DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 May 2026 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Claims 1 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 April 2023.
Claim Rejections - 35 USC § 103
Claims 15, 17, 26-29, and 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1).
Merical et al. is directed to a polymeric film used to form packaging for moisture sensitive products, such as pharmaceutical products (paragraph 0026). The film may be a multilayer film comprising: a product contact layer, a barrier layer, tie or adhesive layers, and an outer layer (Figure 2 and paragraph 0055). The product contact layer corresponds to the contact layer of the claims; the barrier layer corresponds to the base layer that is water and/or oxygen resistant of the claims; tie/adhesive layer corresponds to the tie layer of the claims; the outer layer corresponds to the first outer layer of claim 34. The product contacting layer may be a layer formed of high density polyethylene having a thickness of approximately 100 micron (paragraph 0069). The film structure may be formed by coextrusion (paragraph 0071). The tie layer may be a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0057). The film may be used as lidding (paragraphs 0089-0093).
Merical et al. do not specifying the loading, or coating weight, of the tie layer.
Leplatois et al. is directed to an extrusion coated lidding foil used in blister packaging (paragraph 0001). The lidding comprises a foil on which one or more tie layers and sealant layers are extrusion coated (paragraph 0019). The one or more tie layers are applied in an amount of about 3 to 8 g/m2 (claim 10).
It would have been obvious to one of ordinary skill in the art to apply the tie layer(s) of Merical et al. at about 3 to 8 g/m2 because the courts have held the selection of a known material (e.g., tie layer(s) of about 3 to 8 g/m2) based on its suitability for its intended use (e.g. bonding layers together in films used for blister packaging) supported a prima facie obviousness determination. See MPEP 2144.07.
Regarding the limitation that the high density polyethylene has a relative energy difference value of greater than 1 in relation to one or more of nicotine, fentanyl, lidocaine, and rivastigmine, this limitation is taken to be an intrinsic property of high density polyethylene for the following reasons. According to paragraph 0124 on page 22 of the specification, the relative energy difference value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties. According to Table 1.1 of the referenced Handbook, the solubility parameter may be determined based on contributions provided by groups present in the structure of the compound, for example -CH2-. Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter (and thus its relative energy difference value) one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene of Merical et al. to be about the same as that of the HDPE of the invention such that it would be greater than 1 in relationship to one or more of nicotine, fentanyl, lidocaine and rivastigmine.
Regarding claim 17, a pharmaceutical product reads on an aggressive chemical substance.
Regarding claim 26, since contact layer of the instant invention typically comprises a thickness of 18-22 m (see paragraph 0026 on page 5 of the instant specification), one of ordinary skill in the art would expect a contact layer having a thickness of approximately 100 m to inherently satisfy the loading - i.e. coating weight - limitations of this claim.
Regarding claims 27 and 28, the limitations of these claims are taken to be met since the claims do not require the tie layers to be composed of different materials and one of ordinary skill in the art would expect a tie layer formed from a coextrusion of 3 layers of identical polymer to be structurally the same as an extrusion of a single layer.
Regarding claim 33, Merical et al. illustrates a pouch formed by sealing two laminates together such that the product contact layer is the innermost layer of each laminate that would be expected to be in contact with the product (206) (Figure 4).
Regarding claim 35, based on the thickness ranges recited for the product contact layer (paragraph 0069) and the barrier layer (paragraph 0070), one of ordinary skill in the art would expect the overall thickness of the film of Merical et al. to overlap the range recited in claim 35. This is further supported by Examples 1 and 2, illustrating embodiments wherein the film has a total thickness of about 85-110 m (Tables 1 and 2). Since the thickness range of the film of Merical et al. overlaps the range recited in claim 35, the courts have held that a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 36, the heat sealing layer (i.e., layer corresponding to the contact layer of the claims) is bonded to the barrier layer (i.e., layer corresponding to the base layer of the claims) by means of an adhesive layer (112).
Regarding claim 37, a limitation directed to a reason why HDPE might be selected for the contact layer is a product-by-process type limitation since it is directed to procedure by which HDPE would have been chosen for the contact layer. When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim in a product-by-process claim, the burden is on the applicant to present evidence from which the examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. In re Brown, 459 F. 2d 531, 173 USPQ 685 (CCPA 1972); In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). This burden is NOT discharged solely because the product was derived from a process not known to the prior art. In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). Furthermore, the determination of patentability for a product-by-process claim is based on the product itself and not on the method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) and MPEP § 2113. In this case, one laminate having HDPE as a contact layer is the same as another laminate having HDPE as a contact layer regardless of the reason why HDPE was chosen as the contact layer.
Regarding claim 38, Merical et al. teach that the tie layer may be a bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) as applied to claim 15 above, and further in view of Liu et al. (WO 2017/100182 A1).
Merical et al. taken in view of Leplatois et al. suggest all the limitations of claim 18, as outlined above, except for specifying the pharmaceutical product contained in the packaging. However, the package of Merical et al. may be a blister package (paragraph 0041).
Liu et al. is directed to a package for pharmaceutical products (paragraph 0002), such as a blister package (paragraph 0012). The pharmaceutical products to be packaged maybe one containing nicotine (paragraph 0088).
Liu et al. illustrate that nicotine containing products may be contained in blister packages designed for pharmaceutical products. Therefore, it would have been obvious to one of ordinary skill in the art to use the blister package of Merical et al. for nicotine products since the courts have held the selection of a known material (e.g., blister packaging suitable for pharmaceutical) based on its suitability for its intended use (e.g., containing nicotine products) supported a prima facie obviousness determination. See MPEP 2144.07.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) as applied to claim 15 above, and further in view of Christensen et al. (WO 2017/114922 A1).
Merical et al. taken in view of Leplatois et al. suggest all the limitations of claims 30 and 31, as outlined above, except for the specific materials of the tie layer. However, Merical et al. do teach that the tie layer by a bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056).
Christensen et al. is directed to a chemically resistant film comprising a tie and contact layer coextruded with a base layer for use as packaging for aggressive chemicals (page 1, lines 4-8). The tie layer may be composed to 1 to 5 layers (page 6, lines 8-11), such as a layer comprising a copolymer of ethylene and methacrylic acid as well as a copolymer of ethylene and acrylic acid (page 6, lines 15-21) or a bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene.
Regarding claim 30, Christensen et al. show that a single layer comprising a copolymer of ethylene and methacrylic acid and a bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene are known in the art as functionally equivalent tie layers for pharmaceutical packaging. Therefore, because these two tie layers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute single layer comprising a copolymer of ethylene and methacrylic acid for the bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene taught by Merical et al.
Regarding claim 31, Christensen et al. teach that the tie layer may be 1 to 5 layer and may be formed of a composition comprising a copolymer of ethylene and methacrylic acid and a copolymer of ethylene and acrylic acid. As such and in the absence of a showing of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art to use a tie layer having at least two layers wherein each layer is a composition comprising a copolymer of ethylene and methacrylic acid and a copolymer of ethylene and acrylic acid.
Claims 15, 17, 26-29, and 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) and Barbaroux et al. (US 2013/0161229 A1).
Merical et al. is directed to a polymeric film used to form packaging for moisture sensitive products, such as pharmaceutical products (paragraph 0026). The film may be a multilayer film comprising: a product contact layer, a barrier layer, tie or adhesive layers, and an outer layer (Figure 2 and paragraph 0055). The product contact layer corresponds to the contact layer of the claims; the barrier layer corresponds to the base layer that is water and/or oxygen resistant of the claims; tie/adhesive layer corresponds to the tie layer of the claims; the outer layer corresponds to the first outer layer of claim 34. The product contacting layer may be a layer having a thickness of approximately 100 micron (paragraph 0069). The film structure may be formed by coextrusion (paragraph 0071). The tie layer may be a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). The film may be used as lidding (paragraphs 0089-0093).
Merical et al. do not specifying the loading, or coating weight, of the tie layer. Furthermore, while Merical et al. do not teach the use of a polyvinylidene fluoride as the product contact layer, there is a teaching that polyvinyl chloride may be the product contact layer (paragraph 0069).
Leplatois et al. is directed to an extrusion coated lidding foil used in blister packaging (paragraph 0001). The lidding comprises a foil on which one or more tie layers and sealant layers are extrusion coated (paragraph 0019). The one or more tie layers are applied in an amount of about 3 to 8 g/m2 (claim 10).
Barbaroux et al. is directed to tubes for storing and transporting biopharmaceutical substances (paragraph 0001). The contact layer of the tube is made from a material suitable for being in contact with the biopharmaceutical substance, such as polyvinylidene fluoride (paragraph 0031). The contact layer is used as a replacement for polyvinylidene chloride (paragraph 0031), since polyvinylidene chloride can be dangerous when recycled or incinerated (paragraph 0014).
It would have been obvious to one of ordinary skill in the art to apply the tie layer(s) of Merical et al. at about 3 to 8 g/m2 because the courts have held the selection of a known material (e.g., tie layer(s) of about 3 to 8 g/m2) based on its suitability for its intended use (e.g. bonding layers together in films used for blister packaging) supported a prima facie obviousness determination. See MPEP 2144.07.
Additionally, it would have been obvious to one of ordinary skill in the art to use polyvinylidene fluoride as the contact layer, since it has been held that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination. See MPEP 2144.07. One of ordinary skill in the art would have an expectation of success using polyvinylidene fluoride as the contact layer since it is designed to serve as a replacement for polyvinylidene chloride - a material taught by Merical et al. as a suitable material for the contact layer.
Regarding claim 17, a pharmaceutical product reads on an aggressive chemical substance.
Regarding claim 26, since contact layer of the instant invention typically comprises a thickness of 18-22 m (see paragraph 0026 on page 5 of the instant specification), one of ordinary skill in the art would expect a contact layer having a thickness of approximately 100 m to inherently satisfy the loading - i.e. coating weight - limitations of this claim.
Regarding claims 27 and 28, the limitations of these claims are taken to be met since the claims do not require the tie layers to be composed of different materials and one of ordinary skill in the art would expect a tie layer formed from a coextrusion of 3 layers of identical polymer to be structurally the same as an extrusion of a single layer.
Regarding claim 33, Merical et al. illustrates a pouch formed by sealing two laminates together such that the product contact layer is the innermost layer of each laminate that would be expected to be in contact with the product (206) (Figure 4).
Regarding claim 35, based on the thickness ranges recited for the product contact layer (paragraph 0069) and the barrier layer (paragraph 0070), the one of ordinary skill in the art would expect the overall thickness of the film of Merical et al. to overlap the range recited in claim 35. This is further supported by Examples 1 and 2, illustrating embodiments wherein the film has a total thickness of about 85-110 m (Tables 1 and 2). Since the thickness range of the film of Merical et al. overlaps the range recited in claim 35, the courts have held that a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 36, the heat sealing layer (i.e., layer corresponding to the contact layer of the claims) is bonded to the barrier layer (i.e., layer corresponding to the base layer of the claims) by means of an adhesive layer (112).
Regarding claim 37, the limitations of this claim are met since the claim, while specifying details directed to the selection process for opting for HDPE as the contact layer, does not require the contact layer to be HDPE.
Regarding claim 38, Merical et al. teach that the tie layer may be a bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056)
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) and Barbaroux et al. (US 2013/0161229 A1) as applied to claim 15 above, and further in view of Liu et al. (WO 2017/100182 A1).
Merical et al. taken in view of Leplatois et al. and Barbaroux et al. suggest all the limitations of claim 18, as outlined above, except for specifying the pharmaceutical product contained in the packaging. However, the package of Merical et al. may be a blister package (paragraph 0041).
Liu et al. is directed to a package for pharmaceutical products (paragraph 0002), such as a blister package (paragraph 0012). The pharmaceutical products to be packaged maybe one containing nicotine (paragraph 0088).
Liu et al. illustrate that nicotine containing products may be contained in blister packages designed for pharmaceutical products. Therefore, it would have been obvious to one of ordinary skill in the art to use the blister package of Merical et al. for nicotine products since the courts have held the selection of a known material (e.g., blister packaging suitable for pharmaceutical) based on its suitability for its intended use (e.g., containing nicotine products) supported a prima facie obviousness determination. See MPEP 2144.07.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) and Barbaroux et al. (US 2013/0161229 A1) as applied to claim 15 above, and further in view of Christensen et al. (WO 2017/114922 A1).
Merical et al. taken in view of Leplatois et al. and Barbaroux et al. suggest all the limitations of claims 30 and 31, as outlined above, except for the specific materials of the tie layer. However, Merical et al. do teach that the tie layer by a bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056).
Christensen et al. is directed to a chemically resistant film comprising a tie and contact layer coextruded with a base layer for use as packaging for aggressive chemicals (page 1, lines 4-8). The tie layer may be composed to 1 to 5 layers (page 6, lines 8-11), such as a layer comprising a copolymer of ethylene and methacrylic acid as well as a copolymer of ethylene and acrylic acid (page 6, lines 15-21) or a bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene.
Regarding claim 30, Christensen et al. show that a single layer comprising a copolymer of ethylene and methacrylic acid and a bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene are known in the art as functionally equivalent tie layers for pharmaceutical packaging. Therefore, because these two tie layers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute single layer comprising a copolymer of ethylene and methacrylic acid for the bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene taught by Merical et al.
Regarding claim 31, Christensen et al. teach that the tie layer may be 1 to 5 layer and may be formed of a composition comprising a copolymer of ethylene and methacrylic acid and a copolymer of ethylene and acrylic acid. As such and in the absence of a showing of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art to use a tie layer having at least two layers wherein each layer is a composition comprising a copolymer of ethylene and methacrylic acid and a copolymer of ethylene and acrylic acid.
Double Patenting
Claims 15, 17, 18, 26-31, and 33-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of U.S. Patent No. 11,325,350 B2 in view of Merical et al. (US 2006/0269708 A1).
Claims 1 and 3-6 of U.S. Patent No. 11,325,350 B2 recite a laminate film comprising a base layer and a coextrusion layer which itself comprises a tie layer (including multiple tie layers, see claim 6) and a contact layer meeting the limitations of claims 15, 17, 18, 24, 26-31, and 33-35 except for a contact layer comprising CBC, PVDF, COP, HDPE, or EMAA. However, claim 1 of U.S. Patent No. 11,325,350 B2 does recite the use of a cyclic olefin copolymer as the contact layer.
Merical et al. is directed to a polymeric film used to form packaging for moisture sensitive products, such as pharmaceutical products (paragraph 0026). The film may be a multilayer film comprising: a product contact layer, a barrier layer, tie or adhesive layers, and an outer layer (Figure 2 and paragraph 0055). The product contacting layer may be a layer formed of cyclic olefin copolymer or high density polyethylene having a thickness of approximately 100 micron (paragraph 0069). The product contact layer corresponds to the contact layer of the claims; the barrier layer corresponds to the base layer that is water and/or oxygen resistant of the claims; tie/adhesive layer corresponds to the tie layer of the claims; the outer layer corresponds to the first outer layer of claim 34.
Merical et al. show that high density polyethylene and cyclic olefin copolymer are known in the art as functionally equivalent materials for the product-contact layer of a packaging film. Therefore, because these two polymers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute high density polyethylene for cyclic olefin copolymer in the packaging film claimed in U.S. Patent No. 11,325,350 B2.
Regarding the limitation that the high density polyethylene has a relative energy difference value of greater than 1 in relation to one or more of nicotine, fentanyl, lidocaine, and rivastigmine, this limitation is taken to be an intrinsic property of high density polyethylene for the following reasons. According to paragraph 0124 on page 22 of the specification, the relative energy difference value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties. According to Table 1.1 of the referenced Handbook, the solubility parameter may be determined based on contributions provided by groups present in the structure of the compound, for example -CH2-. Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter (and thus its relative energy difference value) one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene of Merical et al. to be about the same as that of the HDPE of the invention such that it would be greater than 1 in relationship to one or more of nicotine, fentanyl, lidocaine and rivastigmine.
Regarding claim 26, since contact layer of the instant invention typically comprises a thickness of 18-22 m (see paragraph 0026 on page 5 of the instant specification), one of ordinary skill in the art would expect a contact layer having a thickness of approximately 100 m to inherently satisfy the loading - i.e. coating weight - limitations of this claim.
Regarding claims 27 and 28, the limitations of these claims are taken to be met since the claims do not require the tie layers to be composed of different materials and one of ordinary skill in the art would expect a tie layer formed from a coextrusion of 3 layers of identical polymer to be structurally the same as an extrusion of a single layer.
Regarding claim 33, Merical et al. illustrates a pouch formed by sealing two laminates together such that the product contact layer is the innermost layer of each laminate that would be expected to be in contact with the product (206) (Figure 4).
Regarding claim 34, it would have been obvious to one of ordinary skill in the art to provide an outer abuse layer on the other side of the base layer recited in claim 1 of U.S. Patent No. 11,325,350 B2 to provide the resulting packaging with additional protection.
Regarding claim 35, it would have been obvious to one of ordinary skill in the art to fabricate the film recited in the claims of U.S. Patent No. 11,325,350 B2 at a thickness satisfying the limitations of this claim since Merical et al. illustrates that such films may suitably have a total thickness of 2.99 to 3.48 mil (paragraph 0033), i.e., about 76-88 m.
Regarding claim 36, since Merical et al. illustrates bonding layers corresponding to the contact layer and base layer by means of an adhesive layer (e.g., layer 112 in Figure 4), it would have been obvious to one of ordinary skill in the art to adhesively attach the base layer to the coextruded layer.
Regarding claim 37, a limitation directed to a reason why HDPE might be selected for the contact layer is a product-by-process type limitation since it is directed to procedure by which HDPE would have been chosen for the contact layer. When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim in a product-by-process claim, the burden is on the applicant to present evidence from which the examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. In re Brown, 459 F. 2d 531, 173 USPQ 685 (CCPA 1972); In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). This burden is NOT discharged solely because the product was derived from a process not known to the prior art. In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). Furthermore, the determination of patentability for a product-by-process claim is based on the product itself and not on the method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) and MPEP § 2113. In this case, one laminate having HDPE as a contact layer is the same as another laminate having HDPE as a contact layer regardless of the reason why HDPE was chosen as the contact layer.
Claims 15, 17, 18, 26-31, and 33-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-27 and 32 of U.S. Patent No. 11,376,814 B2 in view of Merical et al. (US 2006/0269708 A1) and Christensen et al. (WO 2017/114922 A1).
Claims 25-27 and 32 of U.S. Patent No. 11,376,814 B2 recite a laminate comprising an outer layer and a chemical resistant film which itself comprises a tie layer-contact layer coextrusion meeting the limitations of claims 15, 17, 18, 24, 26-31, and 33-35 except for a contact layer comprising CBC, PVDF, COP, HDPE, or EMAA and the coating weight of the tie layer. However, claim 25 of U.S. Patent No. 11,376,814 B2 does recite the use of a polyamide or ethylene vinyl alcohol copolymer as the contact layer.
Merical et al. is directed to a polymeric film used to form packaging for moisture sensitive products, such as pharmaceutical products (paragraph 0026). The film may be a multilayer film comprising: a product contact layer, a barrier layer, tie or adhesive layers, and an outer layer (Figure 2 and paragraph 0055). The product contacting layer may be a layer formed of cyclic olefin copolymer or high density polyethylene having a thickness of approximately 100 micron (paragraph 0069). The product contact layer corresponds to the contact layer of the claims; the barrier layer corresponds to the base layer that is water and/or oxygen resistant of the claims; tie/adhesive layer corresponds to the tie layer of the claims; the outer layer corresponds to the first outer layer of claim 34.
Christensen et al. is directed to a packaging film for aggressive pharmaceutical products comprising a contact layer, tie layer, and base layer (page 1, lines 4-15). The contact layer may be a cyclic olefin copolymer, a polyamide, or an ethylene vinyl alcohol copolymer (page 7, lines 1-3). The tie layer may be a single layer or multiple layers; the tie layer has a loading in the range of 7 to 20 g/m2 while the contact layer has a loading of in the range of 4 to 20 g/m2 (page 8, lines 32-35).
Merical et al. and Christensen et al. illustrate that high density polyethylene, cyclic olefin copolymer, polyamide, and ethylene vinyl alcohol copolymer are known in the art as functionally equivalent polymers for forming the contact layer of a packaging for pharmaceutical products. Therefore, because these polymers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute high density polyethylene for polyamide or ethylene vinyl alcohol copolymer in the packaging film recited in claims 25-27 and 32 of U.S. Patent No. 11,376,814 B2.
Moreover, it would have been obvious to one of ordinary skill in the art to employ the tie layer at a loading of 7 to 20 g/m2 since Christensen et al. show the suitability of using tie layers at that loading and the courts have held the selection of a known material (e.g. an adhesive layer at a loading of 7 to 20 g/m2) based on its suitability for its intended use (e.g. tie layer in a pharmaceutical packaging film) supported a prima facie obviousness determination. See MPEP 2144.07.
Regarding the limitation that the high density polyethylene has a relative energy difference value of greater than 1 in relation to one or more of nicotine, fentanyl, lidocaine, and rivastigmine, this limitation is taken to be an intrinsic property of high density polyethylene for the following reasons. According to paragraph 0124 on page 22 of the specification, the relative energy difference value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties. According to Table 1.1 of the referenced Handbook, the solubility parameter may be determined based on contributions provided by groups present in the structure of the compound, for example -CH2-. Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter (and thus its relative energy difference value) one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene of Merical et al. to be about the same as that of the HDPE of the invention such that it would be greater than 1 in relationship to one or more of nicotine, fentanyl, lidocaine and rivastigmine.
Regarding claim 26, since contact layer of the instant invention typically comprises a thickness of 18-22 m (see paragraph 0026 on page 5 of the instant specification), one of ordinary skill in the art would expect a contact layer having a thickness of approximately 100 m to inherently satisfy the loading - i.e. coating weight - limitations of this claim.
Regarding claims 27 and 28, the limitations of these claims are taken to be met since the claims do not require the tie layers to be composed of different materials and one of ordinary skill in the art would expect a tie layer formed from a coextrusion of 3 layers of identical polymer to be structurally the same as an extrusion of a single layer.
Regarding claim 33, Merical et al. illustrates a pouch formed by sealing two laminates together such that the product contact layer is the innermost layer of each laminate that would be expected to be in contact with the product (206) (Figure 4).
Regarding claim 34, it would have been obvious to one of ordinary skill in the art to provide an outer abuse layer on the other side of the base layer recited in claim 1 of U.S. Patent No. 11,325,350 B2 to provide the resulting packaging with additional protection.
Regarding claim 35, it would have been obvious to one of ordinary skill in the art to fabricate the film recited in the claims of U.S. Patent No. 11,325,350 B2 at a thickness satisfying the limitations of this claim since Merical et al. illustrates that such films may suitably have a total thickness of 2.99 to 3.48 mil (paragraph 0033), i.e., about 76-88 m.
Regarding claim 36, since Merical et al. illustrates bonding layers corresponding to the contact layer and base layer by means of an adhesive layer (e.g., layer 112 in Figure 4), it would have been obvious to one of ordinary skill in the art to adhesively attach the base layer to the coextruded layer.
Regarding claim 37, a limitation directed to a reason why HDPE might be selected for the contact layer is a product-by-process type limitation since it is directed to procedure by which HDPE would have been chosen for the contact layer. When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim in a product-by-process claim, the burden is on the applicant to present evidence from which the examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. In re Brown, 459 F. 2d 531, 173 USPQ 685 (CCPA 1972); In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). This burden is NOT discharged solely because the product was derived from a process not known to the prior art. In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). Furthermore, the determination of patentability for a product-by-process claim is based on the product itself and not on the method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) and MPEP § 2113. In this case, one laminate having HDPE as a contact layer is the same as another laminate having HDPE as a contact layer regardless of the reason why HDPE was chosen as the contact layer.
Claims 15, 17, 18, 24, 26-29, 31, and 33-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,122,139 B2 in view of Merical et al. (US 2006/0269708 A1).
Claims 1-13 of U.S. Patent No. 12,122,139 B2 differ from instant claims 15, 17, 18, 24, 26-31, and 33-35 in that they recite cycloolefin copolymer as the material from which the contact layer is formed.
Merical et al. is directed to a polymeric film used to form packaging for moisture sensitive products, such as pharmaceutical products (paragraph 0026). The film may be a multilayer film comprising: a product contact layer, a barrier layer, tie or adhesive layers, and an outer layer (Figure 2 and paragraph 0055). The product contacting layer may be a layer formed of cyclic olefin copolymer or high density polyethylene having a thickness of approximately 100 micron (paragraph 0069). The product contact layer corresponds to the contact layer of the claims; the barrier layer corresponds to the base layer that is water and/or oxygen resistant of the claims; tie/adhesive layer corresponds to the tie layer of the claims; the outer layer corresponds to the first outer layer of claim 34.
Merical et al. show that high density polyethylene and cyclic olefin copolymer are known in the art as functionally equivalent materials for the product-contact layer of a packaging film. Therefore, because these two polymers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute high density polyethylene for cyclic olefin copolymer in the packaging film claimed in U.S. Patent No. 12,122,139 B2.
Regarding the limitation that the high density polyethylene has a relative energy difference value of greater than 1 in relation to one or more of nicotine, fentanyl, lidocaine, and rivastigmine, this limitation is taken to be an intrinsic property of high density polyethylene for the following reasons. According to paragraph 0124 on page 22 of the specification, the relative energy difference value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties. According to Table 1.1 of the referenced Handbook, the solubility parameter may be determined based on contributions provided by groups present in the structure of the compound, for example -CH2-. Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter (and thus its relative energy difference value) one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene of Merical et al. to be about the same as that of the HDPE of the invention such that it would be greater than 1 in relationship to one or more of nicotine, fentanyl, lidocaine and rivastigmine.
Regarding claim 26, since contact layer of the instant invention typically comprises a thickness of 18-22 m (see paragraph 0026 on page 5 of the instant specification), one of ordinary skill in the art would expect a contact layer having a thickness of approximately 100 m to inherently satisfy the loading - i.e. coating weight - limitations of this claim.
Regarding claims 27 and 28, the limitations of these claims are taken to be met since the claims do not require the tie layers to be composed of different materials and one of ordinary skill in the art would expect a tie layer formed from a coextrusion of 3 layers of identical polymer to be structurally the same as an extrusion of a single layer.
Regarding claim 33, Merical et al. illustrates a pouch formed by sealing two laminates together such that the product contact layer is the innermost layer of each laminate that would be expected to be in contact with the product (206) (Figure 4).
Regarding claim 34, it would have been obvious to one of ordinary skill in the art to provide an outer abuse layer on the other side of the base layer recited in claim 1 of U.S. Patent No. 12,122,139 B2 to provide the resulting packaging with additional protection.
Regarding claim 35, it would have been obvious to one of ordinary skill in the art to fabricate the film recited in the claims of U.S. Patent No. 12,122,139 B2 at a thickness satisfying the limitations of this claim since Merical et al. illustrates that such films may suitably have a total thickness of 2.99 to 3.48 mil (paragraph 0033), i.e., about 76-88 m.
Regarding claim 36, since Merical et al. illustrates bonding layers corresponding to the contact layer and base layer by means of an adhesive layer (e.g., layer 112 in Figure 4), it would have been obvious to one of ordinary skill in the art to adhesively attach the base layer to the coextruded layer.
Regarding claim 37, a limitation directed to a reason why HDPE might be selected for the contact layer is a product-by-process type limitation since it is directed to procedure by which HDPE would have been chosen for the contact layer. When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim in a product-by-process claim, the burden is on the applicant to present evidence from which the examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. In re Brown, 459 F. 2d 531, 173 USPQ 685 (CCPA 1972); In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). This burden is NOT discharged solely because the product was derived from a process not known to the prior art. In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). Furthermore, the determination of patentability for a product-by-process claim is based on the product itself and not on the method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) and MPEP § 2113. In this case, one laminate having HDPE as a contact layer is the same as another laminate having HDPE as a contact layer regardless of the reason why HDPE was chosen as the contact layer.
Claims 15, 17, 18, 24, 26-29, 33, 34, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 30, and 31 of copending Application No. 17/621,591 in view of Liu et al. (WO 2017/100182 A1) and Christensen et al. (WO 2017/114922 A1).
Claims 27, 28, 30, and 31 of copending Application No. 17/621,591 are directed to a laminate film comprising a base layer and a contact layer differ from instant claims 15, 17, 18, 24, 26-31, 33, and 34 in that they do not specify that the contact layer is adhesively bound to the base layer by means of a coextruded tie layer nor the coating weight of the tie layer.
Liu et al. is directed to a package for pharmaceutical products formed from a film comprising a contact layer of cyclic olefin copolymer (paragraph 0002). The film comprises exterior and gas barrier layers in addition to the product contact layer (Figure 1 and paragraph 0044). The exterior layer is configured to prevent damage due to handling and other external influences (paragraph 0064). The layers are combined by coextrusion (paragraph 0045). Adhesive layers may be added between the layers (paragraph 0046). The film may be formed into a pouch or lidding of a blister package (paragraphs 0010-0018) to package pharmaceutical products containing nicotine (paragraph 0088).
Christensen et al. is directed to a packaging film for aggressive pharmaceutical products comprising a contact layer, tie layer, and base layer (page 1, lines 4-15). The tie layer may be a single layer or multiple layers; the tie layer has a loading in the range of 7 to 20 g/m2 while the contact layer has a loading of in the range of 4 to 20 g/m2 (page 8, lines 32-35).
It would have been obvious to one of ordinary skill in the art to bond adhesive and contact layers to the base layer recited in claims 27, 28, 30, and 31 of copending Application No. 17/621,591 via coextrusion since Liu et al. illustrate that coextrusion may be used to bond barrier and contact layers in packaging films and the courts have held the selection of a known technique based on its suitability for its intended use supported a prima facie obviousness determination. See MPEP 2144.07.
Moreover, it would have been obvious to one of ordinary skill in the art to employ the tie layer at a loading of 7 to 20 g/m2 since Christensen et al. show the suitability of using tie layers at that loading and the courts have held the selection of a known material (e.g. an adhesive layer at a loading of 7 to 20 g/m2) based on its suitability for its intended use (e.g. tie layer in a pharmaceutical packaging film) supported a prima facie obviousness determination. See MPEP 2144.07.
Regarding the limitation that the high density polyethylene has a relative energy difference value of greater than 1 in relation to one or more of nicotine, fentanyl, lidocaine, and rivastigmine, this limitation is taken to be an intrinsic property of high density polyethylene for the following reasons. According to paragraph 0124 on page 22 of the specification, the relative energy difference value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties. According to Table 1.1 of the referenced Handbook, the solubility parameter may be determined based on contributions provided by groups present in the structure of the compound, for example -CH2-. Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter (and thus its relative energy difference value) one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene recited in the claims of copending Application No. 17/621,591 to be about the same as that of the HDPE of the invention such that it would be greater than 1 in relationship to one or more of nicotine, fentanyl, lidocaine and rivastigmine.
Regarding claim 26, it would have been obvious to one of ordinary skill in the art to employ the contact layer at a loading of 4 to 20 g/m2 since Christensen et al. show the suitability of using a contact layer at that loading and the courts have held the selection of a known material (e.g. a contact layer at a loading of 4 to 20 g/m2) based on its suitability for its intended use (e.g. contact layer in a pharmaceutical packaging film) supported a prima facie obviousness determination. See MPEP 2144.07.
Regarding claim 33, it would have been obvious to form the packaging as a pouch or a blister pad with lidding since Lui et al. show that it is known to form pouches and lidding out of packaging film for the purpose of packaging nicotine products.
Regarding claim 36, it would have been obvious to one of ordinary skill in the art to use the tie layer of the co-extrusion layer to bond the contact layer to the base layer of the laminate since the contact layer must be an outermost layer if it is to contact external component(s).
Claims 30, 31, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 30, and 31 of copending Application No. 17/621,591 in view of Liu et al. (WO 2017/100182 A1) and Christensen et al. (WO 2017/114922 A1), as applied to claim 15 above, and further in view of Mehta et al. (US 2018/0361724 A1).
Claims 27, 28, 30, and 31 of copending Application No. 17/621,591 taken in view of Liu et al. and Christensen et al. suggest all the limitations of claims 30, 31, and 35, as outlined above, except for details regarding the tie layer material and the overall thickness of the film.
Mehta et al. is directed to a packaging laminate for pharmaceutical products (paragraph 0001). The tie layer may a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). In the embodiments of Examples 1 and 2, the film has a total thickness of about 85-110 m (Tables 1 and 2).
Regarding claims 30 and 31, it would have been obvious to one of ordinary skill in the art to use a tie layer having a single layer constructure formed from a blend of low density polyethylene and ethylene acrylic acid copolymer or bilayer construction having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer since it has been held that the selection of a known material (e.g. the adhesive configurations of Mehta et al.) based on its suitability for its intended use (e.g. bonding a contact layer to a base material) supported a prima facie obviousness determination. See MPEP 2144.07.
Regarding claim 35, it would have been obvious to one of ordinary skill in the art to form the film with a total thickness of about 85-110 mm since Mehta et al. illustrate that films of such a thickness may be used as packaging films for pharmaceutical products and the courts have held that the selection of a known material (e.g. film with total thickness of 85-110 m) based on its suitability for its intended use (i.e. packaging film for pharmaceutical product) supported a prima facie obviousness determination.
Withdrawn Rejection
The rejection of claim 17 under 35 U.S.C. 112(b) has been withdrawn in view of the arguments presented in the reply filed 28 May 2026.
Response to Arguments
Applicant's arguments filed 28 May 2026 have been fully considered but they are not persuasive.
The applicant argues that the Office action has not provided evidence that a person skilled in the art would expect Merical to teach or suggest that their HDPE has a RED value of greater than 1 in relation to nicotine, fentanyl, lidocaine, and/or rivastigmine. The applicant argues that the action has shown neither that all or most commercially available HDPEs possess this RED value nor that there was any reason in Merical to select a material with a RED value greater than 1 that was specific to nicotine, fentanyl, lidocaine, and/or rivastigmine. The applicant asserts that, since RED is not the same as the Hansen solubility parameter, factors such as crystallinity, molecular weight, and processing technique may impact the RED value.
This is not persuasive for the following reasons. According to paragraph 0124 on page 22 of the applicant's specification, the RED value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties resulting from contributions provided by groups present in the structure of the compound. Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter (and thus its relative energy difference value), a prima facie case exists that one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene recited in the claims of copending Application No. 17/621,591 to be about the same as that of the HDPE of the invention as both would be expected to possess the same groups as both are high density chains of polyethylene. The allegation that other factors might play a role appears to be the applicant's opinion and not supported by any evidence on the record.
Additionally, it has been held that there is no requirement that a person of ordinary skill in the art would have recognized the inherent property (in this case, RED values with respect to nicotine, fentanyl, lidocaine, and/or rivastigmine), only that the subject matter be inherent. Since the examiner has provided a rationale showing a prima facie case of inherency, the burden of production shifts to the applicant. See MPEP 2112.
The applicant argues that, in combining of Merical and Leplatois, the Office improperly dissected the claimed invention into discrete elements and did not consider the invention as a whole. The applicant asserts that, while Merical is directed to a film structure utilized in a package for a product that may be sensitive to moisture, Leplatois is directed to achieving specific mechanical push-through properties for a lidding foil. As such, the applicant argues that one of ordinary skill seeking to implement Merical's desiccant technology would be focused on optimizing moisture absorption and not the mechanical push-though properties taught by Leplatois.
This is not persuasive for the following reasons. Merical explicitly teaches that their packaging film, comprising an adhesive layer, may be used as a lidding on the package, including for use in blister packages of the sort described by Leplatois (e.g., see paragraphs 0041 and 0074). Leplatois, also directed to lidding for packaging applications, illustrates suitable coating weights for the adhesive layers of lidding used in packaging applications. As such, it would have been obvious for one of ordinary skill in the art to look to the teachings of Leplatois for guidance as to the amount of adhesive used in the film of Merical, particularly since the packaging film of Merical may be used as lidding in blister packaging.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAMSEY E ZACHARIA whose telephone number is (571)272-1518. The best time to reach the examiner is weekday mornings, Eastern time.
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/RAMSEY ZACHARIA/Primary Examiner, Art Unit 1787
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