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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 3 recites “pure acrylic adhesive” but the specification does not disclose “pure” such adhesive. (Note the rejection under 35 USC 112(b) of claim 3 below.)
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 2, “laminates” should be “laminate”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a laminate having “a water vapour transmission rate (WVTR) of less than 0.0035 gm/pkg/day.” The limitation raises several issues that render the claim indefinite. First, the specification states: “The terms “Water Vapour Transmission Rate” or “WVTR” refers to a steady state rate at which water vapour permeates through a film at specified conditions of temperature and relative humidity.” (2:25+); however, the claim does not specify temperature or relative humidity conditions, which would be expected to affect the rate. Additionally, although not specifically defined, the phrase “gm/pkg/day” has been interpreted as referring to units of grams per package per day (see, e.g., Table 15 in the specification at 30:2+); however, a “package” does not appear to be a standard unit of measure nor does the specification provide a definition establishing an objective unit of measure. The area of a package would be expected to affect the rate. Dependent claims are rejected for the same reason.
Claim 6 depends from claim 1 and requires the WVTR to be “measured for cold formed blisters adapted to accommodate a capsule of at least “0” size.” This further limitation does not appear to resolve the indefinite issues raised by the parent claim 1. Additionally, it is not clear what range of capsule sizes is being claimed. Standard capsule sizes include, from largest volume to smallest volume: 000; 00; 0; 1; 2; 3; 4; and 5. The claim recitation of “at least “0” size” is unclear because it is not clear if the increasing value (“at least”) refers to increasing volumes (i.e., the claim encompasses capsules of size 000, 00, and 0) or increasing size numbers (i.e., the claim encompasses capsules of size 0, 1, 2, etc.). The claim has been interpreted to encompass increasing volume (i.e., the claim encompasses capsules of size 000, 00, and 0).
Claims 8-17 depend from claim 1 and require “a WVTR of [a given value] gm/pkg/day at 37.8 deg. C. and 90% RH, when measured in accordance with ASTM F1249 standard, that is adapted to accommodate capsules of at least “0” size.” These further limitations do not appear to resolve the indefinite issues raised by the parent claim 1, except that a temperature and relative humidity are defined. Additionally, it is not clear what range of capsule sizes is being claimed for the reasons described above with respect to claim 6. Additionally, although the ASTM F1249 standard is recited, the standard does not appear to define a particular “package” or “pkg” size, but rather refers to units of grams per square meter per day.
Claim 3 recites an acrylic based adhesive “selected from the group consisting of pure acrylic adhesive, and ester acrylic adhesive.” The claim is indefinite because it is not clear what is meant or encompassed by the phrase “pure acrylic adhesive,” particularly the word “pure”. The specification does not use the word “pure” and the acrylic adhesive is not further described. It appears the word “pure” may be intended to contrast between an adhesive made from acrylic acid and an adhesive made from an acrylic acid ester. For examination purposes, “pure acrylic adhesive” is interpreted to refer to an adhesive made from acrylic acid and not an acrylic acid ester.
Claim 18 recites “wherein said operative inner surface is coated by using a heat seal lacquer” in the last two lines of the claim. The claim, however, recites multiple instances of “an operative inner surface”, such that the claim is indefinite because it is not clear which instance is being further limited. For examination purposes, the limitation is interpreted to refer to the operative inner surface of the lid. Dependent claims are rejected for the same reason.
Claim 19 recites four instances of “an angle φ”. The claim is indefinite because it is not clear if each recitation is distinct from the other recitations because “φ” is used for each angle, but the claim uses an indefinite article (“an”) before each one. Therefore, it is not clear if the four side walls must all be slanted at the same angle or if each side wall can be at an independent angle.
Claim 20 recites “said angle φ is in the range of 15° to 25°.” The claim is indefinite because it is not clear if all four angles φ described in claim 19 must be within the claimed range, nor is it clear if all four angles must be the same angle.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 5-6, and 8-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (WO 2008/039182) in view of Migliorini et al. (US 6,863,964).
Regarding claim 1:
Walker discloses blister packaging comprising a base sheet and a lid sheet (abstract; 1:5+; 2:15+). The blisters are formed in the base sheet, including by cold-forming methods (3:18+; 9:28+). In one embodiment, the base sheet comprises successive layers of oriented polyamide (OPA), adhesive, aluminum foil, adhesive, and high-density polyethylene (HDPE) (6:20+). In another embodiment, the base sheet comprises successive layers of OPA, adhesive, aluminum foil, adhesive, and low-density polyethylene (LDPE) (6:25+). The thickness of each layer is: the OPA layer is 10-100 µm (16:32+); the aluminum foil is 15-60 µm (4:25+) the HDPE layer is 10-60 µm (6:20+); and the LDPE layer is 10-60 µm (6:25+). Specific examples use an OPA layer thickness of 25 µm; an aluminum foil thickness of 60 µm; and either LDPE or HDPE layer at a thickness of 40 µm (18:13-21). Although Walker discloses embodiments of the base sheet comprising PVC (e.g., 6:5+), these are alternative embodiments from the ones identified above, which do not contain PVC.
Walker is silent with regard to metallizing the surface of the polyamide layer.
Metallization of polymer films was known in the art to have utility. For example, Migliorini discloses a metallized multilayer film suitable for packaging applications (abstract; 1:5+; 3:30+). The film comprises a core layer A, a skin layer B, and a metallized layer C deposited thereon (3:42+; 6:3+; Fig. 1). The skin layer comprises polyamide (9:7+; 9:60+). Migliorini teaches applying the metallized layer to an optical density of about 1.5-5.0, preferably about 1.5-3.0 (10:20+). The film has good moisture and oxygen barrier properties (2:62+).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to further metallize Walker’s polyamide layer, including at a thickness providing an optical density within the claimed range, to provide additional barrier properties as known in the art.
Walker teaches the base sheet comprises a polymeric material with low water vapor permeability, preferably less than 0.3 g/100 in2/day at 25°C according to ASTM E96-635 (4:31+). Although the presently described unit of “gm/pkg/day” and the conditions of measuring the water vapor transmission rate (WVTR) are unclear (see rejections under 35 USC 112), the examiner submits the laminate taught by Walker in view of Migliorini that otherwise meets the claimed requirements necessarily meets the claimed WVTR because the laminate otherwise comprises the same materials and has the same structure as claimed. Alternatively, Walker and Migliorini suggest providing a low WVTR (high barrier) to packaging to protect any packaged contents. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the WVTR (e.g., by adjusting the thickness of the barrier layers) low values, including those falling within the presently claimed range, to protect any packaged contents, and thereby arrive at the claimed invention.
Regarding claim 2:
Walker teaches acrylic adhesives (19:10+).
Regarding claims 5-6:
As described above, the units and conditions of the claimed WVTR are unclear (see rejections under 35 USC 112), the examiner submits the laminate taught by Walker in view of Migliorini that otherwise meets the claimed requirements necessarily meets the claimed WVTR because the laminate otherwise comprises the same materials and has the same structure as claimed. Alternatively, Walker and Migliorini suggest providing a low WVTR (high barrier) to packaging to protect any packaged contents. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the WVTR (e.g., by adjusting the thickness of the barrier layers) low values, including those falling within the presently claimed range, to protect any packaged contents, and thereby arrive at the claimed invention.
Regarding claims 8-17:
The present claims require specific thicknesses of the previously described layers and a WVTR. The units and conditions of the claimed WVTR are unclear (see rejections under 35 USC 112). The claimed thicknesses represent particular values within the ranges disclosed by the prior art. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The examiner submits the laminate taught by Walker in view of Migliorini that otherwise meets the claimed requirements necessarily meets the claimed WVTR because the laminate otherwise comprises the same materials and has the same structure as claimed. Alternatively, Walker and Migliorini suggest providing a low WVTR (high barrier) to packaging to protect any packaged contents. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the WVTR (e.g., by adjusting the thickness of the barrier layers) low values, including those falling within the presently claimed range, to protect any packaged contents, and thereby arrive at the claimed invention.
Rejections continue on the next page.
Claim(s) 1-6 and 8-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan (US 2017/0137159) in view of Migliorini et al. (US 6,863,964).
Regarding claim 1:
Sullivan discloses blister packages comprising a metal-polymer (plastic) laminate and a lid [abstract; 0003; 0012-0013]. The blisters are formed in the metal-polymer laminate, including by cold-forming methods [0020]. Embodiments of the laminate include: OPA/ALU/PE, where OPA is oriented polyamide, ALU is aluminum, and PE is polyethylene [0072-0078]. Suitable polyethylenes include low-, medium-, and high-density polyethylene, as well as linear polyethylene [0065]. An adhesive can be used between the plastic layers and the foil [0069].
Sullivan teaches the plastic layers have a thickness of about 8-80 µm, including 20-50 µm [0062]. The aluminum layer has a thickness of about 8-200 µm [0068]. Specific example thicknesses are: OPA is 12 µm, aluminum is 45 or 60 µm, and polyethylene is 30 g/m2 [0072-0074]. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Sullivan is silent with regard to metallizing the surface of the polyamide layer.
Metallization of polymer films was known in the art to have utility. For example, Migliorini discloses a metallized multilayer film suitable for packaging applications (abstract; 1:5+; 3:30+). The film comprises a core layer A, a skin layer B, and a metallized layer C deposited thereon (3:42+; 6:3+; Fig. 1). The skin layer comprises polyamide (9:7+; 9:60+). Migliorini teaches applying the metallized layer to an optical density of about 1.5-5.0, preferably about 1.5-3.0 (10:20+). The film has good moisture and oxygen barrier properties (2:62+).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the thickness of each of Sullivan’s layers, including over values within the claimed ranges, to provide properties (e.g., barrier, robustness, mechanical strength) as desired for a given end use. Additionally, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to further metallize Sullivan’s polyamide layer, including at a thickness providing an optical density within the claimed range, to provide additional barrier properties as known in the art.
Sullivan teaches its laminate have high barrier properties and that it is desirable to prevent water vapor transmission [0005; 0012; 0088]. Although the presently described unit of “gm/pkg/day” and the conditions of measuring the water vapor transmission rate (WVTR) are unclear (see rejections under 35 USC 112), the examiner submits the laminate taught by Sullivan in view of Migliorini that otherwise meets the claimed requirements necessarily meets the claimed WVTR because the laminate otherwise comprises the same materials and has the same structure as claimed. Alternatively, Sullivan and Migliorini suggest providing a low WVTR (high barrier) to packaging to protect any packaged contents. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the WVTR (e.g., by adjusting the thickness of the barrier layers) low values, including those falling within the presently claimed range, to protect any packaged contents, and thereby arrive at the claimed invention.
Regarding claims 2-3:
Sullivan teaches acrylic adhesives, including ethylene-acrylic acid copolymer (considered to be “pure” acrylic) and ethylene-methacrylic acid copolymer [0069].
Regarding claim 4:
Sullivan teaches the adhesives have a thickness of 0.1-12 µm to provide a desired level of bonding between adjacent layers [0069]. Although Sullivan is silent with regard to the amount of adhesive layer present in units of grams per square meter (gsm), the reference discloses a range of suitable thicknesses (amounts) of adhesive to provide an adhesive layer. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the thickness, and therefore the amount (gsm), of the adhesive material, including over values resulting in amounts as claimed, to provide the desired dimensions and adhesive properties (e.g., strength) required for a given end use.
Regarding claims 5-6:
As described above, the units and conditions of the claimed WVTR are unclear (see rejections under 35 USC 112), the examiner submits the laminate taught by Sullivan in view of Migliorini that otherwise meets the claimed requirements necessarily meets the claimed WVTR because the laminate otherwise comprises the same materials and has the same structure as claimed. Alternatively, Sullivan and Migliorini suggest providing a low WVTR (high barrier) to packaging to protect any packaged contents. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the WVTR (e.g., by adjusting the thickness of the barrier layers) low values, including those falling within the presently claimed range, to protect any packaged contents, and thereby arrive at the claimed invention.
Regarding claims 8-17:
The present claims require specific thicknesses of the previously described layers and a WVTR. The units and conditions of the claimed WVTR are unclear (see rejections under 35 USC 112). The claimed thicknesses represent particular values within the ranges disclosed by the prior art. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The examiner submits the laminate taught by Sullivan in view of Migliorini that otherwise meets the claimed requirements necessarily meets the claimed WVTR because the laminate otherwise comprises the same materials and has the same structure as claimed. Alternatively, Sullivan and Migliorini suggest providing a low WVTR (high barrier) to packaging to protect any packaged contents. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the WVTR (e.g., by adjusting the thickness of the barrier layers) low values, including those falling within the presently claimed range, to protect any packaged contents, and thereby arrive at the claimed invention.
Regarding claim 18:
Sullivan discloses a blister package comprising a metal polymer laminate formed into a blister (cup) and a lid sheet as previously explained. The lid sheet comprises a sealing layer [0006; 0013; 0026; 0031; 0070; 0087-0088; claim 24]. Sullivan teaches sealing layers have thickness of may be about 8-80 µm [0062]. Although Sullivan is silent with regard to the amount of sealing layer present in units of grams per square meter (gsm), the reference discloses a range of suitable thicknesses (amounts) of sealant to provide a sealable layer. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to vary the thickness, and therefore the amount (gsm), of the sealant material, including over values resulting in amounts as claimed, to provide the desired dimensions and sealing properties (e.g., strength) required for a given end use.
Regarding claims 19-20:
Sullivan teaches the blisters can be given any desired shape, including blisters having a blunted cone shape and having steep angled or vertical walls [0081].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to impart any desired shape, including a shape having first, second, third, and fourth side walls slanted at an angle φ and a flat wall as presently claimed, to provide a blister capable of holding the desired packaging contents, and thereby arrive at the claimed invention. Furthermore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to select any steep angled walls, including those at an angle φ in the range of 15-25°, to provide such a shape to hold the desired packaging contents, and thereby arrive at the claimed invention.
Allowable Subject Matter
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Walker (WO 2008/039182) discloses blister packaging comprising a base sheet and a lid sheet as explained above. The reference is silent with regard to modifying its polyethylene with a linear block copolymer as in present claim 7.
Sullivan (US 2017/0137159) discloses blister packages comprising a metal-polymer laminate and a lid as explained above. The reference is silent with regard to modifying its polyethylene with a linear block copolymer as in present claim 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D FREEMAN whose telephone number is (571)270-3469. The examiner can normally be reached Monday-Friday 11-8PM EST.
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/JOHN D FREEMAN/Primary Examiner, Art Unit 1787