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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 28-30 and 32-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12, 19-20, and 22-24 of U.S. Patent No. 12133543 in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1).
Both claim 28 of the present application and claim 1 of U.S. Patent No. 12133543 teach a packaged, heat-treated beverage preparation having a pH in the range of 2-4.7 in U.S. Patent No. 12133543 (where the currently claimed range of 3.0-4.3 falls within this range), the beverage preparation comprising: a total amount of protein of 5 to 45% w/w relative to the weight of the beverage preparation in U.S. Patent No. 12133543 (which overlaps with the currently claimed range of 2 to 45% w/w), wherein at least 85% w/w of the total amount of protein is beta-lactoglobulin (BLG), wherein the beverage preparation optionally further comprises a sweetener, sugar polymers and/or flavour, wherein the beverage preparation is at least pasteurized.
Claim 1 of U.S. Patent No. 12133543 is silent on the beverage preparation having a turbidity of at most 200 NTU and a viscosity of at most 200 cP (centipoise), measured at 22 degrees Celsius at a shear rate of 100/s.
Etzel teaches (Paragraph 0003, 0042) methods and compositions involving a whey protein isolate that has low turbidity across a wide range of pH values, wherein, in some embodiments, there is a high protein clear beverage comprising substantially purified whey protein with a protein concentration of at least about 25 g/L and a turbidity of about or less than about 100 NTU. Also, Etzel teaches (Paragraph 0015) in many embodiments, the isolate contains beta-lactoglobulin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify U.S. Patent No. 12133543 to provide a beverage with a turbidity of at most 200 NTU as taught by Etzel since both are directed to beverage products containing beta-lactoglobulin, since a beverage product containing beta-lactoglobulin with a turbidity of at most 200 NTU is known in the art as shown by Etzel, since a cloudy (high turbidity) beverage is unappetizing to the average consumer (Etzel, Paragraph 0013), and since the characteristic of the whey protein product of the invention to form clear solutions is of considerable importance for use in food products such as in edible foodstuffs including drinks, gels, and health products requiring bio-active, nondenatured whey protein (Etzel, Paragraph 0131).
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0100) the viscosity of the liquid enteral nutritional composition is lower than 500 mPas, measured at 20°C (i.e., room temperature) at a shear rate of 100 s-1, preferably between 10 and 200 mPas, more preferably between 10 and 100 mPas, most preferably below 50 mPas (50 cP).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify U.S. Patent No. 12133543 to adjust the viscosity below 50 mPas (50 cP) as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a viscosity below 200 cP is known in the art as shown by Minor, since this viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity (Minor, Paragraph 0100), and since this viscosity is also ideal for unit dosages that are tube fed (Minor, Paragraph 0100), which would be of benefit to consumers dependent on tube feeding due to illness or injury.
Both claim 29 of the present application and claim 2 of U.S. Patent No. 12133543 teach the preparation is sterile.
Both claim 30 of the present application and claim 3 of U.S. Patent No. 12133543 teach the protein fraction of the beverage preparation has an intrinsic tryptophan fluorescence emission ratio (1330 nm/1350 nm) of at least 1.11.
Both claim 32 of the present application and claim 1 of U.S. Patent No. 12133543 teach the protein fraction has a degree of protein denaturation of at most 10%.
Claim 4 of U.S. Patent No. 12133543 teaches a pH in the range of 3.0-4.3, which overlaps with the currently claimed range of 3.0-3.9 in claim 33 of the present application.
Both claim 34 of the present application and claim 5 of U.S. Patent No. 12133543 teach the protein fraction of the beverage preparation has a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature.
Both claim 35 of the present application and claim 6 of U.S. Patent No. 12133543 teach the beverage preparation has a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature.
Both claim 36 of the present application and claim 7 of U.S. Patent No. 12133543 teach the sum of the amounts of Na, K, Mg and Ca is at most 750 mM.
Claim 8 of U.S. Patent No. 12133543 teaches a turbidity of at most 200 NTU, which encompasses the currently claimed range of at most 40 NTU of claim 37 of the present application.
Regarding claim 38 of the present application, U.S. Patent No. 12133543 is silent on a viscosity of at most 40 cP centipoise, measured at 22 degrees Celsius at a shear rate of 100/s.
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0100) the viscosity of the liquid enteral nutritional composition is lower than 500 mPas, measured at 20°C (i.e., room temperature) at a shear rate of 100 s-1, preferably between 10 and 200 mPas, more preferably between 10 and 100 mPas (10 and 100 cP, which overlaps with the claimed range of at most 40 cP).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify U.S. Patent No. 12133543 to adjust the viscosity to at most 40 cP as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a viscosity of at most 40 cP is known in the art as shown by Minor, since this viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity (Minor, Paragraph 0100), and since this viscosity is also ideal for unit dosages that are tube fed (Minor, Paragraph 0100), which would be of benefit to consumers dependent on tube feeding due to illness or injury.
Claim 1 of U.S. Patent No. 12133543 teaches a total amount of protein of 5 to 45% w/w relative to the weight of the beverage preparation, which overlaps with the currently claimed ranges of 4.0 to 35 % w/w and 4.0 to 30% w/w in claim 39 of the present application.
Regarding claim 40 of the present application, U.S. Patent No. 12133543 is silent on carbohydrate in a range between 0 to 95% of the total energy content of the beverage preparation.
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0091) the liquid nutritional composition according to the invention further comprises carbohydrate, said carbohydrate providing between 30 to 60% of the total energy content of the composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify U.S. Patent No. 12133543 to incorporate carbohydrates providing between 30 to 60% of the total energy content of the composition as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a carbohydrate between 0 to 95% of the total energy content of the beverage is known in the art as shown by Minor, since the composition is capable of supplementing a person's diet providing complete nutritional support by providing ingredients including a carbohydrate (Minor, Paragraph 0086), since the composition of the carbohydrate preferably is such that high viscosities, excessive sweetness, excessive browning (Maillard reactions) and excessive osmolarities are avoided (Minor, Paragraph 0092), and since the carbohydrate can include trehalose, which gives rise to a low viscosity, no undesired Maillard reactions and it has a sweetness about half of that of sucrose, where a person may easily consume a serving having a low viscosity (Minor, Paragraph 0094, 100).
Both claim 41 of the present application and claim 12 of U.S. Patent No. 12133543 teach each main non-BLG whey protein is present in a weight percentage relative to total protein which is at most 15% of its weight percentage relative to total protein in a standard whey protein concentrate from sweet whey.
Both claim 42 of the present application and claim 20 of U.S. Patent No. 12133543 teach a method of producing a packaged, heat-treated beverage preparation having a pH in the range of 2-4.7 in U.S. Patent No. 12133543 (where the currently claimed range of 3.0-4.3 falls within this range), comprising the following steps: a) providing a liquid solution comprising a total amount of protein of 5 to 45% w/w relative to the weight of the liquid solution in U.S. Patent No. 12133543 (which overlaps with the currently claimed range of 2 to 45% w/w), wherein at least 85% of the total amount of protein is BLG, wherein the liquid solution optionally further comprises a sweetener, sugar polymers and/or flavour, b) packaging the liquid solution, wherein the liquid solution of step a) and/or the packaged liquid solution of step b) is subjected to a heat-treatment comprising at least pasteurization.
Claim 1 of U.S. Patent No. 12133543 is silent on the beverage preparation having a turbidity of at most 200 NTU and a viscosity of at most 200 cP (centipoise), measured at 22 degrees Celsius at a shear rate of 100/s.
Claim 20 of U.S. Patent No. 12133543 is silent on the beverage preparation having a turbidity of at most 200 NTU and a viscosity of at most 200 cP (centipoise), measured at 22 degrees Celsius at a shear rate of 100/s.
Etzel teaches (Paragraph 0003, 0042) methods and compositions involving a whey protein isolate that has low turbidity across a wide range of pH values, wherein, in some embodiments, there is a high protein clear beverage comprising substantially purified whey protein with a protein concentration of at least about 25 g/L and a turbidity of about or less than about 100 NTU. Also, Etzel teaches (Paragraph 0015) in many embodiments, the isolate contains beta-lactoglobulin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify U.S. Patent No. 12133543 to provide a beverage with a turbidity of at most 200 NTU as taught by Etzel since both are directed to methods of producing beverage products containing beta-lactoglobulin, since a beverage product containing beta-lactoglobulin with a turbidity of at most 200 NTU is known in the art as shown by Etzel, since a cloudy (high turbidity) beverage is unappetizing to the average consumer (Etzel, Paragraph 0013), and since the characteristic of the whey protein product of the invention to form clear solutions is of considerable importance for use in food products such as in edible foodstuffs including drinks, gels, and health products requiring bio-active, nondenatured whey protein (Etzel, Paragraph 0131).
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0100) the viscosity of the liquid enteral nutritional composition is lower than 500 mPas, measured at 20°C (i.e., room temperature) at a shear rate of 100 s-1, preferably between 10 and 200 mPas, more preferably between 10 and 100 mPas, most preferably below 50 mPas (50 cP).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify U.S. Patent No. 12133543 to adjust the viscosity below 50 mPas (50 cP) as taught by Minor since both are directed to methods of producing liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a viscosity below 200 cP is known in the art as shown by Minor, since this viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity (Minor, Paragraph 0100), and since this viscosity is also ideal for unit dosages that are tube fed (Minor, Paragraph 0100), which would be of benefit to consumers dependent on tube feeding due to illness or injury.
Both claim 43 of the present application and claim 22 of U.S. Patent No. 12133543 teach a method of treating a subject who suffers from diseases associated with protein malabsorption, the method comprising providing to the subject the packaged, heat-treated beverage preparation of claim 1 in U.S. Patent No. 12133543 and claim 28 is the present application.
Both claim 44 of the present application and claim 23 of U.S. Patent No. 12133543 teach a method of treating a subject who is in need of a dietary supplement, the method comprising providing to the subject the packaged, heat-treated beverage preparation of claim 1in U.S. Patent No. 12133543 and claim 28 is the present application.
Both claim 45 of the present application and claim 24 of U.S. Patent No. 12133543 teach said beverage preparation is ingested before, during or after exercise.
Both claim 46 of the present application and claim 19 of U.S. Patent No. 12133543 teach at least 92% w/w of the protein is beta-lactoglobulin (BLG).
Claim 1 of U.S. Patent No. 12133543 teaches a total amount of protein of 5 to 45% w/w relative to the weight of the beverage preparation, which overlaps with the currently claimed ranges of 2.0 to 10 % w/w and 5.0 to 9.0% w/w in claim 47 of the present application.
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 28-41 and 43-47 are 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.
Claim 28 recites the limitation "the beverage preparation" on lines 1-2, 6, and 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the beverage" on line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 29-41and 46-47 are rejected as indefinite as a result of depending upon indefinite claim 28.
Claims 43 and 44, which recite the packaged, heat-treated beverage preparation of claim 28 are rejected as indefinite for the same reasons as claim 28.
Claim 45 is rejected as indefinite as a result of depending upon indefinite claim 44.
Claim 29 recites the limitation "the preparation" on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the protein fraction" on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the protein fraction" on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32recites the limitation "the protein fraction" on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the protein fraction" on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the beverage preparation" on line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the beverage preparation" on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 39, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 39 recites the broad recitation “a total amount of protein of 4.0 to 35 % w/w relative to the weight of the beverage”, and the claim also recites “preferably 4.0 to 30% w/w” and “more preferably 10 to 20% w/w” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 39 recites the limitation "the beverage " on lines 2, 3, and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the beverage preparation" on lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 41, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 41 recites the broad recitation “a weight percentage relative to total protein which is at most 15% of its weight percentage relative to total protein in a standard whey protein concentrate from sweet whey”, and the claim also recites “preferably at most 10%,” “even more preferably at most 6%,” and “most preferably at most 4%” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 46, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 46 recites the broad recitation “at least 90% w/w of the protein is beta-lactoglobulin (BLG)”, and the claim also recites “preferably at least 92% w/w of the protein is beta-lactoglobulin (BLG)”, “most preferably at least 94% w/w of the protein is beta-lactoglobulin (BLG)”, “more preferably at least 96% w/w of the protein is beta-lactoglobulin (BLG)”, and “even more preferably at least 98% w/w of the protein is beta-lactoglobulin (BLG)” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 47, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 47 recites the broad recitation “a total amount of protein of 2.0 to 10 % w/w relative to the weight of the beverage”, and the claim also recites “preferably 5.0 to 9.0 % w/w” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 28-29, 33, 38-42, and 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1).
Regarding claim 28, Patel teaches (Paragraph 0005, 0011) shelf-stable, clear liquid nutritional compositions, wherein embodiments of the shelf-stable, clear liquid nutritional compositions have a pH ranging from 2.5 to 4.6, including a pH ranging from 3 to 3.5 in certain embodiments (which falls within the claimed range of 3.0-4.3). Patel further teaches (Paragraph 0053) the shelf-stable, clear liquid nutritional compositions disclosed herein include ready-to-drink liquid nutritional products (beverages). Also, Patel teaches (Paragraph 0042) in certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein are heat sterilized, wherein typical sterilization techniques used with the shelf-stable, clear liquid nutritional compositions disclosed herein involve some manner of heat treatment to eliminate the microorganisms capable of growth in the hermetically sealed, packaged final product. In addition, Patel teaches (Paragraph 0006) the composition comprises water; at least one source of EGCg in an amount sufficient to provide 200-1700 mg/L of EGCg (in the sterilized, clear liquid nutritional composition); and at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (in the sterilized, clear liquid nutritional composition). Assuming a basis of, for example, 1 Liter (where 1 L of water has a mass of approximately 1000 grams), the weight fraction of protein would range from 25 g / (25 g + 1.7 g + 1000 g) or 2.4% w/w to 45 g / (45 g + 0.2 g + 1000 g) or 4.3% w/w, which falls within the claimed range of 2 to 45% w/w. Furthermore, Patel teaches (Paragraph 0021, 0023) the shelf-stable, clear liquid nutritional compositions disclosed herein includes at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (which includes embodiments containing only one source of protein), wherein, in accordance with certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein contain at least one source of protein comprising β-lactoglobulin, wherein, in certain embodiments, suitable whey-based proteins that provide β-lactoglobulin comprise 20-95% of β-lactoglobulin by weight of the solids of the whey-based protein (which overlaps with the claimed range of at least 85% w/w). Additionally, Patel teaches (Paragraph 0034) in certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein may include at least one high intensity sweetener. Patel also teaches (Paragraph 0007) in an embodiment, heating an unsterilized liquid nutritional composition having a pH ranging from 2.5 to 4.6 to a temperature ranging from 85°C (185° F) to 152°C (306°F) for a period of time sufficient to produce a sterilized liquid nutritional composition (at least pasteurized).
Patel does not explicitly state that the beverage preparation has a turbidity of at most 200 NTU and a viscosity of at most 200 cP (centipoise), measured at 22 degrees Celsius at a shear rate of 100/s. However, one of ordinary skill in the art would recognize that, since the prior art discloses a beverage with the same composition and treated in the same manner as the claimed invention, the beverage of the prior art would be expected to possess the same properties, including turbidity and viscosity, as the claimed invention.
Furthermore, the claimed turbidity is known in the prior art.
Etzel teaches (Paragraph 0003, 0042) methods and compositions involving a whey protein isolate that has low turbidity across a wide range of pH values, wherein, in some embodiments, there is a high protein clear beverage comprising substantially purified whey protein with a protein concentration of at least about 25 g/L and a turbidity of about or less than about 100 NTU. Also, Etzel teaches (Paragraph 0015) in many embodiments, the isolate contains beta-lactoglobulin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel to provide a beverage with a turbidity of at most 200 NTU as taught by Etzel since both are directed to beverage products containing beta-lactoglobulin, since a beverage product containing beta-lactoglobulin with a turbidity of at most 200 NTU is known in the art as shown by Etzel, since a cloudy (high turbidity) beverage is unappetizing to the average consumer (Etzel, Paragraph 0013), and since the characteristic of the whey protein product of the invention to form clear solutions is of considerable importance for use in food products such as in edible foodstuffs including drinks, gels, and health products requiring bio-active, nondenatured whey protein (Etzel, Paragraph 0131).
Also, the claimed viscosity is known in the prior art.
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0100) the viscosity of the liquid enteral nutritional composition is lower than 500 mPas, measured at 20°C (i.e., room temperature) at a shear rate of 100 s-1, preferably between 10 and 200 mPas, more preferably between 10 and 100 mPas, most preferably below 50 mPas (50 cP).
It is noted that the measuring temperature is slightly different from the claimed measuring temperature. However, one of ordinary skill in the art could easily account for minor temperature differences, and a temperature difference of 2 degrees is unlikely to significantly change the measured viscosity.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel to adjust the viscosity below 50 mPas (50 cP) as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a viscosity below 200 cP is known in the art as shown by Minor, since this viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity (Minor, Paragraph 0100), and since this viscosity is also ideal for unit dosages that are tube fed (Minor, Paragraph 0100), which would be of benefit to consumers dependent on tube feeding due to illness or injury.
Regarding claim 29, Patel teaches (Paragraph 0007) in an embodiment, heating an unsterilized liquid nutritional composition for a period of time sufficient to produce a sterilized liquid nutritional composition.
Regarding claim 33, Patel teaches (Paragraph 0005, 0011) shelf-stable, clear liquid nutritional compositions, wherein embodiments of the shelf-stable, clear liquid nutritional compositions have a pH ranging from 2.5 to 4.6, including a pH ranging from 3 to 3.5 in certain embodiments (which falls within the claimed range of 3.0-3.9).
Regarding claim 38, Patel is silent on the packaged, heat-treated beverage preparation having a viscosity of at most 40 cP centipoise, measured at 22 degrees Celsius at a shear rate of 100/s.
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0100) the viscosity of the liquid enteral nutritional composition is lower than 500 mPas, measured at 20°C (i.e., room temperature) at a shear rate of 100 s-1, preferably between 10 and 200 mPas, more preferably between 10 and 100 mPas (10 and 100 cP, which overlaps with the claimed range of at most 40 cP).
It is noted that the measuring temperature is slightly different from the claimed measuring temperature. However, one of ordinary skill in the art could easily account for minor temperature differences, and a temperature difference of 2 degrees is unlikely to significantly change the measured viscosity.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel, as modified above, to adjust the viscosity to at most 40 cP as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a viscosity of at most 40 cP is known in the art as shown by Minor, since this viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity (Minor, Paragraph 0100), and since this viscosity is also ideal for unit dosages that are tube fed (Minor, Paragraph 0100), which would be of benefit to consumers dependent on tube feeding due to illness or injury.
Regarding claim 39, Patel teaches (Paragraph 0006) the composition comprises water; at least one source of EGCg in an amount sufficient to provide 200-1700 mg/L of EGCg (in the sterilized, clear liquid nutritional composition); and at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (in the sterilized, clear liquid nutritional composition). Assuming a basis of, for example, 1 Liter (where 1 L of water has a mass of approximately 1000 grams), the weight fraction of protein would range from 25 g / (25 g + 1.7 g + 1000 g) or 2.4% w/w to 45 g / (45 g + 0.2 g + 1000 g) or 4.3% w/w, which falls within the claimed ranges of 4.0 to 35% w/w and 4.0 to 30% w/w.
Regarding claim 40, Patel teaches (Paragraph 0031) in certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein may include at least one source of carbohydrates.
Patel is silent on the packaged, heat-treated beverage preparation comprising carbohydrate in a range between 0 to 95% of the total energy content of the beverage preparation.
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0091) the liquid nutritional composition according to the invention further comprises carbohydrate, said carbohydrate providing between 30 to 60% of the total energy content of the composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel to incorporate carbohydrates providing between 30 to 60% of the total energy content of the composition as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a carbohydrate between 0 to 95% of the total energy content of the beverage is known in the art as shown by Minor, since the composition is capable of supplementing a person's diet providing complete nutritional support by providing ingredients including a carbohydrate (Minor, Paragraph 0086), since the composition of the carbohydrate preferably is such that high viscosities, excessive sweetness, excessive browning (Maillard reactions) and excessive osmolarities are avoided (Minor, Paragraph 0092), and since the carbohydrate can include trehalose, which gives rise to a low viscosity, no undesired Maillard reactions and it has a sweetness about half of that of sucrose, where a person may easily consume a serving having a low viscosity (Minor, Paragraph 0094, 100).
Regarding claim 41, as shown above, Patel teaches (Paragraph 0021, 0023) the shelf-stable, clear liquid nutritional compositions disclosed herein includes at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (which includes embodiments containing only one source of protein), wherein, in accordance with certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein contain at least one source of protein comprising β-lactoglobulin, wherein, in certain embodiments, suitable whey-based proteins that provide β-lactoglobulin comprise 20-95% of β-lactoglobulin by weight of the solids of the whey-based protein. Thus, non-BLG proteins would comprise 5-80% of the composition, which overlaps with the claimed ranges of at most 15%, at most 10%, and at most 6%.
Regarding claim 42, Patel teaches (Paragraph 0005, 0011) methods for preparing shelf-stable, clear liquid nutritional compositions, wherein embodiments of the shelf-stable, clear liquid nutritional compositions have a pH ranging from 2.5 to 4.6, including a pH ranging from 3 to 3.5 in certain embodiments (which falls within the claimed range of 3.0-4.3). Patel further teaches (Paragraph 0053) the shelf-stable, clear liquid nutritional compositions disclosed herein include ready-to-drink liquid nutritional products (beverages). Also, Patel teaches (Paragraph 0042) in certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein are heat sterilized, wherein typical sterilization techniques used with the shelf-stable, clear liquid nutritional compositions disclosed herein involve some manner of heat treatment to eliminate the microorganisms capable of growth in the hermetically sealed, packaged final product. In addition, Patel teaches (Paragraph 0006) the composition comprises water; at least one source of EGCg in an amount sufficient to provide 200-1700 mg/L of EGCg (in the sterilized, clear liquid nutritional composition); and at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (in the sterilized, clear liquid nutritional composition). Assuming a basis of, for example, 1 Liter (where 1 L of water has a mass of approximately 1000 grams), the weight fraction of protein would range from 25 g / (25 g + 1.7 g + 1000 g) or 2.4% w/w to 45 g / (45 g + 0.2 g + 1000 g) or 4.3% w/w, which falls within the claimed range of 2 to 45% w/w. Furthermore, Patel teaches (Paragraph 0021, 0023) the shelf-stable, clear liquid nutritional compositions disclosed herein includes at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (which includes embodiments containing only one source of protein), wherein, in accordance with certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein contain at least one source of protein comprising β-lactoglobulin, wherein, in certain embodiments, suitable whey-based proteins that provide β-lactoglobulin comprise 20-95% of β-lactoglobulin by weight of the solids of the whey-based protein (which overlaps with the claimed range of at least 85% w/w). Additionally, Patel teaches (Paragraph 0034) in certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein may include at least one high intensity sweetener. Also, Patel teaches (Paragraph 0007) in an embodiment, heating an unsterilized liquid nutritional composition having a pH ranging from 2.5 to 4.6 to a temperature ranging from 85°C (185° F) to 152°C (306°F) for a period of time sufficient to produce a sterilized liquid nutritional composition (at least pasteurized).Patel further teaches (Paragraph 0027) at least one source of protein comprising β-lactoglobulin used in accordance with certain embodiments of the liquid nutritional compositions disclosed herein contains native (undenatured) β-lactoglobulin, denatured β-lactoglobulin such as heat denatured β-lactoglobulin, and combinations thereof.
Patel does not explicitly state that the beverage preparation has a turbidity of at most 200 NTU and a viscosity of at most 200 cP (centipoise), measured at 22 degrees Celsius at a shear rate of 100/s. However, one of ordinary skill in the art would recognize that, since the prior art discloses a beverage with the same composition and treated in the same manner as the claimed invention, the beverage of the prior art would be expected to possess the same properties, including turbidity and viscosity, as the claimed invention.
Furthermore, the claimed turbidity is known in the prior art.
Etzel teaches (Paragraph 0003, 0042) methods and compositions involving a whey protein isolate that has low turbidity across a wide range of pH values, wherein, in some embodiments, there is a high protein clear beverage comprising substantially purified whey protein with a protein concentration of at least about 25 g/L and a turbidity of about or less than about 100 NTU. Also, Etzel teaches (Paragraph 0015) in many embodiments, the isolate contains beta-lactoglobulin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel, as modified above, to provide a beverage with a turbidity of at most 200 NTU as taught by Etzel since both are directed to beverage products containing beta-lactoglobulin, since a beverage product containing beta-lactoglobulin with a turbidity of at most 200 NTU is known in the art as shown by Etzel, since a cloudy (high turbidity) beverage is unappetizing to the average consumer (Etzel, Paragraph 0013), and since the characteristic of the whey protein product of the invention to form clear solutions is of considerable importance for use in food products such as in edible foodstuffs including drinks, gels, and health products requiring bio-active, nondenatured whey protein (Etzel, Paragraph 0131).
Also, the claimed viscosity is known in the prior art.
Minor teaches (Paragraph 0020, 0032, 0033) a shelf-stable liquid enteral composition for providing nutrition with a high protein content of whey protein, wherein the whey protein source is a WPC or WPI and the whey protein isolate consists mainly of a mixture of beta-lactoglobulin. Minor further teaches (Paragraph 0100) the viscosity of the liquid enteral nutritional composition is lower than 500 mPas, measured at 20°C (i.e., room temperature) at a shear rate of 100 s-1, preferably between 10 and 200 mPas, more preferably between 10 and 100 mPas, most preferably below 50 mPas (50 cP).
It is noted that the measuring temperature is slightly different from the claimed measuring temperature. However, one of ordinary skill in the art could easily account for minor temperature differences, and a temperature difference of 2 degrees is unlikely to significantly change the measured viscosity.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel, as modified above, to adjust the viscosity below 50 mPas (50 cP) as taught by Minor since both are directed to liquid, consumable products including beta-lactoglobulin, since providing a liquid, consumable product including beta-lactoglobulin with a viscosity below 200 cP is known in the art as shown by Minor, since this viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity (Minor, Paragraph 0100), and since this viscosity is also ideal for unit dosages that are tube fed (Minor, Paragraph 0100), which would be of benefit to consumers dependent on tube feeding due to illness or injury.
Regarding claim 46, Patel teaches (Paragraph 0021, 0023) the shelf-stable, clear liquid nutritional compositions disclosed herein includes at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (which includes embodiments containing only one source of protein), wherein, in accordance with certain embodiments, the shelf-stable, clear liquid nutritional compositions disclosed herein contain at least one source of protein comprising β-lactoglobulin, wherein, in certain embodiments, suitable whey-based proteins that provide β-lactoglobulin comprise 20-95% of β-lactoglobulin by weight of the solids of the whey-based protein (which overlaps with the claimed ranges of at least 90% w/w, at least 92% w/w, and at least 94% w/w).
Regarding claim 47, Patel teaches (Paragraph 0006) the composition comprises water; at least one source of EGCg in an amount sufficient to provide 200-1700 mg/L of EGCg (in the sterilized, clear liquid nutritional composition); and at least one source of protein in an amount sufficient to provide 25-45 g/L of total protein (in the sterilized, clear liquid nutritional composition). Assuming a basis of, for example, 1 Liter (where 1 L of water has a mass of approximately 1000 grams), the weight fraction of protein would range from 25 g / (25 g + 1.7 g + 1000 g) or 2.4% w/w to 45 g / (45 g + 0.2 g + 1000 g) or 4.3% w/w, which falls within the claimed range of 2.0 to 10 %w/w.
Claim(s) 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Siemensma (US 20140170266 A1) and Tai et al. (β-Lactoglobulin Influences Human Immunity and Promotes Cell Proliferation).
Regarding claim 30, as noted in the Applicant’s Specification (Page 17, lines 32-34) the intrinsic tryptophan fluorescence emission ratio R=l330/1350 is a measure of protein nativity, and when R is at least 1.11 the native conformation is predominant, while when R is less than 1.11 an at least partial unfolding and aggregation is predominant.
Patel teaches (Paragraph 0027) at least one source of protein comprising β-lactoglobulin used in accordance with certain embodiments of the liquid nutritional compositions disclosed herein contains native (undenatured) β-lactoglobulin, denatured β-lactoglobulin such as heat denatured β-lactoglobulin, and combinations thereof. Also, Patel teaches (Paragraph 0024, 0027) the β-lactoglobulin-EGCg complex helps prevent degradation of the EGCg in the liquid nutritional compositions during processing, e.g., sterilization, and storage by shielding the EGCg from oxidation, which in turn, helps maintain the clarity of the liquid nutritional composition, and EGCg has a greater affinity and, thus, binds more readily to the more open structure of denatured β-lactoglobulin.
Patel, as modified above, is silent on the protein fraction of the beverage preparation having an intrinsic tryptophan fluorescence emission ratio (I330nm/I350nm) of at least 1.11.
Siemensma teaches (Paragraph 0009, 0101) a dairy based composition wherein the proteins are denatured to a minimal level, wherein, in a most preferred embodiment, less than 5% of the total amount of alpha-Lactalbumin, β-lactoglobulin and bovine serum albumin is denatured. Siemensma also teaches (Paragraph 0002) pasteurization or sterilization provides safe products in microbial terms, however the heat treatment denatures proteins, such as antibodies and other bioactive proteins that would have been beneficial in native state.
Tai et al. teaches (Section 5, Conclusions) β-lactoglobulin promotes cell proliferation which can enhance immune responses, but β-lactoglobulin does not stimulate cell proliferation when thermally or chemically denatured.
Thus, Patel discloses that the beverage may comprise both denatured and undenatured protein, where the tryptophan fluorescence emission ratio is dependent upon the relative amounts of denatured and undenatured protein, and Patel, Siemensma, and Tai et al. disclose the effects of denatured and undenatured protein in products comprising β-lactoglobulin.
In consideration of the prior art, the claimed tryptophan fluorescence emission ratio (I330nm/I350nm) of at least 1.11 would have been used during the course of normal experimentation and optimization procedures in the method of producing the product of Patel, as modified above, based upon factors such as the time and temperature of sterilization (where less protein/β-lactoglobulin would be denatured at lower temperatures and shorter times), the intended nutritional or health benefits of the beverage (where β-lactoglobulin does not stimulate cell proliferation when thermally or chemically denatured (Tai et al., Section 5, Conclusions)), the preferred extent of sterilization (where pasteurization or sterilization provides safe products in microbial terms, however the heat treatment denatures proteins, such as antibodies and other bioactive proteins that would have been beneficial in native state (Siemensma, Paragraph 0002)), the intended clarity of the beverage (where a β-lactoglobulin-EGCg complex can help prevent degradation of the EGCg in the liquid nutritional compositions during processing, e.g., sterilization, and storage by shielding the EGCg from oxidation, which in turn, helps maintain the clarity of the liquid nutritional composition, and EGCg has a greater affinity and, thus, binds more readily to the more open structure of denatured β-lactoglobulin (Patel, Paragraph 0024, 0027)), etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed tryptophan fluorescence emission ratio (I330nm/I350nm) of at least 1.11 that would render it non-obvious.
Regarding claim 31, as noted in the Applicant’s Specification (Page 17, lines 32-34) the intrinsic tryptophan fluorescence emission ratio R=l330/1350 is a measure of protein nativity, and when R is at least 1.11 the native conformation is predominant, while when R is less than 1.11 an at least partial unfolding and aggregation is predominant.
Patel teaches (Paragraph 0027) at least one source of protein comprising β-lactoglobulin used in accordance with certain embodiments of the liquid nutritional compositions disclosed herein contains native (undenatured) β-lactoglobulin, denatured β-lactoglobulin such as heat denatured β-lactoglobulin, and combinations thereof. Also, Patel teaches (Paragraph 0024, 0027) the β-lactoglobulin-EGCg complex helps prevent degradation of the EGCg in the liquid nutritional compositions during processing, e.g., sterilization, and storage by shielding the EGCg from oxidation, which in turn, helps maintain the clarity of the liquid nutritional composition, and EGCg has a greater affinity and, thus, binds more readily to the more open structure of denatured β-lactoglobulin.
Patel, as modified above, is silent on the protein fraction of the beverage preparation having an intrinsic tryptophan fluorescence emission ratio (I330nm/I350nm) of less than 1.11.
Siemensma teaches (Paragraph 0009, 0101) a dairy based composition wherein the proteins are denatured to a minimal level, wherein, in a most preferred embodiment, less than 5% of the total amount of alpha-Lactalbumin, β-lactoglobulin and bovine serum albumin is denatured. Siemensma also teaches (Paragraph 0002) pasteurization or sterilization provides safe products in microbial terms, however the heat treatment denatures proteins, such as antibodies and other bioactive proteins that would have been beneficial in native state.
Tai et al. teaches (Section 5, Conclusions) β-lactoglobulin promotes cell proliferation which can enhance immune responses, but β-lactoglobulin does not stimulate cell proliferation when thermally or chemically denatured.
Thus, Patel discloses that the beverage may comprise both denatured and undenatured protein, where the tryptophan fluorescence emission ratio is dependent upon the relative amounts of denatured and undenatured protein, and Patel, Siemensma, and Tai et al. disclose the effects of denatured and undenatured protein in products comprising β-lactoglobulin.
In consideration of the prior art, the claimed tryptophan fluorescence emission ratio (I330nm/I350nm) of less than 1.11 would have been used during the course of normal experimentation and optimization procedures in the method of producing the product of Patel, as modified above, based upon factors such as the time and temperature of sterilization (where more protein/β-lactoglobulin would be denatured at higher temperatures and longer times), the intended nutritional or health benefits of the beverage (where β-lactoglobulin does not stimulate cell proliferation when thermally or chemically denatured (Tai et al., Section 5, Conclusions)), the preferred extent of sterilization (where pasteurization or sterilization provides safe products in microbial terms, however the heat treatment denatures proteins, such as antibodies and other bioactive proteins that would have been beneficial in native state (Siemensma, Paragraph 0002)), the intended clarity of the beverage (where a β-lactoglobulin-EGCg complex can help prevent degradation of the EGCg in the liquid nutritional compositions during processing, e.g., sterilization, and storage by shielding the EGCg from oxidation, which in turn, helps maintain the clarity of the liquid nutritional composition, and EGCg has a greater affinity and, thus, binds more readily to the more open structure of denatured β-lactoglobulin (Patel, Paragraph 0024, 0027)), etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed tryptophan fluorescence emission ratio (I330nm/I350nm) of less than 1.11 that would render it non-obvious.
Regarding claim 32, Patel teaches (Paragraph 0027) at least one source of protein comprising β-lactoglobulin used in accordance with certain embodiments of the liquid nutritional compositions disclosed herein contains native (undenatured) β-lactoglobulin, denatured β-lactoglobulin such as heat denatured β-lactoglobulin, and combinations thereof.
Patel is silent on the protein fraction having a degree of protein denaturation of at most 10%.
Siemensma teaches (Paragraph 0009, 0101) a dairy based composition wherein the proteins are denatured to a minimal level, wherein, in a most preferred embodiment, less than 5% of the total amount of alpha-Lactalbumin, β-lactoglobulin and bovine serum albumin is denatured (which falls within the claimed range of at most 10%). Siemensma further teaches (Paragraph 0022) during the production of the food composition heat treatment is performed. Also, Siemensma teaches (Paragraph 0069) in one embodiment, the composition may be provided in liquid form (beverage).
Tai et al. teaches (Section 5, Conclusions) β-lactoglobulin promotes cell proliferation which can enhance immune responses, but β-lactoglobulin does not stimulate cell proliferation when thermally or chemically denatured.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel to provide a composition with a degree of protein denaturation of at most 10% (such as by modifying the heat-treatment) in view of Siemensma and Tai et al. since both Patel and Siemensma are directed to heat-treated, consumable liquids containing dairy-derived proteins, since Patel teaches providing a composition that, in embodiments comprises a combination of denatured and undenatured proteins and in embodiments comprises a protein fraction of up to 95% β-lactoglobulin, since a food composition comprising a mixture of proteins including β-lactoglobulin with less than 10% denaturation is known in the art as shown by Siemensma, since heat treatment denatures proteins, such as antibodies and other bioactive proteins that would have been beneficial in native state (Siemensma, Paragraph 0002) so minimizing denaturation would prevent the loss of the beneficial functions of denatured proteins, since heat treatment kills pathogens that would otherwise harm consumers, so some amount of heat treatment is still beneficial, since there are opposite requirements for microbial safe food products and low-allergenic food products (Siemensma, Paragraph 0002) so using the minimal heating to remove dangerous microbes would prevent the proteins from being denatured extensively while preserving consumer health, and since β-lactoglobulin promotes cell proliferation which can enhance immune responses, but β-lactoglobulin does not stimulate cell proliferation when thermally or chemically denatured (Tai et al., Section 5, Conclusions).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Taniguchi (JP H09238614 A).
Regarding claim 34, Patel, as modified above, is silent on the protein fraction of the beverage preparation having a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature.
Taniguchi teaches (Paragraph 0001, 0018, 0020) white whey, its powder, and a method for producing milk powder using the same, wherein whitened whey is prepared by generation of whey protein micelles (WPM), and in an exemplary embodiment, a sample of the whey protein micelles had a b value of 0.50. Also, Taniguchi teaches (Paragraph 0010) the micelle state refers to a state in which the main component is β-lactoglobulin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel to adjust the color of the protein fraction to a b value of 0.50 as taught by Taniguchi, since both are directed to protein products containing beta-lactoglobulin, since preparing a protein fraction with a color value delta b* in the range of -0.10 to +0.51 is known in the art as shown by Taniguchi, since the whey solution has a white, milk-like state (Taniguchi, Paragraph 0006), thus appealing to consumers by resembling a product consumers are already familiar with, since the milk protein micelle solution, which is made by associating this micellar whey protein with a specific amount of casein, exhibits a milk-like whiteness similar to the whey solution containing micellar whey protein, and has excellent thermal stability and gels when heated (Taniguchi, Paragraph 0011), and since a white color is neutral and thus easier to incorporate into food preparations that are desired to be a specific color compared to the yellow untreated whey.
It is noted that Taniguchi does not explicitly state the conditions for measuring the color. However, adjusting and measuring the color of a food item are well known in the art, and the claimed protein fraction of the beverage preparation has a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature would have been used during the course of normal experimentation and optimization procedures in the method of producing the product of Patel, as modified above, based upon factors such as the desired color of the beverage containing the protein fraction (where a white, milk-like color would appeal to consumers by resembling a product consumers are already familiar with), the intended composition of the protein fraction (where different types of proteins will have varying effects of the coloration of the protein fraction), the type and amount of sweetener (where certain sweeteners, such as certain sugars have a pure white color), consumer preferences in coloration, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed protein fraction of the beverage preparation has a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature that would render it non-obvious.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Taniguchi (JP H09238614 A) and Navarro (WO 2008136671 A1).
Regarding claim 35, Patel, as modified above, is silent on the beverage preparation having a color value delta b* in the range of -0.10 to +0.51 at the CIELAB color scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature.
As shown above with regard to claim 34, Taniguchi teaches a protein fraction with a color value delta b* in the range of -0.10 to +0.51, and use of such a color value would be obvious to one of ordinary skill in the art for the reasons stated above with regard to claim 34.
It is noted that Taniguchi is directed to a protein product rather than a beverage containing the protein. However, prior art such as Navarro teaches (Page 7, lines 9-14) a low-calorie milk product with a b*-value with the range of 0 ± 9.0, which encompasses the claimed range. Thus, beverages that include the clamed range of b* values are known in the art.
Furthermore, the claimed beverage preparation having a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature, would have been used during the course of normal experimentation and optimization procedures in the method of producing the product of Patel, as modified above, based upon factors such as the desired color of the beverage containing the protein fraction (where a white, milk-like color would appeal to consumers by resembling a product consumers are already familiar with), the intended composition of the protein fraction (where different types of proteins will have varying effects of the coloration of the protein fraction), the type and amount of sweetener (where certain sweeteners, such as certain sugars have a pure white color), consumer preferences in coloration, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed beverage preparation having a colour value delta b* in the range of -0.10 to +0.51 at the CIELAB colour scale, wherein delta b* = bsample standardized to 6.0 w/w% protein* - bdemin. water*, measured at room temperature that would render it non-obvious.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Stack (US 5747647 A) and Liu (CN 107048137 A).
Regarding claim 36, Patel, as modified above, is silent on the sum of the amounts of Na, K, Mg and Ca is at most 750 mM.
Stack teaches (Col. 1, lines 4-6; Col. 3, lines 14-15, 22-24) recovery of protein and other products from whey and in particular to the fractionation of alpha-lactalbumin and beta-lactoglobulin from whey, wherein raw whey is treated to reduce its mineral content, and a cation exchanger is used to remove sodium, potassium, magnesium and particularly calcium.
Liu teaches (Paragraph 0062) a whey protein powder low in potassium, which has certain benefits in improving the imbalance of the above elements in the serum of patients with chronic renal failure and renal dialysis, thereby reducing the risk of hyperphosphatemia.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel to reduce the concentration of sodium, potassium, magnesium and calcium as taught by Stack and Liu since both Patel and Stack are directed to protein products derived from whey, since reducing the concentration of sodium, potassium, magnesium and calcium in a protein product is known in the art as shown by Stack, since very low calcium ion concentration combined with the heat treatment has the effect of inducing change in the alpha-lactalbumin fraction without promoting the aggregation of protein, and thus, after the heat treatment step, the whey proteins exist as substantially soluble protein (Stack, Col. 3, lines 29-33), since reducing the concentration of sodium, potassium, magnesium and calcium will alter the taste and nutritional profile of the beverage, which will better suit the needs of consumers who do not need excess amounts of sodium, potassium, magnesium and calcium in their diet, and since some components, like potassium, can cause potential issues like hyperphosphatemia in consumers with conditions like with chronic renal failure (Liu, Paragraph 0062).
Furthermore, while Patel, as modified above, does not explicitly teach a concentration of 750 mM, the claimed value would have been used during the course of normal experimentation and optimization procedures in the method of producing the product of Patel, as modified above, based upon factors such as the desired solubility of the protein product, the desired taste profile (where components such as sodium will alter the taste of the beverage), the desired nutritional value (where some consumers do not need excess amounts of sodium, potassium, magnesium and calcium), potential health risks (since some components, like potassium, can cause potential issues like hyperphosphatemia in consumers with conditions like with chronic renal failure as taught by Liu (Paragraph 0062)), etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the concentration of Na, K, Mg and Ca being at most 750 mM that would render it non-obvious.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Sherwood (US 20150064317 A1).
Regarding claim 37, Patel, as modified above, is silent on the beverage preparation having a turbidity of at most 40 NTU.
However, the claimed turbidity of at most 40 NTU would have been used during the course of normal experimentation and optimization procedures in the method of producing the product of Patel, as modified above, based upon factors such as the beverage composition (where the turbidity is affected by the presence of artificial or natural flavors, colorants, and sweeteners (Sherwood, Paragraph 0105)), the amount of denatured and undenatured protein (where a β-lactoglobulin-EGCg complex can help prevent degradation of the EGCg in the liquid nutritional compositions during processing, e.g., sterilization, and storage by shielding the EGCg from oxidation, which in turn, helps maintain the clarity of the liquid nutritional composition, and EGCg has a greater affinity and, thus, binds more readily to the more open structure of denatured β-lactoglobulin (Patel, Paragraph 0024, 0027)), the heating time and temperature for at least pasteurizing the beverage (where heating can cause changes in composition that affect the clarity or turbidity of the beverage), consumer preferences in appearance and texture, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed turbidity of at most 40 NTU that would render it non-obvious.
Furthermore, since Patel is silent with regards to a turbidity of at most 40 NTU one of ordinary skill in the art would have been motivated to look to the art for suitable turbidity values.
Sherwood teaches (Paragraph 0007, 0041, 0042) a carbonated protein beverage/drink which can include whey protein isolate, wherein whey protein may include several protein fractions, including, for example, beta-lactoglobulin, and wherein the pH value of the carbonated protein beverage/drink ranges from about 2.0 to about 4.6. Sherwood further teaches (Paragraph 0046) the turbidity of the carbonated protein beverage composition is less than 30 NTU (which falls within the claimed range of at most 40 NTU).
Selection of a known composition parameter (turbidity) based on its suitability for its intended use (acidic beverage comprising beta-lactoglobulin) supports a prima facie obviousness determination (See MPEP 2144.07).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Liebrecht (US 5641531 A).
Regarding claim 43, as shown above, the packaged, heat-treated beverage preparation of claim 28 would be obvious to one of ordinary skill in the art in view of Patel (US 20150250221 A1), Etzel (US 20060003073 A1), and Minor (US 20110046048 A1).
Patel, as modified above, is silent on providing the packaged, heat-treated beverage preparation of claim 28 to a subject who suffers from diseases associated with protein malabsorption.
Liebrecht teaches (Col. 2, lines 44-47; Col. 8, lines 45-51) a nutritional supplement beverage comprising (1) water; (2) from about 1% to about 10% by weight whey protein isolate; and (3) at least one source of carbohydrate, wherein the product is intended to be used as a necessary nutritional supplement for patients with conditions including disease related malnutrition and intractable malabsorption.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel, as modified above, to provide the beverage preparation to a subject who suffers from diseases associated with protein malabsorption in view of Liebrecht, since both Patel and Liebrecht teach beverage preparations comprising whey based proteins, since providing a whey based protein beverage to a patient with malabsorption is known in the art as shown by Liebrecht, since liquids can be digested faster than solid foods, and since ensuring that consumers suffering for malabsorption receive an adequate amount of protein will lead to better health outcomes, since protein is essential for human health.
Claim(s) 44 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20150250221 A1) in view of Etzel (US 20060003073 A1) and Minor (US 20110046048 A1), and further in view of Cavallo (US 20120064058 A1).
Regarding claim 44, as shown above, the packaged, heat-treated beverage preparation of claim 28 would be obvious to one of ordinary skill in the art in view of Patel (US 20150250221 A1), Etzel (US 20060003073 A1) and Minor (US 20110046048 A1).
Patel, as modified above, is silent on providing the packaged, heat-treated beverage preparation of claim 28 to a subject who is in need of a dietary supplement.
Cavallo teaches (Paragraph 0014, 0036-0037, 0042) a human use protein-based dietary composition, wherein the composition can be either in powder form or in beverage form, and the protein component can be a milk protein, in particular a milk protein selected from a group that includes beta-lactoglobulin. Also, Cavallo teaches (Paragraph 0002, 0021) the present invention relates also to human use supplement compositions for such protein-based diets, said supplements being able to compensate for typical drawbacks of said diets, wherein it is a feature of the invention to provide such a human use supplement composition which is helpful to prevent and cure diabetic complications.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Patel, as modified above, to provide the beverage preparation as a dietary supplement as taught by Cavallo, since both are directed to methods of providing beverage preparations comprising beta-lactoglobulin, since using a beverage preparation including beta-lactoglobulin as a dietary supplement is known in the art as shown by Cavallo, since the supplement is able to compensate for typical drawbacks of protein-based diets (Cavallo, Paragraph 0002), since the dietary composition is suitable for reducing body fat mass, and to prevent body lean mass reduction (Cavallo, Paragraph 0014), since the supplement can prevent constipation, which is a typical drawback of protein-based diets (Cavallo, Paragraph 0016).
Regarding claim 45, while not explicitly stated, the beverage preparation of Patel would obviously be ingested before, during or after exercise, since ingesting the beverage preparation at any time would constitute ingesting it before, during, or after exercise, since no limits are placed on how soon before or how far after exercise, and since exercise may be broadly interpreted to include any sustained physical activity, including walking, stretching, etc. that is done by almost all consumers at some point.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wiles (US 8192780 B2) teaches a dairy product and process where the ingredients include at least 0.5% non-denatured whey protein concentrate and at least 0.5% denatured whey protein concentrate.
Tsuchita (US 20060127492 A1) teaches a novel food or drink, and pharmaceuticals which exhibit sustained recovery effects on muscular fatigue comprising beta-lactoglobulin.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUSTIN P TAYLOR whose telephone number is (571)272-2652. The examiner can normally be reached M-F 8:30am-5pm.
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/AUSTIN PARKER TAYLOR/Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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