosity ramp of less than 0.20 BU/sec during 30 minutes heating at 95 °C, pH 3.0, and 5.5% solids; Veelaert in view of Klemaszewski teaches a stabilized succinic anhydride modified waxy starch composition that is substantially identical to the claimed composition and is produced by a substantially identical process as outlined above. Thus, the stabilized starch composition of Veelaert in view of Klemaszewski, is considered to exhibit a viscosity ramp of less than 0.20 BU/sec during 30 minutes heating at 95 °C, pH 3.0 and 5.5% solids, absent convincing arguments or evidence to the contrary.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP §2112.01 (I).
Regarding claims 4, 14 and 15 Veelaert teaches the base starch has a protein content of between 0.2 to 0.4% [0021]. This overlaps with the claimed range of between 0.1% and 0.38%, as required by claim 4, encompasses the claimed range of between 0.2% and 0.35%, as required by claim 14 and encompasses the claimed range of between 0.25% and 0.3%, as required by claim 15.
Regarding claims 7 and 16, Klemaszewski teaches that the base starch is modified by a chemical with an n-alkenyl succinic anhydride, as required by claim 7, specifically with n-octenyl succinic anhydride, as required by claim 16 (Abstract, [0049-0052]).
Regarding claim 9, Veelaert teaches the stabilization reaction is carried out at a pH from 3 to 12, preferably a pH of 7.5 to 11.5 [0019], which encompasses the claimed pH of between 8.0 and 9.0. Veelaert does not teach the base starch is a nOSA starch. Klemaszewski teaches the base starch is a nOSA starch (n-octenylsuccinylation (nOSA) chemical modification is carried out on the starch before the hypochlorite treatment, or treatment with reactant, making it the base starch [0052]).
Regarding claim 10, the recitations “for soups and sauces” and “for meat products” are construed to be directed towards the intended use of the claimed product. As long as the prior art formulation is capable of performing the intended use, then it meets the claim.
Regardless, Veelaert teaches a product of thickeners for sauces and dairy product containing the stabilized starch of claim 1 (bechamel sauce, where the stabilized starch is used as a thickener imparting a heavy texture to the sauce, the sauce is a dairy product containing milk and butter; [0207-0215]).
Regarding claim 11, Veelaert teaches a dairy product selected from the group consisting of milk and butter, said dairy product containing the stabilized starch of claim 1 (bechamel sauce, containing milk and butter containing the stabilized starch; [0207-0212]).
Regarding claims 17-22, Veelaert teaches the amount of the reactant is sufficient to provide between 100 to 8000 ppm active chlorine during the stabilization reaction [0014-0019], [0057-0058]. This overlaps the claimed ranges of at least 4200 ppm, 4300 ppm, 4400 ppm and 4500 ppm active chlorine, as required by claims 17, 18, 19 and 20 respectively. This also overlaps the claimed ranges of 4010 ppm to 8200 ppm and 4050 ppm to 7000 ppm of active chlorine, as required by claims 21 and 22 respectively.
Response to Declaration
The declaration under 37 CFR 1.132 filed 12/09/2025 is insufficient to overcome the rejection of claims 1, 4, 7, 9-11 and 14-22 based upon the combination of references applied under 35 U.S.C 103 as set forth in the last Office action.
The declarant responds, on pg. 2 section 6 of the declaration, to the examiner’s remarks on treatment order from the office action dated 09/12/2025. Declarant states that a person of ordinary skill in the art would understand that if the treatment order has an effect at 5000 ppm active chlorine and 3% nOSA, the treatment order would have the same effect at the other claimed concentrations, including at greater than 4000 ppm and below 8200 ppm of active chlorine. Declarant asserts that a person of ordinary skill would not expect a different result if the concentration of active chlorine or nOSA was varied. Declarant contends that increased active chlorine treatment levels above 4000 ppm will further increase the stability level of the starch by increasing the cross-bonding level, leading to even more stable starch that can withstand even more intense food processes. Declarant notes the graph on pg. 3 of the declaration where samples were tested with increasing levels of active chlorine, pointing out samples C, D, and E, treated with 4000 ppm, 5000 ppm and 7500 ppm active chlorine, respectively.
The examiner recognizes that increasing the active chlorine when modifying starch does affect the properties of the modified starch and increases oxidation of the starch granules. The examiner also recognizes the graph that shows the additional data point within the claimed range, specifically Sample E at 7500 ppm active chlorine, but notes that this graph does not look at comparing treatment order at these different active chlorine ranges and just looks at the claimed treatment order. Additionally, this graph still only provides two data points within the claimed range, Sample D and Sample E. There are no data points showing the significance of a stabilized starch reacted, for instance, with a reactant sufficient to provide 4010 ppm, or 4050 ppm, or at least 4200 ppm active chlorine, as required in claims 21, 22, and 17 respectively. These data points would show the significance of using the reactant within the claimed range when compared to 4000 ppm active chlorine, which is out of the claimed range. Further, no testing of samples over the claimed range of 8199 ppm or “below 8200 ppm,” as required by claim 1, has been provided. This would show the significance of the claimed range at the upper end of the claim. Moreover, the claims also allow the base starch to be modified by a chemical reaction with any amount of nOSA, but the data provided only show 3% nOSA.
While the graph on pg. 3 of the declaration does give one more data point within the claimed range of active chlorine, data points showing the full range of active chlorine that is claimed still has not been provided. The significance of the range, especially at the end points and outside the end points of active chlorine has not been shown. Declarant has not provided a nexus between the submitted evidence and all of the claimed limitations in the invention, including the full claimed range of chlorine. Thus, the showings in the declaration are not commensurate in scope with the claims. See MPEP 716.02(d).
The declarant states, on pg. 3 section 7 of the declaration, that a person of ordinary skill would be able to extrapolate the demonstrated results to any waxy starch. Declarant states waxy starches are known to be almost entirely composed of amylopectin. Declarant asserts any other waxy starch would be expected to behave similarly and have a similar stability as the tested waxy corn examples.
The examiner acknowledges that waxy starch is made almost entirely of branched amylopectin, but waxy starches from different botanical origin do not behave exactly the same in terms of viscosity and other properties. No evidence has been given to how other base starches claimed in claim 1 would behave. All the samples tested in the declaration are still only limited to waxy corn starch, while the claim is not limited to waxy corn starch, but includes other types of base starch. Declarant has not provided a nexus between the submitted evidence and all of the claimed limitations in the invention, including the claimed base starches. Thus, the showings in the declaration are not commensurate in scope with the claims. See MPEP 716.02(d).
The declarant responds, on pgs. 3-4 section 8, to the examiner’s comment that the declaration dated 04/22/2025 describes how treating starch with 4000 ppm, 5000 ppm and 7500 ppm active chlorine exhibited a stable viscosity at the test conditions. Declarant states that the stability of the starch is improved at active chlorine levels above 4000 ppm. Declarant explains that modified starches are specified within a viscosity range, not at one viscosity value because there will always be small variations in viscosity stability. Declarant then notes the graph on pg. 4 which shows two duplicate samples, Sample F and Sample G, both prepared using the waxy corn as the base starch and treating with 3% nOSA and then 4000 ppm active chlorine. The declarant notes how the dip in the curve of Sample F shows instability of the starch.
The examiner agrees that modified starches prepared in the same manner will have small variations in viscosity stability and recognizes the need for using a range in viscosity. However, it is also noted that treating a modified starch with 4000 ppm active chlorine can provide a starch that has a stable viscosity at the test conditions. Thus, a person of ordinary skill in the art, when finding that a modified starch treated with 4000 ppm active chlorine, sometimes provided a stable viscosity at certain test conditions, that person would be likely to treat the modified starch with higher amounts of active chlorine.
The declarant states, on pgs. 4-5 section 9, that the results from the experiment described in the April 22, 2025 declaration, in the graph on pg. 7, is not intended to demonstrate the claimed process. Declarant asserts that this is to show that if the prior art reference, Veelaert, had a starch base that was treated with protease and then treated with high active chlorine, it would result in hydrolytic breakdown. Declarant states that a person of ordinary skill in the art would be aware of this effect and would not have combined or modified the references as suggested.
It is noted that Veelaert does not require a protease treatment on their base starch. The protease treatment step is one of several treatments that can be done, but it is not required ([0019], [0028], Claim 18, Claim 26). Veelaert states in [0028], “the current invention relates to a process wherein the treatment of step a) is performed with a reactant selected from the group consisting of proteases, lipases, chlorine-free oxidants, alkaline solution, alkaline aqueous solution, and mixtures thereof.” A person of ordinary skill in the art can choose any of the reactants selected from the group, including an alkaline solution, and does not need to use the protease reactant. Thus, while a person of ordinary skill may be aware of the potential of hydrolytic breakdown of a starch that has been treated with protease and then high active chlorine, the starch of Veelaert, does not require the use of a protease treatment.
The declarant states, on pg. 5 section 10, that Veelaert in view of Klemaszewski would not suggest, to a person of ordinary skill in the art, a process that would result in the claimed starch, with the claimed properties and viscosity ramp. Declarant asserts a person of ordinary skill in the art would have had to pick and choose many treatment parameters, treatment steps and step order. Declarant contends the cited references do not provide any guidance on how to achieve the claimed invention with the claimed viscosity ramp.
As shown by the above rejection, Veelaert in view of Klemaszewski does teach a substantially identical product to the claimed product. Since the product of Veelaert in view of Klemaszewski is substantially identical to the claimed product, it would also have substantially identical properties, such as the claimed viscosity ramp, see In re Best, 562 F.2d 1252, 1255 (CCPA 1977), MPEP §2112.01 (I). Additionally, all of the treatment processes disclosed in the instant specification, to make the claimed product, are known. However, it is noted that the claims are directed towards a product and not a process, so while there may be many treatment parameters, process steps and process step order to consider, the method to produce the starch is not being claimed.
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive.
The 35 U.S.C. § 103 Rejection
Applicant argues, on pg. 5 of their remarks, that Veelaert does not teach treating the starch with a nOSA reaction. Applicant contends that because Veelaert does not teach the nOSA reaction, that it cannot teach the order of nOSA reaction and active chlorine treatment of starch. However, the Office disagrees for the following reasons.
As noted in the above rejection, Veelaert teaches the base starch can be modified by a chemical reaction and specifically states the starch can be modified “before” treatment with active chlorine [0047]. While Veelaert does not mention the starch being modified by a chemical reaction with a succinic anhydride to have a succinic anhydride modified waxy starch, Veelaert does state it can be modified. Klemaszewski provides motivation to have an nOSA modified base starch, because nOSA modified starch has improved heat and shear stability, and is also a starch that can be used in products as a fat mimetic, or in other words used to replace the fat in food products, resulting in improved nutrition by reducing the fat in the overall product, [0018], [0048], [0086]. Thus, Veelaert does teach treatment order, and Veelaert in view of Klemaszewski teaches the nOSA reaction and then active chlorine treatment to produce the stabilized starch.
Applicant argues, on pg. 6, that there is not requirement to provide a nexus between the evidence and all of the claimed limitations. Rather, the MPEP provides that “the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary consideration.” Applicant states that it has been established that “there must be a nexus to some aspect of the claim not already in the prior art.” Applicant contends, the evidence presented by the declarant is sufficient to provide a nexus between the evidence and the claims and must be considered by the examiner. However, the Office disagrees for the following reasons.
It is noted that the examiner has considered the evidence and thoroughly reviewed the declarations submitted. However, it has been determined by the examiner that the declarant has not provided a nexus between the submitted evidence and the claimed limitations in the invention, including the full claimed range of chlorine, which has been specifically addressed above. Thus, the showings in the declaration are not commensurate in scope with the claims. See MPEP 716.02(d).
Applicant, on pgs. 6-10 of their remarks, reviews statements from the examiner submitted in the non-final rejection dated 09/12/2025 and reviews statements from the inventor in the declaration filed 04/22/2025 and 12/09/2025. These statements, which are used as the applicant’s argument, have been addressed and fully answered in the Response to Declaration section above. The examiner did view the references as a whole and based on all relevant prior art teachings maintains that a person of ordinary skill in the art would have been motivated and would have a reasonable expectation of success in preparing the claimed stabilized starch based on Veelaert in view of Klemaszewski.
Conclusion
THIS ACTION IS MADE FINAL. 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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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759