DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This is an office action in response to Applicant's arguments and remarks filed on 11/03/2025. Claims 6, 12, 14, 17, 20, 38, 39, 44, 50, 52, 55, 60, 61, 63, 64, 68, 70, 71, 76, 82, 83, 90-92, 94, and 116-133 are pending in the application and are being examined herein.
Status of Objections and Rejections
3. The rejection of claim 38 under 35 U.S.C. 103 as being unpatentable over Freedman in view of Griesbach is withdrawn in view of Applicant's amendment.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Freedman in view of Griesbach is maintained in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 for new claims 124-133 are necessitated by the amendments.
Response to Arguments
4. In the arguments presented on p.13-15 of the amendment, the Applicant argues that amended claim 6, specifically the limitation of “a moisture trigger that liquifies when contacted by water” is not taught by Freedman in view of Griesbach. Specifically, Griesbach utilizes an acid-releasing agent in order to generate chlorine dioxide.
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive.
The part of Griesbach that is only used to modify Freedman is the application of liquid water as an alternative to the water supply means (i.e., water vapor of Freedman), not the acid-releasing agent of Griesbach. Both liquid water and water vapor would still contribute as the water reactant in the chlorine dioxide generation reaction.
In response to applicant's argument that the acid-modulated chlorine dioxide generation mechanism of Griesbach is not compatible nor taught with Freedman, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Consequently, the amended limitation of the moisture trigger being contacted by water is inherently achieved when the polymer composition is contacted with moisture in liquid form. If the entire polymer composition is contacted with liquid water via Freedman in view of Griesbach, then the moisture trigger also should be contacted by water, as the moisture trigger is a part of the polymer composition.
In the arguments presented on p.15-17 of the amendment, the Applicant argues that a person of ordinary skill would not have a reasonable expectation of success to accomplish claims 14 and 17, because Freedman discloses a process initiated by water vapor. Given that chlorine dioxide release rate triggered by liquid water would be slower than water vapor, the result of chlorine dioxide generation under a water-vapor trigger is not applicable to a liquid water trigger.
Applicant's arguments of claims 14 and 17 have been fully considered but they are not persuasive. Even if the liquid water release rate was slower (e.g., more than 12 hours, which is greater than Freedman’s 11), this would still read on the claimed ranges. The object being sealed for 11 hours still means that the object is sealed at hour 1, 2, 3, up to 11, which overlaps with Applicant’s range.
Furthermore, Freedman is not a standalone reference in this rejection. Modified Freedman (Freedman in view of Griesbach) would teach a liquid water trigger.
In the arguments presented on p.17-18 of the amendment, the Applicant argues that Freedman states the agent is used in a closed system, and has no specificity as to when the contact of the polymer composition with moisture occurs.
Applicant's arguments of claim 44 have been fully considered but they are not persuasive. A closed system cannot be achieved unless the container is sealed (i.e., after closing). Thus, Freedman reciting “the volatile antimicrobial releasing agent is generally used in a closed system” means the agent is not used (i.e., contact with moisture) until the container is sealed.
In the arguments presented on p.18-19 of the amendment, the Applicant argues that the difference between Griesbach’s color change upon formation of an effective amount of chlorine dioxide gas and Applicant’s claim 63 and 119 claim language of color change upon the formation of chlorine dioxide gas is significant. Because the two criteria are not equivalent, there is no relationship between the two parameters.
Applicant's arguments of claim 63 and 119 have been fully considered but they are not persuasive. The term “upon formation of an effective amount of chlorine dioxide” is more specific than “upon formation of chlorine dioxide”. Formation of any amount of chlorine dioxide gas (i.e., an effective amount) is still considered is a formation of chlorine dioxide gas.
In the arguments presented on p.19-20 of the amendment, the Applicant argues that a person of ordinary skill would not expect similar release rates under water-vapor-triggered conditions and liquid-water-triggered conditions, and thus one cannot manipulate the liquification rate of the releasing agent without undue experimentation (as stated in the claim 70 and 121 rejection). Furthermore, the Examiner fails to propose exactly how a person of skill, knowledgeable of Freedman, would be able to manipulate the liquification rate of the antimicrobial releasing agent, with a reasonable expectation of success, and without undue experimentation.
Applicant's arguments of claim 70 and 121 have been fully considered but they are not persuasive. There is no mention of critical parameters of the liquid water moisture trigger such as the volume of liquid water per area/volume of polymer composition in the instant claims. Likewise, Freedman is also silent on the concentration of water vapor supplied to the humidity trigger (e.g., the concentration of water vapor can be extremely high/low). Thus, there is no indication that the resulting chlorine dioxide gas generation from both liquid water and water vapor triggers is truly different because there is no disclosure of the critical parameters responsible for the chlorine dioxide gas generation.
Furthermore, Freedman teaches that “the trigger may be formulated to liquefy upon contact with moisture at different rates” ([0078]). This is a teaching of how the liquification rate can be manipulated, and thus one of ordinary skill would be able to manipulate the liquification rate of the antimicrobial releasing agent, with a reasonable expectation of success, and without undue experimentation.
Because there is no evidence of a difference between the water-vapor and the liquid water moisture in terms of chlorine dioxide gas generation and manipulating the formulation of the trigger, one of ordinary skill can arrive at the claimed range of the peak concentration being between 10 minutes to 2 hours after moisture contact by manipulating the liquification rate of the antimicrobial releasing agent.
In view of these response to arguments of claims 14/17 and 70/121, Applicant’s arguments regarding the claim 71 rejection on p.20 of the amendment and claim 129 on p.26 relying on these other claim rejection arguments is unpersuasive.
In the arguments presented on p.21 of the amendment, the Applicant argues that Kibele fails to teach dipping/submerging the polymer composition into moisture in liquid form.
Applicant’s arguments, see p.21, filed 11/03/2025, with respect to the rejection(s) of claim(s) 38 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Freedman in view of Griesbach, further in view of Anderson et al. (US 20020022050 A1).
In the arguments presented on p.22-23 of the amendment, the Applicant argues that Kibele fails to teach the polymer composition comprising silica gel (as stated in claims 55 and 61). Specifically, nothing in Kibele teaches or suggests that the silica gel desiccant can serve the purpose of the moisture trigger of the instant application.
Applicant's arguments of claim 55 and 61 have been fully considered but they are not persuasive. The silica gel that is being combined into modified Freedman is not the moisture trigger. While it is true that both the moisture trigger and the silica gel absorb moisture, the purpose of incorporating the silica gel into modified Freedman’s polymer composition was to predictably increase the absorption of moisture (i.e., both the silica gel and the moisture trigger absorb moisture, so one of ordinary skill would have incorporated a silica gel desiccant into the polymer composition in order to predictably increase the absorption of moisture).
In the arguments presented on p.24-25 of the amendment, the Applicant argues when addressing claim 124 that secondary reference Griesbach fails to teach a suitable color indicator for chlorine dioxide gas, because Griesbach does not teach that the indicator may be incorporated into a polymer (or function properly even if incorporated).
Applicant's arguments of claim 124 have been fully considered but they are not persuasive. Freedman teaches a colorant ([0043]), and Griesbach in this modification would merely provide additional structure to the colorant and the improvement of showing a color change given an effective amount of chlorine dioxide gas. As discussed in the response to Applicant’s claim 63 and 119 arguments, the term “upon formation of an effective amount of chlorine dioxide” is more specific than “upon formation of chlorine dioxide”. Formation of any amount of chlorine dioxide gas (i.e., an effective amount) is still considered is a formation of chlorine dioxide gas.
In response to applicant's argument that Griesbach does not teach that the indicator may be incorporated into a polymer (or function properly even if incorporated), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Claim Rejections - 35 USC § 112
5. 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.
6. Claim 64 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 64 recites “wherein the color indicator measures the concentration of chlorine dioxide gas inside the container”. It is unclear as to how the color indicator measures the concentration of chlorine dioxide gas. A color indicator can be a proxy for the concentration of chlorine dioxide gas, but direct measurement of concentration is not possible off of qualitative color. The burden is shifted to Applicant to provide evidence on the contrary. The color indicator will be interpreted as a proxy for the concentration of chlorine dioxide gas.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 6, 14, 17, 20, 39, 44, 50, 52, 55, 61, 63-64, 68, 70, 71, 82, 90, and 117-119 and 121-133 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1).
Regarding claim 6, Freedman teaches a method of disinfecting an object (abstract), the method comprising the steps of:
(a) placing the object to be disinfected into a container having an interior space therein (“placing the good in the container”, [0008]), a headspace being formed of a portion of the interior space that is not occupied by the object (“a headspace formed by the interior space that is not occupied by the good”, [0007]);
(b) placing into the interior space a polymer composition (“positioning the at least one entrained polymer article within the interior space of the container”, [0008]) comprising:
(i) a base polymer ([0012]);
(ii) a chlorine dioxide gas forming agent ([0013]) comprising a carrier material (sulfuric acid clay, [0013]); an active compound (sodium chlorite, [0013]); and a moisture trigger (calcium chloride, [0013]); and
(iii) a channeling agent that forms channels though the base polymer ([0037]);
(c) contacting the polymer composition with moisture to form chlorine dioxide gas (“The term “volatile antimicrobial releasing agent” includes any compound that when it comes into contact with a fluid (e.g., water or the juice from a food product), produces a gas and/or gas phase such as vapor of released antimicrobial agent”, to which “preferred antimicrobial releasing agents are volatile antimicrobial agents that release chlorine dioxide (ClO.sub.2) in gas form as the released antimicrobial material”, [0051]); and
(d) enclosing the container sufficiently enough to allow the chlorine dioxide gas to accumulate in the headspace, wherein the chlorine dioxide gas disinfects the object (“a headspace formed by the interior space that is not occupied by the good, and a cover to close and/or seal the container”, with “an antimicrobial releasing agent configured to release a released antimicrobial gas”, [0007]);
wherein the interior space further includes a color indicator (“Optionally, a three phase composition or structure may include an additional phase, e.g., a colorant”, [0043]);
wherein the amount of chlorine dioxide gas in the ambient environment around the container is undetectable the entire time that the method is performed and immediately after removal of the object from the container (the container is sealed during disinfection, [0007], to which during the method the chlorine dioxide gas is separately generated only in the container, [0051]; in the case for immediately after removal of the object from the container, the chlorine dioxide gas is no longer present as shown in hour 102 of Fig. 14 of the chlorine dioxide generating films).
Freedman teaches a color indicator, but fails to teach a color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed, the color indicator being a standalone device that is not part of the polymer composition. Freedman also teaches contacting the polymer composition with moisture to form chlorine dioxide gas, but not of moisture in liquid form.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed (sterilant indicator 13, Fig. 1A-1D, to “provide a visible indication upon exposure to an effective amount of a sterilant”, col. 4, lines 64-66), the color indicator being a standalone device that is not part of the polymer composition (sterilant indicator 13 is a standalone device that is not part of the sterilant generator 9, Fig. 1A-1D).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing colorants.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the colorant/color indicator of Freedman by incorporating a standalone color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed as taught by Griesbach in order to “provide a visible indication upon exposure to an effective amount of a sterilant” (Griesbach, col. 4, lines 64-66).
Griesbach also teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a sterilant activator (19, Fig. 1A-1D) for the sterilant generator (9, Fig. 1A-1D), to which the sterilant activator may be “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior” (col. 5, lines 28-57) for the purpose of chlorine dioxide gas generation (col. 6, lines 23-26).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing moisture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volatile antimicrobial releasing agent/chlorine dioxide generator being activated by moisture of Freedman by incorporating a feature such as activating the chlorine dioxide generator via sprayed liquid water as taught by Griesbach in order to generate a chlorine dioxide gas within the container (Griesbach, col. 6, lines 23-26).
With this modification, modified Freedman would inherently teach “a moisture trigger that liquifies when contacted by water” because the moisture trigger is part of the polymer composition and Freedman in view of Griesbach teaches contacting the polymer composition with liquid water.
Regarding claim 14, modified Freedman teaches wherein the object remains in the sealed container for a period of about 10 minutes to about 10 hours (“For each of the trays, the CIO2 release rate was measured in one-hour intervals over an 11-hour period”, to which the object is still in the sealed container for a period of about 10 minutes to 10 hours, even 11 hours, [00103]).
Regarding claim 17, modified Freedman teaches wherein the object remains in the sealed container for a period of about 10 minutes to about 2 hours (“For each of the trays, the CIO2 release rate was measured in one-hour intervals over an 11-hour period”, to which the object is still in the sealed container for a period of about 10 minutes to 2 hours, even 11 hours, [00103]).
Regarding claim 20, modified Freedman teaches wherein the polymer composition does not physically contact the object within the sealed container (entrained polymer films 114 are disposed on sidewalls 106 and an object would not be physically making contact with a product placed on base 104 due to the existence of a headspace, Fig. 7 and [0070-0071]).
Regarding claim 36, modified Freedman teaches wherein the moisture is water, acetone or an alcohol (“water or the juice from a food product”, [0051]).
Regarding claim 39, Freedman teaches wherein the polymer composition is contacted with moisture (“water or the juice from a food product”, [0051]), but fails to teach wherein the polymer composition is contacted with moisture in liquid form by pouring, spraying or spritzing the moisture onto the polymer composition.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a sterilant activator (19, Fig. 1A-1D) for the sterilant generator (9, Fig. 1A-1D), to which the sterilant activator may be “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior” (col. 5, lines 28-57) for the purpose of chlorine dioxide gas generation (col. 6, lines 23-26).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing moisture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer composition being activated by moisture of Freedman by incorporating a feature such as activating the polymer composition via sprayed liquid water as taught by Griesbach in order to generate a chlorine dioxide gas within the container (Griesbach, col. 6, lines 23-26).
Regarding claim 44, modified Freedman teaches wherein the polymer composition is contacted with the moisture within the container after the container is closed or substantially closed (“the volatile antimicrobial releasing agent is generally used in a closed system so that the released antimicrobial material (gas and/or vapor) does not escape”, [0051]), but fails to teach the moisture being in liquid form.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a sterilant activator (19, Fig. 1A-1D) for the sterilant generator (9, Fig. 1A-1D), to which the sterilant activator may be “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior” (col. 5, lines 28-57) for the purpose of chlorine dioxide gas generation (col. 6, lines 23-26).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing moisture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer composition being activated by moisture of Freedman by incorporating a feature such as activating the polymer composition via sprayed liquid water as taught by Griesbach in order to generate a chlorine dioxide gas within the container (Griesbach, col. 6, lines 23-26).
Regarding claim 50, modified Freedman teaches wherein the concentration of the chlorine dioxide gas forming agent in the polymer composition is about 50% by weight of the total weight of the polymer composition (”the antimicrobial releasing agent loading level or concentration can range from… 45% to 55% by weight with respect to the total weight of the entrained polymer”, [0061]) and wherein the concentration of the channeling agent in the polymer composition is in a range of from 2% to 15% by weight of the total weight of the polymer composition (“the channeling agent may be provided in a range of 2% to 10% by weight”, [0061]).
Regarding claim 52, modified Freedman teaches wherein the distribution of the chlorine dioxide gas forming agent within the polymer composition is essentially homogeneous (the polymer composition is monolithic, [0007], to which “the term "entrained polymer" is defined as a monolithic material formed of at least a base polymer with an active agent and optionally also a channeling agent entrained or distributed throughout”, [0039]).
Regarding claim 63, modified Freedman teaches a colorant/color indicator phase as part of a monolithic entrained polymer ([0043]), but fails to teach wherein the color or shade of at least a portion of the polymer composition prior to contact with moisture is different than the color or shade of the at least a portion of the polymer composition after formation of the chlorine dioxide gas.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed (sterilant indicator 13, Fig. 1A-1D, to “provide a visible indication upon exposure to an effective amount of a sterilant”, col. 4, lines 64-66).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing colorants.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the colorant/color indicator phase of Freedman by incorporating a feature of the colorant that changes color or shade to indicate that chlorine dioxide gas has been formed as taught by Griesbach in order to “provide a visible indication upon exposure to an effective amount of a sterilant” (Griesbach, col. 4, lines 64-66).
Regarding claim 64, Freedman in view of Griesbach teaches wherein the color indicator (Griesbach, sterilant indicator 13, Fig. 1A-1D) measures the concentration of chlorine dioxide gas inside the container (“Sterilant indicator 13 may also be composed of multiple indicia materials that are responsive to varying concentrations of sterilants such as chlorine dioxide”, col.5, lines 22-24, for the modification purposes stated in claim 6 rejection above).
Regarding claim 68, modified Freedman teaches wherein the polymer composition and/or the chlorine dioxide gas forming agent is coated with at least one extended release coating or layer to effectuate a pre-determined release profile of the chlorine dioxide gas within the closed container (“the agent may be coated with extended release coatings of varying thicknesses and/or properties to achieve the desired release profile”, [0076]).
Regarding claim 70, Freedman teaches wherein a peak concentration of chlorine dioxide gas in the container is reached after contact with moisture at 18 hours (X2597 4g, Fig. 14, see [00125]), but fails to teach in a period of from 10 minutes to 2 hours.
Freedman further teaches that “a controlled release and/or desired release profile may be achieved by modifying the formulation of the trigger of the antimicrobial releasing agent. For example, the trigger, when contacted by moisture, liquefies and then reacts with the active component (e.g., sodium chlorite) to cause release of the antimicrobial gas. The trigger may be formulated to liquefy upon contact with moisture at different rates. The faster the trigger liquefies, the faster the release of antimicrobial gas and vice versa”.
Knowing the manipulability of the release profile of the polymer composition, it would have been obvious to one of ordinary skill in the art to have had a reasonable expectation of success to arrive at the claimed limitation of a peak concentration of chlorine dioxide gas between a period of 10 minutes to 2 hours from the original 18 hour peak by manipulating the trigger liquification rate of the antimicrobial releasing agent, yielding the predictable result of quicker sterilization.
Regarding claim 71, modified Freedman teaches wherein the concentration of chlorine dioxide gas formed in the container effectuates a reduction of at least one type of infectious agent contained on the object to be disinfected, the reduction being at least a 4 log base 10 reduction in colony forming units per gram (CFU/g) compared to the initial number of colony forming units of the at least one type of infectious agent at ambient temperature (4 log reduction in CFU/g on pathogens at ambient temperature of 7°C, [0010]).
Regarding claim 80, modified Freedman teaches wherein the level of disinfection renders the object sterilized pursuant to guidelines for sterilization set forth by the United States Centers for Disease Control pursuant to the Code of Federal Regulations, Title 21, Section 110.3(o) (the object is adequately treated by the 4 log reduction in CFU/g on pathogens at ambient temperature of 7°C, [0010]).
Regarding claim 82, modified Freedman teaches wherein the object to be disinfected is a medical device (“the solutions disclosed herein may be adapted for use in sterilization of disposable medical devices”, [0087]).
Regarding claim 90, modified Freedman teaches the use in a package for the distribution and/or storage of a product (“when the product is provided within the interior space and under storage conditions of 7°C”, [0010]).
Regarding claim 117, modified Freedman teaches wherein the polymer composition does not physically contact the object to be disinfected (entrained polymer films 114 are disposed on sidewalls 106 and an object would not be physically making contact with a product placed on base 104 due to the existence of a headspace, Fig. 7 and [0070-0071]); and
the object to be disinfected is a medical device (“the solutions disclosed herein may be adapted for use in sterilization of disposable medical devices”, [0087]).
Regarding claim 118, Freedman teaches wherein the container is a sealable chamber with an openable door that is locked shut to seal the object within the chamber during disinfection (“the package or container may be closed, covered and/or sealed using a variety of mechanisms including a cover, a lid, lidding sealant, an adhesive and a heat seal, for example”, [0044]).
Regarding claim 119, Freedman teaches a colorant/color indicator phase as part of a monolithic entrained polymer ([0043]), but fails to teach wherein the color or shade of at least a portion of the polymer composition prior to contact with moisture is different than the color or shade of the at least a portion of the polymer composition after formation of the chlorine dioxide gas.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed (sterilant indicator 13, Fig. 1A-1D, to “provide a visible indication upon exposure to an effective amount of a sterilant”, col. 4, lines 64-66).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing colorants.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the colorant/color indicator phase of Freedman by incorporating a feature of the colorant that changes color or shade to indicate that chlorine dioxide gas has been formed as taught by Griesbach in order to “provide a visible indication upon exposure to an effective amount of a sterilant” (Griesbach, col. 4, lines 64-66).
Regarding claim 121, Freedman teaches wherein a peak concentration of chlorine dioxide gas in the container is reached after contact with moisture at 18 hours (X2597 4g, Fig. 14, see [00125]), but fails to teach in a period of from 10 minutes to 2 hours.
Freedman further teaches that “a controlled release and/or desired release profile may be achieved by modifying the formulation of the trigger of the antimicrobial releasing agent. For example, the trigger, when contacted by moisture, liquefies and then reacts with the active component (e.g., sodium chlorite) to cause release of the antimicrobial gas. The trigger may be formulated to liquefy upon contact with moisture at different rates. The faster the trigger liquefies, the faster the release of antimicrobial gas and vice versa”.
Knowing the manipulability of the release profile of the polymer composition, it would have been obvious to one of ordinary skill in the art to have had a reasonable expectation of success to arrive at the claimed limitation of a peak concentration of chlorine dioxide gas between a period of 10 minutes to 2 hours from the original 18 hour peak by manipulating the trigger liquification rate of the antimicrobial releasing agent, yielding the predictable result of quicker sterilization.
Regarding claim 122 and 123, modified Freedman teaches wherein the trigger is calcium chloride (calcium chloride, [0013]).
Regarding claim 124, Freedman teaches a method of disinfecting an object (abstract), the method comprising the steps of:
(a) placing the object to be disinfected into a container having an interior space therein (“placing the good in the container”, [0008]), a headspace being formed of a portion of the interior space that is not occupied by the object (“a headspace formed by the interior space that is not occupied by the good”, [0007]);
(b) placing into the interior space a polymer composition (“positioning the at least one entrained polymer article within the interior space of the container”, [0008]) comprising:
(i) a base polymer ([0012]);
(ii) a chlorine dioxide gas forming agent ([0013]) comprising a carrier material (sulfuric acid clay, [0013]); an active compound (sodium chlorite, [0013]); and a moisture trigger (calcium chloride, [0013]); and
(iii) a channeling agent that forms channels though the base polymer ([0037]);
(c) contacting the polymer composition with moisture to form chlorine dioxide gas (“The term “volatile antimicrobial releasing agent” includes any compound that when it comes into contact with a fluid (e.g., water or the juice from a food product), produces a gas and/or gas phase such as vapor of released antimicrobial agent”, to which “preferred antimicrobial releasing agents are volatile antimicrobial agents that release chlorine dioxide (ClO.sub.2) in gas form as the released antimicrobial material”, [0051]); and
(d) enclosing the container sufficiently enough to allow the chlorine dioxide gas to accumulate in the headspace, wherein the chlorine dioxide gas disinfects the object (“a headspace formed by the interior space that is not occupied by the good, and a cover to close and/or seal the container”, with “an antimicrobial releasing agent configured to release a released antimicrobial gas”, [0007]);
wherein the interior space further includes a color indicator (“Optionally, a three phase composition or structure may include an additional phase, e.g., a colorant”, [0043]).
Freedman teaches a color indicator, but fails to teach wherein the color or shade of at least a portion of the polymer composition prior to contact with moisture is different than the color or shade of the at least a portion of the polymer composition after formation of the chlorine dioxide gas. Freedman also teaches contacting the polymer composition with moisture to form chlorine dioxide gas, but not of moisture in liquid form.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed (sterilant indicator 13, Fig. 1A-1D, to “provide a visible indication upon exposure to an effective amount of a sterilant”, col. 4, lines 64-66).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing colorants.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the colorant/color indicator composition portion of Freedman by incorporating a color indicator that changes color or shade to indicate that chlorine dioxide gas has been formed as taught by Griesbach in order to “provide a visible indication upon exposure to an effective amount of a sterilant” (Griesbach, col. 4, lines 64-66).
With this modification, the modified colorant portion (incorporating Griesbach’s sterilant indicator) of the polymer composition of modified Freedman teaches the color or shade of at least a portion of the polymer composition being different prior than after chlorine dioxide gas formation.
Griesbach also teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a sterilant activator (19, Fig. 1A-1D) for the sterilant generator (9, Fig. 1A-1D), to which the sterilant activator may be “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior” (col. 5, lines 28-57) for the purpose of chlorine dioxide gas generation (col. 6, lines 23-26).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing moisture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volatile antimicrobial releasing agent/chlorine dioxide generator being activated by moisture of Freedman by incorporating a feature such as activating the chlorine dioxide generator via sprayed liquid water as taught by Griesbach in order to generate a chlorine dioxide gas within the container (Griesbach, col. 6, lines 23-26).
With this modification, modified Freedman would inherently teach “a moisture trigger that liquifies when contacted by water” because the moisture trigger is part of the polymer composition and Freedman in view of Griesbach teaches contacting the polymer composition with liquid water.\
Regarding claim 125, modified Freedman teaches wherein the concentration of the chlorine dioxide gas forming agent in the polymer composition is about 50% by weight of the total weight of the polymer composition (”the antimicrobial releasing agent loading level or concentration can range from… 45% to 55% by weight with respect to the total weight of the entrained polymer”, [0061]) and wherein the concentration of the channeling agent in the polymer composition is in a range of from 2% to 15% by weight of the total weight of the polymer composition (“the channeling agent may be provided in a range of 2% to 10% by weight”, [0061]).
Regarding claim 126, modified Freedman teaches wherein the object remains in the sealed container for a period of about 10 minutes to about 2 hours (“For each of the trays, the CIO2 release rate was measured in one-hour intervals over an 11-hour period”, to which the object is still in the sealed container for a period of about 10 minutes to 2 hours, even 11 hours, [00103]).
Regarding claims 127 and 128, modified Freedman teaches wherein the trigger is calcium chloride (calcium chloride, [0013]).
Regarding claim 129, Freedman teaches a method of disinfecting an object (abstract), the method comprising the steps of:
(a) placing the object to be disinfected into a container having an interior space therein (“placing the good in the container”, [0008]), a headspace being formed of a portion of the interior space that is not occupied by the object (“a headspace formed by the interior space that is not occupied by the good”, [0007]);
(b) placing into the interior space a polymer composition (“positioning the at least one entrained polymer article within the interior space of the container”, [0008]) comprising:
(i) a base polymer ([0012]);
(ii) a chlorine dioxide gas forming agent ([0013]) comprising a carrier material (sulfuric acid clay, [0013]); an active compound (sodium chlorite, [0013]); and a moisture trigger (calcium chloride, [0013]); and
(iii) a channeling agent that forms channels though the base polymer ([0037]);
(c) contacting the polymer composition with moisture to form chlorine dioxide gas (“The term “volatile antimicrobial releasing agent” includes any compound that when it comes into contact with a fluid (e.g., water or the juice from a food product), produces a gas and/or gas phase such as vapor of released antimicrobial agent”, to which “preferred antimicrobial releasing agents are volatile antimicrobial agents that release chlorine dioxide (ClO.sub.2) in gas form as the released antimicrobial material”, [0051]); and
(d) enclosing the container sufficiently enough to allow the chlorine dioxide gas to accumulate in the headspace, wherein the chlorine dioxide gas disinfects the object (“a headspace formed by the interior space that is not occupied by the good, and a cover to close and/or seal the container”, with “an antimicrobial releasing agent configured to release a released antimicrobial gas”, [0007]).
Regarding the limitation “wherein a peak concentration of chlorine dioxide gas in the container is reached after contact with moisture in a period of from 10 minutes to 2 hours", Freedman further teaches that “a controlled release and/or desired release profile may be achieved by modifying the formulation of the trigger of the antimicrobial releasing agent. For example, the trigger, when contacted by moisture, liquefies and then reacts with the active component (e.g., sodium chlorite) to cause release of the antimicrobial gas. The trigger may be formulated to liquefy upon contact with moisture at different rates. The faster the trigger liquefies, the faster the release of antimicrobial gas and vice versa” ([0078]).
Knowing the manipulability of the release profile of the polymer composition, it would have been obvious to one of ordinary skill in the art to have had a reasonable expectation of success to arrive at the claimed limitation of a peak concentration of chlorine dioxide gas between a period of 10 minutes to 2 hours from the original 18 hour peak by manipulating the trigger liquification rate of the antimicrobial releasing agent, yielding the predictable result of quicker sterilization.
Modified Freedman also teaches contacting the polymer composition with moisture to form chlorine dioxide gas, but not of moisture in liquid form.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a sterilant activator (19, Fig. 1A-1D) for the sterilant generator (9, Fig. 1A-1D), to which the sterilant activator may be “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior” (col. 5, lines 28-57) for the purpose of chlorine dioxide gas generation (col. 6, lines 23-26).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing moisture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volatile antimicrobial releasing agent/chlorine dioxide generator being activated by moisture of Freedman by incorporating a feature such as activating the chlorine dioxide generator via sprayed liquid water as taught by Griesbach in order to generate a chlorine dioxide gas within the container (Griesbach, col. 6, lines 23-26).
With this modification, modified Freedman would inherently teach “a moisture trigger that liquifies when contacted by water” because the moisture trigger is part of the polymer composition and Freedman in view of Griesbach teaches contacting the polymer composition with liquid water.
Regarding claim 130, modified Freedman teaches wherein the concentration of the chlorine dioxide gas forming agent in the polymer composition is about 50% by weight of the total weight of the polymer composition (”the antimicrobial releasing agent loading level or concentration can range from… 45% to 55% by weight with respect to the total weight of the entrained polymer”, [0061]) and wherein the concentration of the channeling agent in the polymer composition is in a range of from 2% to 15% by weight of the total weight of the polymer composition (“the channeling agent may be provided in a range of 2% to 10% by weight”, [0061]).
Regarding claim 131, modified Freedman teaches wherein the object remains in the sealed container for a period of about 10 minutes to about 2 hours (“For each of the trays, the CIO2 release rate was measured in one-hour intervals over an 11-hour period”, to which the object is still in the sealed container for a period of about 10 minutes to 2 hours, even 11 hours, [00103]).
Regarding claims 132 and 133, modified Freedman teaches wherein the trigger is calcium chloride (calcium chloride, [0013]).
9. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claim 6 above, and further in view of Fujita et al. (US 20150284249 A1).
Regarding claim 12, modified Freedman teaches wherein the container is a polypropylene or polyethylene plastic resealable storage bag (“A pouch or flexible bag may be made from, e.g., polypropylene or polyethylene. The package or container may be closed, covered and/or sealed using a variety of mechanisms including a cover, a lid, lidding sealant, an adhesive and a heat seal, for example. The package or container is composed or constructed of various materials, such as plastic (e.g., polypropylene or polyethylene)”, [0044]) having an interior volume of about one quart to about two gallons (see claim 13), but fails to teach the bag being a zipper bag.
Fujita teaches a gas tight zipper bag (bag 30 having zipper 30r, where bag is made of polyethylene, Fig. 3 and see [0063] and [0067]) that contains a chlorine dioxide gas generator (1, Fig. 3) for the purpose of sterilizing (abstract).
Modified Freedman and Fujita are both considered to be analogous to the claimed invention because they are in the same field of plastic bags having chlorine dioxide gas generators for the purpose of sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plastic bag of modified Freedman with a plastic zipper bag as taught by Fujita because the substitution of this feature yields the predictable result of storing the object.
10. Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claim 6 above, and further in view of Anderson et al. (US 20020022050 A1).
Regarding claim 38, Freedman in view of Griesbach teaches wherein the polymer composition is contacted with moisture (Griesbach, “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior”, col. 5, lines 28-57 for the modification purposes as stated in claim 6 rejection above), but fails to teach wherein the polymer composition is contacted by submerging or dipping the polymer composition therein.
Anderson teaches a chlorine-dioxide generating polymer composition (wiper, abstract), where the chlorine dioxide is generated when contacted with water ([0057]), specifically exemplifying an instance of contact such as "washing and rinsing" ([0040]), which is a form of submerging the polymer composition into water.
The Freedman/Griesbach combination and Anderson are both considered to be analogous to the claimed invention because they are in the same field of chlorine-dioxide generating polymer compositions when contacted with water.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Griesbach’s teachings of spraying liquid water onto the polymer composition of Freedman with simply submerging and washing the polymer composition in liquid water, because this substitution yields the predictable result of chlorine dioxide gas generation. Both are a form of contacting the polymer composition with liquid water, and are thus interchangeable.
11. Claim 55 and 61 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claim 6 above, and further in view of Kibele (US 20190270069 A1).
Regarding claim 55, modified Freedman teaches the polymer composition (see claim 6 rejection above), but fails to teach wherein the polymer composition comprises silica gel.
Kibele teaches a polymer composition having a base polymer and an active agent (abstract), to which the active agent can be a silica gel to function as a desiccant ([0043]), but also releasing agent such as chlorine dioxide releasing agents. In the context of Freedman, it is important to note that the chlorine dioxide releasing agent also absorbs moisture in order to provide a reaction that produces chlorine dioxide gas ([0014], inherently the reaction producing chlorine dioxide gas is not possible unless moisture is a reactant, thus making the chlorine dioxide releasing agent a desiccant as well).
Modified Freedman and Kibele are both considered to be analogous to the claimed invention because they are in the same field of entrained polymer films having chlorine dioxide generating agents.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the polymer composition of modified Freedman having a chlorine dioxide gas releasing agent with silica gel as taught by Kibele because this combination would yield the predictable result of absorbing moisture (i.e., desiccant).
Regarding claim 61, modified Freedman teaches wherein the polymer composition comprises sodium chlorite ([0013]), calcium chloride ([0013]), ethylene vinyl acetate ([0035]), and polyethylene glycol ethyl vinyl acetate ([0035]), but fails to teach wherein the polymer composition comprises silica gel.
Kibele teaches a polymer composition having a base polymer and an active agent (abstract), to which the active agent can be a silica gel to function as a desiccant ([0043]), but also releasing agent such as chlorine dioxide releasing agents. In the context of Freedman, it is important to note that the chlorine dioxide releasing agent also absorbs moisture in order to provide a reaction that produces chlorine dioxide gas ([0014]; the reaction producing chlorine dioxide gas is not possible unless moisture is a reactant, thus making the chlorine dioxide releasing agent a desiccant as well).
Modified Freedman and Kibele are both considered to be analogous to the claimed invention because they are in the same field of entrained polymer films having chlorine dioxide generating agents.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the polymer composition of modified Freedman having a chlorine dioxide gas releasing agent with silica gel as taught by Kibele because this combination would yield the predictable result of absorbing moisture (i.e., desiccant).
12. Claims 92, 94, and 118 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claims 6 and 117 above, and further in view of Park et al. (US 20160206767 A1).
Regarding claim 92, modified Freedman teaches wherein the container is a sealable chamber with an openable door to seal the object within the chamber during disinfection (“the package or container may be closed, covered and/or sealed using a variety of mechanisms including a cover, a lid, lidding sealant, an adhesive and a heat seal, for example”, [0044]), but fails to teach the door being operable to be locked shut.
Park teaches a sterilization chamber utilizing chlorine dioxide (2, Fig. 1, and abstract) for the sterilization of objects such as medical instruments ([0010]) having a “door locking device for the door to be opened or closed only when the gaseous chlorine dioxide remaining in the chamber after the sterilization is completed” ([0014]).
Modified Freedman and Park are both considered to be analogous to the claimed invention because they are in the same field of sterilizing contents in chlorine dioxide sterilization containers/enclosures/packages.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container having an openable door/lid of modified Freedman by incorporating a door locking device as taught by Park in order to only be opened “when the gaseous chlorine dioxide remaining in the chamber after the sterilization is completed, is completely removed” (Park, [0014]).
Regarding claim 94, modified Freedman teaches the method of chlorine dioxide gas generation within a container (see claim 6 rejection above), but fails to teach a chlorine dioxide gas sensor within the chamber configured to detect chlorine dioxide gas concentration within the chamber, the sensor being configured to transmit a signal indicative of the chlorine dioxide gas concentration within the chamber at a given time to a readout display, wherein the door is configured not to unlock until detected concentration of chlorine dioxide within the chamber has reached a predetermined safe level for human exposure.
Park teaches a sterilization chamber utilizing chlorine dioxide (2, Fig. 1, and abstract) for the sterilization of objects such as medical instruments ([0010]) having a chlorine dioxide gas sensor within the chamber configured to detect chlorine dioxide gas concentration within the chamber (a photoionization detecting part 4, Fig. 2, measures the concentration of a gaseous chlorine dioxide in the chamber, [0011]),
the sensor being configured to transmit a signal indicative of the chlorine dioxide gas concentration within the chamber at a given time to a readout display, wherein the door is configured not to unlock until detected concentration of chlorine dioxide within the chamber has reached a predetermined safe level for human exposure (“The electronic control part 5 is able to convert a sterilization condition set on the operation panel and a concentration measurement value of the wet gaseous chlorine dioxide received from the photoionization detecting sensor into an electrical signal and display the converted electrical signal [operation panel 7, Fig. 1]… and is able to control a door locking device for the door to be opened or closed only when the gaseous chlorine dioxide remaining in the chamber after the sterilization is completed”, Fig. 1 and [0014]).
Modified Freedman and Park are both considered to be analogous to the claimed invention because they are in the same field of sterilizing contents in chlorine dioxide sterilization containers/enclosures/packages.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container having an openable door/lid of modified Freedman by incorporating Park’s teaching of an electronic control part in order to transmit the sensor concentration signal to a display/operation panel and the teaching of locking the door until the concentration of chlorine dioxide gas is completely removed (Park, [0014]).
Regarding claim 118, modified Freedman teaches wherein the container is a sealable chamber with an openable door to seal the object within the chamber during disinfection (“the package or container may be closed, covered and/or sealed using a variety of mechanisms including a cover, a lid, lidding sealant, an adhesive and a heat seal, for example”, [0044]), but fails to teach the door being operable to be locked shut.
Park teaches a sterilization chamber utilizing chlorine dioxide (2, Fig. 1, and abstract) for the sterilization of objects such as medical instruments ([0010]) having a “door locking device for the door to be opened or closed only when the gaseous chlorine dioxide remaining in the chamber after the sterilization is completed” ([0014]).
Modified Freedman and Park are both considered to be analogous to the claimed invention because they are in the same field of sterilizing contents in chlorine dioxide sterilization containers/enclosures/packages.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container having an openable door/lid of modified Freedman by incorporating a door locking device as taught by Park in order to only be opened “when the gaseous chlorine dioxide remaining in the chamber after the sterilization is completed, is completely removed” (Park, [0014]).
13. Claims 76 and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claim 6 above, further in view of Suzue et al. (WO 2019004137 A1).
Regarding claim 76, modified Freedman teaches a method of disinfecting an object having pathogens ([0010], which includes Salmonella, E. Coli, Listeria and/or Geotrichum), but fails to specifically teach a norovirus.
Suzue teaches a method of disinfecting contents within a closed space via chlorine dioxide (abstract), where the chlorine dioxide has a broad sterilization capability against contaminants such as “E. coli and Salmonella… viruses such as influenza virus, norovirus, HIV, hepatitis B virus” (see p.2, 5th to last paragraph of English translation).
Modified Freedman and Suzue are both considered to be analogous to the claimed invention because they are in the same field of sterilizing contents in chlorine dioxide sterilization containers/enclosures/packages.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of disinfecting an object having pathogens such as E. coli of Freedman by incorporating noroviruses as part of the method of disinfecting as taught by Suzue because chlorine dioxide gas a broad sterilization capability against contaminants (Suzue, see p.2, 5th to last paragraph of English translation).
Regarding claim 116, modified Freedman teaches a method of disinfecting an object having pathogens ([0010], which includes Salmonella, E. Coli, Listeria and/or Geotrichum), but fails to specifically teach a hepatitis virus.
Suzue teaches a method of disinfecting contents within a closed space via chlorine dioxide (abstract), where the chlorine dioxide has a broad sterilization capability against contaminants such as “E. coli and Salmonella… viruses such as influenza virus, norovirus, HIV, hepatitis B virus” (see p.2, 5th to last paragraph of English translation).
Modified Freedman and Suzue are both considered to be analogous to the claimed invention because they are in the same field of sterilizing contents in chlorine dioxide sterilization containers/enclosures/packages.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of disinfecting an object having pathogens such as E. coli of Freedman by incorporating a hepatitis virus as part of the method of disinfecting as taught by Suzue because chlorine dioxide gas has a broad sterilization capability against contaminants (Suzue, see p.2, 5th to last paragraph of English translation).
14. Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claim 82 above, further in view of Aoyagi (US 20030136426 A1).
Regarding claim 83, modified Freedman teaches wherein the object to be disinfected is a medical device (see claim 82 rejection above), but fails to specifically teach an endoscope being the medical device.
Aoyagi teaches a method of sterilizing medical equipment, specifically endoscopes ([0030]) utilizing chlorine dioxide gas to destroy pathogens (chlorine dioxide supply 20, Fig. 2, [0028] and [0030]) in a container (16, Fig. 2).
Modified Freedman and Aoyagi are both considered to be analogous to the claimed invention because they are in the same field of sterilizing medical devices in chlorine dioxide sterilization enclosures.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of disinfecting a medical device of Freedman by incorporating an endoscope as the medical device being disinfected as taught by Aoyagi because endoscopes require sterilization after each use (Aoyagi, [0004]).
15. Claim 120 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (WO 2018089933 A1), further in view of Griesbach et al. (US 6767509 B1), as applied to claim 117 above, further in view of Hekal (US 6613405 B1).
Regarding claim 120, Freedman teaches wherein the polymer composition is contacted with the moisture in when being placed into the container (“water or the juice from a food product”, [0051]), but fails to teach the moisture being in liquid form and wherein the polymer composition is contacted with the liquid moisture prior to being placed in the container.
Griesbach teaches a self-sterilizing packaging (sterilization system 1, Fig. 1A-1D) having a sterilant activator (19, Fig. 1A-1D) for the sterilant generator (9, Fig. 1A-1D), to which the sterilant activator may be “a fabric pad or web holding a supply of water, [or] a device that directly releases a water spray mist within the package interior” (col. 5, lines 28-57) for the purpose of chlorine dioxide gas generation (col. 6, lines 23-26).
Freedman and Griesbach are both considered to be analogous to the claimed invention because they are in the same field of sterilizing objects placed in chlorine dioxide sterilization containers/enclosures/packages utilizing moisture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volatile antimicrobial releasing agent/chlorine dioxide generator being activated by moisture of Freedman by incorporating a feature such as activating the chlorine dioxide generator via sprayed liquid water as taught by Griesbach in order to generate a chlorine dioxide gas within the container (Griesbach, col. 6, lines 23-26).
Hekal teaches a monolithic composition having a water-insoluble polymer and a deliquescent material formed into a film (abstract, Fig. 2) in order to absorb water (col. 2, lines 41-58), where the deliquescent material is pre-loaded to a specific hydrate level prior to inserting into the package in order to maintain the relative humidity in the package at a predetermined level (see col.7, lines 55-61).
Modified Freedman and Hekal are both considered to be analogous to the claimed invention because they are in the same field of monolithic polymer film compositions having a water-insoluble polymer and a deliquescent material (deliquescent materials absorb water vapor, see col.8, lines 37-39 of Hekal, wherein the sodium chlorite salt of Freedman inherently absorbs water via the generation of chlorine dioxide gas).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify contacting the polymer composition with liquid moisture in the container of the Freedman/Griesbach combination by incorporating pre-loading the polymer film having the deliquescent to a specific hydrate level as taught by Hekal in order to maintain the relative humidity in the package at a predetermined level (Hekal, col.7, lines 55-61).
Allowable Subject Matter
16. Claims 60 and 91 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 60, the prior art, alone or in combination, fails to teach or fairly suggest the structural limitations of the present claim. The closest prior art to the claimed invention (Freedman – of record) is set forth above but does not teach or suggest wherein the chlorine dioxide gas forming agent consists essentially of from 10% to 15% sodium chlorite, from 5% to 15% calcium chloride, and from 70% to 80% silica gel by weight based on the total weight of the chlorine dioxide gas forming agent, wherein the chlorine dioxide gas forming agent and/or the silica gel has a pH of from 1.4 to 3.1. Freedman teaches sodium chlorite (active agent), calcium chloride (humidity trigger), and sulfuric acid clay (catalyst), but is short on the limitations of the silica gel wherein the chlorine dioxide gas forming agent and/or the silica gel has a pH of from 1.4 to 3.1, and the specific percentages by weight of each of the components.
Regarding claim 91, the prior art, alone or in combination, fails to teach or fairly suggest the structural limitations of the present claim. The closest prior art to the claimed invention (Freedman – of record) is set forth above but does not teach or suggest wherein the moisture is applied to the polymer composition via a wet roller mechanism during an in-line packaging process. Freedman in view of Griesbach teaches wherein the moisture of liquid form is applied to the polymer composition (see claim 6 rejection above), but is short on the concept of utilizing a wet roller mechanism to apply the moisture during an in-line packaging process.
Conclusion
17. 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.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aham Lee whose telephone number is (703)756-5622. The examiner can normally be reached Monday to Thursday, 10:00 AM - 8:00 PM EST.
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/Aham Lee/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758