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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 8, 2024 has been entered.
Response to Amendment
Those rejections not repeated in this Office Action have been withdrawn.
Claims 12-14, 16, 23, 27-32, 34, 47-51, 53, 55-56 and 106-109 are currently pending and rejected.
Claim Objections
Claim 47 is objected to because of the following informalities:
Claim 47 recites, “the entrained polymer composition provides, on a per gram of the entrained polymer basis, a concentration of at least 3 ppm of ClO2 5 hours after initiation.” (see liens 30-32). This limitation ends with a period however, the claim further recites steps “(c)” and “(d)” with a period after step “(d).” Therefore the period after “initiation” should be deleted and replaced with a semi-colon.
Appropriate correction is required.
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 12-14, 16, 23, 27-32, 34, 47-51, 53 and 55-56 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.
Claims 12, 27, 30 and 47 recite the “as perceived by an ordinary consumer without special detection equipment.” The term “ordinary” and “special detection equipment” are seen to be relative terms which have not been clearly defined by the claims or specification. That is, paragraph 15 last sentence and paragraph 101 last sentence of Applicant’s specification as filed refers to “an ordinary consumer” and “special detection equipment” however, the disclosure does not provide sufficient guidance as to what type of consumer is an “ordinary” consumer and what type of detection equipment would be construed as “special” versus “not special.” Therefore, the scope of these terms is unclear and therefore indefinite.
Claim 47 recites, “and the entrained polymer composition further characterized in that, when evaluated using either of the following test conditions….” The limitation recites “when” but does not recite what is the effect of the test conditions. If it is intended for the three liens above step c to be the result of the “when”, then this limitation should be indented:
“and the entrained polymer composition further characterized in that, when evaluated using either of the following test conditions:
(i) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a piece of filter paper saturated with 1 mL water is placed such that the filter paper is not in direct contact with the entrained polymer, the mason jar being enclosed by a lid; or
(ii) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a sponge that has absorbed 10 mL water is placed within the mason jar such that the sponge is not in direct contact with the entrained polymer, the mason jar being enclosed by a lid,
the entrained polymer composition provides, on a per gram of the entrained polymer basis, a concentration of at least 3 ppm of ClO2 5 hours after initiation;
Claims 13, 14, 16, 23, 28, 29, 31, 32, 34, 48-51, 53, 55 and 56 are rejected based on their dependence to a rejected claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 12-14, 16, 23, 27-30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kibele (WO 2014152539) in view of Wellinghoff (US 6605304), Machado (US 20110253562), Speronello (US 6676850) and Hekal (US 6486231) and in further view of Annous (US 20170332674) and Bar-On (WO 2016020755) and in further view of Svoboda (US 4021585).
Regarding claim 12, Kibele teaches container defining an interior space therein (see figures 4, 6, 9). Kibele further teaches a closed container with a food product stored in the closed container because Kibele teaches embodiments such as in figure 9, where the container is closed, and where the closed container can be used for foods such as fruit and vegetable (paragraph 31, 42).
Regarding a headspace formed within a volume of the interior space, since Kibele teaches that the materials can release a gas there would have been a reasonable expectation of a headspace formed within the container that is not occupied by the product.
This would further have been obvious in view of Kibele teaching a closed package (see figure 9), and where the active agent interacts with external moisture via the channels of the entrained polymer, to generate and release gas (see paragraph 22, 26). This would have suggested some amount of headspace for the gas to release and moisture to travel into the channels of the figure 9 package.
If it could have been construed that Kibele was not specific in teaching a headspace that is not occupied by the product, then it is noted that Wellinghoff teaches sealed containers with a headspace (column 20, lines 21-28) within which a chlorine dioxide gas can be released for eliminating / inhibiting bacteria and microorganisms from spoiling the food therein (see at least, column 6, lines 24-30; column 39, lines 11-13, 14-15, 19-22, 22-26). Machado also teaches sealed containers that have a headspace (see figure 5 and 8) and where an active agent that can release an antimicrobial gas is placed within the container (see paragraph 44 - “release at least one agent… and thus further modify the atmosphere of the MAP to gain the desired effect… Additionally, the releasing device… control a release of chlorine dioxide for sanitation of the contents…”). Machado also teaches moisture activation due to humidity in the container from the storage items in the container such as produce (see paragraph 48).
Since Kibele already teaches an active agent that can release an antimicrobial agent in the form of a gas and where the release is due to moisture (paragraph 22, 26, 28); and since Kibele also teaches packaging respiring fruits and vegetables (paragraph 31), to thus modify Kibele and to provide a headspace that is not occupied by the product would have been obvious to one having ordinary skill in the art, for the purpose providing the space for allowing the gas to be distributed throughout the container so as to provide disinfection to the contents within the package as well as for using the headspace to activate the ingredient that is to be released due to water vapor within the headspace.
Kibele also teaches, an entrained polymer composition (see the abstract) comprising a base polymer (see at least, paragraph 5), which can be used at 24-60% (see page 29, claim 49) thus overlapping with the claimed range; a channeling agent (see at least paragraph 5, “channeling agent”) used at 2-10% (see page 29, claim 48), thus overlapping with the claimed range. Kibele further teaches an active agent that can release an antimicrobial gas (see paragraph 22, 34 and 36: “an antimicrobial agent” “releasing material could be in the form of a … gas”), which can be used at 50% or 10-80% (paragraph 39) thus encompassing and falling within the claimed range.
As Kibele teaches the use of a base polymer, channeling agent and active agent that falls within and overlaps with the claimed range, where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima face case of obviousness exists.
To modify Kibele and to use an amount of the channeling agent at 10% for example, with active agent being used at 50% and the remainder, being the base polymer at 40% for instance would have been obvious to one having ordinary skill in the art, as an obvious matter of engineering and/or design based on factors such as the desired size and structure for the entrained polymer.
Kibele also teaches that the active agent can react with a selected material (see the abstract); and where the selected material can be moisture (see for example, paragraph 26 which states that moisture can travel through the channels in the entrained polymer to the particles of an active agent that would react with the moisture).
Kibele also teaches that the channeling agent forms a plurality of channels through the base polymer (see figure 2 and 10, item 45; paragraph 24 - “the channeling agent forms interconnecting channels through the entrained polymer”). The channels are shown in figures 2 and 10 to penetrate through the base polymer and are interconnected with each other and allow for transport of moisture and gas.
Claim 12 differs from Kibele in specifically reciting that the active agent used at “about 35% to about 50%” is “a chlorine dioxide gas releasing agent comprising an alkaline metal chlorite, a catalyst and a humidity trigger, wherein the chloride dioxide gas releasing agent forms chlorine dioxide gas by reaction with moisture.”
However, as discussed above, Kibele already teaches that the releasing agent can release an antimicrobial gas used at 50% (see paragraph 39, where the active agent can be used at 50%). Speronello teaches compositions for controlled release of chlorine dioxide gas, at 0.001-1000ppm (see the abstract) for killing microbes (see column 1, lines 43-46) where the releasing agent comprises an alkaline metal chlorite (see the abstract and at least, column 4, line 55), acidified clays (which can be a catalyst) (column 5, lines 3-6, 13, 15; column 9, lines 42-47) and a humidity trigger such as calcium chloride (column 5, lines 8-10; column 5, lines 26-27; column 6, lines 65-66), and where the chlorine dioxide is released due to the reaction of the metal chlorite in the presence of water vapor (see the abstract). Speronello teaches such compositions to release gas within a closed container (see for example, examples 1-3 - “sealed glass jar”). Wellinghoff also teaches sodium chlorite (see column 19, line 59 to column 20, line 9) which can be part of a co-continuous network (see figure 18,19 and column 34, line 53 to column 35, line 5), which can also comprise a base polymer such as ethylene vinyl acetate (column 35, line 16) together with a channeling agent (percolating agent such as polyethylene glycol (see column 36, line 49 to column 37, line 17) which can contain passages that are capable of transmitting moisture to the gas-generating material to release a gas (see column 5, line 61 to column 6, line 15) and where such activation can be delayed if desired (column 8, lines 4-15). Wellinghoff further teaches that the sodium chlorite has been used to release gas and where such activation can be controlled due to moisture (see column 3, lines 44 to column 4, line 33). Wellinghoff’s entrained polymer as shown in figures 18 and 19 is similar to that already suggested by Kibele. Annous has been further relied on to teach that it has been desirable to release chlorine dioxide into sealed packages (see paragraph 2) for killing microorganisms on a food item (see paragraph 2), where gaseous chlorine dioxide has the ability to penetrate and inactivate human pathogens, such as salmonella (see paragraph 10), attached to hard-to-reach sites on produce surfaces (see paragraph 4). Annous further teaches active packaging that releases chlorine dioxide as desired (see paragraph 8, 9) and where the chlorine dioxide gas releasing agent comprises an alkaline metal chlorite (see at least, the abstract “sodium chlorite”).
Since Kibele already teaches the desirability of providing antimicrobial releasing agents in the channels of the polymer used for packaging foods, to thus modify Kibele and to use another conventional antimicrobial release agent such as a chlorine dioxide gas generating release agent, as taught by Speronello and Wellinghoff, would have been obvious to one having ordinary skill in the art, for the purpose of using the advantageous disinfecting properties of chlorine dioxide gas to reach hard to reach sides on the food surface to inhibit microbial growth.
Regarding the limitation of, “after a span of 5 days following the food product being placed within the interior space, and under storage conditions of 7°C, the antimicrobial releasing agent is structured to control release of chlorine dioxide gas to effectuate at least a 2 log base 10 reduction in CFU/g of at least one type of pathogen selected from Salmonella, E.Coli, Listeria and Geotrichum, while not causing perceptible organoleptic degradation of the food product,” it is noted that as the prior art teaches a similar entrained polymer composition, it would have been reasonable to conclude that the entrained polymer composition as taught by the prior art would have performed similarly.
That is, in view of Speronello, the combination further teaches that the antimicrobial releasing agent sodium chlorite, catalysts such as acidified clays (column 5, lines 3-6, 13 and 15; column 9, lines 42-47) together with a humidity trigger, such as calcium chloride (column 5, lines 8-10; column 5, lines 26-27; column 6, lines 65-66) and therefore teaches a similar chlorine dioxide releasing agent. Speronello also teaches that factors such as the amount of the alkaline metal chlorite as well as the amount of moisture for activation can affect the amount of chlorine dioxide generated and thus the time for generation (see at least, column 6, line 29-59). Speronello teaches that the concentrations produced can be 0.001-1000ppm and where the gas can be released for 13 days (see the figures which show a span of about 350 hours (i.e. 14.5 days)).
Also, Wellinghoff suggests using clays similar to Speronello (see Wellinghoff column 27, lines 32-40), together with sodium chlorite and a humectant (i.e. humidity trigger) such as calcium chloride (see column 35, line 47-49). Wellinghoff further teaches that the release of chlorine dioxide can be delayed (column 8, lines 4-10) and where the delay can be days or weeks (see also column 4, lines 3-6: “within days or weeks…after being activated…”; column 15, lines 27-55 and figures 15-16). Therefore, Wellinghoff encompasses that the antimicrobial releasing agent can provide antimicrobial protection after a span of 5 days following the food product being placed within the container.
Even further, Hekal teaches entrained polymers (see figures 1-8) which can comprise an ethylene vinyl acetate base polymer (see column 7, lines 66-67; column 8, lines 3-4; column 9, lines 47-53) at 38%(see column 19, line 56), about 50% of a gas releasing agent (see column 7, line65-66; column 8, lines 9-10, 13, 17, 46-51 and 63; column 19, line 54-55) and about 12% of a channeling agent such as polyethylene glycol (see column 6, lines 36-38; column 7, line 67; column 8, line 6; and column 19, lines 55-56). Example 1 on column 15, line 3 of Hekal suggests that using 12% polyethylene glycol has been conventional in the art for providing the requisite pathways for allowing gas to migrate from the entrained polymer to outside the polymer (see column 2, lines 35-50). Hekal is therefore teaching a similar entrained polymer as suggested by Kibele and Wellinghoff.
In view of these teachings, it would have been reasonable to conclude that the entrained polymer composition as taught by the prior art would have performed similarly.
While Kibele, Speronello and Wellinghoff do not specifically discuss a particular degree of reduction in at least one of Salmonella, E.Coli, Listeria and Geotrichum, after the span of 5 days following the food product being placed within the interior space, Annous also suggests that it has been known to provide at least a 2 log reductions of salmonella using chlorine dioxide (see for example, paragraph 10, 12, 58, 59). Machado similarly teaches that the release of chlorine dioxide can provide a 3.4log reduction in E.Coli and 4.3 log reduction in Salmonella (see paragraph 51). Bar-On also evidences that it has been known in the art to release chlorine dioxide gas, which can provide a 2-10 log reduction in microbes, such as E.coli (see paragraph 7, 214: “total eradication of 103; see also paragraph 1087) and where the gas concentrations are known to be variable (see at least, figure 25).
Furthermore, the art has recognized providing gas activation due to moisture from the product, as suggested by Machado and Annous. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the Kibele/Speronello/Wellinghoff combination and tailored the particular concentrations of chlorine dioxide to provide at least a 2 log base 10 reduction in pathogens within 5 days following placement of food within the interior space for the known purpose of ensuring the requisite reduction in pathogens and storage life of the packaged food.
Since the combination already teaches the use of chlorine dioxide gas for treating foods, it would have been within the normal practice of one having ordinary skill in the art to experiment with the concentrations to prevent “bleaching or otherwise discoloration as perceived by an ordinary consumer of the food product, especially as the prior art teaches that the purpose of using chlorine dioxide gas is to maintain the product freshness (see Annous paragraph 18; paragraph 13 of Machado). Additionally however, it is noted that Svoboda teaches that it has also been recognized that chloride dioxide gas at concentrations such as 5-25ppm can successfully provide antimicrobial properties while also not bleaching a food product (see column 3, lines 55-62; column 4, lines 36-57). Therefore, it would have been reasonable for one having ordinary skill in the art to have experimented and ensured that chlorine dioxide gas was provided at concentrations that prevented altering of the food within the container while providing the desired degree of antimicrobial properties.
Regarding the limitation to claim 12 of, “wherein the entrained polymer composition provides, on a per gram of the entrained polymer basis, a concentration of at least 3 ppm of ClO2 5 hours after initiation,” Speronello already teaches that the particular concentrations can be varied (see at least, the abstract and column 6, lines 7-11,18-28) and thus teaches providing an extended antimicrobial effect via the generation of chlorine dioxide gas. It is further noted that since the prior art combination suggests the claimed entrained polymer composition as part of a closed container, that the prior art would also have been capable of the intended function.
Alternatively, it would have been obvious to one having ordinary skill in the art to have accordingly modified the release characteristics for achieving the requisite chlorine dioxide concentrations for achieving the desired antimicrobial properties to the package. For example, Figure 25 of Bar-On evidences the desirability of providing a chlorine dioxide concentration that is at least 3ppm 5 hours after initiation (see Figure 25, model 1 and models 2-4 and 6). As already discussed above, Wellinghoff also suggests a delayed generation of the chlorine dioxide gas that can occur within hours or days. To therefore modify the combination such that 5 hours after initiation the chlorine dioxide concentration is at least 3ppm would have been obvious to one having ordinary skill in the art, as a result effective variable, routinely determined through experimentation for achieving the desired chlorine dioxide concentration for providing the desired antimicrobial properties to the package.
It is additionally noted that the claim appears to indicate that the concentration of at least 3ppm is associated with a test condition and as such can also be construed as directed to an intended use and not to the specific structure of the closed container.
Regarding the limitation of, “the concentration of the chlorine dioxide gas is measured using either of the following test conditions:(i) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a piece of filter paper saturated with 1 mL water is placed such that the filter paper is not in direct contact with the entrained polymer, the mason jar being enclosed by a lid; or (ii) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a sponge that has absorbed 10 mL water is placed within the mason jar such that the sponge is not in direct contact with the entrained polymer, the mason jar being closed by a lid,” it is noted that this is seen to be an intended use of the entrained polymer composition. Since the prior art teaches and suggests the claimed entrained polymer composition, the prior entrained polymer composition is also seen to be capable of the claimed intended use.
Regarding claim 13, in view of Speronello, the combination teaches the alkaline metal chlorite is sodium chlorite or potassium chlorite (see Speronello, column 4, line 55)
Regarding claim 14, Kibele teaches the channeling agent can be polyethylene glycol (see paragraph 6, 75 and 80, for example; page 29, claim 48).
Regarding claim 16, in view of Speronello as discussed above with respect to claim 12, the combination teaches an acid catalyst and calcium chloride as a humidity trigger.
Regarding claim 23, as discussed above with respect to claim 12, Kibele teaches the base polymer can be ethylene vinyl acetate (see paragraph 40) and used in amounts can overlap with the claimed amount of the ethyl vinyl acetate base polymer and the combination encompasses the claimed amount of the chlorine dioxide gas releasing agent. Regarding the channeling agent, Kibele teaches 10% channeling agent such as polyethylene glycol (see paragraph 6, page 24, claim 2), which can be construed to be “about 12% by weight.” As Kibele teaches the channeling agent to be used for forming channels through the entrained polymer and for transport of a gas phase substance (see paragraph 16) the specific amount of channeling agent would have been obvious to one having ordinary skill in the art for achieving the desired quantity of channeling and degree of gas phase transport. Nonetheless, in view of Hekal, as applied to claim 12 above, the combination teaches the claimed amounts of ethylene vinyl acetate, polyethylene glycol and 50% by weight of the chlorine dioxide gas releasing agent. To thus modify the combination to use 50% of a chlorine dioxide releasing agent; 12% of a channeling agent and thus 38% of base polymer, would have been obvious to one having ordinary skill in the art, for achieving a desired release profile of chlorine dioxide gas through the channels formed in the base polymer.
Regarding claim 27, the combination applied to claim 12 is incorporated herein to teach a closed container comprising food therein, while also comprising an entrained polymer with the claimed amounts of base polymer, channeling agent, chlorine dioxide gas releasing agent and channels. In view of Kibele (figures 4, 6 and 9), the combination teaches a container (i.e. enclosure) having a base, a top opening, one or more sidewalls, an interior space formed by the sidewalls and a headspace; and the combination as applied above to claim 12 further teaches a cover to close the enclosure, as taught by Kibele, Machado and Wellinghoff.
The combination as applied to claim 12 has also been incorporated herein to teach the limitation of the entrained polymer composition provides, on a per gram of the entrained polymer basis, at least 3ppm of chlorine dioxide 5 hours after initiation and wherein after a span of 5 days following the food being placed within the container, and under storage conditions of 7°C, the chlorine dioxide gas effectuates at least a 2 log base 10 reduction in one of the claimed pathogens.
Regarding the limitations of the test conditions, it is noted that the combination as applied to claim 12 above has been incorporated herein.
Regarding claim 28, as discussed above with respect to claims 12 and 23, Kibele teaches the base polymer comprising ethyl vinyl acetate and the channeling agent comprises polyethylene glycol. In view of Speronello, the combination teaches a sulfuric acid clay as an acid catalyst, as discussed above with respect to claim 16.
Regarding claim 29, Kibele also suggests on paragraph 62 that the container can be closed (“when the container 61 is closed). Figure 9 of Kibele teaches an upper surface of the package that contains the entrained polymer article. Figure 9 could be construed as teaching a “cover” having the entrained polymer, and thus being a lidding film.
If it could have been construed that Kibele did not suggest a lid cover or lidding film having the entrained polymer incorporated therein, then Machado further teaches on figure 8, item 222 that a cover provided to close the container can have the gas generating article (figure 8, item 240) thereon; and where said gas generating article can produce chlorine dioxide (paragraph 44). As shown in Kibele’s figures, the entrained polymer article is seen to be incorporated into the packaging walls. In view of these teachings, and since Kibele essentially teaches that the entirety of the interior surface of the closed package can have the entrained polymer article, to thus modify Kibele and to also include the entrained polymer article on the cover would have been obvious to one having ordinary skill in the art for the purpose of providing the gas generating article around the entirety of the product and package interior space.
Regarding claim 30, the combination applied to claims 12 and 27 has been incorporated herein to teach the limitations of the claim. The combination teaches a closed container having an article of an entrained polymer disposed into the interior space of the container (see figure 4, item 55 for example; and see Kibele who teaches a plug of the entrained polymer within a container; paragraph 10, 42) .
Regarding claim 32, as shown in figure 9, Kibele teaches a flexible plastic bag.
Claims 47-50, 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Kibele (WO 2014152539) in view of Machado (US 20110253562), Speronello (US 6676850), Wellinghoff (US 6605304), Hekal (US 6486231), Annous (US 20170332674) and Bar-On (WO 2016020755) and in further view of Harrison (US 20120070508).
Regarding claim 47, the combination applied to claim 12 teaches a method that can inhibit growth of microbes, because the combination teaches a closeable package with a headspace and further teaches an entrained polymer composition that can be moisture activated to release chlorine dioxide gas into the package headspace to disinfect hard to reach sites on the product surfaces. In view of this, it would have been obvious to one having ordinary skill in the art, for the combination to teach placing a product into the interior space of an enclosure, the enclosure having some form of headspace. In view of Kibele, the combination teaches an entrained polymer, comprising a gas releasing antimicrobial agent, and where the entrained polymer also comprises a base polymer and a channeling agent.
Further regarding the step of placing a food product that exudes liquid, it is noted that foods such as fruit and vegetables, as taught by Kibele (see paragraph 31) are known to exude liquid. Furthermore, it is noted that Annous teaches that moisture released from produce can be used for releasing chlorine dioxide gas (see paragraph 17). Machado also teaches that the humidity in the container to trigger the release of chlorine dioxide can be via the moisture released from the produce (see paragraph 48). Kibele also teaches using moisture for activating gas release, as does Speronello and Wellinghoff. Wellinghoff also teaches packaging of produce (column 20, lines 50-54).
Therefore, it would have been obvious to one having ordinary skill in the art to have placed food that “exudes moisture” for the known purpose of using the moisture from the food to trigger the release of chlorine dioxide.
In view of Speronello and Wellinghoff as discussed above with respect to claim 12, the combination further teaches a chlorine dioxide gas releasing agent that is contacted with moisture to initiate the formation and release of chlorine dioxide gas. It would thus have been obvious to one having ordinary skill in the art to contact the entrained polymer with moisture so as to form chlorine gas so as to provide antimicrobial protection to the contents. Closing the enclosure so as to allow the chlorine dioxide releasing agent to generate chlorine dioxide that can accumulate in the headspace would have been obvious to one having ordinary skill in the art, especially as the combination teaches the release of chlorine dioxide gas within a closed space (see Speronello, Annous, Machado).
Regarding the particular structure of the entrained polymer composition, the combination as applied to claims 12 is seen to suggest this structure.
Regarding the chlorine dioxide gas being effective to provide a sufficient antimicrobial effect prior to dissolution of the chlorine dioxide gas in water to improve the shelf life of the food product for a two week period, it is noted that since the combination teaches a similar entrained polymer composition, that it would have been reasonable to conclude that a similar composition would have provided similar results. Additionally however, Wellinghoff also teaches that the purpose of the chlorine dioxide producing agent, which can be part of an entrained polymer composition (see figure 18-19) can be useful for providing extended release of chlorine dioxide, which can occur for weeks for achieving the desired antimicrobial effect (see column 14, lines 66 to column 15, lines 23 - see specifically, column 15, lines 19-23). Therefore, the prior art is seen to teach chlorine dioxide gas that is effective to provide a sufficient antimicrobial effect for a two week period and where it would alternatively have been obvious to have modified the release characteristics to provide an antimicrobial effect for a two week period.
Regarding the limitations to claim 47 of, “the entrained polymer composition provides, on a per gram of the entrained polymer basis, at least 3 ppm of ClO2 5 hours after initiation,” the combination as applied to claim 12 above has been incorporated herein.
Regarding the limitation of, “the entrained polymer composition further characterized in that when evaluated using either of the following test conditions:(i) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a piece of filter paper saturated with 1 mL water is placed such that the filter paper is not in direct contact with the entrained polymer, the mason jar being enclosed by a lid; or (ii) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a sponge that has absorbed 10 mL water is placed within the mason jar such that the sponge is not in direct contact with the entrained polymer, the mason jar being closed by a lid,” it is further noted that the prior art suggests using similar amounts of the entrained polymer composition as recited in claim 47. Therefore, it would have been reasonable to conclude that the prior art entrained polymer would have performed similarly, absent a showing of how the claimed entrained polymer differs structurally from that suggested by the prior art. In any case, it is further noted that Speronello also teaches and suggests testing by placing the chlorine dioxide emitting material into a sealed jar with and without humidity (see column 9, line 65 to column 10, line 7; column 11, lines 40-45). While Speronello does not specifically discuss the claimed size to the jar and either of a filter paper or sponge impregnated with water, it is noted that Harrison teaches sealing a chlorine dioxide producing agent into a sealed container which also includes a filter paper impregnated with a liquid, which is used for establishing a desired humidity within the container, so as to determine the chlorine dioxide concentrations that can be developed (see example 11 and paragraphs 118-129).
Therefore, one having ordinary skill in the art would have been routinely motivated to test the concentrations of chlorine dioxide gas that can be produced by the entrained polymer based on conventional techniques for generating a humid environment to trigger the development of chlorine dioxide gas from a chlorine dioxide producing agent. While Harrison does not specifically discuss 2grams of the entrained polymer in a 2.1L mason jar with the filter paper saturated with 1mL of water, it is not seen that the relative proportions of the test conditions would have provided a patentable significance absent a sufficient showing of criticality. It is also noted that the term “when” means that the particular step need not occur within the claimed process but that when such testing has been performed, the claimed concentration would have been reached. In light of the rejection under 35 U.S.C. 112b, it is further noted that when the evaluation has been performed, the entrained polymer composition would have provided at least 3 ppm of ClO2 5 hours after initiation.
Regarding claim 48, the claim is rejected for the reasons similarly discussed above with respect to claim 12 and 23 above.
Regarding claims 49 and 50, Kibele teaches that the antimicrobial gas releasing agent can be moisture activated. Furthermore, Speronello also evidences a chlorine dioxide gas releasing agent which can be activated via moisture (see at least, figure 1). Also, Annous teaches that the moisture released from the respiration of the produce can act on the antimicrobial release agent to generate chlorine dioxide over time (see paragraph 17). Since Kibele already teaches moisture activated antimicrobial release agents, to thus modify the combination and to use the moisture generated from the product to release the antimicrobial agent would have been obvious to one having ordinary skill in the art, as a matter of engineering and/or design, based on conventional expedients for activating a moisture activated release agent.
Regarding claims 55-56, which recite that the concentration is no longer detectable after a particular period of time, it is noted that Speronello further teaches that the reaction to produce the chlorine dioxide gas can last for several minutes to many hours based on the relative amounts of the constituents in the chlorine dioxide gas releasing agent (see column 7, lines 56-67). Bar-On also evidences no detectable chlorine dioxide gas concentration after 16 hours (see figure 25 and Model 1 for instance and paragraph 7 where the 2 log reduction in microbes can be between 1-60 minutes). This is seen to suggest that the concentration of gas present can be released for several minutes, such that it would have been obvious for the concentration to not have been detectable after 16 hours or after inhibiting the growth of microbes, especially since the combination teaches similar amounts of the channeling agent and chlorine dioxide gas releasing agent.
Claims 31 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to claim 30 and 47, above, which relies on Kibele (WO 2014152539) as the primary reference and in further view of Wellinghoff (US 20080026029).
Regarding claims 31 and 51, Kibele teaches that the entrained polymer can be part of the construction of rigid containers, as a plug inserted into the interior of the container (paragraph 42), and can also be a liner that can conform to an interior of the container, or can be simultaneously co-molded with the container body (see paragraph 43). Paragraph 44 teaches that the entrained polymer can be used to form an entrained polymer sheet. This is seen to suggest that the entrained polymer can be provided as a film. In view of figure 9, Kibele is seen to teach
Claims 31 and 51 differ in specifically reciting that the film has a thickness of 0.1mm to 1mm.
However, Wellinghoff’029 teaches that pellets having a gas releasing powder (paragraph 111) can be formed into a film that has a thickness of 10 mil (see paragraph 112). Wellinghoff’029 teaches powders incorporated into forming various thermoplastic articles (paragraph 59) and where the powders can generate gas (see paragraph 64) for releasing chlorine dioxide sufficient to eliminate bacteria fungi, molds etc (paragraph 9). Wellinghof’029’s teachings of a film a thickness of 10 mil equates to a thickness of 0.25mm.
To thus modify Kibele who already teaches various forms of the entrained polymer provided as a film, and to use a thickness of 0.25mm for instance, would have been obvious to one having ordinary skill in the art, as a matter of engineering and/or design based on conventional thicknesses of films that can generate and release gas therefrom.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to claim 30 above, which relies on Kibele (WO 2014152539) as the primary reference and in further view of Shelley (US 20090067760).
Regarding claim 34, Kibele (figures 4-6) teaches the container having at least one sidewall, the at least one sidewall having a sidewall midline. The liner that comprises the entrained polymer as shown in figure 6 is seen to be disposed on the container sidewall and therefore, teaches a film disposed above the midline on at least one of the side-walls.
If it could have been construed that Kibele did not teach the entrained polymer film as above the midline, then it is further noted that Machado teaches in figure 8, that the gas generating agent (see paragraph 44 - “release at least one agent… and thus further modify the atmosphere of the MAP to gain the desired effect… Additionally, the releasing device… control a release of chlorine dioxide for sanitation of the contents…”) can be positioned on the container sidewall, near a midpoint of the container sidewall (see figure 8, item 226 and at least, paragraph 69). Additionally, Shelley teaches chlorine dioxide generating (paragraph 98) articles (see figure 2, item 50; paragraph 73) where the gas generating structure is positioned higher on the container sidewall such that it would have been obvious to one having ordinary skill in the art that the gas generating article would have had a midline that would have been at least as high as the sidewall midline, or higher. Therefore, positioning Kibele’s film on the container sidewall such that the film is above the midline of the container sidewall would have been obvious to one having ordinary skill in the art as a matter of engineering and/or design based on conventional positioning of a gas generating article on a container sidewall.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to claim 47 above and in further view of Barenberg (US 5980826) and in further view of Svoboda (US 4021585).
Regarding claim 53, which recites, “wherein the product and the chlorine dioxide gas is provided in a headspace concentration over a determined time period to effectuate after a span of 2 days from initiation and under storage conditions of 7°C, at least a 1 log base 10 reduction in CFU/g of microbes present on the food, without the food product being bleached or otherwise discolored, as perceived by an ordinary consumer without special detection equipment,” it is noted that the prior art teaches a similar composition and thus there would have been a reasonable expectation for such a combination to behave similarly.
That is, in view of Speronello, the combination further teaches that the antimicrobial releasing agent comprises hydrous clays such as bentonite (see column 5, lines 3-6) and acidified clays (column 5, line 13; column 9, lines 42-47) contacted with acids such as sulfuric acid (column 5, lines 15). Speronello also teaches the powder (column 7, lines 48-55) can include a humidity trigger, such as calcium chloride (column 5, lines 8-10; column 5, lines 26-27; column 6, lines 65-66) and therefore teaches a similar chlorine dioxide releasing agent. Speronello also teaches that factors such as the amount of the alkaline metal chlorite as well as the amount of moisture for activation can affect the amount of chlorine dioxide generated and thus the time for generation (see at least, column 6, line 29-59).
Also, Wellinghoff suggests using clays similar to Speronello (see Wellinghoff column 27, lines 32-40), together with sodium chlorite and a humectant (i.e. humidity trigger) such as calcium chloride (see column 35, line 47-49). Wellinghoff further teaches that the release of chlorine dioxide can be delayed (column 8, lines 4-10) and where the delay can be days or weeks (see also column 4, lines 3-6: “within days or weeks…after being activated…”; column 15, lines 27-55 and figures 15-16). Therefore, Wellinghoff encompasses that the antimicrobial releasing agent can provide antimicrobial protection after a span of 5 days following the food product being placed within the container.
Thus it would have been reasonable to conclude that the entrained polymer composition as taught by the prior art would have performed similarly.
While Kibele, Speronello and Wellinghoff do not specifically discuss a particular degree of reduction in at least one of Salmonella, E.Coli, Listeria and Geotrichum, after a span of 5 days following the food product being placed within the interior space, Annous also suggests that it has been known to provide at least a 2 log reductions of salmonella using chlorine dioxide (see for example, paragraph 10, 12, 58, 59). Machado similarly teaches that the release of chlorine dioxide can provide a 3.4log reduction in E.Coli and 4.3 log reduction in Salmonella (see paragraph 51). Bar-On has been relied on as already discussed above with respect to claim 12 to evidence that it has been known to use concentrations of chlorine dioxide gas for a 2-10 log reduction of microbes, such as E.coli (see paragraph 7, 214: “total eradication of 103; see also paragraph 1087) and where the gas concentrations are known to be variable (see at least, figure 25).
Furthermore, the art has recognized providing gas activation due to moisture from the product, as suggested by Machado and Annous. It is further noted that Barenberg also teaches that the chlorine dioxide gas could be released over one to 200 days (see column 12, lines 57-63). Barenberg also teaches a maximum initial loading of 10-20ppm chlorine dioxide where higher loadings can be used to increase the maximum initial concentration and prolong the release (see column 27, lines 44-57). Barenberg also suggests storage of fruits and vegetables, similar to Kibele, Annous and Machado (see Barenberg column 13, lines 9-14) and also suggests known storage conditions such as 8°C, which can propagate bacterial growth (see column 28, lines 17-21). The prior art also teaches room temperature storage (see Machado paragraph 51) as well as refrigerated storage (Annous paragraph 51).
Since the combination already teaches the use of chlorine dioxide gas for treating foods, it would have been within the normal practice of one having ordinary skill in the art to experiment with the concentrations of chlorine dioxide gas in the headspace to effectuate after 5 days from initiation and under storage conditions of 7°C at least a 2 log base reduction in microbes for the known purpose of extending storage of the product.
Regarding the limitation of “without the food product being bleached or otherwise discolored as perceived by an ordinary consumer without special detection equipment,” it is noted that it would have been obvious to one having ordinary skill in the art to ensure that the treatment of the product using chlorine dioxide gas did not unduly affect the properties of the product, especially as the prior art teaches that the purpose of using chlorine dioxide gas is to maintain the product freshness (see Annous paragraph 18; paragraph 13 of Machado). Additionally however, it is noted that Svoboda teaches that it has also been recognized that chloride dioxide gas at concentrations such as 5-25ppm can successfully provide antimicrobial properties while also not bleaching a food product (see column 3, lines 55-62; column 4, lines 36-57). Therefore, it would have been reasonable for one having ordinary skill in the art to have experimented and ensured that chlorine dioxide gas was provided at concentrations that prevented altering of the food within the container while providing the desired degree of antimicrobial properties.
Claims 106-109 are rejected under 35 U.S.C. 103 as being unpatentable over Kibele (WO 2014152539) in view of Wellinghoff (US 6605304), Machado (US 20110253562), Speronello (US 6676850) and Annous (US 20170332674) and in further view of Hekal (US 6486231) and Bar-On (WO 2016020755) and in further view of Harrison (US 20120070508).
Regarding claim 106, Kibele, Machado, Speronello, Wellinghoff and Annous have been incorporated herein, as discussed above with respect to claims 12, 23, 27 and 30 to teach a closed container comprising an entrained polymer comprising about 38-53% of a base polymer; about 12% by weight of a channeling agent; from 35-50% by weight of a chlorine dioxide gas releasing agent and a plurality of channels formed of the channeling agent that permeate through the base polymer and are interconnected with each other. The combination further teaches a food product stored in the closed container.
If it could have been construed that Kibele’s teaching of “10%” of a channeling agent was not “about 12%” then it is further noted that Hekal teaches similar types of entrained polymers (see figures 1-8), which also include a base polymer such as polypropylene, and a channeling agent such as polyethylene glycol, which can be used at 5-20% or “about 10wt%” (see column 7, line 64 to column 8, line 8); and where the base polymer can also be ethylene vinyl acetate (see column 9, lines 47-57). Example 1 on column 15, line 3 of Hekal suggests that using 12% polyethylene glycol has been conventional in the art for providing the requisite pathways for allowing gas to migrate from the entrained polymer to outside the polymer (see column 2, lines 35-50). To thus modify Kibele, if necessary, and to use about 12% of polyethylene glycol as a channeling agent would have been obvious to one having ordinary skill in the art, for the known purpose of providing the requisite interconnecting channels to the composition. In view of Kibele, Speronello and Wellinghoff, the combination suggests using 50% of chlorine dioxide gas releasing agent, and in view of Hekal, the combination further suggests using 12% of a channeling agent. Therefore, the combination would have suggested the remaining 38% would have been a base polymer, which falls within the claimed range. To thus modify the combination, if necessary, and to use about 12% of polyethylene glycol as a channeling agent would have been obvious to one having ordinary skill in the art, for the known purpose of providing the requisite interconnecting channels to the composition.
Regarding the limitation to claims 106-109 of, “wherein the entrained polymer composition provides, on a per gram of the entrained polymer basis, at least 10 ppm of ClO2 for a period of at least 12 hours as recited in claim 106; at least 10ppm for at least 24 hours as recited in claim 107; at least 30ppm for at least 12 hours, as recited in claim 108 and at least 30ppm for at least 24 hours as recited in claim 109), using either of the following test conditions:(i) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a piece of filter paper saturated with 1 mL water is placed such that the filter paper is not in direct contact with the entrained polymer, the mason jar being enclosed by a lid; or (ii) a 2 g piece of the entrained polymer is placed in a 2.1 L mason jar where a sponge that has absorbed 10 mL water is placed within the mason jar such that the sponge is not in direct contact with the entrained polymer, the mason jar being closed by a lid,” it is noted that this is seen to be an intended use of the entrained polymer composition. Since the prior art teaches and suggests the claimed entrained polymer composition, the prior entrained polymer composition is also seen to be capable of the claimed intended use.
Furthermore, it is noted that as the prior art teaches a similar entrained polymer composition, the prior art would have been reasonably expected to perform similarly. This is further evidenced by Table 4 of Applicant’s specification which appears to use 50% the antimicrobial releasing agent as taught by Speronello, together with 38% of a base polymer, EVA and 12% of what appears to be the channeling agent. The combination similarly teaches 50% of an antimicrobial releasing agent, together with 12% of a channeling agent and 38% of a base polymer.
In any case, Kibele, Wellinghoff and Speronello have been relied on as already discussed above to teach varying the sodium chlorite concentrations for achieving a desired chlorine dioxide concentration and thus desired antimicrobial effect for a given period of time. Furthermore, it would have been obvious to one having ordinary skill in the art to have accordingly modified the release characteristics for achieving the requisite chlorine dioxide concentrations for achieving the desired antimicrobial properties to the package. Additionally however, Figure 25 of Bar-On evidences the desirability of providing a chlorine dioxide concentration that is at least 10ppm for a period of at least 12 hours (see for example, figure 25, Model 4). Figure 11 of Harrison teaches chlorine dioxide release concentrations such as at least 30 ppm for about 24hours (see figure 11, 0.5g at 85%RH).
To therefore modify the combination such that the chlorine dioxide concentration is at least 10 or 30 ppm for at least 12 or 24 hours would have been obvious to one having ordinary skill in the art, as a result effective variable, routinely determined through experimentation for achieving the desired chlorine dioxide concentration for providing the desired antimicrobial properties to the package.
Response to Arguments
The Declaration filed April 8, 2024 has been considered but is not seen to be sufficient to overcome the prima facie case of obviousness as presented in this Office Action for the following reasons.
At paragraphs 10-12 the Declaration states that paragraph 77 of the published application discusses that while chlorine dioxide can provide antimicrobial activity due to being a strong oxidizing agent, it can cause bleaching such that it can be difficult to find a sweet spot balance for a chlorine dioxide treatment that is sufficient for the required antimicrobial activity while still avoiding bleaching and discoloration. It is urged that stopping chlorine dioxide treatment at will is possible when using in-house chlorine dioxide generating equipment but such stopping would not be possible for packaging based chlorine dioxide treatment such that preventing bleaching and discoloration is more challenging compared to in-house treatment.
It is noted however, that the specification appears to indicate that a quick burst of 10-35ppm (Paragraph 98); as well as peak values of up to 30ppm (see paragraph 192 and figure 4) provided successful headspace concentration without bleaching. In this regard, the prior art has also recognized similar concentrations of chlorine dioxide as not bleaching food products while still providing the requisite antimicrobial activity. In combination with the prior art teaching a similar entrained polymer, a similar chlorine dioxide releasing agent, as well as a reason to combine the chlorine dioxide releasing agent with the entrained polymer, it would have been reasonable to expect or at least modify the accumulation of chlorine dioxide within the package for the purpose of preventing bleaching, which has been recognized to be undesirable.
At paragraph 17, the Declaration states that the particular release profile is valuable since it assures that chlorine dioxide exposure will not extend longer than is necessary for treatment of the food product.
It is noted however, that the accumulation of chlorine dioxide or the decrease in the release of chlorine dioxide would also appear to be reaction limited. That is, the prior art teaches moisture activation such that once the particular amount of moisture is exhausted, it would also appear that the reaction to release chlorine dioxide would have been limited. In combination with the remarks presented above, it is unclear as to how the claimed entrained polymer composition as part of the closed container would have differed in its release properties from the prior art which also teaches a closed container with the entrained polymer composition. As also discussed above, the claim limitations with respect to the “at least 3ppm concentration of chlorine dioxide, is directed to a test condition and not to the release profile as part of the closed container. That is, the claim recites that “a concentration of at least 3 ppm of ClO--2 5 hours after iniitation and the concentration of the chlorine dioxide gas is measured using either of the following test conditions:…a 2g piece of the entrained polymer is placed n a 2.1L mason jar…” Therefore the release profile as claimed is associated with a test condition using a 2.lL mason jar and not with the claimed “closed container” having a food product stored in the closed container.
On paragraphs 21-26 of the Declaration, it is stated that regardless of the different experimentation conditions of Annous, Machado and Lee, nothing in them suggests the successful antimicrobial activity of claim 12, which requires a span of 5 days.
It is noted however, that Annous has been relied on to teach that it has been known to activate chlorine dioxide generation via moisture and which chlorine dioxide can release up to about 19mg/L (i.e. 19ppm) of chlorine dioxide, for the purpose of inactivating pathogens such as salmonella (see paragraph 12). Such concentrations would have been suggested to be within the bounds of what would have been expected by the prior art to also prevent bleaching. Paragraphs 18-20 of Annous are also teaching that it has been recognized to control the release profile of the chlorine dioxide gas and at paragraph 29 and 66, Annous teaches that inactivation of microorganisms should occur on fresh produce without comprising their quality attributes, thus encompassing attributes such as color. Machado, like Annous, teaches using moisture activation for packaging based chlorine dioxide generation while further teaching it has been conventional to use such packaging based chlorine dioxide generation to provide multiple log reductions of e.coli using concentrations which would have been suggested to not bleach or discolor (see Machado paragraph 50, 4mg/L and 18mg/L).
On page 15 of the response, Applicant urges that there would not have been a reasonable expectation of success in achieving the claimed invention based on combining Kibele and Speronello in combination with the other references because Kibele is disclosing a slow moisture uptake and therefore if combined with Speronello’s chlorine dioxide active agent would still have resulted in a release profile that would have been slower or later compared to the powder alone; and would not teach the claimed concentration of at least 3ppm of ClO2 5 hours after initiation.
It is noted however, that the claim limitation directed to the concentration of at least 3ppm of ClO2 5 hours after initiation is directed to a testing condition or property of an entrained polymer. That is, “a concentration” of at least 3ppm of ClO2, 5 hours after initiation is using a particular amount of the entrained polymer placed in a particular sized mason jar. Claims 12, 27, 30 and 106 are directed to a closed container, which is different from the 2.1L mason jar as recited in the test conditions section of the claim; and the structure as recited in claims 12, 27, 30 and 106 is of a closed container of any size, having 30-70% of a base polymer, 6-12% of a channeling agent, 35-50% of a chlorine dioxide releasing agent that comprises an alkaline metal chlorite, a catalyst, and a humidity trigger and a plurality of channels formed of the channeling agent that penetrates the base polymer and are interconnected with each other. In this regard, the combination is seen to provide motivation for arriving at the claimed entrained composition.
On page 16 of the response, Applicant urges that the rejection picks specific features from each of the references while ignoring the context of each prior art invention, such as Speronello not teaching an entrained polymer and relying on the gas release property of Speronello’s material without acknowledging the difference in the material structure.
It is noted however, that the rejection is not relying on Speronello as a primary reference, but rather relies on Speronello to suggest moisture activated forms of an antimicrobial gas generating material. Since Kibele is already suggests an antimicrobial gas generating material which can be particulate (see at least, paragraph 13 spanning pages 3-4) without providing further specificity, it would have been obvious to one having ordinary skill in the art to look to other forms of antimicrobial gas generating materials, such as Speronello’s powdered (see for example, column 7, lines 41-47) chlorine dioxide gas generating material as known types of gas generating antimicrobial materials for food storage. Speronello already suggests that the gas release properties can be adjusted and the combination teaches using similar amounts of a base polymer and channeling agent. Therefore, the combination is seen to suggest the claimed entrained polymer composition as part of a closed container. It is further noted that paragraphs 64 and 65 of Applicant’s specification, as filed, also appear to refer to using Speronello’s chlorine dioxide gas releasing agent to be part of the entrained polymer composition.
On page 17 of the response, Applicant urges that the value of an entrained polymer having the gas release profile as set forth in the claims is that a container provided with this material can provide antimicrobial activity to foodstuffs while minimizing bleaching or discoloration due to excessive or prolonged contact with chlorine dioxide gas.
It is noted however, that the prior art is teaching that concentrations of chlorine dioxide gas within the range of 5-25ppm, for example, can provide a requisite degree of antimicrobial protection, while also preventing bleaching or some form of discoloration on food, as suggested by Svoboda. This would have provided evidence or at minimum, a reasonable expectation that similar concentrations of chlorine dioxide gas would also have prevented bleaching or some other type of discoloration that could have been perceived by an ordinary consumer without special detection equipment. Furthermore, as the prior art is teaching an entrained polymer with the claimed composition as well as the claimed chlorine dioxide gas releasing agent, there would have been a reasonable expectation that the prior art would also have provided effective antimicrobial activity without the food product being bleached. Regarding the gas release profile, it is noted that the claims are not reciting that the closed container as presented in the preamble of claim 1 has the recited gas release profile, but rather, when the entrained polymer is tested using a set of conditions, the entrained polymer has the recited gas release profile. Therefore the limitations directed to the test conditions are seen to be an intended use of the entrained polymer composition.
On pages 17-18, Applicant urges that the gas uptake and/or release by the entrained polymer of claim 12 cannot be expected to closely match that of a reference material which is different in structure (that does not include the entrained polymer such).
It is noted however, that the rejection does not rely on the above reasoning, but rather, is relying on Speronello and Wellinghoff teaching the use of chlorine dioxide releasing material that is similar to the chlorine dioxide gas releasing agent claimed, and where it has been recognized in the art to have adjusted the amounts and proportions of the chlorine dioxide gas releasing material for achieving a desired effectiveness against pathogens; and which have been recognized to have been used with an entrained polymer composition. It is also noted that Wellinghoff teaches that the chlorine dioxide gas generated material can be part of an entrained polymer, as shown in figures 18 and 19, while also suggesting controlling the gas release (see for example, column 8, lines 54-64 which teaches changing or controlling the humidity for activation to release chlorine dioxide gas).
Further on page 18 of the response, Applicant urges that the entrained polymer of claim 12 was not known prior to the filing date of the instant application and therefore a property of an unknown material cannot be known beforehand.
This urging is acknowledged and appreciated, however is not seen to be sufficient for the reasons already discussed above. While the prior art might not specifically anticipate the claimed entrained polymer, the prior art clearly teaches and suggests an entrained polymer with the claimed base polymer and channeling agent and which desirably also includes a chlorine dioxide releasing agent, as suggested by Wellinghoff. The prior art also teaches that the claimed chlorine dioxide releasing agent has been known in the art, because Applicant’s specification refers to the antimicrobial releasing agent of Speronello (US 6676850) as a suitable releasing agent. Furthermore, it is noted that the claims are not seen to provide clear specificity as to what would have structurally differed between the prior art combination which teaches a similar composition for the entrained polymer within a closed container, and that of the claims.
On pages 19-20 of the response, Applicant urges that a person of skill, knowledgeable of kinetics and familiar with Kibele would be aware of the slow moisture uptake of Kibele’s material and therefore would have approximated the first step of a postulated mechanism could only be as fast as this step.
It is noted however, that there is not seen to be sufficient evidence to support this conclusion because Kibele’s disclosure does not provide sufficient specificity to predict what would have occurred when using the base polymer, channeling agent and chlorine dioxide gas releasing agent as suggested by the secondary references of the prior art. For instance, Kibele’s data as part of Example 1 on pages 19-21 is directed to a different composition compared to that suggested by Kibele’s broader disclosure and the entrained polymer composition as suggested by the prior art combination. Therefore, it is not seen that Kibele provides sufficient specificity to suggest that the composition as taught by the prior art would have had a slow uptake of moisture.
On pages 20-21 of the response, regarding Wellinghoff, Applicant urges that the reference does not teach or suggest the claimed release profile, does not show the release profile of a chlorine dioxide releasing agent as part of a polymer and is silent regarding the antimicrobial activity and bleaching and discoloration effects as claimed,
These urgings are not seen to be persuasive for the reasons already discussed above with respect to the claimed release profile. Furthermore, it is noted that Wellinghoff has been relied on to teach and suggest the incorporation of a chlorine dioxide gas releasing material, such as sodium chlorite, which can be incorporated into an entrained polymer composition.
On pages 21-22 of the response, Applicant urges that Machado provides little guidance to a person of skill for the subject matter of claim 12 because the reference is not discussing longer term antibacterial activity or any organoleptic damage such as bleaching and discoloration due to long-term chlorine dioxide exposure.
This argument is not persuasive because the reference has only been relied on to further teach desirable log reductions of E.Coli and Salmonella using chlorine dioxide, such that it would have been obvious to one having ordinary skill in the art to have modified the concentrations of chlorine dioxide to be produced for achieving known log reductions of pathogens.
On pages 22-23 of the response, Applicant reiterates those remarks already presented above with respect to the combination of Kibele and Speronello.
These urgings are not seen to be sufficient for the reasons discussed above. Regarding the effects of chlorine dioxide on bleaching and discoloration, these urgings are not seen to be sufficient for the reasons discussed above. That is, the prior art is teaching that concentrations of chlorine dioxide gas within the range of 5-25ppm, for example, can provide a requisite degree of antimicrobial protection, while also preventing bleaching or some form of discoloration on food, as suggested by Svoboda. This would have provided evidence or at minimum, a reasonable expectation that similar concentrations of chlorine dioxide gas would also have prevented bleaching or some other type of discoloration that could have been perceived by an ordinary consumer without special detection equipment. Furthermore, as the prior art is teaching an entrained polymer with the claimed composition as well as the claimed chlorine dioxide gas releasing agent, there would have been a reasonable expectation that the prior art would also have provided effective antimicrobial activity without the food product being bleached.
On page 23 of the response, Applicant urges that Annous does not provide any guidance on the conditions required for antimicrobial efficacy for chlorine dioxide generated by a different method at different temperatures.
However, the reference evidences desirable log reductions in salmonella, for example, using a release of chlorine dioxide gas within a container. Therefore, it would have been obvious to have modified the entrained polymer composition and release profile for achieving desirable levels of chlorine dioxide gas for achieving known log reductions in salmonella.
On page 24 of the response, regarding Bar-On applicant urges that the reference is directed to a different form releasing chlorine dioxide compared to the claimed entrained polymer, and does not discuss the effects of chlorine dioxide on bleaching or discoloration.
Similar to Machado and Annous, it is noted that the reference has not been relied on for its specific mechanism for releasing chlorine dioxide, but rather, has been relied on to teach known log reductions in microbes such as E.coli via the release of chlorine dioxide gas, such that it would have been obvious to one having ordinary skill in the art to have experimented with the entrained polymer comprising a chlorine dioxide gas releasing agent, as taught by the combination, for achieving similar log reductions in microbes. Regarding bleaching and discoloration, this urging is not seen to be sufficient in view of the remarks as already presented in the rejections and responses above.
On page 25 of the response, Applicant urges that the prior art teachings do not provide a person of ordinary skill in the art with a reasonable expectation of success at achieving disinfection without bleaching or discoloring the food product.
These urgings are not seen to be sufficient for the reasons already presented in the rejection and responses above.
Applicant’s remarks on page 25 with respect to the Johnson Declaration have been considered and are not sufficient in view of the responses presented above with respect to the Declaration.
On pages 25-26 of the response, Applicant urges that finding a balance between improving antimicrobial activity and preventing degradation via discoloration and bleaching requires more than routine experimentation; and the claimed quick burst performance is useful and unexpected because it provides a burst of antimicrobial activity followed by a decrease in chlorine dioxide concentration without requiring manual intervention
These urgings are not sufficient for the reasons already discussed above. That is, the prior art teaches and suggests an entrained polymer with the claimed composition which would have been expected to have performed similarly, and the prior art teaches that it has been recognized to control the release profile of chlorine dioxide generation for achieving the desired antimicrobial properties.
On pages 26-27 of the response, Applicant urges that Kibele does not exemplify gas release of any sort let alone the claimed chlorine dioxide release from the entrained polymer.
This urging is not persuasive because Kibele is seen to broadly suggest that the entrained polymer can be used to release an antimicrobial gas (see paragraph 22 which discusses releasing of an antimicrobial agent and paragraph 34 which suggests releasing of a gas). In combination with Speronello and Wellinghoff the combination suggests that the gas releasing material can be a chlorine dioxide gas releasing material.
Further on pages 26-27 of the response, Applicant urges that the gas release behavior from Wellinghoff or Machado would have had little predictive value for the gas release behavior from the entrained polymer of claim 12, especially due to the slow gas uptake behavior of Kibele’s entrained polymer.
These urgings are not seen to be sufficient for the reasons already discussed above. Furthermore, Wellinghoff and Machado have been further relied on to teach that it has been known to modify the particular release kinetics of chlorine dioxide gas and it would have been obvious to one having ordinary skill in the art, through experimentation to provide a desired chlorine dioxide concentration for achieving the desired antimicrobial properties to the package.
Further on page 27 of the response, Applicant urges that in order to find the claim obvious, the prior art must teach or suggest an entrained polymer with sufficient chlorine dioxide releasing properties to provide antimicrobial activity that meets the claimed requirements.
As already presented in the responses above, it is unclear as to how the prior art teachings of a similar entrained polymer composition would have reacted differently from that recited by the claims, especially as Applicant’s specification appears to suggest using the Speronello chlorine dioxide gas releasing material and since the prior art teaches the combination of the claimed entrained polymer composition together with Speronello’s chlorine dioxide gas releasing material. Furthermore, it is noted that the claims recite that the entrained polymer composition provides on a per gram of the entrained polymer basis “a concentration” of at least 3 ppm of ClO2 5 hours after initiation, and “the concentration” of the chlorine dioxide gas is measured using either of the following test conditions.” This appears to recite that the claimed concentration is achieved via placement of the specifically claimed entrained polymer being positioned in a different container (i.e. a mason jar). Therefore, the claims are not seen to provide sufficient specificity as to how the prior art teaching of a similar entrained polymer composition would not have performed similarly ( MPEP 2112.01(II)).
On pages 30-31 of the response, Applicant urges that a person of ordinary skill in the art would not have known the outcome of the gas release studies performed by Applicant and the rejection relies on Applicant’s disclosure of the release profile and that since the prior to Applicant’s disclosure the entrained polymer composition had not been manufactured, its gas release properties would have been unknown. Applicant further urges that the similarities or differences of the composition to that disclosed in a reference is not material if the claim as a whole is novel and nonobvious over the art.
These urgings are not seen to be persuasive for the reasons already discussed above, because the combination teaches an entrained polymer composition as claimed which uses a chlorine dioxide gas releasing material that reads on the claimed chlorine dioxide gas releasing material, used in similar quantities to that which has been claimed. While the Office Action relies on a combination, it is maintained that it is unclear as to what would have resulted in a different in the release profile if the prior art teaches the same entrained polymer composition.
Further on page 31 of the response, Applicant urges that at paragraph 73, Kibele discusses desiccant formulations where modification of the desiccant or polymer would have been expected to worsen moisture uptake performance.
These urgings are not seen to be persuasive because as discussed above, the rejection is not relying on Kibele’s specific example, but rather, is relying on Kibele’s broader disclosure.
On page 33 of the response, Applicant urges that one of ordinary skill in the art would not expect that a hypothetically optimized variant of Speronello’s material, once incorporated into an entrained polymer, will retain the same gas release behavior.
This urging is not persuasive in view of the responses already discussed above. It is further noted that it would have been obvious to one having ordinary skill in the art that the gas release kinetics would also have been a function of the particular concentrations of the chlorine dioxide releasing agents. That is, it would have been reasonable for one having ordinary skill in the art to expect that combining differing amounts of a chlorine dioxide gas releasing agent with the entrained polymer composition as taught by the prior art can modify the amount of gas release by the chlorine dioxide gas releasing material.
On page 36 of the response, Applicant urges that even if the polymer composition of claim 12 has been taught or suggested, nothing in the references teaches or suggests that this composition will necessarily satisfy the organoleptic claim requires.
These urgings are not persuasive in view of the remarks as already presented above, with respect to bleaching or discoloration that could be perceived by an ordinary consumer without special detection equipment.
Applicant’s remarks on pages 37-45 reiterate those remarks already presented and discussed above.
With respect to Applicant’s remarks on page 45 regarding claim 106, it is noted that the responses above directed to the prior art teaching the same entrained polymer composition are incorporated herein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIREN THAKUR whose telephone number is (571)272-6694. The examiner can normally be reached M-F: 10:30-7:00pm.
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/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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