DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 20, 2026 has been entered.
Response to Amendment
Those objections and rejections that are not repeated in this Office Action have been withdrawn.
Claims 1, 10-14, 20, 21 and 24-28 are pending and rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 10-14, 20, 21, 24-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 14 recite the limitation, “approximately 254 nm.” This limitation was presented in claim 14 in the reply filed 5/15/2025. This limitation is new matter because applicant’s original disclosure does not discuss the wavelength of approximately 254 nm. Page 23, line 8, page 31, line 1 and page 34, lines 12 and 15 of the specification as filed only disclose a wavelength of 254 nm and not “approximately” 254 nm. Therefore, the limitation is new matter since it would allow for a wavelength that would have been broader than what was originally disclosed.
Claims 10-14, 20, 21 and 24-28 are rejected based on their dependence to a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 10-14, 20, 21 and 24-26 are rejected under 35 U.S.C. 103 as being anticipated by Elowe (WO 2017027560 – cited on IDS) in view of Pattanayaiying (“Incorporation of nisin Z and lauric arginate into pullulan films to inhibit foodborne pathogens associated with fresh and ready-to-eat muscle foods”), Trinetta (“Pullulan: A suitable biopolymer for antimicrobial food packaging applications”- cited on IDS) and Carroll (US 20060073190) and in further view of Ylitalo (US 20090155451) and in further view of “UV Disinfection for Food Packaging, Cleanroom Technology”, Dudenhoeffer (US 5302402), Martin (US 20190300718) and “Ultraviolet.com”
Regarding claim 1, Elowe discloses an antimicrobial material for use in food packaging (see the abstract), the antimicrobial material comprising: i) a first layer (see the abstract, “dry film layer”) that includes a combination of ingredients including an antimicrobial agent and a carrier (see at least the abstract). Elowe discloses that this layer can further comprise gelatin (see page 17, lines 21-23; page 18, line 4), xanthan gum (see page 18, line 5; page 22, lines 9-16, “combinations of those described herein”), glycerol (see page 23, line 1), and an effective amount of lauric arginate (page 11, lines 14-19; see page 14, lines 16-19). Applicant’s specification also refers to “Lauric arginate” as LAE (see page 2, line 18)
Elowe also teaches that the dry film layer can absorb moisture and where an aqueous solution can be cast, thus teaching the first layer comprising water (see page 17, lines 18-19; page 21, lines 5-14).
Elowe’s above discussed film layer can also be construed as a biopolymer film because Elowe also teaches polymeric polysaccharide carriers such as methylcellulose (see page 21, lines 12-16) and which layer contacts food (see page 5, lines 8-11). Elowe’s disclosure of using xanthan gum and pectin, for example, also teaches film forming components as part of the first layer, which are polysaccharide biopolymers. Applicant’s specification also refers to polysaccharide biopolymer (see at least, page 5, lines 28-29).
Elowe teaches ii) a second layer comprising a polyethylene (see page 24, lines 15-23 which discloses polyethylene as the substrate; see also page 27, lines 7-15 and page 28, lines 16-22 which disclose a polyethylene substrate).
Elowe teaches that the dry film layer is applied and adhered to the second polyethylene layer (see page 5, line 12-15: “adheres to the substrate (e.g., a packaging film)”).
While Elowe teaches water soluble polysaccharides such as pectin, guar gum and cellulose ethers (page 18, lines 3-26), claim 1 differs in specifically reciting the first layer comprising pullulan.
Pattanayaiying teaches that it has been desirable to combine antimicrobial agents such as lauric arginate together with pullulan to form a film (see page 78, section 2.3 where pullulan and LAE are combined and subsequently cast). Like the film forming agents as taught by Elowe, pullulan is also a film forming polysaccharide (see page 77, left column, 2nd to last line) and has good solubility in water (see page 77, right column, lines 2-3), and is strong and exhibits low permeability against oil and oxygen (see page 77, right column, lines 10-13).
Additionally, Trinetta teaches using pullulan in combination with antimicrobial agents (see page 392, table 4, raw beef). Trinetta also teaches that pullulan based films work well when incorporated with active antimicrobial compounds (see page 394, lines 1-9) and which can allow less antimicrobials to be used for pathogen inhibition, while prolonging inhibitory activity and allowing for a controlled migration of the antimicrobial compound from the film to the food product (see page 394, 3rd paragraph which is directly above section 30.5). Trinetta also teaches that pullulan has high film forming ability, considerable mechanical strength and the ability to form thin layers, while also being water soluble and flexible (see page 385, 2nd paragraph of section 30.2). Water solubility is also what Elowe desires (see at least, page 16, lines 3-8).
Carroll also evidences that pullulan as well as the film forming agents taught by Elowe can be used for making a film more elastic or pliable, and aid in the ability of forming a thin film or dryable film that can be manipulated during processing and sealed (see paragraph 18, for example: “A hydrocolloid or gum can function to soften or make the film more elastic or pliable during production or aid in the ability of the low viscosity polymer to form a thin film or dryable film that can be manipulated during processing and sealed…”).
In view of the teachings of Pattanayaiying, Trinetta and Carroll who are all directed to similar types of packaging films, it would therefore have been obvious to one having ordinary skill in the art to have modified Elowe and to have used pullulan as part of the first layer comprising the at least one antimicrobial agent, for the purpose of providing a film layer that has high forming ability, considerable mechanical strength and the ability to form thin layers while also being water soluble and flexible and can reduce the amount of antimicrobial agent needed for pathogen inhibition while prolonging inhibitory activity and allowing for a controlled migration of Elowe’s antimicrobial compound from the film to the food product. In view of this combination, the prior art is further teaching and suggesting a biopolymer film.
Regarding the thickness of the first layer, Elowe teaches a thickness of 0.3mil (7.6 microns) or greater (see page 24, lines 7-9) which would therefore overlap with the claimed range.
However, the claim differs from the above combination in specifically reciting, “wherein the second layer has been exposed to ultraviolet light having a wavelength of approximately 254nm prior to adhering the first layer to the second layer and wherein the first layer has a thickness of approximately 40 microns to about 50 microns.”
Regarding the specific thickness, Ylitalo (US 20090155451) teaches antimicrobial film layers (see figure 1, item 10 and paragraph 61) and which antimicrobial layer has been applied to a substrate layer 12 (see figure 1 and 2, item 12). Ylitalo further teaches that the antimicrobial layer can have a thickness of 50 microns (see paragraph 57) for the purpose of providing a suitable degree of the antimicrobial agent to the surface of the substrate (see paragraph 54).
To therefore modify the combination and to apply Elowe’s antimicrobial first layer with a thickness of 50 microns would have been obvious to one having ordinary skill in the art, for the purpose of providing the requisite degree of antimicrobial agent to the surface of Elowe’s packaging film.
Regarding the second layer being exposed to UV light with a wavelength of approximately 254nm prior to adhering the first layer, Elowe further teaches altering the surface energy of the substrate layer for improving the wetting and/or adhesion characteristics (see page 7, lines 1-9), but the claim differs in specifically reciting that the second layer has been exposed to ultraviolet light at approximately 254 nm prior to application of the first layer.
However, Cleanroom Technology teaches that UV irradiation is an environmentally friendly and economical method of disinfecting packaging materials (see page 1, first paragraph). Dudenhoeffer also teaches that a known expedient for controlling surface energy, or the wetting tension of films, is to use expedients such as corona discharge as well as ultraviolet treatment (see column 6, lines 3-19) and where the film can be a polyethylene film (see column 3, lines 35-48).
While the above combination does not specifically recite a wavelength of 254nm, Martin teaches that UV treatment of films at 254nm has been a conventional expedient to activate the surface of the film to improve adhesion (see paragraph 100) and Ultraviolet.com also teaches that UV treatment at 254nm is a known expedient for germicidal treatment of surfaces (see page 3/6: Approximately 95% of the ultraviolet energy emitted is at the mercury resonance line of 254 nanometers. This wavelength is in the region of maximum germicidal effectiveness and is highly lethal to virus, bacteria and mold spores”).
To therefore modify Elowe and to treat the second layer with ultraviolet radiation at 254nm prior to contacting the antimicrobial composition with the second layer would have been obvious to one having ordinary skill in the art, for the purpose of providing sterility to the film as well as for controlling the surface energy for providing a desired degree of wettability and adhesion.
Regarding claims 10-12, it is noted that Elowe discloses that the first layer comprising the antimicrobial agent is in contact with muscle meat (see page 3, line 19-24; page 26, lines 24-26; see page 37, lines 25-26) and the purpose of the antimicrobial agent is for reducing contaminants on the meat (see page 4, lines 16-24) thus disclosing some degree of inhibition or reduction of bacterial on muscle meat.
Regarding claim 13, Elowe teaches that the antimicrobial material can comprise the first layer and second layer comprising a film and where the antimicrobial material is usable for food packaging and where the antimicrobial material can be used as food packaging for storage of muscle meat under refrigeration conditions (see page 4, lines 6 to page 5, line 11). Elowe also teaches that the concentrations of the antimicrobial agents can be varied and selected based on its activity and surface area of food product to be preserved, for example (see page 11, lines 14-19). Elowe also teaches that multiple antimicrobial agents can be used (see page 5, lines 21-22, 24-26; page 6, lines 1-8; page 10, lines 8-10, 11; page 11, line 5-6, 20-21, “one or more”; page 15, lines 11-24).
Nonetheless, claim 13 differs in specifically reciting that the growth of bacteria can be inhibited for a period for 14 days under refrigerated conditions.
However, since Elowe also teaches similar antimicrobial agents and where the amounts and types of antimicrobial agents can be accordingly adjusted, it would have been obvious to one having ordinary skill in the art to have modified Elowe to provide extended storage times under refrigerated conditions, as a matter of engineering and/or design based on ensuring the requisite antimicrobial protection when using the film for food storage.
Additionally however, Pattanayaiying teaches that the growth of bacteria is inhibited (i.e. restrained or held in check) for a period of 14 days under refrigeration conditions using a film that comprises pullulan and LAE (see page 80, Table 2.). Trinetta also teaches bacterial inhibition using pullulan based films that comprise an antimicrobial agent, for periods such as 3 weeks and 4 weeks under refrigerated conditions (see page 390, section 30.4.2, 3rd and 4th paragraphs).
Therefore, since Elowe also teaches similar antimicrobial agents and where the amounts and types of antimicrobial agents can be accordingly adjusted, it would have been obvious to one having ordinary skill in the art to have modified Elowe to provide extended storage times under refrigerated conditions, as a matter of engineering and/or design based on ensuring the requisite antimicrobial protection when using the film for food storage.
Regarding claim 14, the combination as applied to claim 1 above teaches combining water, gelatin, xanthan gum, glycerol, LAE and pullulan to form a first layer for including in an antimicrobial material used for food packaging.
Regarding the step of exposing polyethylene to ultraviolet light having a wavelength of approximately 254nm to form a second layer for including the in the antimicrobial material, Elowe further teaches altering the surface energy of the substrate layer for improving the wetting and/or adhesion characteristics (see page 7, lines 1-9). Elowe also teaches on page 28, lines 4-8 to cast the film forming composition comprising the antimicrobial agent onto a corona-treated polyethylene film and then allowing the product to dry.
As discussed with respect to claim 1, Elowe teaches adhering the first layer to the polyethylene second layer for use in food packaging.
Claim 14 differs from Elowe in specifically reciting, wherein the second layer is subjected to ultraviolet radiation prior to contacting the antimicrobial composition of a) with the second layer and applying the first layer to the polyethylene that has been exposed to UV light with a wavelength of approximately 254nm by spreading the first layer to a thickness of about 40 microns to about 50 microns and drying the first layer while adhered to the polyethylene.
Regarding treating of the polyethylene to UV light with a wavelength of 254nm, Cleanroom Technology teaches that UV irradiation is an environmentally friendly and economical method of disinfecting packaging materials (see page 1, first paragraph). Dudenhoeffer also teaches that a known expedient for controlling surface energy, or the wetting tension of films, is to use expedients such as corona discharge as well as ultraviolet treatment (see column 6, lines 3-19) and where the film can be a polyethylene film (see column 3, lines 35-48).
While the above combination does not specifically recite a wavelength of 254nm, Martin teaches that UV treatment of films at 254nm has been a conventional expedient to activate the surface of the film to improve adhesion (see paragraph 100) and Ultraviolet.com also teaches that UV treatment at 254nm is a known expedient for germicidal treatment of surfaces (see page 3/6: Approximately 95% of the ultraviolet energy emitted is at the mercury resonance line of 254 nanometers. This wavelength is in the region of maximum germicidal effectiveness and is highly lethal to virus, bacteria and mold spores”)
To therefore modify the combination and to first treat the second layer with ultraviolet radiation at 254nm prior to contacting the antimicrobial composition with the second layer would have been obvious to one having ordinary skill in the art, for the purpose of providing sterility to the film as well as for controlling the surface energy for providing a desired degree of wettability and adhesion.
Regarding the particular thickness of the first layer, since Elowe teaches a thickness of 0.3mil (7.6 microns) or greater (see page 24, lines 7-9), the reference encompasses the claimed thickness.
Nonetheless, Ylitalo (US 0090155451) teaches antimicrobial film layers (see figure 1, item 10 and paragraph 61) and which antimicrobial layer has been applied to a substrate layer 12 (see figure 1 and 2, item 12). Ylitalo further teaches that the antimicrobial layer can have a thickness of 50 microns (see paragraph 57) for the purpose of providing a suitable degree of the antimicrobial agent to the surface of the substrate (see paragraph 54).
To therefore modify the combination and to apply Elowe’s antimicrobial first layer with a thickness of 50 microns would have been obvious to one having ordinary skill in the art, for the purpose of providing the requisite degree of antimicrobial agent to the surface of Elowe’s packaging film.
Regarding claim 20, Elowe teaches applying the antimicrobial material comprising the first layer and the second layer to a food product (see page 3, lines 5-11; page 37, lines 25-26).
Regarding claim 21, the combination as applied to claim 1 has been incorporated herein to teach the structure of the antimicrobial material.
Further regarding claim 21, Elowe discloses a method of increasing the shelf life of a food product and/or inhibiting growth of bacteria in the food product comprising: packaging the food product with an antimicrobial material of claim 1, (see the abstract and the discussions above with respect to claim 1; see also page 37, lines 25-26 which necessarily discloses increasing the shelf life by packaging the food product with the antimicrobial material). Because the purpose of Elowe’s composition is for inhibiting or reducing spoilage, the reference is inhibiting growth of bacteria to some degree (see page 4, lines 6 to page 5, line 11 which also discloses packaging and inhibiting growth of bacteria).
Further regarding the limitation of, “wherein the lauric acid in the biopolymer film of the first layer is released from the first layer and wherein growth of bacteria is inhibited on the food product for a period of 7-28 days at approximately 4°C,” Elowe teaches that moisture can hydrate the film layer and release the active antimicrobial agent (see page 26, line 20-22).
Regarding the particular degree of time and the temperature at which growth is inhibited, it is noted that Elowe teaches that samples of food such as chicken were inoculated with bacteria and then stored in the antimicrobial packaging film at 4°C (see page 29, lines 3-9) and where there is no detectable levels of bacteria at 3 days (see page 31, lines 8-9). While this does not specifically show a period of 7-28 days, Elowe further teaches storage for 7-10 days, for example (see page 35, Table 5). Even further, Pattanayaiying teaches that the growth of bacteria is inhibited (i.e. restrained or held in check) for a period of 14 days under refrigeration conditions using a film that comprises pullulan and LAE (see page 80, Table 2.). Trinetta also teaches bacterial inhibition using pullulan based films that comprise an antimicrobial agent, for periods such as 3 weeks and 4 weeks under refrigerated conditions (see page 390, section 30.4.2, 3rd and 4th paragraphs).
Therefore, since Elowe also teaches similar antimicrobial agents and where the amounts and types of antimicrobial agents can be accordingly adjusted, it would have been obvious to one having ordinary skill in the art to have modified Elowe to store a food using the film as suggested by the combination applied to claim 1, for extended storage times under refrigerated conditions, to ensure that the food product retained the requisite antimicrobial protection for keeping it fresh for extended periods of storage. The prior art teachings also provide a reasonable expectation of success in achieving inhibition of bacterial growth for 7-28 days at approximately 4°C.
Regarding claim 24, in view of the discussion above with respect to claim 1, the combination discloses an antimicrobial material for use in food packaging. Regarding the limitations of, “made according to the method of claim14,” it is noted that this is a product by process limitation. As such since the combination discloses the same structure as that recited in claim 14, the combination suggests the claimed antimicrobial material.
Regarding claims 25-26, Elowe discloses that the antimicrobial material is in the form of a sheet or a bag (see at least, page 8, lines 1-2; page 26, lines 8-26; see page 27, lines 7-15 and page 28, lines 18-22).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over the combination, as applied to claim 1 and in further view of Leung (US 20010022964), Trinetta (“Effects of ingredient composition on optical and mechanical properties of pullulan film for food-packaging applications” - i.e. Trinetta II) and Theinsathid (“Antimicrobial Activity of Lauric Arginate-coated Polylactic Acid films against Listeria monocytogenes and Salmonella Typhimurium on Cooked Sliced Ham.”)
Regarding claim 27, it is noted that Elowe teaches that the antimicrobial material can be cast as a solution to form a film layer (see page 6, lines 9-13) and then dried (see page 28, lines 4-13). In this regard, it appears that the claimed composition is that of the first layer prior to drying (see page 23, lines 5-17 of Applicant’s specification as filed, which discusses that the composition comprising 78.8% water is then dried to form the antimicrobial film).
Elowe teaches that the amount of gelatin can be modified for providing the desired film layer (see page 22, lines 1-8). Similarly, Elowe teaches that the amounts of xanthan gum can be modified as needed to form the desired film layer (see page 22, lines 9-14). Elowe also teaches glycerol used at no greater than 7% (see page 23, lines 1-4). Elowe also teaches and suggests that the amounts of LAE can be selected based on its activity, the amount and surface area of the food (see pgae 11, lines 14-19) further teaching that it would have been obvious to experiment with amounts of LAE.
Nonetheless, claim 27 differs from the combination in specifically reciting, that the antimicrobial material comprises approximately: 78.8% water, 2/4% gelatin, 10.6% pullulan, 0.2% xanthan gum, 5.5% glycerol and 2.5% LAE.
Leung teaches films formed using 40-80% water (see paragraph 92), with 0-5% gelatin (see paragraph 42) thus encompassing the claimed amount; with 0.1-2% xanthan gum (see paragraph 41), which reads on approximately 0.2% xanthan gum; Leung also teaches that pullulan can be used at 11% (see table 2, example 18), which is approximately 10.6% and further teaches that pullulan can be used in amounts from 0.01 to 99% (see paragraph 33, thus encompassing the claimed range).
Pattanayaiying teaches that known amounts of LAE that can be part of packaging films can be, for example 2.6%, thus falling within the claimed approximately 2.5% (see page 80, left column, line 8: 2.6% LAE-coated polylactic film”). This is further supported by Theinsathid on page 144, right column, 2nd paragraph of Results and Discussion which disclose 2.6% LAE coated on the film. Theinsathid also teaches a thickness of the antimicrobial coating of 45 microns (see page 145, Table 2), which falls within the claimed range.
Carroll (US 20060073190) teaches films that can also use glycerin as a plasticizer (see paragraph 18), used in amounts such 5.53% (see page 5, table 1, film #4, and ingredient 3).
Trinetta II further teaches that pullulan can provide desirable mechanical properties for packaging films (see page 2299, section 3.4, 1st paragraph) and can be desirably used at 10-13.5% (see page 2300, left column, lines 10-14; 100g/l and 135g/l) and that xanthan gum can be used at 0.2% for achieving the desired elasticity to the film (see page 2297, left column, under section 2.1: 1-5g/l; see page 2299, section 3.4, 3rd paragraph, “Xa was significant only for elasticity”). Trinetta II also teaches that it has been conventional to use glycerol at about 5% (see Table 1, “50 g/l”) which can be useful for influencing the thickness of the film (see page 2298, section 3.2, 3rd paragraph), the films elongation properties (see page 2299, section 3.3, 3rd paragraph: “Gly had a positive impact on EL values…. Similar effects were observed by increasing Gly in film formulations and setting Xa at low levels.”) and tensile strength (see page 2299, section 3.4, 2nd paragraph).
Since Elowe generically teaches amounts of water, gelatin, pullulan, xanthan gum, glycerol and LAE, it would have been obvious to one having ordinary skill in the art to have looked to the prior art packaging films for knowns amounts of these components for the same purpose of providing a dissolvable film. In view of this, to modify Elowe and to specifically provide approximately 78.8% water, 2.4% gelatin, 10.6% pullulan, 0.2% xanthan gum, 5.5% glycerol and 2.5% LAE would have been obvious to one having ordinary skill in the art, as a matter of routine experimentation for the purpose of providing the requisite degree of antimicrobial protection due to the amount of LAE, and where gelatin, pullulan, xanthan gum and glycerol are known to be used in varied amounts for the purpose of providing the desired properties to the formed film.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over the combination, as applied to claim 27 and in further view of Kalmar (US 2506793).
Regarding claim 28, Elowe already teaches that the antimicrobial material desirably migrates into the food product upon contact with the food (see page 5, lines 8-11, 22-24). While Elowe is not specific as to the particular migration of 1-5mm, it is noted that the claim is directed to the antimicrobial material and not the particular method of using, such that it would have been obvious to one having ordinary skill in the art to have achieved the requisite degree of migration commensurate with the degree of antimicrobial protection that was desired. It is further noted that the claim limitation is directed to an intended use that the prior art would have been capable of performing.
Nonetheless, Kalmar teaches that it has been conventional to allow a preservative to migrate into the food to a depth of 5/16th of an inch (or 7mm) (see column 5, lines 6-16). Since it has been known in the art to allow a preservative to penetrate into the depth of a food, and since Elowe already teaches that the LAE antimicrobial migrates to the food, it would have been obvious to one having ordinary skill in the art to provide a degree of penetration into the food for achieving the requisite degree of antimicrobial protection.
Response to Arguments
On page 6 of the response, Applicant urges that the present specification and claims do not require formation of a hydrogel and there is no dripping or spreading over time, which would have weakened antimicrobial efficacy after initial application, which is in contrast to Elowe. Applicant urges that the dripping or spreading over time as disclosed by Elowe would weaken antimicrobial efficacy after the initial application of the claimed material.
This argument is not persuasive because the arguments are not commensurate in scope with the claims. That is, the prior art combination teaches and suggests a first layer comprising film forming layer that includes an antimicrobial agent that has been applied to a film substrate and which combination can serve as packaging material where the antimicrobial agent can contact food to migrate the antimicrobial agent from the packaging material to the food product. It is also noted that Elowe teaches that in some embodiments the film layer comprising lauric arginate forms a hydrogel (see page 6, line 9) thus suggesting other embodiments where a hydrogel need not form. Regarding Elowe’s disclosure of the hydrated film layer may drip, there is insufficient evidence to suggest that the reference’s disclosure of dripping across the food product surface over time would have weakened antimicrobial efficacy, especially as this would also have been a function of an inner surface of the packaging material not being in contact with a food product (see Elowe page 8, lines 15-18). Additionally, this is not seen to teach away from embodiments where the entirety of the inner film contacts the food product which that there need not be dripping. Furthermore, it is noted that Applicant’s disclosure also suggests a release of the antimicrobial agent onto the food surface, which would appear to be similar to what Elowe is disclosing (see Applicant’s specification on page 6, lines 11-20 and page 8, lines 20-28).
Further on page 6 of the response, Applicant urges that Elowe only uses the term glycerol once to describe it as a glycol solvent which is in contrast to the glycerol as used int eh present disclosure and claims to overcome limitations of using sufficient LAE concentration.
This argument is not persuasive because the reference is still seen to teach and suggest using some amount of glycerol as part of the first layer. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). It is further noted that the prior art teaches and suggests amounts of glycerin as a plasticizer as well as for achieving a desired thickness and tensile strength to the material (see Carroll, paragraph 18 and Trinetta II).
Further on page 6 of the response, Applicant urges that Elowe’s use of UV absorbers would reduce the effectiveness of the recited UV treatment such that Elowe teaches away from the claimed UV treatment. Applicant also urges that Elowe’s disclosure of improving the wetting and/or adhesion characteristics is only in the context of corona treatment and not with the use of a UV treatment such that there is no teaching or suggestion for the claimed UV exposure at approximately 254 nm prior to adhesion of the first layer.
This argument is not persuasive because Elowe is not disclosing that UV light absorbers are mandatory. Furthermore, while Elowe teaches using corona treatment to alter the surface energy and improve wetting and adhesion, Elowe also discloses on page 7, lines 6-7 that the surface layer of the substrate can be “otherwise modified” to also improve wetting and adhesion. Therefore, the reference is open to other forms of treatment that can also alter surface energy and improve wetting and adhesion and is not seen to teach away from ultraviolet irradiation. In this regard, the prior art teaches that ultraviolet irradiation as well as corona discharge can also alter surface energy of films such as polyethylene films and that ultraviolet irradiation at 254 nm can provide germicidal treatment of surfaces. As such, the prior art is teaching and suggesting that it has been conventional to use UV treatment at 254 nm to improve wettability and adhesion, similar to what Elowe already desires, and to further sterilize surface - both of which teach and suggest the claimed ultraviolet treatment.
On page 7 of the response, Applicant urges that Dudenhoeffer’s disclosure of UV light treatment is only in relation to its use on both surfaces and that corona discharge is the preferred treatment for altering the surface energy.
These arguments are not persuasive because Dudenhoeffer’s disclosure of corona discharge treatment being the preferred high energy to film surface transfer method does not teach away from Dudenhoeffer’s disclosure that ultraviolet treatment can also be used for the similar effect of increasing the wetting tension of the film for improved adhesion. While Dudenhoeffer might suggest application of ultraviolet treatment to both an inner patch and the bag film to which the patch is to be bonded, this is not seen to teach away from Dudenhoeffer’s disclosure that ultraviolet treatment can also improve the wetting tension for improving adhesion, which is also what Elowe desires.
Further on page 7 of the response, Applicant urges that Martin’s disclosure is not related to materials used for food packaging and Ultraviolet.com teaches a germicidal effectiveness in the context of UV purifier units and therefore has no relation to food packaging.
It is noted however, that 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). In this instance, Cleanroom Technology and Ultraviolet.com teach and suggest ultraviolet treatment at wavelengths such as 254 nm would reasonably have provided germicidal effectiveness on packaging materials such as Elowe’s substrate layer with a reasonable expectation of success. For instance, Ultraviolet.com teaches that ultraviolet wavelengths such as 254nm can provide beneficial germicidal treatment such as with food packaging (see page 3, “bottling facilities”). While the reference is disclosing ultraviolet purifiers, the reference is also teaching the general functionality of ultraviolet light with a wavelength of 100-280nm to deactivate the DNA of bacteria, viruses and other pathogens (see page 2) and therefore would have been equally applicable to sterilizing packaging films, especially as Cleanroom Technology also teaches and suggests ultraviolet irradiation of food packaging films.
On pages 7-8 of the response, Applicant urges that the Office Action combines eight references to arrive at the stated obviousness such that the rejection relies on hindsight.
In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). In this instance, Elowe already teaches and suggests a film forming layer comprising LAE which has been adhered to a polyethylene layer. While not specific to the use of pullulan, the secondary references provide motivation in the references themselves to use pullulan because the material works well when incorporated with active antimicrobial materials while providing high film forming, mechanical strength and flexibility. The prior art also teaches and suggests a thickness of an antimicrobial layer within the claimed range for providing the requisite degree of antimicrobial agents to be supplied to the surface of the film. Therefore, the obviousness it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 9 of the response, Applicant urges that Leung teaches that glycerin can yield products that were too most and/or self-adhering or easily break into pieces such that there is o motivation to combine the prior art references as presented in the Office Action, especially because Leung would suggest excluding the use of glycerol.
This argument is not persuasive because Elowe already teaches and suggests that glycerol at less than 7% would have been a suitable amount of glycerol (see page 23, lines 1-4). Furthermore, Leung has not specifically been relied on to teach glycerol but rather has been relied on to teach known amounts of water, gelatin, xanthan gum and pullulan used for producing films that can comprise antimicrobial components. Additionally, Leung’s disclosure of using a plasticizing agents other than glycerin is directed to a preferred formulation due to films that can comprise high oil contents (see paragraph 35). This is not seen to teach away from using glycerin, especially since Elowe already teaches that glycerin can be desirably used to produce the antimicrobial film.
Further on page 9 of the response, Applicant urges that Ebner discloses an antimicrobial agent as part of a sealant layer and Ebner teaches that use of a film that contained LAE to control microbial growth on a meat product was not effective, thus showing that the claimed invention provides unexpected results.
These arguments are not persuasive in view of the rejection as presented in this Office Action. It is initially noted that the arguments are not commensurate in scope with the claims - which do not recite any particular food. Additionally, Elowe already teaches and suggests that the amounts of LAE that are used can be varied; and Ebner had only been relied on to teach that it has been conventional to use LAE in amounts that encompass 2.5%. However, the reference has not been relied on in this Office Action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Francini (US 20200231773) teaches antimicrobial film layers coated onto a thermoplastic substrate layer (see the abstract) and which coating can have a thickness of 50 microns (see paragraph 20).
Siegel (US 20070014953) discloses a packaging material having a layer in contact with food (figure 1, item 122 and paragraph 212) and which layer includes a myoglobin blooming agent, but which can also include an antimicrobial agent (see paragraph 183 and page 33, claim 27). Siegel further teaches that this layer can result in substances penetrating into the food to a depth of 0.05-0.25 of an inch (i.e. 1.27-6.35mm) (see paragraph 143-144).
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/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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