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 .
This office action has been written in response to the Applicant’s Remarks filed 7/9/26. Claims 16-22, 28, 31-35, 56-58, 64-68 are pending and have been examined on the merits. Claims 1-15, 23-27, 29-30, and 36-55 were previously cancelled. Claims 59-63 have been cancelled. Claims 64-68 are new.
Prosecution Reopened
This application was previously abandoned on 12/11/24 for Applicant’s non-response to a Non-Final rejection sent on 5/20/24.
Applicant petitioned to revive the application on the grounds of unintentional delay on 7/9/26. The petition was granted by the office on 7/9/26.
Withdrawn Rejections
The 112(d) rejection of claim 63 has been withdrawn due to the cancellation of the claim.
The 103(a) rejections of claims 59-63 have been withdrawn due to the cancelations of the claims.
The 103(a) rejections of claims 16, 21, 22, 32-34, and 57 over Farneth et al. (US 2005/0205840) in view of Kalum et al. (WO 2005/070220) have been withdrawn.
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 16, 17, 19-22, 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over O’ Driscoll (US 3,859,169) in view of Farneth et al. (US 2005/0205840) and Plumere et al. (US 2012/0211372).
Regarding Claims 16, 19, 32: O’Driscoll discloses a dried powder containing polymers, glucose oxidase and catalase for stable use [abstract; col. 4, lines 19-26, 59-66; claim 1]. O’Driscoll discloses a composition containing gel forming polymers and that the composition can be in dry form and that the gel can be reconstituted [abstract]. O’Driscoll discloses polymers of an alginic acid, a dextran, or an agarose [col. 4, lines 3-8; claim 1].
O’Driscoll does not disclose a closed package.
O’Driscoll does not disclose pyranose oxidase.
Farneth discloses oxygen scavenging compositions where the oxygen is removed in a sealed container [abstract]. Farneth discloses that the composition contains enzymes including a laccase and that the composition can be in dry form [0056]. Farneth discloses the sealed containers as food or beverage containers [0033; 0043].
Plumere discloses pyranose oxidase and catalase in a reaction system to deplete oxygen [abstract; 0012; 0014]. Plumere discloses that pyranose oxidase overcomes drawbacks of glucose oxidase and that it produces a non-reactive product and the enzyme retains most of its reactivity [0034; 0051]. Plumere discloses the product of oxidases is a reaction product and peroxide [0010; 0031]. Plumere discloses a carbohydrate as a co-substrate [abstract]. Plumere discloses an enzymatic system is used to reduce oxygen from foodstuff in a closed container [0005]. Plumere discloses the reduction or elimination of oxygen is carried out in a bi-enzymatic system that uses oxygen and an aldohexose as substrates to generate an oxidized carbohydrate and hydrogen peroxide, which is then converted to water and oxygen catalyzed by a catalase [0031]. Plumere discloses that the oxygen produced by the catalase is recycled into the bi-enzymatic process, and the solution can be driven to exhaust the oxygen in the system [0031]. Plumere discloses that an aldohexose substrate is converted by an aldohexose specific oxidase enzyme to form hydrogen peroxide [0032]. Plumere discloses that a catalase then converts the hydrogen peroxide to water and oxygen, and that oxygen re-enters the system until its depleted [0032]. “The oxygen in the solution arising from either the reaction sequence or diffusion from the gaseous environment is essentially entirely removed and the solution is maintained in an anaerobic condition”[0032].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to include the oxygen scavenging composition in a sealed container as in Farneth in order to remove or maintain the level of oxygen and to provide a shelf stable environment for the food or beverage product.
Further, it would have been obvious to modify the glucose oxidase of O’Driscoll for the pyranose oxidase of Plumere in order to overcome drawbacks of glucose oxidase and to utilize an enzyme that will retain most of its reactivity.
It would have been obvious that O’Driscoll would have had the feature where “within the closed package the pyranose oxidase uses oxygen and an aldohexose substrate to produce hydrogen peroxide in a pyranose oxidase reaction, the catalase converts the hydrogen peroxide to water and oxygen, and the oxygen produced by the catalase re-enters the pyranose oxidase reaction” as in Plumere since it discloses the same two enzyme system in a closed vessel and it would have followed the same reaction mechanism.
Regarding Claim 17: O’Driscoll as modified discloses as discussed in claim 16. O’Driscoll discloses the presence of oxygen in the void or headspace in a sealed container [0048].
Regarding Claim 20: O’Driscoll as modified discloses as discussed above in claim 16. O’Driscoll discloses glucose as a substrate [Ex. XIV; XV]. Plumere discloses as oxidase substrate and carbohydrate as substrates [abstract; 0010].
Regarding Claim 21: O’Driscoll as modified discloses as discussed above in claim 16. O’Driscoll does not disclose wherein the closed package encloses a food item comprising water or beverage comprising water.
Farneth discloses beverages as discussed above. Although Farneth does not explicitly disclose water it is known in the art that water is the base for beverages whether it be natural juices, drinks, sodas, wine etc. and therefore it would have been obvious that the beverage of Farneth would have contained water.
Regarding Claim 22: O’Driscoll discloses as discussed above in claim 16. O’Driscoll discloses glucose as a substrate [Ex. XIV; XV]. O’Driscoll does not disclose wherein the closed package encloses a food item comprising water and an oxidase substrate or a beverage comprising water and an oxidase substrate.
Plumere discloses an oxidase substrate and carbohydrate as substrates [abstract; 0010].
Farneth discloses beverages as discussed above. Although Farneth does not explicitly disclose water it is known in the art that water is the base for beverages whether it be natural juices, drinks, sodas, wine etc. and therefore it would have been obvious that the beverage of Farneth would have contained water.
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to include the oxidase substrate as in Plumere with the water/beverage as in Farneth in order to allow for the conversion of oxygen by the oxidase in the beverage.
Regarding Claim 31: O’Driscoll discloses as discussed above in claim 16. O’Driscoll does not disclose wherein the pyranose oxidase is present at a concentration of at least 0.3 U/mL of dry polymeric carrier composition, and/or wherein the catalase is present at a concentration of at least 0.5 U/mL of dry polymeric carrier composition. Plumere discloses pyranose oxidase at 0.5mg/ml and catalase at 0.5mg/ml [0051].
However, it would have been obvious to one having ordinary skill in the art at the time of the invention to adjust the amount to enzyme needed for the breakdown of oxygen, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272.
Regarding Claim 33: O’Driscoll discloses as discussed above in claim 16. O’Driscoll does not disclose wherein the dry polymeric carrier composition is further enclosed in a liquid and gas permeable enclosure.
Farneth discloses an oxygen scavenging composition in air permeable packaging [011]. Farneth also discloses activation and scavenging by direct contact with liquid [0057].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to further enclose the dry polymeric carrier in liquid and gas permeable enclosures as in Farneth in order to provide a functional barrier between the composition and the target substrate.
Regarding Claim 34: O’Driscoll discloses as discussed above in claim 16. O’Driscoll does not disclose wherein the closed package is a food tray, a packing foil, or a bottle cap.
Farneth discloses foil or cap [0123; abstract; 0010].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to provide the packaging as in Farneth in order to provide a functional barrier between the composition and the target substrate.
Regarding Claim 35: O’Driscoll discloses as discussed above in claim 16. O’Driscoll discloses stable enzymes for 1-30 days [0085].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over O’ Driscoll (US 3,859,169) in view of Farneth et al. (US 2005/0205840) and Plumere et al. (US 2012/0211372) as applied to claim 16 above and in further view of Ying et al. (EP 0934702).
Regarding Claim 18: O’Driscoll discloses as discussed in claim 16. O’Driscoll does not disclose dissolved oxygen in a liquid contained in the package.
Ying discloses an enzyme composition of glucose oxidase and a catalase used to reduce oxygen in beverage system [abstract]. Ying discloses beverages in a sealed container [0007-0015]. Ying discloses the removal of dissolved oxygen contained in the beverage by the action of the enzymes [0035; 0042].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of O’Driscoll to include beverages containing dissolved oxygen as in Ying since both O’Driscoll and Ying disclose the same enzymes for the purpose of reducing oxygen.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over O’ Driscoll (US 3,859,169) in view of Farneth et al. (US 2005/0205840) and Plumere et al. (US 2012/0211372) as applied to claim 16 above and in further view of Richards et al. (WO 2016/094359).
Regarding Claim 28: O’Driscoll discloses as discussed above in claim 16. O’Driscoll does not disclose wherein the pyranose oxidase has a pH activity range of between pH 5-10 and/or wherein the catalase has a pH activity range of between pH 3-11.
Richards discloses an oxygen scavenging system which includes catalase where the catalase is at an optimum pH of 4-11 [pg. 9, lines 27-32].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art that the catalase of O’Driscoll would have been useful at a pH of 4-11 as in Richards since this is a wide pH of range applicable to many food and beverage products.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over O’ Driscoll (US 3,859,169) in view of Farneth et al. (US 2005/0205840) and Plumere et al. (US 2012/0211372) as applied to claim 16 above and in further view of Askari et al. (US 2014/0302051).
Regarding Claim 56: O’Driscoll discloses as discussed above in claim 16. O’Driscoll does not disclose wherein said hydrogel-forming polymer has a pore size of between 2 to 10 nanometers (nm).
Askari discloses hydrogel polymers and that the hydrogels have a pore size of about 10 nm, about 5 nm, about 2 nm, less than 10 nm, less than 5 nm [0097].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of O’Driscoll to include the hydrogel polymers having a pore size of about 2, 5, 10 nm as in Askari in order to allow the desired elution rate of the enzymes.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over O’ Driscoll (US 3,859,169) in view of Farneth et al. (US 2005/0205840) and Plumere et al. (US 2012/0211372) as applied to claim 16 above and in further view of Chow et al. (US 2008/0075785).
Regarding Claim 57: O’Driscoll discloses as discussed above in claim 16. O’Driscoll does not disclose where the polymer is PVA.
Chow discloses hydrogel polymers that can be alginate, PVA, amongst others [0031].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the polymer of O’Driscoll to include the PVA of Chow since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious engineering choice. In re Leshin 125 USPQ 416
Claims 64-68 are rejected under 35 U.S.C. 103 as being unpatentable over O’ Driscoll (US 3,859,169) in view of Farneth et al. (US 2005/0205840) and Plumere et al. (US 2012/0211372) and Ying et al. EP 0934702.
Regarding Claims 64 and 65: O’Driscoll discloses a method of making dried powder containing polymers, glucose oxidase and catalase for stable use [abstract; col. 4, lines 19-26, 59-66; claim 1]. O’Driscoll discloses a composition containing gel forming polymers and that the composition can be in dry form and that the gel can be reconstituted [abstract]. O’Driscoll discloses polymers of an alginic acid, a dextran, or an agarose [col. 4, lines 3-8; claim 1]. O’Driscoll discloses maintaining the stability of the enzymes for 1-30 days [0085].
O’Driscoll does not disclose a closed package.
O’Driscoll does not disclose pyranose oxidase.
O’Driscoll does not disclose an aldohexose substrate.
Farneth discloses a method of making oxygen scavenging compositions where the oxygen is removed in a sealed container [abstract]. Farneth discloses that the composition contains enzymes including catalase and a laccase and that the composition can be in dry form [0056]. Farneth discloses the sealed containers as food or beverage containers [0033; 0043]. Farneth discloses an oxygen scavenging composition in air permeable packaging [011]. Farneth also discloses activation and scavenging by direct contact with liquid [0057].
Plumere discloses using pyranose oxidase and catalase in a reaction system to deplete oxygen [abstract; 0012; 0014]. Plumere discloses that pyranose oxidase overcomes drawbacks of glucose oxidase and that it produces a non-reactive product and the enzyme retains most of its reactivity [0034; 0051]. Plumere discloses the product of oxidases is a reaction product and peroxide [0010; 0031]. Plumere discloses the product of oxidases is a reaction product and peroxide [0010; 0031]. Plumere discloses a carbohydrate as a co-substrate [abstract]. Plumere discloses an enzymatic system is used to reduce oxygen from foodstuff in a closed container [0005]. Plumere discloses the reduction or elimination of oxygen is carried out in a bi-enzymatic system that uses oxygen and an aldohexose as substrates to generate an oxidized carbohydrate and hydrogen peroxide, which is then converted to water and oxygen catalyzed by a catalase [0031]. Plumere discloses that the oxygen produced by the catalase is recycled into the bi-enzymatic process, and the solution can be driven to exhaust the oxygen in the system [0031]. Plumere discloses that an aldohexose substrate is converted by an aldohexose specific oxidase enzyme to form hydrogen peroxide [0032]. Plumere discloses that a catalase then converts the hydrogen peroxide to water and oxygen, and that oxygen re-enters the system until its depleted [0032]. “The oxygen in the solution arising from either the reaction sequence or diffusion from the gaseous environment is essentially entirely removed and the solution is maintained in an anaerobic condition”[0032].
Ying discloses an antioxidant system with glucose oxidase, a glucose oxidase substrate, and catalase [abstract]. Ying discloses including the ingredients with a beverage and discloses sealing the ingredients in a container [0014; 0015]. Ying discloses that the glucose oxidase substrate can be present in the beverage or added to the beverage substrate or both [0025]. Ying discloses glucose (an aldohexose) as a substrate. Ying discloses holding the antioxidant system containing the enzymes and ingredients at less than 60°C [0029]. Ying discloses a reduction in the O2 content over time [0042]. Ying discloses the reduction of O2 during a 60 minute trial and after 12 days [0034-0040].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to include its oxygen scavenging composition in a sealed container as in Farneth in order to remove or maintain the level of oxygen and to provide a shelf stable environment for the food or beverage product.
Further, it would have been obvious to modify the glucose oxidase of O’Driscoll for the pyranose oxidase of Plumere in order to overcome drawbacks of glucose oxidase and to utilize an enzyme that will retain most of its reactivity.
It would have been obvious that O’Driscoll would have had the feature where “within the closed package the pyranose oxidase uses oxygen and an aldohexose substrate to produce hydrogen peroxide in a pyranose oxidase reaction, the catalase converts the hydrogen peroxide to water and oxygen, and the oxygen produced by the catalase re-enters the pyranose oxidase reaction” as in Plumere since it discloses the same two enzyme system in a closed vessel and it would have followed the same reaction mechanism.
Further it would have been obvious that the system of O’Driscoll would have continuously reduced O2 levels in a sealed container over a period of at least 24 hours as in Ying since Ying discloses using an oxidase, an oxidase substrate and catalase in a sealed container and it discloses reduction of O2 in a 1 hour period through a 12 day period of time.
Although Ying does not explicitly disclose at least 24 hours one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Ying overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claim 66: O’Driscoll as modified discloses pyranose oxidase as discussed above in claim 64. The references do not explicitly disclose the pyranose where it belongs to the enzyme class EC 1.1.3.10. However, this limitation does not add anything to the claim because it is known in the art that pyranose oxidase has been classified as EC 1.1.3.10 and this classification can be used interchangeably with the name and is synonymous with pyranose oxidase.
Regarding Claim 67: O’Driscoll as modified discloses as discussed above in claim 64. O’Driscoll does not disclose wherein the pyranose oxidase and the catalase are present in the dry composition at a molar ratio of pyranose oxidase to catalase of from 1:10 to 10:1.
Plumere discloses pyranose oxidase and catalase in a reaction system to deplete oxygen [abstract; 0012; 0014]. Plumere discloses pyranose oxidase at 0.5 mg/ml and catalase at 0.5 mg/ml (a 1:1 ratio)[0051].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to include the oxidase and catalase at a ratio of 1:1 as in Plumere since at this ratio the enzymes were effective in removing oxygen.
Regarding Claim 68: O’Driscoll as modified discloses as discussed above in claim 64. O’Driscoll does not disclose depleting the oxygen over a period of a least 24 hours at 2 to 8°C.
Ying discloses an antioxidant system as discussed previously and discloses holding the antioxidant system containing the enzymes and ingredients at less than 60°C [0028; 0029]. Ying discloses a reduction in the O2 content over time [0042]. Ying discloses the reduction of O2 during a 60 minute trial and after 12 days [0034-0040].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of O’Driscoll to conduct the treatment at temperature less than 60°C as in Ying since Ying discloses that the oxidase and catalase are functional at these temperatures.
Although Ying does not explicitly disclose 2 to 8°C one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Ying overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Response to Arguments
The 112(d) rejection of claim 63 has been withdrawn due to the cancellation of the claim.
The 103(a) rejections of claims 59-63 have been withdrawn due to the cancelations of the claims.
The 103(a) rejections of claims 16, 21, 22, 32-34, and 57 over Farneth et al. (US 2005/0205840) in view of Kalum et al. (WO 2005/070220) have been withdrawn.
The Examiner maintains that O'Driscoll clearly discloses a similar oxygen depleting system for food absent the use of a closed container and pyranose oxidase. The Examiner maintains that it would have been obvious to modify the glucose oxidase of O'Driscoll for the pyranose oxidase of Plumere due to the disclosed advantage of the pyranose oxidase over glucose oxidase. Further providing the oxygen depleting system in a closed package as in Farneth is an obvious step since if the container were not closed, the system would constantly be exposed to oxygen and further a closed package is sanitary and aids in prolonging shelf life. The references are from the same field of endeavor and are concerned with controlling the exposure of food products to oxygen.
The Examiner maintains that it would have been obvious to modify the glucose oxidase for the pyranose oxidase of Plumere due to the advantage of the pyranose oxidase over glucose oxidase. Further, regarding the form of the pyranose oxidase, there is no particular patentable difference between a composition which is in dry form and one which is the same composition with the addition of water. The mere matter of liquid form, if respective compositions are substantially the same, cannot lend patentability to applicant’s claims. In re Nelson 1938 CD 708. The examiner maintains that the composition being in dry form cannot lend to the patentability of the invention.
The Applicants assert that the enzyme activity of O'Driscoll is very low. The Examiner disagrees because O'Driscoll is drawn to the preservation of the activity of an enzyme that is contained within a hydrogel especially when it is provided in dried form. The Applicants assert that there is nothing in O'Driscoll leading the compound to be in dry form. The Examiner disagrees because O'Driscoll explicitly discloses improving the stability of enzymes by entrapping them in hydrogels and that the compound is effective in either wet or dry form [col. 1, lines 49- 62]. The Applicants assert that O'Driscoll does not disclose stability from 1 to 30 days. The Examiner notes that O'Driscoll discloses enzyme stability over a 50 day period [fig. 1]. Farneth disclosed stability for 1- 30 days in paragraph 0085].
Further, Applicant is using known components to obtain expected results. There is nothing patentable unless the applicant, by a proper showing, further establishes a coaction or cooperative relationship between the selected ingredients, which produces a new, unexpected, and useful function. It is not seen where Applicant has provided support for unexpected results. In the absence of a showing of unexpected results, the amounts claimed are merely a matter of choice and well within the skill of the art. At most the amounts are seen merely as optimization.
In the absence of unexpected results, it is not seen how the claimed invention differs from the teachings of the prior art. Applicant's claims are drawn to a combination of known components which produces expected results.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Heidenbach EP 2820961 discloses an enzymatic process where a fruit juice is treated with a carbohydrate oxidase and a catalase [abstract]. Heidenbach discloses treating at -10 to 15°C [abstract]. Heidenbach discloses juice containing glucose (an aldohexose).
Merrill (US 2006/0008555) discloses foods treated with an oxidoreductase [0048; abstract]. Merrill specifically discloses pyranose oxidase [0048; 0117]. Merril also discloses the inclusion of a catalase [0022; 0035; 0079]. Merrill discloses the inclusion of reducing sugars including aldohexoses [0049]. Merrill discloses a self-sustaining catalytic cycle involving the oxidoreductase, substrate, and catalase [0120].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
Prosecution Insights