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 .
Response to Amendment
The amendment filed on 12/22/25 has been entered. Applicant amendments to the claims have overcome the objection of claim 1 for minor informalities as set forth in the Office Action mailed on 7/22/25. Claim 9 previously required “wherein the concentration of maltodextrin in step (c) is 2-20% by dry weight of the composition”. The claim has been amended to now specifically requiring “wherein the amount of maltodextrin added to the first agglomerate in step (c) is in the range of 2-20% by dry weight of the first agglomerate”.
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.
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 1-3, 5-11, 13, 15 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Arakawa [JP 2011229440 A], in view of Takahashi et al. [JP 2008068194 A], hereinafter Takahashi, and Takenaka et al. [JP 2011244809 A], hereinafter Takenaka, evidenced by USDA, [Dextrin 2010 Petition], (used for claim 19).
Note: See PTO-892 of Office Actions mailed on 3/28/24 and 10/01/24 for the cited prior art of record.
Regarding claim 1, Arakawa teaches a thickener granule (agglomerate) and a method for producing the same [Arakawa, 0001]. The method provide a thickener granule that has good dispersibility in water, does not form lumps, and increases viscosity suitable for use in food products [Abstract]. The invention comprises:
Providing a dry blend of xanthan gum, carboxymethyl cellulose (CMC) [0029], and dextrin [0027], in powder form (primary raw material powders) [0038];
Contacting the dry blend (primary raw material powders) of step a) with a solution (water or dextrin solution as binder liquid) [0031], to provide a first agglomerate (primary granules) [0026, claim 1];
Contacting the first agglomerate (referred as dextrin coating step by Arakawa [0031, 0035-0036]) of step b) with a solution (dextrin solution as binder) to provide a second agglomerate [0031, 0035-0036]; and
Recovering the second agglomerate [0036].
Arakawa does not teach contacting the dry blend of step (a) with a solution of a calcium salt to provide a first agglomerate as required in step (b).
Regarding the calcium salt solution (binder) of step (b):
Takahashi teaches a method for granulating (agglomerating) powder and easily dispersive/easily soluble granule composition. The powder is granulated using an aqueous solution of a calcium salt as a binder (as required in step (b)), where the calcium salt may be calcium chloride or calcium lactate [Takahashi, Abstract, 0009], (as disclosed by Applicant on [0023] of the instant Specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the aqueous calcium salt solution as a binder as taught by Takahashi, to contact the dry blend of step (a) in the invention of Arakawa to produce the first agglomerate, because they both are in the same field of granulation of polymer powders that are easily dispersible and highly soluble, suitable for use in foods and dysphagia patients, where both teach using the same starting raw materials (dry blend of xanthan gum, carboxymethyl cellulose (CMC), and dextrin [Takahashi, 0016]), and both also teach using aqueous solutions as binders, and because Takahashi teaches that using a solution of calcium salt as binder for agglomerating/granulating processes of dry blends of polymers (dry blend of xanthan gum, carboxymethyl cellulose (CMC), and dextrin) would provide for an agglomerate product that is easily dispersed and dissolved without causing lumps [Takahashi, 0008] even under weak stirring conditions [Takahashi, Abstract].
Regarding the specific type of dextrin being maltodextrin of step (a) as part of the dry blend, and step (c) as a maltodextrin solution (binder):
Modified Arakawa in view of Takahashi do not teach the dextrin type used in the process in step (a) (dry maltodextrin powder) and (c) (maltodextrin solution as binder) is specifically maltodextrin.
Regarding the maltodextrin of step (a) as part of the dry blend:
Takenaka teaches a thickening agent and method of making, having dispersibility and viscosity development [Takenaka, Title]. The method comprise providing a primary granulated product (first agglomerate) using xanthan gum powder as at least one of the raw materials and one or more excipients [Takenaka, 0012, 0016, 0023], such as maltodextrin in powder form [Takenaka, 0029].
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the maltodextrin powder of Takenaka in the primary raw material powder blend (xanthan gum, CNC, dextrin/maltodextrin) of modified Arakawa for the first agglomerate, since all are directed to methods of granulation of polymers and saccharide powders that are easily dispersible and highly soluble suitable for use in foods and dysphagia patients, particularly since Arakawa broadly teaches using dextrin and does not teach away from using the specific type of dextrin maltodextrin, and since the substitution of one known form (i.e. dextrin of Arakawa) for another (i.e. maltodextrin of Takenaka) would have yielded predictable results to one of ordinary skill in the art, and lastly because Takenaka teach both dextrin and maltodextrin are suitable for producing the agglomerates [Takenaka, 0029].
Regarding the maltodextrin of step (c) as a maltodextrin solution (binder):
Further, it would have been also obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to not only use the maltodextrin powder of Takenaka as part of the dry blend for the primary agglomerate as explained above, but also use the maltodextrin of Takenaka as binder in an aqueous solution of maltodextrin to provide for secondary granules as required by instant step (c), because Arakawa teach that the dextrin used in the primary raw material powder (claimed step (a) dry blend of powders comprising maltodextrin) may be the same type of dextrin used as binder liquid (claimed step (c) maltodextrin solution) in order to avoid confusion and operational errors during production [Arakawa, 0028, 0033]. Therefore a skilled artisan would envisage the use of maltodextrin in both step (a) as part of the dry blend, and step (c) as a maltodextrin solution to avoid confusion.
Regarding the specific use of calcium salt solution in a first binding step (b) and maltodextrin solution in a second binding step (c):
Moreover, it would have been also obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to perform the two binding steps separately with the different binding solutions such as first contacting the dry blend of step (a) with the calcium salt solution to form the first agglomerate as already taught and explained above by Arakawa in view of Takahashi to improve dispersion of the agglomerate, and further because Takenaka also explicitly teach that in order to further improve the dispersibility of the thickener compound (dispersible hydrocolloid agglomerate as claimed), calcium salts (calcium chloride) [Takenaka, 0031, line 428-430] may be added at any time or step such as during the primary granulation of the powder blend of xanthan gum and maltodextrin in the form of a calcium salt solution (after calcium salt being dissolved in binder liquid) [Takenaka, 0031, lines 434-438], and then in a second binding step contacting the first agglomerate of step (b) with the solution of maltodextrin of Arakawa in view of Takenaka because Arakawa teach to use the same dextrin type throughout the entire process to avoid confusion as explained above, therefore a skilled artisan making the selection of maltodextrin for the production of the agglomerate as taught by Takenaka would have used maltodextrin in the dry blend of starting material and also as the binder solution of step (c) to simplify the process and the amount of ingredients needed which would avoid confusion during the agglomerate manufacturing process as taught by Arakawa [Arakawa, 0028, 0033].
Regarding claims 2-3, Arakawa teaches both agglomeration steps are carried out in a fluidized bed by spraying a solution onto the dry blend of powdery primary raw materials provided in step a) [Arakawa, 0037-0038] (forming a first agglomerate), and spraying a solution onto the first agglomerate formed in step b) [Arakawa, 0035-0036] (forming a second agglomerate).
Regarding claim 5, Arakawa teaches the xanthan gum (polysaccharide contained in the primary raw material, 0027) may be present in an amount from 30 to 45% by mass and CMC in an amount of 1 to 4% by mass [Arakawa, 0030], in powder form [Arakawa, 0038], therefore is by dry weight.
Moreover, Takahashi disclose an example where a first agglomerate is prepared from a powdery dry blend comprising thickening polymer powders such as xanthan gum [Takahashi, 0016], at a concentration of 30% by dry weight of the composition [Takahashi, 0035], and Takenaka teach primary or first agglomerates with comprising xanthan gum at concentration of 100% by weight may be used [Takenaka, 0023], however the xanthan gum may be combined with excipients such as maltodextrin in any proportions without limitations [Takenaka, 0029] to provide compositions comprising xanthan gum in amounts of 35% by weight or more [Takenaka, 0030].
Regarding claim 6, Arakawa teaches the dextrin may be present in the primary raw material (mix of polysaccharide thickener and dextrin in powder form [0038]), in amounts of from 0.1 to 45 parts by mass of dextrin per 100 parts by mass of the polysaccharide thickener [Arakawa, 0027]. While Arakawa does not explicitly recite percent by weight of the composition and instead use percent by weight of thickening polysaccharide, Arakawa does teach that the selection of the thickening polysaccharide may be one or more, where thickening polysaccharide weight percent ranges from as low as 0.5% by mass for guar gum and as high as 45% by mass for xanthan gum [Arakawa, 0029-0030].
Moreover, Takahashi disclose an example where a first agglomerate is prepared from a powdery dry blend comprising dextrin at a concentration of 70% by dry weight of the composition [Takahashi, 0035], and Takenaka teach agglomerates made from a dry blend of powders including xanthan gum and maltodextrin (excipient) [Takenaka, 0029], wherein the xanthan gum and maltodextrin (excipient) proportions are not limited and the maltodextrin may be present in amounts of from 40 to 400 parts by mass per 100 parts by mass of xanthan gum (29% to 80% by weight of maltodextrin) [Takenaka, 0028].
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use maltodextrin at concentrations in the range of 40-90% by dry weight of the composition in the dry powder blend of step a) as primary raw material to provide “the first agglomerate”, because said concentration would have been used in the method of Arakawa in view of Takahashi and Takenaka during the course of normal experimentation and optimization procedures due to factors such as the type and amount of thickening polysaccharide as well as the type and amount of calcium salt solution binder used for the composition and the particular application in which the agglomerate composition is being used. Regarding the dextrin being maltodextrin, see claim 1 rejection of Arakawa in view of Takenaka above.
Regarding claim 7, modified Arakawa in view of Takahashi and Takenaka teach the formation of first and secondary agglomerate or granules (Arakawa, 0010, 0012 and Takenaka, Abstract) by contacting the powders to be granulated with a calcium salt solution (Takahashi Abstract, 0009), as discussed above in claim 1 rejection, where the concentration of the calcium salt aqueous solution is 5 to 50% by weight based on the powder to be granulated (agglomerate composition), [Takahashi, 0013].
Regarding claims 8 and 20, modified Arakawa in view of Takahashi teach the calcium salt may be selected from a group including calcium chloride and calcium lactate [Takahashi, 0008]. It would have been obvious to one of ordinary skill in the art to select calcium chloride and/or calcium lactate based on the particular application or type of food in which the agglomerate is being used.
Regarding claim 9, Arakawa teaches using the same type of dextrin throughout the entire process (dry and liquid), modified Arakawa in view of Takenaka teach using the specific dextrin type maltodextrin, thus teaching using maltodextrin solution as binder in step (c) as explained above in claim 1 rejection. Therefore modified Arakawa teach the amount of maltodextrin added to the first agglomerate in step c) is in the range of 2 to 20% (1-20%) by mass (by dry weight), since Arakawa teach that the same applies to the binder liquid (maltodextrin solution) used in the next dextrin coating step [Arakawa, 0031]. Regarding the amount of maltodextrin added in the range of 2-20% being specifically based on dry weight of the first agglomerate, Arakawa teach that the total amount of binder liquid (maltodextrin solution) added in the coating (contacting) steps is preferably in the range of 1-10% or 3-8% by mass of the total amount of agglomerate to be produced [Arakawa, 0032]. As such, there is reasonable basis to conclude that the amount of maltodextrin added to the first agglomerate in step c) is in the range of 2 to 20% by dry weight of the first agglomerate, because the total amount of maltodextrin solution added to the first and second agglomerates does not exceeds 10% by weight of the total weight of the agglomerate produced [Arakawa, 0032]. Furthermore, differences in maltodextrin concentration for the maltodextrin solution of step c) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such maltodextrin concentration is significant. 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 in view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.).
Regarding claim 10, Arakawa teaches the production of secondary aggregated particles (step d agglomerates) [Arakawa, 0038], but is silent as for the particle size of the second agglomerate.
Takahashi teach example 1, preparation of easily dispersible and easily soluble granule composition where the particle size is adjusted from 250 to 1000 µm, therefore some particles would have a size above 50 µm and above 200 µm [Takahashi, 0027, lines 19-20]. Regarding the percentage of particles (particle size distribution), one of ordinary skill in the art would recognize the ability to adjust the size of particles according to the various food applications in which the granules are being used as disclosed by Takahashi [0023-0024]. Therefore, absent any evidence of criticality, it would have been obvious to one of ordinary skill in the art to adjust the particle size based on the desired diameter of granules of the final product. Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, see MPEP 2144.04, IV. A.
Regarding claim 11, Arakawa teaches various examples of agglomerated granules produced with hydrocolloids such as xanthan gum and (CMC) carboxymethyl cellulose in a two stage process, where a first agglomerate is produced and a second agglomerate is produced from the first agglomerate [Arakawa, 0030, 0037-0044]. The granule composition of Arakawa exhibits good dispersibility in water, does not forms lumps, quickly increases in viscosity, has a high equilibrium viscosity and does not impair the flavor of food and drink products [Arakawa, Abstract].
Further, claim 11 is considered a product-by-process claim. The cited prior art(s) teaches all of the positively recited structure of the claimed product. The determination of patentability is based upon the product structure itself. The patentability of a product does not depend on its method of production or formation. If the product in the product-by-process claim 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Regarding claim 13, Arakawa does not explicitly recites a dispersibility of 3 or more when determined by a method involving stirring a 2% sample of the agglomerated particles in water using a magnetic stirrer at 600 rpm for 10 seconds.
However, given that the raw materials and process of preparing an agglomerate thickener composition with good dispersibility in water [Arakawa, 0053], based on the disclosure in Arakawa combined with the teachings in Takahashi and Takenaka are the same to that in the instant claims, it is the examiner's position that the agglomerate thickener composition having good dispersibility in water made by the process of Arakawa in view of Takahashi and Takenaka would be expected to have the instantly claimed dispersibility of 3 or more when determined by a method involving stirring a 2% sample of the agglomerated particles in water using a magnetic stirrer at 600 rpm for 10 seconds. Since the USPTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
If the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP §2112.01.
Regarding claim 15, Arakawa teaches a granule composition and method of making the same, suitable for use in food and drinks for people with difficulty chewing and swallowing (dysphagia) [Arakawa, Abstract].
Regarding claim 18, Arakawa teaches the xanthan gum (contained in the primary raw material, par.0027) may be present in an amount from 30 to 45% by mass and CMC in an amount of 1 to 4% by mass, in powder form, therefore is by dry weight as explained above in claim 5 rejection [Arakawa, 0030 and 0038]. While the amounts mentioned would yield a total of xanthan gum and CMC of 49%, the disclosure teach that these are preferred amounts [Arakawa, 0029-0030].
Regarding preferred embodiments (i.e., preferred amounts of components and examples in the disclosure) MPEP 2123 states:
Patents are relevant as prior art for all thy contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. MPEP 2123 II. States: Nonpreferred and alternative embodiments constitute prior art. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use."
Furthermore, while Arakawa’s disclosure mentions the preferred amount of xanthan gum and CMC are 30-45% and 1-4% respectively, one of ordinary skill in the art would recognize the use of the components in various concentrations/ratios depending on the particular application or food being treated in order to achieve de desired thickness/viscosity as shown in Example 1 on Table 1, of Arakawa where xanthan gum is present in the composition in the amount of 66.1% mass and CMC is present in the composition in the amount of 3.5% mass (xanthan gum and CMC total amount of 69.6% mass) [see translation of Arakawa, Example1, Table 1, below or attached copy provided by the examiner in the last Office action mailed 10/1/24]. Therefore, the claimed amount of xanthan gum/CMC would have been used during the course of normal experimentation and optimization procedures due to factors such as the ratios of the various ingredients, the desired end texture and consistency, and/or the desired final taste characteristics in the final product of the method of Arakawa.
Table 1: Primary Raw Materials Mixture Examples 1-5.
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46
1040
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414
1039
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As shown in Table 1, 66.1% mass xanthan gum and 3.5% mass CMC in primary raw material mix, example 1.
Regarding concentration amounts and/or proportion of components MPEP 2144.05 II. A. states:
"It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929). "[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). "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 of percentage ranges is the optimum combination of percentages", In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Regarding claim 19, as explained above in claim 6 rejection, Arakawa teaches the dextrin may be present in the primary raw material (mix of polysaccharide thickener and dextrin in powder form [0038]), in amounts of from 0.1 to 45 parts by mass of dextrin per 100 parts by mass of the polysaccharide thickener (0.1 to 45wt% of dextrin, (pph, %) part per hundred), [Arakawa, 0027]. While Arakawa does not explicitly recite percent by weight of the composition and instead use percent by weight of thickening polysaccharide, Arakawa does teach that the selection of the thickening polysaccharide may be one or more, where thickening polysaccharide weight percent ranges from as low as 0.5% by mass for guar gum and as high as 45% by mass for xanthan gum [Arakawa, 0029-0030]. Therefore, the claimed range of 50-80% by dry weight of the composition in step a) by providing a dry powder blend of primary raw material to provide “the first agglomerate” is possible based on the type and amount of thickening polysaccharide used for the composition which is a matter of choice and routinely determinable by one of ordinary skill in the art, see MPEP 2144.05 II. A. Regarding the dextrin being maltodextrin, see claim 1 rejection of Arakawa in view of Takenaka above.
Moreover, the examiner notes that while Arakawa refers to xanthan gum and CMC as polysaccharide thickeners, dextrins (including maltodextrin) are also considered polysaccharides and thickeners (see attached evidentiary reference of USDA, Dextrin 2010 Petition, p.7, attached copy provided by the examiner in the last Office action mailed 10/1/24), and one of ordinary skill in the art would recognize the use of dextrins such as maltodextrin alone or in combination such as in equal parts i.e., 50% dextrin and 50% xanthan gum or CMC if desired based on the food and or particular application/method in which the polysaccharide thickener is being used. Since Arakawa teach the use of the polysaccharides xanthan gum and/or CMC are not limited and one or more (single or in combination) may be used [Arakawa,0029].
Regarding claim 20, see claim 8 and 20 rejections above.
Regarding claim 21, Arakawa teaches the methods and concepts for preparation of readily dispersible hydrocolloid compositions as discussed in claims 1 and 11 rejections above, but is silent regarding the composition, when hydrated, exhibits non-Newtonian flow behavior.
Modified Arakawa in view of Takenaka teaches the readily dispersible hydrocolloid composition comprises xanthan gum in amounts and/or proportions enough such that when used under weak stirring conditions (i.e., manual stirring), it has high thickening (high viscosity) effect [Takenaka, 0030, lines 421-422], (equivalent to exhibits non-Newtonian flow behavior, as disclosed on page 5, par.0019 of the instant Specification, “The hydrated composition should show the following features: It should exhibit non-Newtonian flow behaviour. It should show a relatively higher viscosity at lower shear rate……”).
Claims 4 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Arakawa, in view of Takahashi and Takenaka as applied to claim 1 above, and further in view of Obata et al. [US 20130022730 A1], hereinafter Obata.
Regarding claim 4, Arakawa teaches an embodiment where xanthan gum may be present in an amount from 30 to 45% and CMC in an amount of 1 to 4% by mass [Arakawa, 0030], but is silent as for the specific ratios of xanthan gum to CMC being between 90:10 and 30:70.
Obata teaches a cellulose composite of cellulose and hydrophilic gum known to form cellulose colloid for use in the field of foods as suspension, emulsification and thickening stabilizer as well as dispersion stability [Obata, 0002 and 0019]. The hydrophilic gum of the composition may be selected from various gums including xanthan gum [Obata, 0036]. The cellulose composition of Obata’s invention may further contain a water soluble gum other than a hydrophilic gum selected from a group that include (CMC) carboxymethyl cellulose [Obata, 0061-0062]. The cellulose composite may be formed as powder form for easy handling [Obata, 0088]. The composition may contain the hydrophilic gum (xanthan gum) and the water soluble gum (CMC) in a ratio of from 30:70 to 99:1 (which encompass the claimed xanthan gum to carboxymethyl cellulose ratio of from 30:70 to 90:10), [Obata, 0023].
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arakawa and include the xanthan gum to carboxymethyl cellulose ratios of from 30:70 to 90:10 as taught by Obata, because Obata teach that the use a wide range of ingredient ratios would produce colloid compositions that provide excellent dispersion stability, and excellent suspension stability in acidic or high salt concentration water dispersion [Obata, 0024] suitable in the field of foods as suspension, emulsification and thickening stabilizers [Obata, 0002 and 0019]. Further because Obata teach that foods and drinks having excellent dispersion stability can be provided by adding the cellulose composite of his invention, and because when a water-insoluble component such as a functional food material is added to these foods and drinks, foods and drinks giving homogeneous appearance and having excellent suspension stability can be provided while suppressing e.g., separation, aggregation or sedimentation (formation of lumps) thereof [Obata, 0024].
Regarding claims 16-17, Arakawa teaches preferably one or more of xanthan gum and/or CMC may be selected at preferred amounts, where xanthan gum may be present in an amount preferably of from 30 to 45% and CMC may be present in an amount preferably of from 1 to 4% by mass [Arakawa, 0030], but is silent as for the specific ratios of xanthan gum to carboxymethyl cellulose being between 85:15 and 40:60 (claim 16), or the ratio of xanthan gum to carboxymethyl cellulose being between 80:20 and 50:50.
As explained above in claim 4 rejection, Obata teaches the cellulose composite of cellulose and hydrophilic gum known to form cellulose colloid for use in the field of foods as suspension, emulsification and thickening stabilizer as well as dispersion stability [Obata, 0002 and 0019]. The hydrophilic gum of the composition may be selected from various gums including xanthan gum [Obata, 0036]. The cellulose composition of Obata’s invention may further contain a water soluble gum other than a hydrophilic gum selected from a group that include (CMC) carboxymethyl cellulose [Obata, 0061-0062]. The cellulose composite may be formed as powder form for easy handling [Obata, 0088]. The ratio of the hydrophilic gum (xanthan gum) and a water soluble gum (carboxymethyl cellulose (CMC)) may be 40:60 to 90:10, as well as a ratio of xanthan gum to carboxymethyl cellulose of 40:60 to 80:20 [Obata, 0072].
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arakawa and use ratios of xanthan gum to carboxymethyl cellulose between 85:15 and 40:60, or ratios of xanthan gum to carboxymethyl cellulose between 80:20 and 50:50 as taught by Obata, because this would allow the production of dispersible hydrocolloid compositions with a wide range of ingredient ratios such as ratios of water soluble polymers and thickeners, which would provide a broader range in viscosity for various food applications. Furthermore, because Obata teach that the use of a wide range of ingredient ratios would produce colloid compositions that provide excellent dispersion stability, and excellent suspension stability in acidic or high salt concentration water dispersion [Obata, 0024] suitable in the field of foods as suspension, emulsification and thickening stabilizers [Obata, 0002 and 0019]. Further because Obata teach that foods and drinks having excellent dispersion stability can be provided by adding the cellulose composite of his invention, and because when a water-insoluble component such as a functional food material is added to these foods and drinks, foods and drinks giving homogeneous appearance and having excellent suspension stability can be provided while suppressing e.g., separation, aggregation or sedimentation (formation of lumps) thereof [Obata, 0024].
Regarding concentration amounts and/or proportion of components MPEP 2144.05 II. A. states:
"It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929). "[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). "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 of percentage ranges is the optimum combination of percentages", In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Arakawa, in view of Takahashi and Takenaka as applied to claims 1 and 11 above, and further in view of Burbidge et al. [US 2015/0004149 A1], hereinafter Burbidge.
Regarding claim 12, Arakawa teaches the granule composition as discussed above in claim 1 rejection, but is silent regarding a 2% w/w sample of the agglomerated particles in water having a viscosity of 100-400 mPas at a shear rate of 50 s-1.
Burbidge teaches products having improved cohesiveness for promoting safer swallowing of food for patients having swallowing conditions as well as methods of making and using such products. The nutritional products may include nutritional compositions and water-soluble polymers such that the nutritional products have extensional viscosities that provide improved cohesiveness to the nutritional products. The invention also provide methods of administering such nutritional products to patients having impaired swallowing ability and/or dysphagia [Burbidge, Abstract]. The composition may contain various food grade biopolymers such as hydrocolloids including xanthan gum, and thickeners in aqueous solution that is capable of providing a nutritional product a shear viscosity of less than about 100 mPas when measured at a shear rate of 50 s−1 at a temperature of 20°C [Burbidge, 0021, 0027-0028, 0082].
Arakawa and Burbidge are both considered to be analogous to the claimed invention because they are in the same field of colloids or polymeric materials that are dispersible and/or soluble in water to modify rheological properties of foods and treat dysphagia. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arakawa to incorporate the teachings of Burbidge and provide a composition that is able to modify the viscosity of a food product to about 100 mPas. Doing so would aid in providing nutritional products for treatment of dysphagia reducing economic costs of hospitalizations, pneumonia, dehydration malnutrition and other conditions related to dysphagia [Burbidge, 0001-0019].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Arakawa, in view of Takahashi and Takenaka as applied to claims 1 and 11 above, and further in view of Seko et al. [US 2008/0280022 A1], hereinafter Seko.
Regarding claim 14, Arakawa teach the granule composition as discussed above in claim 1 rejection but is silent as for the bulk density of the agglomerated particles.
Seko teaches a granulated xanthan gum thickening composition prepared with xanthan gum powder and potassium salt as binder [Seko, Abstract]. The composition is suitable for adding viscosity to foods or any desired product containing water for people with swallowing disorders [Seko, 0001]. The composition provides excellent dispersibility, improved peak viscosity and suppressed lump formation [Seko, 0010 and 0016]. Seko disclose the thickening composition of the invention is not limited and may be prepared using a modified xanthan gum to which a potassium salt is attached such as carboxymethyl cellulose (CMC), processed starch and dextrin. The dextrin to be used is not particularly limited [Seko, 0017]. Seko disclose a preparation process of the granulated thickening composition where the resulting granule composition had a bulk density of 0.41 g/ml (41g/100ml) [Seko, 0022].
Arakawa and Seko are both considered to be analogous to the claimed invention because they are in the same field of colloids or polymeric agglomerated materials that are dispersible and/or soluble in water to modify rheological properties of foods and treat dysphagia. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arakawa to incorporate the teachings of Seko and provide a composition with the desired bulk density. Doing so would aid in providing a composition suitable for food products for treatment of dysphagia that offers improved dispersibility and peak viscosity [Seko, 0001 and 0010].
Response to Arguments
Applicant's arguments filed 12/22/25 have been fully considered but they are not persuasive.
Regarding claim 1, on page 5, last paragraph, and page 6 of the Remarks, Applicant urges that claim 1 recites 2 separate steps to apply the calcium salt solution and the maltodextrin solution, a first binding step of applying the calcium salt solution to form the first agglomerate (step b), and a second binding step of applying the maltodextrin solution to form the second agglomerate (step c), and that the combination of Arakawa and Takahashi failed to disclose with “sufficient specificity” first using calcium salt and the using maltodextrin to form agglomerates. This argument is not persuasive because the rejection is based on the combination of Arakawa and Takahashi for teaching the first binding step using the calcium salt solution, and modified Arakawa in view of Takenaka for teaching the second binding step using the maltodextrin solution as will be explained separately below.
First binding step of applying the calcium salt solution:
As explained in claim 1 rejection above, Arakawa teach two separate steps for forming a first agglomerate and second agglomerate. To form the first agglomerate Arakawa teach a first binding step of applying an aqueous solution (i.e., water) to the dry blend, but did not teach using a calcium salt solution, however Takahashi does teach using an aqueous solution of a calcium salt as a binder in a first binding step to form a first agglomerate [Takahashi, Abstract, 0009]. Since Takahashi forms only a first agglomerate in a first and only binding step and Arakawa already teach a first and a second binding steps to for a first and second agglomerate, and the first binding step of Arakawa may use water (aqueous solution), a skilled artisan would immediately envisage the use of a calcium salt solution in a first binding step to form a first agglomerate as taught by Takahashi, in the method of Arakawa in order to form a first agglomerate that uses a first binding solution and a second agglomerate that uses the same or different binding solution as taught by Arakawa, and because Takahashi teaches that using a solution of calcium salt as binder for agglomerating dry blends of polymers (dry blend of xanthan gum, carboxymethyl cellulose (CMC), and dextrin) would provide for an agglomerate product that is easily dispersed and dissolved without causing lumps [Takahashi, 0008] even under weak stirring conditions [Takahashi, Abstract]. Further, simple substitution of one known element (the water as binder in Arakawa) for another (for the calcium salt solution as binder in Takahashi) would have yielded predictable results to one of ordinary skill in the art.
Second binding step of applying the maltodextrin solution:
Because Arakawa teach the use of water in a first binding step [Arakawa, 0031], and the use of dextrin (broadly) solution in a second binding step, where the dextrin used as binding solution may be the same type of dextrin used in the starting dry blend material [Arakawa, 0028, 0033], and Takenaka teaches the use of maltodextrin for making agglomerates [Takenaka, 0029], it would have been obvious to one of ordinary skill in the art to incorporate the maltodextrin of Takenaka into the invention of Arakawa to produce a first agglomerate that uses the specific dextrin type of maltodextrin as dry powder in the first agglomerate and then since maltodextrin was used in the first agglomerate, and Arakawa teaches to use the same type of dextrin as a dextrin solution for a second binding step, a skilled artisan would have also used a maltodextrin solution in order to simplify the process and reduce the amount of ingredients needed as well as to avoid confusion and operational errors during production [Arakawa, 0028, 0033].
On pages 6-7 Applicant urges that Arakawa states that the use of calcium salts is not suitable for foods because they produce bitter taste or harsh taste, rendering Arakawa’s invention unsatisfactory for its intended purpose. This argument is not persuasive because Arakawa does not teach away from using a calcium salt, in fact Arakawa teaches that there are known methods in the art of polysaccharide thickener agglomerates that include spraying a specific calcium salt solution as a binder liquid for agglomeration, and in another different methods of agglomeration it is known to include spraying a solution of potassium salt as a binder liquid for agglomerating, and depending on the type of salt used bitterness may occur, and in some cases not suitable for food use [Arakawa, 0005]. Arakawa does not explicitly teach that a calcium salt solution or a specific calcium salt solution would cause bitterness taste or harsh taste.
Moreover, Arakawa in view of Takenaka also teach using calcium salts in a first binding step to produce a first agglomerate to provide a final readily dispersible hydrocolloid composition that can be added to foods and drinks, without changing the component balance of metal salts such as sodium content in the final food and drink product [Takenaka, 0019], while at the same time not affecting negatively the taste quality of the food or drink to which the composition is being added according to the type of individual ingredients comprising the food product [Takenaka, 0005]. As noted, it is clear that Arakawa and Takenaka express interest in obtaining compositions that do not negatively affect the taste of the food and drinks in which is used.
Regarding claim 6, on pages 7-8 of Applicant’s response, Applicant argues that the prior art of record of Arakawa does not teach the claimed concentration of maltodextrin in claimed step a, and that Arakawa teaches away from using more than 31% of dextrin.
The argument is not persuasive because while Arakawa teach that the dextrin in the primary raw material preferably contains 0.1-45 parts by mass of dextrin per 100 parts by mass (31% dextrin) of polysaccharide thickener in one embodiment, Arakawa does recognize that the dextrin content may be higher or exceeds 45 parts by mass of dextrin per 100 parts by mass of polysaccharide thickener, which in that case the amount of dextrin added in subsequent steps (binding/coating) may be decreased in order to achieve the desired total dextrin in the final agglomerate with the desired solubility and/or dispersibility [Arakawa, 0027]. Clearly Arakawa contemplate the adjusting of dextrin ratios between steps and further teach an embodiment where the polysaccharide thickener may comprise xanthan gum preferably in amounts of 30-45% by mass of the agglomerate, guar gum preferably in amounts of 0.5-3% by mass of the agglomerate, CNC preferably in amounts of 1-4% by mass of the agglomerate [Arakawa, 0030], and total amount of the dextrin liquid binder preferably in amounts of 1-10% by mass of the agglomerate [Arakawa, 0032]. Therefore, since the 100% of agglomerate/granule is comprised of dry blend primary raw materials of dextrin, xanthan gum, guar gum, CNC, and dextrin solution binder, wherein if the dextrin in the initial dry blend primary raw materials exceeds 45 parts by weight per 100 parts by weight of the polysaccharide thickener the dextrin binding/coating solution amount may be decreased, and the total composition of the agglomerate (100% of the agglomerate) based on the amounts of polysaccharides disclosed in Arakawa may be for example as follow (using upper limit for all components, except the dextrin coating solution that uses the lower amount since its decreased when the dextrin in the dry raw material exceeds 45 parts by weight, and including guar gum which is not required, [Arakawa 0029, lines 205-206]): 45% dry dextrin, 45% dry xanthan gum, 3% dry guar gum, 4% dry CNC, 3% dextrin solution as coating, equates to a total 100% of the agglomerate, which encompass the claimed range of 40-90% for the dry dextrin in the initial dry blend even considering the use of guar gum. Further, a composition of 100% agglomerate of Arakawa not using guar gum, since the use of polysaccharides are preferably selected from one or more of the list of polysaccharides mentioned by Arakawa in par.0029, lines 205-206, and the agglomerate only requires dextrin and one or more of polysaccharides [Arakawa, 0027, line 177], then a total agglomerate composition of Arakawa (100% agglomerate) would comprise for example 45% dry dextrin, 45% dry xanthan gum, 4% dry CNC, 3% dextrin solution as coating, equates to a total 100% of the agglomerate, 6% dextrin solution as coating (since this dextrin may be in amounts of 1-10% by weight of the total agglomerate and may be reduced i.e., to 6%), equates to a total 100% of the agglomerate, which still encompass the claimed range of 40-90% for the dry dextrin in the initial dry blend when guar gum is not used. The Examiner notes Arakawa teach preferred selection of polysaccharides as well as preferred selection of amounts and concentrations in which dry component raw materials and solution binders are present in the total amount of the agglomerate, and one of ordinary skill in the art would recognize the selection of polysaccharides and the amounts or concentrations at which they are present in the final agglomerate of Arakawa, since the claimed polysaccharides and dextrin concentrations would have been used during the course of normal experimentation and optimization procedures due to factors such as the ratios of the various ingredients, the desired end texture and consistency, the particular food application in which the composition is being used (i.e., beverage, semi-solid foods), type of foods, and/or the desired final taste characteristics in the method of Arakawa.
Moreover, the rejection is based in a combination of references where Arakawa teach the methods and concepts discussed above where the use of dextrin (broadly is disclosed), and Takenaka (the reference relied upon for teaching the use of the specific dextrin type of maltodextrin) teach providing xanthan gum and maltodextrin in powder form [Takenaka, 0029], wherein the xanthan gum and maltodextrin proportions are not limited and the dextrin may be present in amounts of from 40 to 400 parts by mass per 100 parts by mass of xanthan gum (29% to 80% by weight of maltodextrin) [Takenaka, 0028], and Takahashi disclose an example where a first agglomerate is prepared from a powdery dry blend comprising dextrin at a concentration of 70% by dry weight of the composition [Takahashi, 0035]. Therefore, since Arakawa disclose that if the dextrin content exceeds 45 parts by weight per 100 parts by weight of the agglomerate, less dextrin may be used in subsequent dextrin coating/addition processes, and Takenaka and Takahashi teach maltodextrin concentrations that overlaps or encompass the claimed concentration range required by the claim, the rejection of claim 6 over Arakawa in view of Takahashi and Takenaka is maintained. A skilled artisan armed with the teachings of Arakawa, Takahashi and Takenaka would have also recognize the use of various ratios or concentrations of dextrin in the agglomerate composition based on the type of dextrin being used, since different type of dextrins would have different water solubilities as evidenced by BeMiller (only relied upon for showing dextrin types solubility, and not for the rejection of record), where BeMiller disclose that maltodextrin is characterized by having higher solubility in solutions (water) than dextrin [BeMiller, Dextrins, Properties, par.1].
Moreover, regarding concentration amounts and/or proportion of components MPEP 2144.05 II. A. states: "[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). "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 of percentage ranges is the optimum combination of percentages", In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Regarding claim 12, on page 9 of Applicant’s response, Applicant argues that Arakawa’s object is to provide an agglomerate thickener with “high equilibrium viscosity” which is obtained when compositions have a “high viscosity” of 3,000 mPa.s or more [Arakawa, 0051], and that a skilled artisan would not incorporate the teachings of Burbidge because Burbidge teach compositions with viscosities lower than 3,000 mPa.s, such as shear viscosities of less than about 100 mPa.s [Burbidge, 0021, 0044, 0167-170], wherein the term “about” refer to numbers in a range including all integer and fractions within the range [Burbidge, 0068], and Arakawa disclose that equilibrium viscosity is “low” at viscosities that are less than 3,000 mPa.s, which would render the prior art unsatisfactory for its intended purpose.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references to achieve the viscosity required by instant claim 12, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, the Examiner agrees with Applicant in that Arakawa express interest in compositions having high equilibrium viscosity which are compositions with high viscosities in Arakawa’s invention, however it is noted that Arakawa not only express interest in high equilibrium viscosity but also express interest in thickening compositions that are characterized by having other desired properties such as good dispersibility in water, does not form lumps and having quick increase of viscosity, suitable for use in foods for people with chewing and swallowing difficulties (dysphagia) [Arakawa, Abstract]. Burbidge also express interest in providing thickening compositions that are characterized by being soluble in water and are suitable for use in foods for people with chewing and swallowing difficulties (dysphagia) such that the nutritional products have viscosities that provide improved cohesiveness to the nutritional products [Burbidge, Abstract], wherein as opposed to the effects of only shear viscosity, the nutritional products of Burbidge’s invention aim to improve the cohesion of rounded, moistened mass of chewed food with saliva that is ready to be swallowed (food bolus) to prevent said food bolus from being broken up into smaller fragments, which may enter the airway or leave unwanted residues in the oropharyngeal and/or esophageal tract during the swallowing process. For example, food applications such as beverages in which such polymers used for the thickening composition are dissolved and semi-solid foods which need to maintain sufficient integrity to be safely swallowed and where solid and semi-solid particles are held together by a “cohesive" aqueous phase containing such polymers [Burbidge, 0138]. Therefore, one of ordinary skill in the art that is interested in producing dispersible hydrocolloid compositions or soluble polymer compositions that have good dispersibility in liquids, do not form lumps and are suitable for use in dysphagia patients, would immediately envisage the incorporation of the viscosities shown by Burbidge, as different types of foods (i.e., beverages, semi-solid foods or purees) would require different viscosities [Burbidge, 0138], since the viscosity of a food product changes due to shear forces during processing in the mouth and swallowing [Burbidge, 0138], and since the invention provides nutritional products to dysphagic patients having increased bolus cohesion due to extensional viscosity, without dramatically modifying other physical properties of the material such as, for example, its shear viscosity, thus dramatically reducing swallowing effort for the patient [Burbidge, 0141].
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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/L.E.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/ Supervisory Patent Examiner, Art Unit 1792