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 .
Status of Application
Claims 28-38 and 42-43, 49, 51-53, 56 are pending and are under consideration.
Claims 45-48 are withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 28-29, 31-38, 42-43, 49, 51-53, 56 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication No. 2007/0148305 (SHERWOOD).
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SHERWOOD teaches a protein/beverage drink [0039]. The drink can be packaged in cans [0096]. The total amount of protein ranges from 0.01 to 15% [0039]. This overlaps that claimed.
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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Moreover, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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 percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
The protein is a caseinate free protein based on whey type proteins [0040].
The whey type protein may include several protein fractions, including, for example, β-lactoglobulin [0007]. It would have been obvious to one skilled in the art to use β-lactoglobulin as the protein.
The pH is 2 to 5.5 [0065].
As to the viscosity, it is taught that thickening of the beverage is undesirable [0055]. Thus, viscosity is taught as a result effective variable.
It would have been obvious to limit the viscosity as a thick drink is discouraged. Moreover, applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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). "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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
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The beverage can be pasteurized [0095].
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As to claim 30, it is taught that the beverage itself can be pasteurized [0095] and can be placed in sterile cans [0027] with sterile ingredients [0065]. It would have been obvious to one skilled in the art to provide a sterile preparation.
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As to claims 31-32, the intrinsic tryptophan is defined as measuring protein nativity (see [0170] - [0171] in the published version of this specification). In particular, the degree of protein nativeness depends on a number of factors including protein concentration, pH, temperature and time of heat treatment. As to the protein fraction and beverage of the present invention, applicant heats the BLG protein at a temperature of 70-82°C (see [0354] published version of this specification). The pH ranges from 3.0 to 4.7 (see [0190] to [0194] of the published version of this specification).
As SHERWOOD teaches the same protein concentration (0.01 to 15% [0039]), pH (i.e., 2 to 5.5 [0065]) and temperature (i.e., 140o – 188oF at [0065], it considered that the beverage would have the same intrinsic tryptophan fluorescence emission ratio.
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As to claims 33-34, SHERWOOD does not teach denaturing the protein. The term “at most” includes none.
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The pH is 2 to 5.5 [0065]. This encompasses the claimed range.
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As to claims 36-37, coloring agents can be added [0061]. It would have been obvious to vary the color based on the desired appearance of the beverage.
It is noted that the Patent Office does not have the facilities for determining the CIELAB color scale . In this regard, applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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). "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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
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Magnesium can be added [0114]. In claim 27 of SHERWOOD, a magnesium-containing compounds be present in an amounts of 0.1 to 2.0%. However, SHERWOOD also teaches that the magnesium can be added to form specialized products [0114]. It would have been one skilled in the art to vary the amount of magnesium based on the type of specialized product produced.
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As to claims 42-43, 49, 51-52, SHERWOOD teaches a protein/beverage drink [0039]. Sherwood teaches a protein/beverage drink with additional proteins such as [0039], [0041]. It would have been obvious to one skilled in the art to use proteins other than β-lactoglobulin. The drink can be packaged in cans [0096]. The total amount of protein ranges from 0.01 to 15% [0039].
SHERWOOD does not require specific amounts of other of types of proteins. However, it would have been obvious to vary the overall amount of other proteins based on the overall amount of protein desired.
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As to claim 53, SHERWOOD lowering the pH of the aqueous whey protein prior to addition to the beverage composition results in a carbonated protein beverage with superior organoleptic properties, by preventing or at least greatly reducing precipitation and gelling of the protein as it passes through the zone of isoelectric points [0045]. In this regard, it would have been obvious to limit the amount of insoluble material (i.e., keep it at most 15% insoluble matter).
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As to the turbidity, the turbidity can range from clear [0055] to turbid formulations [0091]. In [0091], it is also taught that the turbidity can be varied during processing. Thus, it would have been obvious to one skilled in the art to vary the turbidity of the drink based on the desired appearance of the drink.
Response to Arguments
Applicant's arguments filed 5/20/2026 have been fully considered but they are not persuasive.
The applicant argues that Sherwood does not teach a beverage in which at least 92% w/w of the protein is beta- lactoglobulin; Sherwood's exemplified protein source is whey protein isolate or whey protein concentrate (approximately 50-60% beta-lactoglobulin on total protein), and even more highly enriched SPI as described in the present specification reaches only about 80% beta-lactoglobulin on total protein.
However, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). (see MPEP 2123). The fact remains that Sherwood does teach β-lactoglobulin [0007]. It would have been obvious to one skilled in the art to use β-lactoglobulin as the protein.
The applicant argues that Sherwood does not teach the claimed protein concentration of 6.0 to 45 % w/w; Sherwood's "most typical" protein concentration is 3-5 % w/w, and Sherwood's working examples top out at approximately 7% w/w.
However, as noted above, this does not reflect the overall teachings of Sherwood. SHERWOOD teaches the total amount of protein ranges from 0.01 to 15% [0039]. This still overlaps that claimed. 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Moreover, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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 percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
The applicant argues that Sherwood does not disclose any quantitative viscosity value, much less the claimed viscosity of at most 100 centipoise measured at 22°C at a shear rate of 100/s.
However, it is taught that thickening of the beverage is undesirable [0055]. Thus, Sherwood teaches that it would have been obvious to limit the viscosity as a thick drink is discouraged. The Patent Office does not have the facilities to test the viscosity of prior art products. Applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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). "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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
The applicant argues that the Examiner has expressly conceded that Sherwood does not teach the denaturation limitation of dependent claims 33 and 34.
However, while the Examiner acknowledges that Sherwood does not anticipate claims 33 and 34, SHERWOOD does not teach denaturing the protein but the term “at most” includes none.
The applicant argues that Sherwood does not teach the specific non-BLG whey protein fraction levels recited in dependent claims 43, 51-52, the CIELAB delta b* color value recited in dependent claims 36 and 37, the combined cation content recited in dependent claim 38, or the insoluble matter level recited in dependent claim 53.
However, these are all parameters taught by SHERWOOD that can be optimized.
Sherwood teaches a protein/beverage drink with additional proteins [0039], [0041]. It would have been obvious to one skilled in the art to use additional proteins other than β-lactoglobulin. It would have been obvious to vary the overall amount of other proteins based on the overall amount of protein desired.
As to claims 36-37, coloring agents can be added [0061]. It would have been obvious to vary the color based on the desired appearance of the beverage. It would have been obvious to vary the color based on the desired product, which would directly affect the CIELAB delta b* color value.
Magnesium can be added [0114] to increase energy levels. In claim 27 of SHERWOOD, a magnesium-containing compounds be present in an amounts of 0.1 to 2.0%.
SHERWOOD teaches that one skilled in the art that one wants to reduce precipitation and gelling of the protein as it passes through the zone of isoelectric points [0045]. In this regard, it would have been obvious to limit the amount of insoluble material (i.e., keep it at most 15% insoluble matter).
The applicant argues that the unexpected results documented in the specification, in particular, the maintenance of low viscosity (below 100 cP) in beverages containing at least 92% w/w beta-lactoglobulin at protein concentrations within the claimed range of 6.0 to 45 w/w%, further support the nonobviousness of the claimed invention.
However, it is not clear what is unexpected given Sherwood teaches that it was known to provide a beverage with β-lactoglobulin [0007]. Moreover, it was known that thickening of the beverage is undesirable [0055]. Thus, the viscosity is only a result-effective variable. It would have been obvious to limit the viscosity as a thick drink is discouraged. Moreover, applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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). "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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached on 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP A DUBOIS/Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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