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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 11, 2026 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 5, 8 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Maarel et al (WO 03/002728 A2) in view of Struyf et al (Investigating the impact of a-amylase, a-glucosidase and glucoamylase action on yeast-mediated bread dough fermentation and bread sugar levels).
In regard to claims 1 and 15-17, Van Der Maarel et al discloses:
Also, the invention provides use such a polypeptide or fragment in hydrolysing starch, said uses for example applied in the prevention or at least temporarily avoiding of staling of bakery products such as bread, or as a replacement of acid hydrolysis in the production of starch hydrolysates. Such prevention of staling comprises use of a method for reducing retrogradation of starch comprising treating said starch with a polypeptide or fragment, such as a amylomaltase or branching enzyme provide with hydrolysing activity according to the invention. Improved quality of baked products is further obtained when the alpha-glucanotransferase (e.g. amylomaltase or branching enzyme) provided with hydrolysing activity according to the invention is used in combination with other enzymes, such as a-amylase, maltogenic amylase, cyclodextrin glycosyltransferase, beta-amylase, cellulase, oxidase and/or lipase. Furthermore, the invention provides a bakery ingredient comprising a polypeptide according to the invention and a bakery product such as bread comprising a polypeptide according to the invention. The invention is further explained in the detailed description provided herewith (page 17 lines 9-16).
In regard to claims 1 and 3, Van Der Maarel et al further discloses that amylomaltase is obtained from Thermus thermophilus, Thermus aquaticus or Aquifex aeolicus:
The complete lack of hydrolyzing activity of wild type AMase and its specificity for donor and acceptor substrates makes it a very interesting enzyme to be studied regarding reaction and product specificity.
In another embodiment, the invention provides a nucleic acid encoding an enzyme or polypeptide derived from said non-hydrolysing enzyme, now provided with hydrolysing acitivity. For example, interaction with hydrophobic amino acids, such as F366, which is highly conserved in amylomaltases, is involved in the reaction specificity of the enzyme. Hydrolyzing activity can be introduced by mutating this residue, or other hydrophobic residues such as F251 or Y54. This hydrolyzing activity has significant effects on product profiles of the enzyme, indicating the necessity of complete absence of hydrolysis for the function of the wild type enzyme (the production of longer oligosaccharides from short substrates). Now that the enzyme has been provided with hydrolysing activity, it can be used in preventing retrogradation of starch. Especially useful in such prevention is the use of a newly hydrolising enzyme as provided herein that is derived from thermostable transferase, which can be found in a thermophilic micro-organism. Particulary provided is such an enzyme wherein said micro-organism comprises Thermus thermophilus, Thermus aquaticus or Aquifex aeolicus (page 14).
Hence, Van Der Maarel et al further discloses improvement in quality of baked products is further obtained when the amylomaltase obtained from Thermus thermophilus, Thermus aquaticus or Aquifex aeolicus provided with hydrolysing activity according to the invention is used in combination with other enzymes, such as a-amylase, maltogenic amylase, cyclodextrin glycosyltransferase, beta-amylase, cellulase, oxidase and/or lipase. Van Der Maarel et al discloses a method for producing a starch-containing food, comprising adding (A) at least one amylomaltase derived from a bacterium of the genus Thermus to the starch-containing material.
Van Der Maarel et al does not disclose further adding (C) at least one starch degradation product, or (D) α-glucosidase to the starch-containing material.
In regard to claims 1, 15-17, 19 and 22, Struyf et al discloses impact of α-glucosidase action on yeast-mediated bread dough fermentation and bread sugar levels. Struyf et al discloses that α-glucosidase addition increases glucose/maltose ratio in dough leading to a higher initial fermentation rate (page 42 Col. 2 section 4.3). Further in regard to the addition of α-glucosidase to the bread dough (i.e. starch-containing material), Struyf et al also discloses:
It should be noted that the effect of a-glucosidase on bread volume will be different when other bread making protocols than the Shogren and Finney (1984) method are used. Indeed, when shorter fermentation times are applied, and the proofing period does not overlap with the moment that the CO2 production starts to decrease, a-glucosidase addition might even increase bread volume due to the higher fermentation rate during the first 60 min of fermentation (page 43 Col. 1).
Therefore, it seems to be more useful to use a-glucosidase for bread making procedures with shorter fermentation times and a-amylase for procedures with longer fermentation times (page 43 Col. 1).
One of ordinary skill in the art would have been motivated to modify Van Der Maarel et al in view of Struyf et al and to further employ α-glucosidase for bread improvement as suggested by Struyf et al. Van Der Maarel et al already discloses combination of amylomaltase of the genus Thermus in combination with additional enzymes for bread quality improvement. Therefore to employ α-glucosidase for the same purpose and function of bread quality improvement as suggested by Struyf et al would have been obvious.
In regard to claim 1 and 15-17, one of ordinary skill in the art would have been motivated to vary the particular amount of amylomaltase based on the desired effect of improvement in quality of baked products.
Further in regard to the concentration recitations, it is noted that:
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. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05, II A).
In regard to claim 3, Van Der Maarel et al further discloses that amylomaltase is obtained from Thermus thermophilus, Thermus aquaticus or Aquifex aeolicus (page 14).
In regard to claim 5, it is noted that claim 5 further limits starch degradation product recitation of claim 1, which is an optional limitation that is not required by claims 1 or 5.
In regard to claim 8, Van Der Maarel et al discloses bakery products such as bread (page 17, claim 22).
Claims 18 and 21 require addition of at least one starch degradation product. Struyf et al discloses that supplementation of dough with either enzymes or sugars demonstrates similar trends:
Fig. 3 shows the total amount of CO2 produced during fermentation (60,120 and 180 min) in Bilux dough samples supplemented with different dosages of α -amylase, glucoamylase or α -glucosidase. After 60 and 120 min, no significant differences in total CO2 production were observed between the control dough sample and the α -amylase supplemented dough samples (Fig. 3A). After 180 min, however, the amount of CO2 produced was higher in the α-amylase supplemented dough samples. When glucoamylase was added to dough, a higher total CO2 production was observed compared with the control dough at all time points during fermentation, except for the first time point (60 min) (Fig. 3B). Similar trends were observed when sugars were added to dough (Fig. 3D) (page 40 Col. 1).
Hence, Struyf et al discloses that supplementation of dough with either enzymes or sugars demonstrates similar trends. One of ordinary skill in the art would have been motivated to add sugars to the dough instead of enzymes that degrade starch into sugars (α -amylase, glucoamylase or α -glucosidase) since both demonstrates similar trends.
In regard to claim 20, it is noted that one of ordinary skill in the art would have been motivated to supplement any starch containing products with enzymes as discussed above including rice containing product.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Maarel et al (WO 03/002728 A2) in view of Struyf et al (Investigating the impact of a-amylase, a-glucosidase and glucoamylase action on yeast-mediated bread dough fermentation and bread sugar levels) as applied to claim 1 and further in view of Melim Miguel et al (Enzymes in Bakery: Current and Future Trends).
Van Der Maarel et al does not disclose further adding (E) at least one protein modification enzyme to the starch-containing material in addition to the said (A), and (C) or (D) as recited in claim 6. Van Der Maarel et al does not disclose protein modification enzyme such as glucose oxidase and transglutaminase as recited in claim 7. Melim Miguel et al discloses application of enzymes in bakery. Melim Miguel et al discloses “Enzymes are an important ingredient used in most bakery products. More recently enzymes have assumed an even greater importance in baking, due to the restrictions on the use of chemical additives, especially in the manufacture of bread and other fermented products” (1. Introduction).
In regard to baking, starch and baked products, Melim Miguel et al discloses:
Baking is a common name for the production of baked goods, such as bread, cake, pastries, biscuits, crackers, cookies, pies and tortillas, where wheat flour is both the most essential ingredient and key source of enzyme substrates for the product [12]. Even though based on cereals other than wheat, baked goods such as gluten-free products or rye bread are also considered to be baked products [8]. Baked goods formulations vary significantly depending on the desired final product, and typical ingredients, apart from starch, can include wheat flour (8-16% protein, 71-79% carbohydrate), fats, sugars, eggs, emulsifiers, milk and/or water [13].
Bread is usually made from wheat flour as raw material, which is a mixture of starch, gluten, lipids, non-starch polysaccharides and enzymes. After flour, yeast and water are mixed, complex biochemical and biophysical processes begin, catalyzed by the wheat enzymes and by the yeast, characterizing the dough phase. These processes go on in the baking phase, giving rise to bread. Extra enzymes added to the dough improve control of the baking process, allowing the use of different baking processes, reducing process time, slowing-down staling, compensating for flour variability and substituting chemical additives [14]. Starch is the main component of products such as bread and other bakery goods and is added to different foods, acting as a thickener, water binder, emulsion stabilizer, gelling agent and fat substitute [15]. It is the most abundant constituent and most important reserve polysaccharide of many plants, including cereals, occurring as intracellular, semi-crystalline granules (section 3. Main Constituents of Baked Products).
In regard to enzymes used in baked products, Melim Miguel et al discloses:
The supplementation of flour and dough with enzyme improvers is a usual practice for flour standardization and also as baking aids. Enzymes are usually added to modify dough rheology, gas retention and crumb softness in bread manufacture, to modify dough rheology in the manufacture of pastry and biscuits, to change product softness in cake making and to reduce acrylamide formation in bakery products [8]. The enzymes can be added individually or in complex mixtures, which may act in a synergistic way in the production of baked goods [60-62], and their levels are usually very low (section 5. Enzymes used in baked products).
Further in regard to additional protein modification enzymes, Melim Miguel et al discloses:
Proteases can be subdivided into two major groups according to their site of action: exopeptidases and endopeptidases. Exopeptidases cleave the peptide bond proximal to the amino or carboxy termini of the substrate, whereas endopeptidases cleave peptide bonds distant from the termini of the substrate [77]. Most of the proteolytic activity of wheat and rye flours corresponds to aspartic proteases and carboxypeptidases, which are both active in acid pH. Additionally, aspartic proteases of wheat are partly associated with gluten [78]. Nevertheless, the proteolytic activity of sound, ungerminated grain is normally low [79].
Proteases are used on a large commercial scale in the production of bread, baked goods, crackers and waffles [80]. These enzymes can be added to reduce mixing time, to decrease dough consistency, to assure dough uniformity, to regulate gluten strength in bread, to control bread texture and to improve flavour [16,60]. In addition, proteases have largely replaced bisulfite, which was previously used to control consistency through reduction of gluten protein disulfide bonds, while proteolysis breaks down peptide bonds. In both cases, the final effect is a similar weakening of the gluten network [79].
In bread production, a fungal acid protease is used to modify mixtures containing high gluten content. When proteases are mixed in the blend, it undergoes partial hydrolysis becoming soft and easy to pull and knead [7,60]. Proteases are also frequently added to dough preparations. These enzymes have great impact on dough rheology and the quality of bread possibly due to effects on the gluten network or on gliadin [7].
Proteases are also applied in the manufacture of pastries, biscuits and cookies. They act on the proteins of wheat flour, reducing gluten elasticity and therefore reducing shrinkage of dough or paste after moulding and sheeting [8,81]; for instance, hydrolysis of glutenin proteins, which are responsible for the elasticity of dough, has considerable improving effects on the spread ratio of cookies [81] (section 5.1.2 Proteases).
Further in regard to additional enzymes as recited in claims 1 and 15-17, Melim Miguel et al discloses transglutaminase:
Transglutaminases (EC 2.3.2.13) from microbial sources also have potential for application in bakery products. Food proteins can be modified through cross-linking by transglutaminases, resulting in textured products, protecting lysine in food proteins from undesired chemical reactions, encapsulating lipids and lipid-soluble materials, forming heat and water resistant films, improving elasticity and water-holding capacity, modifying solubility and functional properties, and producing food proteins of higher nutritive value [29,145-153] (section 5.3 Other enzymes).
In the summary of the main application of protein modification enzymes, Melim Miguel et al discloses:
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Both references are directed to the improvement of bread quality. Van Der Maarel et al discloses improvement in quality of baked products is further obtained when the amylomaltase obtained from Thermus thermophilus, Thermus aquaticus or Aquifex aeolicus provided with hydrolysing activity according to the invention is used in combination with other enzymes, such as oxidase and/or lipase. Melim Miguel et al discloses application of enzymes in bakery. Melim Miguel et al discloses use of protease, transglutaminase, glucose oxidase in baking in order to improve bread qualities such as:
Reduction of dough mixing time;
Control of dough rheology or viscoelastic properties of gluten strength in bread;
Enhance dough extensibility;
Increase loaf or bread volumes;
Formation of aminoacids and flavors;
Crispness feature on bread crust;
Production of gluten-free products;
Cross-link between gluten and other peptides, forming a new protein network;
Increase volume and improve structure of breads, better retention of gas;
Improve bread crumb strength, height increase in puff pastry and croissants volume;
Improve dough stability;
Improve properties of gluten-free breads;
Protect frozen doughs from damage.
One of ordinary skill in the art would have been motivated to modify Van Der Maarel et al in view of Melim Miguel et al and to further employ additional enzymes as recited in claims 6-7, for bread improvement as suggested by Melim Miguel et al. i.e. for reduction of dough mixing time; control of dough rheology or viscoelastic properties of gluten strength in bread; enhance dough extensibility; increase loaf or bread volumes; formation of aminoacids and flavors; crispness feature on bread crust; production of gluten-free products; cross-link between gluten and other peptides, forming a new protein network; increase volume and improve structure of breads, better retention of gas; improve bread crumb strength, height increase in puff pastry and croissants volume; improve dough stability; improve properties of gluten-free breads; protect frozen doughs from damage. Van Der Maarel et al already discloses combination of amylomaltase of the genus Thermus in combination with additional enzymes for bread quality improvement. Therefore to employ additional enzymes as recited in claims 6-7 for the same purpose and function of bread quality improvement as suggested by Melim Miguel et al would have been obvious.
Further in regard to claims 6 and 7, Melim Miguel et al discloses glucose oxidase and transglutaminase:
Glucose oxidase (β-D-glucose:oxygen: 1-oxidoreductase; EC 1.1.3.4) catalyzes the oxidation of β-D-glucose to D-glucono-δ-lactone and hydrogen peroxide [118,119]. This enzyme has been obtained from different fungal sources, mainly from genus Aspergillus and Penicillium, being Aspergillus niger the most commonly used [120-123].
Glucose oxidase has been used successfully to remove residual glucose and oxygen in foods and beverages aiming to increase their shelf life. The hydrogen peroxide generated by this enzyme presents antimicrobial properties, and is easily removed by catalase utilization, which is an enzyme that catalyzes the conversion of hydrogen peroxide to oxygen and water [12,124-127]. Glucose oxidase can be used as alternative oxidizing agent instead of potassium bromate in breadmaking. Potassium bromate is an oxidizing agent that was traditionally used in baking, and its use was prohibited in many countries after it was recognized as carcinogenic [128,129] (Section 5.2.2 Glucose oxidase).
Transglutaminases (EC 2.3.2.13) from microbial sources also have potential for application in bakery products. Food proteins can be modified through cross-linking by transglutaminases, resulting in textured products, protecting lysine in food proteins from undesired chemical reactions, encapsulating lipids and lipid-soluble materials, forming heat and water resistant films, improving elasticity and water-holding capacity, modifying solubility and functional properties, and producing food proteins of higher nutritive value [29,145-153] (section 5.3 Other enzymes).
Response to Arguments
Claims 1 and 15-17 have been amended to exclude the addition of component B. The instant claims 1 and 15-17 now require addition of components (C) or (D). Claims 18 and 21 now require addition of component (C). Claims 19 and 22 now require addition of component (D).
As a result of these amendments, the rejection of claim(s) 1, 3, 5-8 and 15-17 under 35 U.S.C. 103 as being unpatentable over Van Der Maarel et al (WO 03/002728 A2) in view of Melim Miguel et al (Enzymes in Bakery: Current and Future Trends) has been withdrawn.
New reference to Struyf et al (Investigating the impact of a-amylase, a-glucosidase and glucoamylase action on yeast-mediated bread dough fermentation and bread sugar levels) was introduced as a teaching of addition of components (C) or (D).
Claim(s) 1, 3, 5, 8 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Maarel et al (WO 03/002728 A2) in view of Struyf et al (Investigating the impact of a-amylase, a-glucosidase and glucoamylase action on yeast-mediated bread dough fermentation and bread sugar levels) for the reasons as stated above.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Maarel et al (WO 03/002728 A2) in view of Struyf et al (Investigating the impact of a-amylase, a-glucosidase and glucoamylase action on yeast-mediated bread dough fermentation and bread sugar levels) as applied to claim 1 and further in view of Melim Miguel et al (Enzymes in Bakery: Current and Future Trends) for the reasons as stated above.
Applicant’s arguments have been considered but are moot in view of the new grounds of the rejection.
Conclusion
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/VERA STULII/Primary Examiner, Art Unit 1791
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