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.
Claims 16 and 40 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 16, the claim limits steps (b) and (c) to occur simultaneously. However the claim states that step (b) occurs at a pressure of 1000 mbar or less and further that the (b) and (c) occur at 500 mbar or less. Therefore it is unclear at which pressure the process steps should be performed at. The resulting claim does not clearly set forth the metes and bounds of the patent protection desired and as a result the claim is indefinite.
Claim 40 states the protein-carbohydrate dispersion is present as a “continuous phase”. In this case, the applicant does not act as his or her own lexicographer because there is no definition for “continuous phase” in the specification and therefore the claim is interpreted in light of the ordinary meaning of a “continuous phase”. In food chemistry the continuous phase supports and surrounds the dispersed phase droplets in an emulsion. In this case it is unclear as what parameters would qualify the protein-carbohydrate dispersion as a continuous phase because the claims do not teach an additional dispersed phase and there is no limitation of the claimed process involving an emulsion. Therefore it is unclear in this aspect what a continuous phase is and thus renders the claim indefinite.
Claims 17-18, 22-26, 31-32, 36-37, and 39-41 are rejected due to their dependency on rejected Claim 16.
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 32 are rejected under 35 U.S.C. 103 as being unpatentable over Mikaelian et al. (herein referred to as, Mikaelian, WO 03082026 A1) in view of Diekhaus et al. (herein referred to as Diekhaus, US 20160255849 A1)
With regard to Claim 16, Mikaelian teaches a process for producing a preparation comprising a protein-carbohydrate conjugate (abstract). Mikaelian teaches the process comprises providing an aqueous dispersion of a protein and a carbohydrate (page 5, lines 13-17). Mikaelian teaches drying the aqueous dispersion at pressure below 1000 mbar (page 6, lines 10-11 and example 1 page 8, lines 30-33 Mikaelian reads such that the dispersion is vacuum dried). Therefore, Mikaelian reads such that the drying temperature range is 0-1000 mbar and thus it would have been obvious to one with ordinary skill in the modify the pressure to achieve the desired drying results. 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). And MPEP 2144.04(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Mikaelian teaches drying the aqueous dispersion using a vacuum drying method (page 6, lines 10-11 and example 1 page 8, lines 30-33) but does not specify the time of drying. In other embodiments that utilize alternative drying methods such as a convection oven, Mikaelian teaches drying time periods of up to 6 hours and 40 minutes (page 15 Example 6) Thus, Mikaelian reads on the drying time.
Therefore, it would have been obvious to one with ordinary skill in the art to adjust the drying time with the vacuum drying belt to achieve the desired results because Mikaelian teaches the drying time does not exceed 16 hours. 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).
However, Mikaelian is silent to the temperature.
Diekhaus teaches a food composition in powder form (abstract). Diekhaus teaches freeing the crystallized product from residual water by using a vacuum belt dryer (abstract). One with ordinary skill in the art would recognize that “freeing the crystallized product from residual water” is equivalent to drying the product. Diekhaus teaches the vacuum belt dryer may be heated and in the heating zones, the temperature is usually about 60 to about 140° C and more particularly about 70 to about 120° C and the pressure is generally about 5 to about 40 mbar and more particularly about 10 to about 30 mbar ([0173]). Diekhaus teaches in principle drying should be carried out at extremely low temperatures, in order to minimize the formation of insoluble particles ([0173]).
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 Mikaelian to include the vacuum drying operating temperatures taught by Diekhaus to minimize the formation of insoluble particles.
With regard to limitation (c), Mikaelian and Diekhaus teach the claimed process steps including the temperature in claim 19 (Diekhaus [0173]), the pressure in claim 20 (Diekhaus [0173]), the process being formed continuously as claimed in claim 18 (Diekhaus [0171]), and the processing time in claim 16 (Mikaelian, page 15 Example 6). In addition, the combination of Mikaelian and Diekhaus specifically teach using the protein (soy protein) and carbohydrate (pectin) taught in preferred embodiments in applicants specification page 6-7. Therefore, because Mikaelian and Diekhaus teach the claimed process with the preferred carbohydrate and protein source and the specific processing conditions in claims 16, 18, 19, and 20, the protein would inherently form a glycosylamine by covalently bonding a free amino group of the protein with a carbonyl group of the carbohydrate. 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 the limitation of (b) and (c) occurring simultaneously, as discussed above, Mikaelian teaches utilizing a vacuum drying method (page 8, example 1) with soy protein isolate and pectin which are the preferred protein and preferred carbohydrate according to applicants specification on page 6. Therefore, because Mikaelian teaches using the same protein and carbohydrate and the same drying method, it can be reasonably deduced by one with ordinary skill in the art that step (c) wherein a glycosylamine is formed would inherently happen during step (b) at the same temperature and pressure profile. 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Continuing, Mikaelian is silent to the temperature of steps (b) and (c).
Diekhaus teaches freeing the crystallized product from residual water by using a vacuum belt dryer (abstract). One with ordinary skill in the art would recognize that “freeing the crystallized product from residual water” is equivalent to drying the product. Diekhaus teaches the vacuum belt dryer may be heated and in the heating zones, the temperature is usually about 60 to about 140° C and more particularly about 70 to about 120° C and the pressure is generally about 5 to about 40 mbar and more particularly about 10 to about 30 mbar ([0173]). Diekhaus teaches in principle drying should be carried out at extremely low temperatures, in order to minimize the formation of insoluble particles ([0173]).
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 Mikaelian to include the vacuum drying operating temperatures taught by Diekhaus to minimize the formation of insoluble particles.
With regard to Claim 22, Mikaelian teaches before (b) the protein and carbohydrate are in a dry weight of 40 % or less (Page 8 example 1, Mikaelian reads such that 5 grams of pectin was prepared in two liters five hundred milliliters of water. Then 500 grams of soy protein isolate was added to the aqueous pectin solution. That equates to the protein and carbohydrate in a dry weight of about 20%)
With regard to Claim 24, Mikaelian teaches the protein is a nature- derived protein (page 3, lines 15-17 Mikaelian reads such that product uses soy protein isolate)
With regard to Claim 25, Mikaelian teaches the carbohydrate is selected from monosaccharides, disaccharides, and polysaccharides (page 5, lines 13-15)
With regard to Claim 26, Mikaelian teaches the dispersion comprises a fruit (page 6, lines 21-27).
With regard to Claim 31, Mikaelian teaches utilizing a vacuum drying method (page 8, example 1) but is silent to it specifically being done with a vacuum belt dryer.
Diekhaus teaches freeing the crystallized product from residual water by using a vacuum belt dryer (abstract). Diekhaus teaches the shift in boiling point under vacuum, which ensures that the evaporation temperature drops and the product can be dried more gently ([0171]).
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 Mikaelian in view of Diekhaus to utilize a vacuum belt drying in which steps (b) and (c) could be performed continuously to dry the product more gently.
With regard to Claims 36-39, Mikaelian is silent to the temperature of steps (b) and (c).
Diekhaus teaches freeing the crystallized product from residual water by using a vacuum belt dryer (abstract). One with ordinary skill in the art would recognize that “freeing the crystallized product from residual water” is equivalent to drying the product. Diekhaus teaches the vacuum belt dryer may be heated and in the heating zones, the temperature is usually about 60 to about 140° C and more particularly about 70 to about 120° C and the pressure is generally about 5 to about 40 mbar and more particularly about 10 to about 30 mbar ([0173]). Diekhaus teaches in principle drying should be carried out at extremely low temperatures, in order to minimize the formation of insoluble particles ([0173]).
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 Mikaelian to include the vacuum drying operating temperatures taught by Diekhaus to minimize the formation of insoluble particles.
With regard to Claim 40, it is first important to address the definition of continuous phase. In this case, applicant does not act as their own lexicographer and therefore the ordinary meaning is used to examine this claim, see 1112(b) rejection above for more details.
Mikaelian teaches the process comprises providing an aqueous dispersion of a protein and a carbohydrate (page 5, lines 13-17). In addition, the combination of Mikaelian and Diekhaus teach the claimed process and the claimed protein-carbohydrate dispersion and therefore the protein-carbohydrate dispersion would be present as a continuous phase during steps (b) and (c). See MPEP 2112.01 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).
With regard to Claim 41, Mikaelian teaches drying the aqueous dispersion at pressure below 1000 mbar (page 6, lines 10-11 and example 1 page 8, lines 30-33 Mikaelian reads such that the dispersion is vacuum dried). Therefore, Mikaelian reads such that the drying temperature range is 0-1000 mbar. Mikaelian does not disclose a change a pressure and therefore one with ordinary skill in the art can assume that the pressure does not change. Thus it would have been obvious to one with ordinary skill in the modify the pressure so that it varies less than 200 mbar to achieve the desired drying results. 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). And MPEP 2144.04(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
However, Mikaelian is silent to the temperature.
Diekhaus teaches the vacuum belt dryer may be heated and in the heating zones, the temperature is usually about 60 to about 140° C and more particularly about 70 to about 120° C and the pressure is generally about 5 to about 40 mbar and more particularly about 10 to about 30 mbar ([0173]). Diekhaus teaches the heating zones, as already mentioned, can be controlled individually, and so it is possible for any desired temperature profile to be applied ([0173]) Diekhaus teaches in principle drying should be carried out at extremely low temperatures, in order to minimize the formation of insoluble particles ([0173]).
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 Mikaelian to include the vacuum drying operating temperatures taught by Diekhaus to minimize the formation of insoluble particles. It would have been obvious to one with ordinary skill in the art through routine experimentation to vary the temperature less than 50℃ to achieve the desired results. See MPEP 2144.05(II) Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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.");
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Mikaelian et al. (herein referred to as, Mikaelian, WO 03082026 A1) in view of Diekhaus et al. (herein referred to as Diekhaus, US 20160255849 A1) and Terp et al. (herein referred to as Terp, WO 2017116807 A1)
With regard to Claim 23, Mikaelian teaches preferably the ratio of the polysaccharide to protein in the aqueous solution is at least about 1/100 w/w which is larger than the claimed ratio of wherein a weight ratio of the protein to the carbohydrate is 1:5 to 5:1.
Terp teaches it is possible to formulate a flavored beverage comprising fat, protein, carbohydrates, and minerals, wherein the beverage develops little or no undesired color during formulation, processing, and storage ([005]). Terp teaches nutritional liquids made by reconstituting nutritional powders described herein prior to use ([0016]). Terp teaches the nutritional compositions according to the general inventive concepts include protein, fat, and carbohydrate ([0028]). Terp teaches the total concentrations or amounts of the protein, fat, and carbohydrate may vary depending upon the product type (i.e., dietary supplement, medical food, human milk fortifier, infant formula, toddler formula, etc.), product form (i.e., nutritional solid, powder, ready-to-feed liquid or concentrated liquid, nutritional bar), and targeted dietary needs of the intended user ([0029]). Terp teaches the protein can be soy protein isolate ([0036]) and protein is present in an amount of 1 g to 25 g per serving ([0037]). Terp teaches the carbohydrate may be pectin ([0040]) and can be present in an amount of 5 g to 50 g per serving ([0041]). Thus, Terp reads such that the ratio of protein to carbohydrate can be 1:50 to 5:1. See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would have been obvious to one with ordinary skill in the art to modify Mikaelian to use the amount of protein and carbohydrate taught by Terp to achieve the desired product type, product form, and/or target dietary needs of the intended user.
With regard to Claim 40, Mikaelian teaches the process comprises providing an aqueous dispersion of a protein and a carbohydrate (page 5, lines 13-17).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Mikaelian et al. (herein referred to as, Mikaelian, WO 03082026 A1) in view of Diekhaus et al. (herein referred to as Diekhaus, US 20160255849 A1) and Kerone (“Infrared Vacuum Heating Systems’)
With regard to Claim 32, Mikaelian teaches utilizing a vacuum drying method (page 8, example 1) but is silent to it specifically being done with a vacuum belt dryer with an infrared radiation means for heating.
Diekhaus teaches freeing the crystallized product from residual water by using a vacuum belt dryer (abstract). Diekhaus teaches vacuum belt dryers consist essentially of a housing with built-in, product-transporting conveyor belts which are drawn over heating assemblies ([0171]). Diekhaus teaches the vacuum belt dryer may be heated with steam, pressurized water or thermal oil ([0173]).
But the combination of Mikaelian and Diekhaus is silent to the using infrared radiation for heating.
Kerone teaches infrared heating is a reliable heating source, having capability to transfer large amount of heat in shorter time (page 3). Kerone teaches with infrared radiation heating there is no need of direct contact with the material under process and are suitable for the Vacuum operational condition (page 4).
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 Mikaelian and Diekhaus in view of Kerone to utilize infrared radiation heating with the vacuum belt dryer because infrared heating can transfer large amount of heat in shorter time and there is no need of direct contact with the material under process.
Response to Arguments
Applicant's arguments filed 19 March 2026 have been fully considered but they are not persuasive.
Applicant argues that Mikaelian does not disclose glycosylamine formation. Applicant further argues that rather Mikaelian describes physical coating or adsorption of polysaccharides on protein particles rather than a chemical conjugation via Maillard-type reactions.
This leads into applicants next argument that glycosylamine formation is not inherent in Mikaelian and points to MPEP 2163.07(a). First the examiner would like to clearly point out that it is not solely Mikaelian that is inherent but a combination of Mikaelian and Diekhaus. In this case, and as stated above, the combination of Mikaelian and Diekhaus teaches the claimed process steps including the temperature in claim 19 (Diekhaus [0173]), the pressure in claim 20 (Diekhaus [0173]), the process being formed continuously as claimed in claim 18 (Diekhaus [0171]), and the processing time in claim 16 (Mikaelian, page 15 Example 6). In addition, the combination of Mikaelian and Diekhaus specifically teach using the protein (soy protein) and carbohydrate (pectin) taught in preferred embodiments in applicants specification page 6-7. Therefore, because Mikaelian and Diekhaus teach the claimed process with the preferred carbohydrate and protein source and the specific processing conditions in claims 16, 18, 19, and 20, the protein would inherently form a glycosylamine by covalently bonding a free amino group of the protein with a carbonyl group of the carbohydrate. 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 inherency, 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I) further goes on to explain "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In applicants remarks, the applicant does not provide evidence that would be convincing to show that the combination of Mikaelian and Diekhaus would not result in the formation of glycosylamine and therefore applicants argument is not found to be persuasive.
Next applicant argues that Diekhaus merely describes drying processes for food material and does not disclose or suggest inducing glycosylamine formation between protein and carbohydrates. This argument is not found persuasive, as explained above, the combination of Mikaelian and Diekhaus teaches all the claimed limitations and therefore glycosylamine formation would be inherent. Diekhaus is not relied upon to teach the entirety of the claimed limitations. Applicants states that the reliance on Diekhaus undermines the inherency argument. However, the inherency argument is very clearly based on the combination of Mikaelian and Diekhaus and therefore applicants argument is not found to be persuasive.
Lastly, applicant argues that the rejection fails to provide a reason why a skilled person would have modified the process of Mikaelian to arrive at the claimed process. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, it would be obvious to modify Mikaelian to include the vacuum drying operating temperatures taught by Diekhaus to minimize the formation of insoluble particles. Diekhaus clearly provides ample motivation to combine. The examiner would again like to highlight that that the “Maillard-type reaction” upon which applicant relies in their argument is not recited in the rejected claims and therefore not taken into consideration.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
Prosecution Insights