DETAILED ACTION
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 07/23/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: the objection to claim 1 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-3 and 6-20
Withdrawn claims: None
Previously canceled claims: 4 and 5
Newly canceled claims: None
Amended claims: 1 and 12
New claims: None
Claims currently under consideration: 1-3 and 6-20
Currently rejected claims: 1-3 and 6-20
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 6-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ferruzzi (U.S. 2004/0096547 A1) in view of Nair et al. (U.S. 2007/0254068 A1).
Regarding claim 1, Ferruzzi discloses a method of preparing a shelf-stable ([0072]) composition ([0018], [0021], [0071], [0072]), the method comprising (i) adding a stabilizer to a proteinaceous component ([0029], [0055]), (ii) subsequently adding an edible acid ([0044]-[0045]) and polyphenols including catechin and epicatechin ([0042]) to the stabilizer/protein component to form a mixture ([0072], where adjusting the pH is performed before the addition of pH-sensitive ingredients), and (iii) subjecting the mixture to aseptic thermal processing ([0072]). Ferruzzi discloses the polyphenols include catechin and epicatechin ([0042]), which renders obvious (-)-epicatechin and (-)-catechin in particular. Ferruzzi also discloses that they may be used together ([0041]). As such, any relative concentration of the two components is considered obvious, including the claimed range of ratios of (-)-epicatechin to (-)-catechin of 8:11 to 11:1 before the thermal processing step. Ferruzzi further discloses the edible composition comprises about 0.05-0.45 mg/g of epicatechin (specifically, from about 0.001-5%, or 0.01-50 mg/g) ([0043]).
Ferruzzi does not explicitly disclose a cocoa extract that constitutes the flavanol components, the specific sterilization protocol, the ratio between (-)-epicatechin and (-)-catechin after thermal processing, or the claimed limit on (-)-catechin increase of less than 15% after thermal processing.
However, Nair et al. discloses a cocoa extract comprising cocoa polyphenols ([0012]) that is useful for producing a beverage ([0013]).
It would have been obvious to one having ordinary skill in the art to incorporate cocoa extract comprising cocoa polyphenols according to Nair et al. into the beverage of Ferruzzi. Nair et al. discloses catechin and epicatechin are among the most abundant flavonoids in cocoa and are useful for addition to a beverage intended to counteract heart disease ([0013], [0009]). Ferruzzi indicates the addition of flavanols to a beverage is particularly preferred for the health benefits of the flavanol ([0041]). Such flavanols include catechin and epicatechin, which may be extracted from vegetables ([0042]). Ferruzzi further discloses the extraction of caffeine from cocoa ([0033]). Since Ferruzzi does not explicitly disclose natural vegetable sources from which flavanols may be extracted, a skilled practitioner would consult Nair et al. to determine an appropriate source. Since cocoa is used in Ferruzzi to extract caffeine, the additional extraction of polyphenols from cocoa would be a desirable source material, as suggested by Nair et al. The use of polyphenols extracted from cocoa that include flavanols is thus considered obvious to a skilled practitioner.
As for the sterilization protocol, Ferruzzi discloses the pH is limited to the maximum acidity for microbial inhibition ([0044]) and indicates that the beverage may be sterilized, pasteurized, or ultrapasteurized “at appropriate process conditions” in order to impart shelf stability ([0072]). Nair et al. discloses that tunnel pasteurization may occur at 175°F (79.4°C) for about 15 minutes and that ultra high temperature sterilization may occur at about 120°C -150°C (248°F -302°F) for “one second to several tens of seconds” ([0024]). Since Ferruzzi indicates a preference for sterilization at appropriate process conditions, a skilled practitioner would be motivated to consult and incorporate sterilization temperatures as taught in Nair et al. Since Nair et al. disclose various sterilization protocols that may be performed for as short as 3 seconds and as long as 15 minutes and at temperatures ranging from 175°F-302°F, any sterilization protocol that fell within those ranges would be obvious to a skilled practitioner, who would readily recognize that specific temperatures/treatment times may be adjusted as necessary to adequately sterilize the product. MPEP 2144.05 II. As such, heat treatment at a temperature of from 195°F-225°F for about 3 seconds to about 10 seconds would be obvious to a skilled practitioner.
As for the stability, Ferruzzi discloses that sterilization results in a shelf stable composition ([0072]), which suggests that the compositional material does not degrade upon such sterilization. The claimed increase in catechin of less than 15% and maintained ratio between (-)-epicatechin and (-)-catechin that remains in the range of 8:1 to 11:1 upon subjecting the composition to aseptic thermal processing is thus considered obvious to a skilled practitioner.
As for claim 2, Ferruzzi discloses that sterilization results in a shelf stable composition ([0072]), which suggests that the compositional material does not degrade upon such sterilization ([0072]). The claimed retention of at least 80% of the cocoa polyphenols after subjecting the mixture to aseptic thermal processing is thus considered obvious to a skilled practitioner.
As for claim 3, Nair et al. discloses the cocoa polyphenols as being cocoa flavanols ([0013]).
As for claim 6, Ferruzzi discloses adding edible acid in an amount to achieve a pH of 2-8 ([0044]), which is considered to encompass both the isoelectric point of the protein (as detailed in paragraph (0032) of the present specification) and a pH of from 0.2 to 0.4 lower, thus rendering the claimed range obvious.
As for claim 7, Ferruzzi discloses adding edible acid in an amount to achieve a pH of about 3.5-4.0 ([0044]).
As for claim 8, Ferruzzi and Nair et al. render the method of claim 1 obvious.
The cited prior art does not explicitly disclose the beverage as retaining at least 75% of the total post-processing amount of the cocoa polyphenols after nine months of storage at room temperature.
However, the present specification discloses “the low pH increases retention of polyphenols over the shelf life of the composition,” resulting in a beverage having the claimed shelf-life properties ([0036]). Ferruzzi discloses the pH of the beverages may preferably range “from about 2.7 to about 4.2” ([0044]). Nair et al. discloses the beverages containing cocoa-polyphenols as being stable for at least six months at room temperature ([0004], [0010]).
A skilled practitioner would find the production of a beverage having the claimed stability properties to be obvious in light of the teachings of Ferruzzi and Nair et al. Ferruzzi discloses the preferred pH of the beverage ([0044]) is comparable to that indicated by the present specification as providing the necessary shelf life of the product ([0032], [0036]). Nair et al. discloses multiple techniques for increasing the shelf-life of a beverage, including aseptic processing ([0010]), filtering, irradiating and heating ([0004]). Since a beverage having the claimed components is considered obvious and the pH is comparable to that indicated as providing the requisite stability, any resulting stability is considered obvious as well. A skilled practitioner would thus find the claimed stability properties to be obvious.
As for claim 9, Ferruzzi discloses the stabilizer is pectin ([0055]).
As for claim 10, Ferruzzi discloses the edible acid as being citric acid ([0045]).
As for claim 11, Ferruzzi discloses the composition as being a ready-to-drink beverage ([0001]).
Regarding claim 12, Ferruzzi discloses an edible composition ([0018], [0021]) comprising a proteinaceous component ([0029]), a stabilizer ([0055]), and polyphenols including catechin, epicatechin, and their derivatives ([0042]), wherein a pH of the composition is from 2 to 8 ([0044]). Ferruzzi further discloses the edible composition comprises about 0.05-0.45 mg/g of epicatechin (specifically, from about 0.001-5%, or 0.01-50 mg/g) ([0043]).
Ferruzzi does not explicitly disclose a cocoa extract that constitutes the polyphenol components, the components as specifically being (-)-epicatechin and (-)-catechin in a ratio of 8:1 to 11:1 both before and after subjecting to aseptic thermal processing, the presence of one or more cocoa flavanol oligomers (procyanidins) ranging from 2 to 10 monomeric units, the claimed limit on (-)-catechin increase of less than 15% after thermal processing, or the pH as being from 0.2 to 0.4 lower than an isoelectric point of the proteinaceous component.
As for the polyphenol components, Nair et al. discloses a cocoa extract comprising cocoa polyphenols ([0012]) that is useful for producing a beverage ([0013]). Nair et al. also discloses that abundant flavanols include oligomeric forms, or procyanidins ([0013]).
It would have been obvious to one having ordinary skill in the art to incorporate cocoa extract comprising cocoa polyphenols according to Nair et al. into the beverage of Ferruzzi. Nair et al. discloses catechin and epicatechin are among the most abundant flavonoids in cocoa and are useful for addition to a beverage intended to counteract heart disease ([0013], [0009]). Ferruzzi indicates the addition of flavanols to a beverage is particularly preferred for the health benefits of the flavanol ([0041]). Such flavanols include catechin and epicatechin, which may be extracted from vegetables ([0042]). Ferruzzi further discloses the extraction of caffeine from cocoa ([0033]). Since Ferruzzi does not explicitly disclose natural vegetable sources from which flavanols may be extracted, a skilled practitioner would consult Nair et al. to determine an appropriate source. Since cocoa is used in Ferruzzi to extract caffeine, the additional extraction of polyphenols from cocoa would be a desirable source material, as suggested by Nair et al. The use of polyphenols extracted from cocoa that include flavanols, including procyanidins ranging from 2-10 monomeric units, is thus considered obvious to a skilled practitioner.
As for the form and ratio of the flavanols, Ferruzzi discloses that the flavanols include catechin and epicatechin ([0042]), which renders obvious (-)-epicatechin and (-)-catechin in particular. Ferruzzi also discloses that they may be used together ([0041]). As such, any relative concentration of the two components is considered obvious, including the claimed range of ratios of (-)-epicatechin to (-)-catechin of 8:11 to 11:1.
As for the stability, Ferruzzi discloses that sterilization results in a shelf stable composition ([0072]), which suggests that the compositional material does not degrade upon such sterilization. The claimed increase in catechin of less than 15% and maintained ratio between (-)-epicatechin and (-)-catechin that remains in the range of 8:1 to 11:1 upon subjecting the composition to aseptic thermal processing is thus considered obvious to a skilled practitioner, especially since no parameters are required for the thermal processing step.
As for the pH, Ferruzzi discloses adding edible acid in an amount to achieve a pH of 2-8 ([0044]), which is considered to encompass both the isoelectric point of the protein (as detailed in paragraph (0032) of the present specification) and a pH of from 0.2 to 0.4 lower, thus rendering the claimed range obvious.
As for claim 13, Ferruzzi discloses that the flavanol comprises from about 0.001% to about 5% of the beverage ((0043]), which corresponds to a concentration of 0.01-50 mg/ml. The present specification discloses a serving may be between 50 to 250 ml (0039). The claimed limitation of (-)-epicatechin, (-)-catechin, and a procyanidin of at least 100 mg/serving is considered to claim a range of concentrations from 100mg/250m1 to 100mg/50ml, or 0.4-2 mg/ml. The range disclosed in Ferruzzi of 0.01-50 mg/ml therefore renders the claimed range of 0.4-2 mg/ml (i.e., 100 mg/serving) obvious to a skilled practitioner.
As for claim 14, Ferruzzi and Nair et al. render the composition of claim 12 obvious.
The cited prior art does not explicitly disclose the composition as retaining at least 75% of the total post-processing amount of the cocoa polyphenols after nine months of storage at room temperature.
However, the present specification discloses “the low pH increases retention of polyphenols over the shelf life of the composition,” resulting in a beverage having the claimed shelf-life properties ([0036]). Ferruzzi discloses the pH of the beverages may preferably range “from about 2.7 to about 4.2” ([0044]). Nair et al. discloses the beverages containing cocoa-polyphenols as being stable for at least six months at room temperature ([0004], [0010]).
A skilled practitioner would find the production of a beverage having the claimed stability properties to be obvious in light of the teachings of Ferruzzi and Nair et al. Ferruzzi discloses the preferred pH of the beverage ([0044]) is comparable to that indicated by the present specification as providing the necessary shelf life of the product ([0032], [0036]). Nair et al. discloses multiple techniques for increasing the shelf-life of a beverage, including aseptic processing ([0010]), filtering, irradiating and heating ([0004]). Since a beverage having the claimed components is considered obvious and the pH is comparable to that indicated as providing the requisite stability, any resulting stability is considered obvious as well. A skilled practitioner would thus find the claimed stability properties to be obvious.
As for claim 15, Ferruzzi discloses the composition as being a ready-to-drink beverage ([0001]).
As for claim 16, Ferruzzi discloses the ready-to-drink beverage as being a non-chocolate flavored beverage ([0015], where “unflavored milks” indicates the beverage is non-chocolate; [0091], where the inclusion of syrups or chocolate pieces is considered optional).
As for claim 17, Ferruzzi discloses the ready-to-drink beverage as being a dairy-based beverage ([0001], [0015]).
As for claim 18, Ferruzzi discloses the product may be a beverage comprising at least 60% water, a beverage concentrate comprising from 20-60% water, and an essentially dry composition comprising less than about 20% water ([0020]). As such, Ferruzzi effectively discloses a range of water content for the product, which would include a water content at which the product would be considered a gel—i.e., a water content at some point between a product considered essentially dry and the fully diluted beverage.
As for claim 19, Ferruzzi discloses the proteinaceous component as being animal milk ([0029]).
As for claim 20, Ferruzzi discloses the stabilizer is pectin ([0055]).
Response to Arguments
Claim Objections: Applicant has overcome the objection of claim 1 based on amendment to the claim. Accordingly, the claim objection has been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of claims 1-3 and 6-20 over Ferruzzi and Nair et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that because claims 1 and 12 specifically recite that the cocoa polyphenols are from the cocoa extract, then Examiner’s argument noting the synthetic production of flavanols is essentially irrelevant (Applicant’s Remarks, p. 6, ¶4).
However, Examiner did not indicate that the claim rejections relied on incorporating synthetic flavanols into the compositions of Ferruzzi. The argument only relied on the disclosure of using synthetic flavanols as support for the conclusion that relatively pure ingredients in various forms would be readily attainable. Such a determination supports the conclusion that any relative concentrations of (-)-epicatechin and (-)-catechin would be obvious (in contrast to material obtainable only via extraction where a specific form of a compound and only certain relative concentrations may be obtained). Examiner maintains that the noted disclosure of Ferruzzi is properly relied on in supporting the obviousness rejections.
Applicant next argued that claims 1 and 12 require the ratio of cocoa flavanols to be between 8:1 and 11:1 both before and after aseptic thermal processing (Applicant’s Remarks, p. 6, ¶5). Applicant asserted that sterilization at conventional sterilization processes cause epimerization to occur, converting (-)-epicatechin to (-)-catechin, such that a change in ratio would be expected upon thermal treatment (Applicant’s Remarks, p. 7, ¶1).
However, present claim 1 does not preclude a change in ratio between the two components. The ratio may change within the range from 11:1 to 8:1 over the course of thermal processing and still fall within the scope of the present method. Further, Applicant’s asserted example of decreased (-)-epicatechin occurs upon heating at 160°C—far outside the range claimed and even higher than the ultra high temperature sterilization disclosed in Nair et al. of about 120°C -150°C. No time is indicated as to how long the 160°C treatment occurs. (“Exhibit A” is understood to be the attachment labeled as such in the Applicant Remarks filed 01/13/2025, although “Table 1” at pages 4846-4854 does not appear to show any data corresponding to the 160°C treatment noted by Applicant). Applicant’s argument is inadequate to overcome the obviousness determination. Claim 12 does not require any conditions for the thermal processing and is consequently broader in scope than Applicant’s arguments, which are thus unpersuasive.
Applicant then asserted that “the claimed method unexpectedly limits the amount of epimerization that occurs”, noting evidence at Table 5 in the specification purporting to support the assertion (Applicant’s Remarks, p. 7, ¶2 – p. 8, ¶1).
However, the lack of any indication as to the heat treatment performed in “Exhibit A” precludes comparison between such data and that of the specification. Further, Example 4 in the specification indicates the samples were heat treated according to Example 2 (0077), where the treatment conditions were for 10 seconds at 222°F and 10 seconds at 197°F (0062). Such treatments being only at the high end of the claimed range provides no basis for analyzing shorter thermal processing times. Applicant has not provided sufficient evidence to persuasively establish that the asserted result of limited change in the ratio would be unexpected, particularly at times as short as 3 seconds.
Applicant next asserted that shelf-stability should not be considered to correlate with prevention of epimerization (Applicant’s Remarks, p. 8, ¶3).
Paragraph [0072] of Ferruzzi states: “Wherein a shelf stable composition is desired, the final mixture can optionally, but preferably, be either pasteurized, ultra-pasteurized, sterilized or filled aseptically at appropriate process conditions.” Ferruzzi thus characterizes the composition obtained before thermal treatment as being the “final mixture”. Examiner maintains that such instruction forms an adequate basis for reasonably expecting that the compositional material does not degrade upon such thermal treatment. If the thermal treatment did degrade the “final mixture”, the composition would likely not be considered to be essentially the same material compositionally both before and after the thermal treatment. Ferruzzi describes the thermal treatment such that no appreciable degradation would be expected or observed, though, especially given the process may be performed “at appropriate process conditions”. Applicant’s argument is unpersuasive.
Applicant then argued that Ferruzzi and Nair et al. provide no instruction “on optimizing the conditions of the sterilization process to prevent epimerization of the flavanols”, again citing “Exhibit A” as disclosing various heating protocols wherein (-)-epicatechin is reduced during heating (Applicant’s Remarks, p. 9, ¶1).
However, Applicant indicates the heating time in “Exhibit A” is for 30 minutes, which is well beyond the claimed maximum time of 10 seconds. Any degradation that occurs upon heating at 100°C or higher for 30 minutes is of essentially no instructive assistance for a heating protocol as short as 10 seconds. Further, Ferruzzi indicates the thermal processing should occur “at appropriate process conditions” ([0072]), which suggests optimizing the thermal processing is well within the ordinary skill in the art. It is readily evident to a skilled practitioner that thermal processing should be performed at the minimal time/temperature conditions to achieve the desired degree of sterilization while minimizing degradation of the product being treated. Applicant’s argument is unpersuasive.
Applicant next argued that Ferruzzi discloses extraction of cocoa for caffeine but not for any other compounds (Applicant’s Remarks, p. 9, ¶2).
Examiner maintains the position detailed in the claim rejection that since Ferruzzi does not explicitly disclose natural vegetable sources from which flavanols may be extracted, a skilled practitioner would consult Nair et al. to determine an appropriate source. Since cocoa is used in Ferruzzi to extract caffeine, the additional extraction of polyphenols from cocoa would be a desirable source material, as suggested by Nair et al. Relying on a single source material for multiple components disclosed as being suitable for addition would allow for improved efficiency to the extent that the number of raw materials may be optimally minimized.
Regarding claim 12, Applicant argued that the claim required a minimum amount of (-)-epicatechin, contradicting Examiner’s statement in the claim rejection.
The statement in the rejection (“particularly where no minimum amount of either component is required to be present in the composition”) was included only for emphasis but was not necessary for the rejection to remain fully supported. The statement was deleted from the present rejection of claim 12, which remains rejected for the reasons detailed previously herein.
The rejections of claims 1-3 and 6-20 have been maintained herein.
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.
Claims 1-3 and 6-20 are rejected.
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793