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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regard to Claim 1, part (b) starts with the limitation “when to..” and further goes on to point (i) which states “an equal amount of guanidinium hydrochloride is added, a resulting solution having a crude protein concentration of 0.1% and a guanidine hydrochloride concentration of 250 mM does not become turbid” and part (ii) “an equal amount of ammonium sulphate is added, a resulting solution having a crude protein concentration of 0.1% and an ammonium sulphate concentration of 2M becomes turbid.”. In this recitation it is unclear if the steps on adding an equal amount of guanidine hydrochloride and an equal amount of ammonium sulphate is positively recited or is merely stating that when an equal amount of guanidine hydrochloride or an equal amount of ammonium sulphate are added to the aqueous solution that the solution reacts in a way where it is either not turbid or turbid. In this case, the claim will be interpreted as the addition of an equal amount of guanidine hydrochloride and an equal amount of ammonium sulphate is not positively recited step and the claim will be read such that the addition of an equal amount of guanidine hydrochloride or an equal amount of ammonium sulphate is merely a characteristic property of the aqueous solution not a positively recited step.
Claims 3-15 are rejected due to their dependency on claim 1.
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.
Claims 1 and 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Akashe et al. (herein referred to as Akashe, WO 2008/088973 A2) in view of Baumer et al. (herein referred to as Baumer, US 20050220979 A1) and Hiroshi et al. (herein referred to Hiroshi, WO 2019189810 A1)
With regard to Claim 1, Akashe teaches a heat stable soy milk concentrate ([0001]) wherein the soy milk concentrate is a protein-containing oil-and-fat emulsion composition ([0013]). Akashe teaches the composition contains protein in an amount of 15 to about 20 percent hydrolyzed soy protein isolate having a molecular weight distribution between 5,500 and 30,000 daltons ([0013]). Thus, the soy protein isolate taught by Akashe satisfies the requirement of (a). Akashe teaches the composition does not contain a carbohydrate and thus reads on the claimed proportion of instant claim 1 ([0013]).
In addition, Akashe teaches the composition contains 5 to about 15% of an edible oil and 65 to about 75 percent water ([0013]). Adjusting the percentages above in accordance with the total amount of the protein, the oil and fat, and the carbohydrate being 100 mass %, the composition contains 50 to 80% protein and 14 to 50% edible oil.
However, the ranges taught by Akashe are outside the instant claim ranges.
Hiroshi teaches protein-containing oil/fat emulsion composition for use in the production of emulsified foods, characterized in that when the total amount of protein, oils and carbohydrates is 100% by mass, the composition is 10-70% by mass of protein, 30-90% by mass of oils and carbohydrates, and 0-40% by mass of carbohydrates ([0009]). Hiroshi teaches by including proteins, fats and oils, and carbohydrates in a stable emulsion composition within such a composition range, the components necessary for emulsion foods can be blended into the emulsion foods in a stabilized state, thereby reducing the amount of proteins, fats and oils, and carbohydrates that need to be blended separately as much as possible ([0014]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Akashe to utilize the protein and oil/fat in the amounts taught by Hiroshi to ensure the product can be blended into the emulsion foods in a stabilized state, thereby reducing the amount of proteins, fats and oils, and carbohydrates that need to be blended separately as much as possible.
However, Akashe is silent to the soy protein isolate being denatured.
Baumer teaches food materials containing a high concentration of vegetable protein and processes for their manufacture (abstract). Baumer teaches an emulsion product containing a soy protein product ([0111]). Baumer teaches for the soy protein product it is desired that at least one of the soy protein materials exhibits low viscosity and low gelling properties. Baumer teaches the viscosity and/or gelling properties of a soy protein isolate may be decreased by partial hydrolysis which partially denatures the protein materials ([0029], [0031]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Akashe in view of Baumer to denature the protein isolate to decrease the viscosity and/or gelling properties of a soy protein isolate. It would have been obvious to one with ordinary skill in the art that, through routine experimentation, the amount of denatured protein can be modify to achieve the desired viscosity and/or gelling properties of a soy protein isolate. See MPEP 2144.05(II)(A) "[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).
With regard to limitation (b), as stated above, the limitation is unclear and is being interpreted as the steps are not positively recited in the claim and are merely a recitation of a physical properties of the aqueous solution. Thus it can be reasonably amused that because the above prior art references satisfies the claims limitations, the above art also satisfies limitation (b). See MPEP 2112.01(I) 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. And MPEP 2112.01(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
With regard to Claim 3, Akashe teaches the composition contains protein in an amount of 15 to about 20 percent hydrolyzed soy protein isolate having a molecular weight distribution between 5,500 and 30,000 daltons ([0013]) but is silent to wherein the denatured protein material further satisfies that an area ratio of components having a molecular weight of less than 2000 Da to the total area is 45% or less.
Hiroshi teaches the area ratio of less than 2000 Da is preferably 15% or less, 13% or less, 9% or less, 8% or less, 7% or less wherein the lower limit is not particularly limited ([0020]). Having such a molecular weight distribution of the vegetable protein can contribute to the size of the emulsified particles of the present emulsified composition ([0020]). Hiroshi teaches the particle size is directly related to the emulsion stability ([0032])
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Akashe in view of Hiroshi so the area ratio of components having a molecular weight of less than 2000 Da to the total area is 45% or less to have a molecular weight distribution of the vegetable protein that can contribute to the size of the emulsified particles of the present emulsified composition to achieve the desired emulsion stability.
With regard to Claim 4, Akashe teaches the composition contains protein in an amount of 15 to about 20 percent hydrolyzed soy protein isolate having a molecular weight distribution between 5,500 and 30,000 daltons ([0013]).
With regard to Claim 5, Akashe teaches the composition contains protein in an amount of 15 to about 20 percent hydrolyzed soy protein isolate having a molecular weight distribution between 5,500 and 30,000 daltons ([0013]) but is silent to wherein the denatured protein material further satisfies that an area ratio of components having a molecular weight of less than 2000 Da to the total area is 45% or less and an area ratio of components having a molecular weight of 10000 Da or greater to the total area is less than 50%.
Hiroshi teaches the area ratio of the molecular weight distribution is 50 to 80% at 10,000 Da or more and the area ratio of less than 2000 Da is preferably 15% or less, 13% or less, 9% or less, 8% or less, 7% or less wherein the lower limit is not particularly limited ([0020]). Having such a molecular weight distribution of the vegetable protein can contribute to the size of the emulsified particles of the present emulsified composition ([0020]). See MPEP 2144.05(I) which states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)” and "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties." In addition, Hiroshi teaches the particle size is directly related to the emulsion stability ([0032])
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Akashe in view of Hiroshi so the area ratio of components having a molecular weight of less than 2000 Da to the total area is 45% or less and 10000 Da or greater to the total area of 50% to have a molecular weight distribution of the vegetable protein that can contribute to the size of the emulsified particles of the present emulsified composition to achieve the desired emulsion stability. One with ordinary skill in the art would understand 50% and less than 50% (i.e., 49.9%) are so close that it would be reasonable to expect the same result.
With regard to Claim 6, Akashe the protein-containing oil-and-fat emulsion composition is free of a milk protein (whole document). It is important to note Akashe teaches dairy oil or vegetable oil may be used as the oil and fat component but Akashe does not teach using milk protein ([0013]).
With regard to Claim 8, Akashe teaches the protein-containing oil-and-fat emulsion composition is free of an animal protein (whole document).
With regard to Claim 9, Akashe teaches all the limitations of instant claim 1. In addition, Akashe teaches the solubility of the protein is directly related to how hydrolyzed the soy protein is ([0028]). One with ordinary skill in the art would recognize that solubility and OD have an inverse relationship being the more soluble the protein the lower the OD reading. Therefore, because the prior art teaches the product as claimed, the product taught by the prior art inherently has the OD claimed in the instant application. See MPEP 2112.01(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
With regard to Claims 10 and 11, Akashe teaches all the limitations of instant claim 1. In addition, Akashe teaches the solubility of the protein is directly related to how hydrolyzed the soy protein is ([0028]). One with ordinary skill in the art would recognize that solubility and OD have an inverse relationship being the more soluble the protein the lower the OD reading. Therefore, because the prior art teaches the product as claimed, the product taught by the prior art inherently has the OD claimed in the instant application. See MPEP 2112.01(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
With regard to Claim 12, Akashe teaches the protein-containing oil-and-fat emulsion composition for producing an emulsified food (title, [0061]-[0063] Akashe teaches an emulsified soy milk concentrate used in soymilk and creamers).
With regard to Claim 13, Akashe teaches the protein-containing oil-and-fat emulsion composition for producing an emulsified food (title, [0061]-[0063] Akashe teaches an emulsified soy milk concentrate used in soymilk and creamers).
With regard to Claim 14, Akashe teaches a heat stable soy milk concentrate ([0001]). Akashe teaches beverage concentrates are often utilized in a cartridge or pod to provide regular strength beverages when diluted by the beverage system ([0002]). Therefore, the concentrate taught by Akashe can be used in any amount to achieve the desired end product such as a “regular (i.e., desired) strength beverage. See MPEP 2144.05(II)(A) "[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).
With regard to Claim 15, Akashe teaches a heat stable soy milk concentrate ([0001]). Akashe teaches beverage concentrates are often utilized in a cartridge or pod to provide regular strength beverages when diluted by the beverage system ([0002]). Therefore, the concentrate taught by Akashe can be used in any amount to achieve the desired end product such as a “regular (i.e., desired) strength beverage. See MPEP 2144.05(II)(A) "[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).
Response to Arguments
Applicant's arguments filed 13 March 2026 have been fully considered but they are not persuasive.
Applicants arguments begin on page 9 of the response filed 13 March 2026. First applicant argues that the contents of the protein and oil of Akashe’s composition do not overlap with the claimed composition. Applicant has further amended to claim to narrow the distribution of the ranges. Akashe is no longer relied upon to teach the claimed ranges and now Hiroshi is relied upon and clearly teaches a protein-containing oil/fat emulsion composition characterized in that when the total amount of protein, oils and carbohydrates is 100% by mass, the composition is 10-70% by mass of protein, 30-90% by mass of oils and carbohydrates, and 0-40% by mass of carbohydrates (Hiroshi [0009]). This teaching overlaps with the claimed ranges and Hiroshi provides ample motivation to combine by teaching that utilizing the protein and oil/fat in the amounts taught by Hiroshi ensures the product can be blended into the emulsion foods in a stabilized state, thereby reducing the amount of proteins, fats and oils, and carbohydrates that need to be blended separately as much as possible. Therefore applicants argument is not found to be persuasive.
Next, the applicant argues that Hiroshi differs from the present claims in both the molecular weight distribution and the degree of denaturation. With regard to the molecular weight distribution, Hiroshi is not relied upon to teach the molecular weight distribution of the composition. In this case Akashe teaches the molecular weight distribution and clearly teaches the composition contains protein in an amount of 15 to about 20 percent hydrolyzed soy protein isolate having a molecular weight distribution between 5,500 and 30,000 daltons ([0013]). However the examiner acknowledges Akashe does not teaches the protein is denatured. Therefore Baumer is brought in to teach the denatured soy protein and provides ample motivation to combine to decrease the viscosity and/or gelling properties of a soy protein isolate. As explained in the rejection above, It would have been obvious to one with ordinary skill in the art that, through routine experimentation, the amount of denatured protein can be modify to achieve the desired viscosity and/or gelling properties of a soy protein isolate. Therefore applicants argument with regard to the molecular weight distribution is not found to be persuasive. With regard to the degree of denaturation in part (b) of the claim, as discussed above in the rejection, Hiroshi is not relied upon to teach (b) the degree of denaturation. In this case, the combination of Akashe, Hiroshi, and Baumer teach all the limitations of the claimed invention and therefore would inherently have the degree of denaturation that step(b) is referring to. Applicant’s argument is not found to be persuasive.
Lastly, applicant argues that Akashe teaches a fundamentally different composition ratio and Hiroshi does not disclose nor suggest the specific molecular weight distribution and denaturation characteristics defined by claim 1. Applicant argues that even if Akashe were combine with Hiroshi there would have been no motivation to arrive at the claimed composition. This is not found to be persuasive because protein and oil/fat in the amounts taught by Hiroshi ensures the product can be blended into the emulsion foods in a stabilized state, thereby reducing the amount of proteins, fats and oils, and carbohydrates that need to be blended separately as much as possible. The examiner would like to highlight 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).
Continuing, applicant points to Example 6 and Table 9-12 in the specification and argues that the experimental data presented demonstrates that the protein corresponding to Hiroshi does not provide the claimed performance. First, it is unclear to which protein the applicant is referring to in their argument. Second, Hiroshi is merely relied upon to teach the claimed amount of protein, the claim does not limit the specific type of protein it merely limits the amount. Lastly, it is unclear what the “claimed performance” metric the applicant is referring to specifically means. Therefore, Applicants argument is not found to be persuasive.
Further applicant argues that a person of ordinary skill in the art would not have been motivated to modify the composition of Akashe to reduce the protein content to the claimed range because such a modification would render Akashe unsatisfactory for its intended purpose. Applicant points to Akashe paragraph [0001] which states he invention relates to methods of producing heat stable soy milk concentrates, and in particular, methods of producing heat stable soy milk concentrates at levels greater than about a 3.2X concentration based on protein. However, the examiner points to paragraph [0010] which states In one embodiment, a method is provided to prepare heat stable soy milk concentrates having between about 9.9 and about 10.8 percent protein (i.e., about 3.3X to about 3.6X) with a pourable and flowable viscosity. Therefore the 3.2X is not in reference to the amount of protein but is in reference to how concentrated the soy milk concentrate is as a whole and it is being measure in relation to the protein. In addition Hiroshi provides ample motivation to combine because, as stated above, the amounts taught by Hiroshi ensures the product can be blended into the emulsion foods in a stabilized state, thereby reducing the amount of proteins, fats and oils, and carbohydrates that need to be blended separately as much as possible. Therefore, applicants arguments are not found to be persuasive.
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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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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