Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/29/26 has been entered.
Claims 21,39, are amended and claims 45-46 are added. Claims 21-22,30,31,33-35,38-39,41-46 are pending.
Claim Rejections - 35 USC § 112
Claims 21-22,30,31,33-35,38-39,41-46 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.
In claim 21,39,45, the limitation “ hydroxypropylated starch having a degree of polymerization of no less than 10 and no more than 90” is not supported by the original disclosure. Paragraphs 0006-0007 discloses the degree of polymerization of the starch. However, there is no disclosure in the paragraphs that the starch is hydroxypropylated starch. The disclosure is to generally starch or modified starch without any specificity on the type of modification. Table 1 and examples 1,2 disclose HPS starch. But, there is no disclosure of the DP of the hydroxypropylated starch. There is no evidence that applicant is in possession of the hydroxypropylated starch having the range of DP of from 10-90 now claimed. The starch now claimed is a single species. It’s not seen possible how a single starch can have a range of DP from 10-90. Claim 45 recites the limitation “ wherein the liquid barrier composition is free of gelatin”. This is a negative limitation that is not disclosed in the instant specification. Negative limitation can only be added if it’s disclosed or there is positive recitation to allow for its exclusion. There is no disclosure on including or excluding gelatin. In claim 46, the limitation “ wherein the liquid barrier composition is free of lipids” has the same problem as in claim 45. There is no disclosure on including or excluding lipids.
Claim Rejections - 35 USC § 103
Claims 21-22,30-31,33-35,38-39,41-46 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Lazard et al (EP 0547551) in view of Gilleland ( 6649188) , Barkalow ( 20040096569) and Satomi (Jp 2007254299) .
For claims 21-22, 39, 45, Lazard et al (Lazard) teaches of barrier compositions comprising 5-40% modified starch , 10-45% plasticizer,5-40% water , 5-40% lipid and up to 30% component such as emulsifier. The plasticizer includes glycerol, ethylene glycol, propylene glycol etc.. (abstract , page 4 lines 20-23 and page 5 lines 11-20). Lazard discloses starch including derivatized starches such as ether starch. In example 1 on page 12 Lazard discloses different preparation of starches to use in the barrier composition. Part C on page 13 discloses ether derivative such as hydroxypropyl high amylose corn starch. Lazard discloses dextrin as the starch and dextrin typically has a D.E. of less than 5. As DE = 100/DP ( so DP = 100/DE). Thus, Lazard disclose DP of at least 20. For claims 30-31, the amount of up to 40% bulking agent includes 0 amount. Furthermore, Lazard discloses up to 30% of optional components may be added to add color, flavor, antioxidant character or other properties to the film ( page 5 lines 11-19) . It would have been obvious to one skilled in the art to add fructose as optional component to add a sweet flavoring. With respect to claims 33-35, 41-43, the steps are processing parameter which does not determine the patentability of product claims.
Lazard does not disclose the amount of plasticizer , the viscosity as in claims 21,39 and hydroxypropylated starch having dp of 10-90 as in claim 21,39,45.
Barkalow discloses edible film. Barkalow teaches to add emulsifier to the edible film. The emulsifier includes propylene glycol, polyglycerol ester etc.. ( see paragraph 0029)
Gilleland discloses a highly flexible starch-based films. The film comprises 25-50% starch material and 50-75% plasticizer. The plasticizers increase flexibility of the film. ( see col. 3-4)
Satomi discloses film coating layer having characteristics such as gloss, no crazing and excellent luster. Satomi discloses to use hydrozyalkylated dextrin having a DE of .1 to less than 5. In preparing the hydroxyalkylated dextrin, the starch is hydroxyalkylated and then hydrolyzed by a known method until the desired DE is obtain. The preferred starch is hydroxypropylated starch. ( abstract, pages 3,5)
The amount of starch fall within the claimed ranges. Lazard discloses the use of dextrin and the preparation of hydroxypropylated starch. As shown in Satomi, hydroxypropylated dextrin is used in preparation of film to form coating layer having gloss, no crazing and excellent luster. It would have been obvious to one of ordinary skill in the art to use hydroxypropylated dextrin in Lazard to obtain barrier layer having gloss , no crazing and excellent luster. The use of hydroxypropylated dextrin is totally compatible because teaches the use of dextrin and the hydroxypropyl starch. The dextrin has the DE to give the DP to be within the range claimed. With regard to the amount of plasticizer, Lazard discloses amount of 10-40%, but Lazard also discloses the inclusion of up to 30% additional components including emulsifier. As shown in Barkalow, emulsifier includes ingredients such as propylene glycol, polyglycerol esters etc.. Thus, the amounts of plasticier in the Lazard can be increased to amount higher than 45%. It would have been obvious to one of ordinary skilled in the art to use emulsifier functioning as plasticizer when desiring to increase the flexibility of the film. As shown in Gilleland, the amount of plasticizer in the film can range form 50-75% to give highly flexible starch-based films. Lazard discloses the additional component including emulsifier can be added up to 30%. It would have been obvious to one of skilled in the art to follow the guideline of Gilleland for amount of plasticizer for flexible film and to optimize depending on the degree of flexibility desired. Generally, difference in concentration does not support patentability in absence of showing of criticality and unexpected results. t would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQe2d 1379 (CAFC 2003). Also, In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
As to the viscosity, Lazard discloses the composition has different viscosity depending on the amount of ingredients as shown in the abstract. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary the viscosity depending on the degree of fluidity desired. Such parameter can readily be determined through routine experimentation to obtain the most optimum one for the intended application of the composition. With regard to claims 38,44,45,46 the language “ consists of” and exclusion of gelatin and lipids do not define over Lazard in view of the Gilleland and Barkalow. Lazard discloses on page 4 lines 1-5, the composition comprises starch or gelatin. Thus, the composition is excluded of gelatin when starch is used. On page 5 lines 8-10, Lazard discloses the lipid component is optional. Thus, it can be excluded. The inclusion of emulsifier as additional component can be additional plasticizer and flavoring can be bulking agent. Thus, Lazard in view of Gilleland and Barkalow discloses composition consists of starch, plasticizer, bulking agent and water.
Response to Arguments
Applicant's arguments filed 6/29/26 have been fully considered but they are not persuasive.
In the response, applicant argues the new limitation of hydroxypropylated starch. The limitation does not define over Lazard in view of the new reference added. The Gilleland and Barkalow references are not relied to teach DP of starch. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that the proposed modification to increase the amount of plasticizer would change the principle operation of the prior art invention being modified. Applicant points to the disclosure on page 3 and table XIII. The examiner respectfully disagrees. Lazard discloses different types of film for different purposes. The films are tailored to different applications by altering the relative amounts of the ingredients. At the bottom of page 3, Lazard discloses 10-40 plasticizer. However, on lines 1-5, Lazard discloses the composition optionally contains one or more additional plasticizer. This disclosure clearly suggests that more plasticizer from the 40% can be added. Lazard also teaches to add up to 30% of additional ingredients including emulsifiers. Barkalow discloses edible film. Barkalow teaches to add emulsifier to the edible film. The emulsifier includes propylene glycol, polyglycerol ester etc.. Thus, the teaching of additional component including emulsifier incorporates additional plasticizer ingredients. Gilleland discloses a highly flexible starch-based films. The film comprises 25-50% starch material and 50-75% plasticizer. The plasticizers increase flexibility of the film.
Thus, if flexibility is a desirable feature, it would have been obvious to one skilled in the art to use more plasticizer and such addition is fully suggested in Lazard.
New claims 45-46 are addressed in the rejection.
Conclusion
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July 11, 2026
/LIEN T TRAN/Primary Examiner, Art Unit 1793
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