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. The amendment filed on November 20, 2025 has been entered in the above-identified application. Clam 18 is canceled. Claims 1-17, 19, and 20 are pending and under consideration.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
3. Claims 1-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US 2009/0317611 A1) in view of Foster (US 4,561,920 A).
Mueller et al. disclose a barrier film (equivalent to the multilayer barrier film of the claimed invention) that maintains an oxygen barrier after being subjected to autoclaving conditions and can be used to make packages for a wide variety of medical and food applications (meeting the limitations of claim 19). In some embodiments, the multilayer barrier film comprises (a) a first layer comprising a polymeric material having a moisture vapor permeability greater than about 40 g-mil/100 in2-day-atm (equivalent to the first exterior layer of the claimed invention and meeting the moisture vapor transmission rate (MVTR) limitations of claim 1 and 2); (b) a second layer directly adjacent to the first layer comprising EVOH (equivalent to the first EVOH layer adjacent to the first exterior layer of the claimed invention); (c) a first region defining a third layer comprising from 1 to 5 distinct sublayers comprising a polymeric material, the third layer (equivalent to the interior layer adjacent to the first EVOH layer of the claimed invention) having moisture vapor permeability of less than about 20 g-mil/100 in2-day-atm; (d) a fourth layer comprising EVOH (equivalent to the second EVOH layer adjacent to the interior layer of the claimed invention), and (e) a second region defining a fifth layer comprising about 1 to 5 sublayers comprising a polymeric material, the fifth layer having a moisture vapor transmission rate of less than about 5 g/100 in2-day-atm. FIG. 1 illustrates a five-layer film that is suitable for forming a flexible pouch for a wide variety of applications. The most basic film construction of the disclosed film can include: highly moisture permeable material/EVOH/low moisture permeable material/EVOH/very low moisture permeable material. The exemplary 5-layer film is illustrated in FIG. 1 in which film 10 has first layer 12 that comprises a highly moisture permeable material; second layer 14 comprising an EVOH layer; third layer 16 that comprises about 1 to 5 sublayers, each sublayer comprising one or more low moisture permeable materials; fourth layer 18 comprising an EVOH layer; and fifth layer 20 that that comprises about 1 to 5 sublayers, each sublayer comprising one or more very low moisture permeable materials. FIG. 2 illustrates in another embodiment a film 11 like the film of FIG. 1, but wherein the third layer (layer 16) comprises 5 sublayers, 25, 30, 35, 40, and 45 and wherein the fifth layer (layer 20) comprises 3 sublayers, 50, 55, and 60. One of ordinary skill in the art would readily understand that the third and fifth layers can each comprise anywhere from 1 to 5 sublayers. A suitable polymeric material for the outside layer of the film is a highly moisture permeable material and suitable materials can include, but are not limited to, polyamide, elastomeric copolyamide, polyether polyamide block copolymer, and combinations thereof. Generally, the outer polyamide layer can be any polyamide or blends of polyamides (meeting the limitations of claims 3 and 6). The barrier layers of the disclosed film must provide a sufficient barrier to gases to provide adequate shelf-life for the product packaged in the film. In the disclosed barrier film, a layer comprising one or more low permeable materials can be positioned between the two EVOH barrier layers. More specifically, the layer (in some embodiments, the third layer of a 5-layer film) can comprise a region comprising about 1 to 5 distinct sublayers comprising low permeable materials. In some embodiments, at least one of the layers of the first and second region in direct contact with an EVOH layer comprises a polymeric adhesive selected from the group consisting of: anhydride grafted ethylene/1-butene copolymer, anhydride grafted ethylene/1-hexene copolymer, polypropylene, propylene ethylene copolymer, ethylene vinyl acetate copolymer, ethylene methyl acrylate copolymer, and anhydride grafted ethylene/1-octene copolymer. In some embodiments, at least one layer of the first or second region comprises a polymer selected from the group consisting of: ethylene alpha olefin copolymer, high density polyethylene, polypropylene, polypropylene ethylene copolymer, and cyclo-olefin copolymer. The function of the layer or sublayers is to provide high relative humidity and moisture protection of the core EVOH layer from the contents of the package (product) that is typically a water-based solution. The high moisture barrier properties of this layer or sublayers prevent the permeation of moisture to the core EVOH layer, especially during exposure of the film to high moisture conditions during the autoclave cycle. In some embodiments, the film can comprise a sealant layer (i.e., a seal layer) adapted to facilitate the heat-sealing of the film to itself or to another object, such as a substrate (equivalent to the sealing layer attached to the oriented outer film of the claimed invention). In general, sealant layers employed in the packaging art have included the genus of thermoplastic polymers. In some embodiments, the film can comprise one or more tie layers adapted for improving the adherence of one layer of said film to another layer (equivalent to the adhesive layer between the sealing layer and the outer oriented film of the claimed invention). In some embodiments, tie layers can comprise any nonpolar polymer having a polar group grafted thereon, so that the polymer is capable of covalent bonding to polar polymers. (See Abstract and paragraphs 0001, 0009, 0011, and 0065-0094). Mueller et al. do not teach the use of polyester layers and metal layers in their multilayer film.
Mueller et al., as discussed above, do not teach that the multilayer barrier film has an oriented outer film, comprises a second exterior layer comprising a polyamide, the thickness of the oriented outer film is greater than or equal to 10 microns and less than or equal to 76 microns, overall composition of the multilayer barrier film comprises less than or equal to 10% polyamide by weight, and the overall composition of the multilayer barrier film comprises less than or equal to 10% EVOH by weight.
However, Foster discloses a biaxially oriented oxygen and moisture barrier film which comprises at least one layer of an ethylene vinyl alcohol copolymer and an adhesive layer wherein the layers are combined into a composite sheet with the adhesive interposed between polyolefin layers and ethylene vinyl alcohol copolymer layers. Ethylene vinyl alcohol copolymer resins offer excellent barrier properties with respect to such gases as oxygen, carbon dioxide and nitrogen. In addition, they are also effective barriers against odors and the loss of flavor. Such resins, hereinafter referred to as EVOH resins, are moisture sensitive and the barrier properties are reduced in the presence of high humidity. Polypropylene offers excellent barrier properties with respect to moisture together with good strength properties and a high use temperature. When EVOH resins are encapsulated by layers of polypropylene, they are protected from moisture and therefore retain their barrier characteristics. The biaxial orientation of EVOH resins enhances their barrier properties as well as reduces their susceptibility to moisture. The biaxial orientation of polypropylene increases its stiffness and enhances both its optical and other physical properties such as tensile strength, tear strength, and other mechanical properties (see Abstract and Column 1, lines 5-42).
Accordingly, it would have been obvious to one having ordinary skill in the art to orient the multilayer barrier film taught by Mueller et al. given that Foster specifically teaches that ethylene vinyl alcohol copolymer resins offer excellent barrier properties with respect to such gases as oxygen, carbon dioxide and nitrogen and the biaxial orientation of EVOH resins enhances their barrier properties as well as reduces their susceptibility to moisture. Furthermore, the Examiner would like to point out that workable physical properties such as number of layers and thicknesses and concentrations are deemed to be obvious routine optimizations to one of ordinary skill in the art, motivated by the desire to obtain the required properties. With regards to the property limitations of claim 4 and 5, the Examiner takes the position that such property limitations are inherent in the layers taught by Mueller et al., given that the chemical composition and structure of the layers as taught by Mueller et al. and that of the claimed invention are identical.
Response to Arguments
4. Applicant’s arguments with respect to claims 1-17, 19, and 20 have been considered but are moot given the new ground of rejection.
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEEBA AHMED whose telephone number is (571)272-1504. The examiner can normally be reached Monday-Thursday 7am-6pm.
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/SHEEBA AHMED/Primary Examiner, Art Unit 1787