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 .
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (USPGPub 2024/0024234) in view of Zolotarsky et al. (USPGPub 2024/0099955).
Re Claim 1, Nassar teaches a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Nassar fails to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (USPGPub 2024/0024234) in view of Zolotarsky et al. (USPGPub 2024/0099955) as applied to Claim 1 above, and further in view of Liu et al. (USPGPub 2023/0277431).
Re Claim 4, Nassar in view of Zolotarsky teach all of the limitations of Claim 1. Nassar in view of Zolotarsky fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 1 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 1 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 1 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Nassar in view of Zolotarsky have a viscosity of 1 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
Re Claim 5, Nassar in view of Zolotarsky as applied to Claim 1 above, and further in view of Liu teach all of the limitations of Claim 4. Nassar further teaches the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 1:1.5 to 1:4 (Nassar ¶ 0120 - teaching weight ratio of 1:3). Nassar in view of Zolotarsky to teach wherein the hydroxypropyl methylcellulose has a viscosity of 400 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 400 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 400 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Nassar in view of Zolotarsky as applied to Claim 1 above, and further in view of Liu have a viscosity of 400 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
Re Claim 6, Nassar in view of Zolotarsky as applied to Claim 1 above, and further in view of Liu teach all of the limitations of Claim 4. Nassar in view of Zolotarsky fail to teach the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 2:1 to 3.5:1. However, Nassar teaches the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 1:7, 1:6, 1:5, 1:4, 1:3 (Nassar ¶ 0120). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 1:7, 1:6, 1:5, 1:4, 1:3 substantially overlaps and thus anticipates the claimed range of 2:1 to 3.5:1. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Nassar have a viscosity of 2:1 to 3.5:1 where the teaching of 1:7, 1:6, 1:5, 1:4, 1:3 as disclosed by Nassar is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Nassar ¶ 0120).
Nassar in view of Zolotarsky also fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 400 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 400 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 400 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Nassar in view of Zolotarsky as applied to Claim 1 above, and further in view of Liu have a viscosity of 400 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
Re Claim 7, Nassar in view of Zolotarsky as applied to Claim 1 above, and further in view of Liu teach all of the limitations of Claim 4. Nassar further teaches the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 1:1.5 to 4:1 (Nassar ¶ 0120). Nassar in view of Zolotarsky fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 1 cP to 100 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 1 cP to 100 cP (Liu ¶ 0065 - teaching viscosity of about 3.6 cP to 5.1 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3.6 cP to 5.1 cP substantially overlaps and thus anticipates the claimed range of 1 cP to 100 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Nassar in view of Zolotarsky as applied to Claim 1 above, and further in view of Liu have a viscosity of 1 cP to 100 cP where the teaching of 3.6 cP to 5.1 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0065).
Claims 8 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (USPGPub 2025/0256081) in view of Nassar et al. (USPGPub 2024/0024234) above and further in view of Zolotarsky et al. (USPGPub 2024/0099955).
Re Claim 8, Kim teaches a patch (100) (Kim Fig. 6), comprising a supportive layer (10) and an adhesive layer (12), and the adhesive layer (12) is disposed on one side of the supportive layer (10) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 1. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
In the present case, prior art Kim teaches a similar formulation of the adhesive layer (12) comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the adhesive layer of Kim with that of Nassar in view of Zolotarsky where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 12, Kim teaches a microneedle patch (100), comprising a needle layer (14), a base layer (12), and a backing layer (10); the base layer (12) is disposed between the needle layer (14) and the backing layer (10); and the backing layer (10) comprises at least one protrusion part (part extending radially from first film 12) which is free of connection with the base layer (12) (as seen in Kim Fig. 6). However, Kim fails to teach wherein the backing layer (10) comprises the layered material of Claim 1. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
In the present case, prior art Kim teaches a similar formulation for a layer comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the backing layer of Kim with that of Nassar in view of Zolotarsky where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 13, Kim in view of Nassar above and further in view of Zolotarsky teach all of the limitations of Claim 12. Kim further teaches wherein the needle layer (14) comprises an effective component (Kim ¶ 0042-0043).
Re Claim 14, Kim in view of Nassar above and further in view of Zolotarsky teach all of the limitations of Claim 12. Kim further teaches wherein the microneedle patch (100) further comprises a water-resistant layer, and the water-resistant layer is disposed on the side of the backing layer (10) which is free of connection with the base layer (12) (Kim ¶ 0012, 0071).
Claims 9-11 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (USPGPub 2025/0256081) in view of Nassar et al. (USPGPub 2024/0024234) above and further in view of Zolotarsky et al. (USPGPub 2024/0099955) and Liu et al. (USPGPub 2023/0277431).
Re Claim 9, Kim teaches a patch (100) (Kim Fig. 6), comprising a supportive layer (10) and an adhesive layer (12), and the adhesive layer (12) is disposed on one side of the supportive layer (10) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 5. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Kim in view of Nassar also fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 400 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 400 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 400 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 400 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
In the present case, prior art Kim teaches a similar formulation of the adhesive layer (12) comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the adhesive layer of Kim with that of Nassar above and further in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 10, Kim teaches a patch (100) (Kim Fig. 6), comprising a supportive layer (10) and an adhesive layer (12), and the adhesive layer (12) is disposed on one side of the supportive layer (10) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 6. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Kim in view of Nassar fail to teach wherein the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 2:1 to 3.5:1. However, Nassar teaches the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 1:7, 1:6, 1:5, 1:4, 1:3 (Nassar ¶ 0120). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 1:7, 1:6, 1:5, 1:4, 1:3 substantially overlaps and thus anticipates the claimed range of 2:1 to 3.5:1. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Nassar have a viscosity of 2:1 to 3.5:1 where the teaching of 1:7, 1:6, 1:5, 1:4, 1:3 as disclosed by Nassar is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Nassar ¶ 0120).
Kim in view of Nassar also fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 400 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 400 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 400 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 400 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
In the present case, prior art Kim teaches a similar formulation of the adhesive layer (12) comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the adhesive layer of Kim with that of Nassar in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 11, Kim teaches a patch (100) (Kim Fig. 6), comprising a supportive layer (10) and an adhesive layer (12), and the adhesive layer (12) is disposed on one side of the supportive layer (10) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 7. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Kim in view of Nassar fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 1 cP to 100 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 1 cP to 100 cP (Liu ¶ 0065 - teaching viscosity of about 3.6 cP to 5.1 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3.6 cP to 5.1 cP substantially overlaps and thus anticipates the claimed range of 1 cP to 100 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 1 cP to 100 cP where the teaching of 3.6 cP to 5.1 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0065).
In the present case, prior art Kim teaches a similar formulation of the adhesive layer (12) comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the adhesive layer of Kim with that of Nassar in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 17, Kim teaches a microneedle patch (100), comprising a needle layer (14), a base layer (12), and a backing layer (10); the base layer (12) is disposed between the needle layer (14) and the backing layer (10); and the backing layer (10) comprises at least one protrusion part (part extending radially from first film 12) which is free of connection with the base layer (12) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 4. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Kim in view of Nassar fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 1 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 1 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 1 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 1 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
In the present case, prior art Kim teaches a similar formulation for a layer comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the backing layer of Kim with that of Nassar in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 18, Kim teaches a microneedle patch (100), comprising a needle layer (14), a base layer (12), and a backing layer (10); the base layer (12) is disposed between the needle layer (14) and the backing layer (10); and the backing layer (10) comprises at least one protrusion part (part extending radially from first film 12) which is free of connection with the base layer (12) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 5. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Kim in view of Nassar fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 400 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 400 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 5)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 400 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 400 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
In the present case, prior art Kim teaches a similar formulation for a layer comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the backing layer of Kim with that of Nassar in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Claim 19, Kim teaches a microneedle patch (100), comprising a needle layer (14), a base layer (12), and a backing layer (10); the base layer (12) is disposed between the needle layer (14) and the backing layer (10); and the backing layer (10) comprises at least one protrusion part (part extending radially from first film 12) which is free of connection with the base layer (12) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 6. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Nassar also teaches the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 1:7, 1:6, 1:5, 1:4, 1:3 (Nassar ¶ 0120). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 1:7, 1:6, 1:5, 1:4, 1:3 substantially overlaps and thus anticipates the claimed range of 2:1 to 3.5:1. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 2:1 to 3.5:1 where the teaching of 1:7, 1:6, 1:5, 1:4, 1:3 as disclosed by Nassar is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Nassar ¶ 0120).
Kim in view of Nassar fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 400 cP to 10000 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 400 cP to 10000 cP (Liu ¶ 0064 - teaching viscosity of about 3000 cP to 5000 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3000 cP to 5000 cP substantially overlaps and thus anticipates the claimed range of 400 cP to 10000 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 400 cP to 10000 cP where the teaching of 3000 cP to 5000 cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0064).
In the present case, prior art Kim teaches a similar formulation for a layer comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the backing layer of Kim with that of Nassar in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Re Claim 20, Kim teaches a patch (100) (Kim Fig. 6), comprising a supportive layer (10) and an adhesive layer (12), and the adhesive layer (12) is disposed on one side of the supportive layer (10) (as seen in Kim Fig. 6). Kim teaches a microneedle patch (100), comprising a needle layer (14), a base layer (12), and a backing layer (10); the base layer (12) is disposed between the needle layer (14) and the backing layer (10); and the backing layer (10) comprises at least one protrusion part (part extending radially from first film 12) which is free of connection with the base layer (12) (as seen in Kim Fig. 6). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 7. Nassar teaches a patch (Nassar ¶ 0124-0128 - circular disc) comprising a layered material for mucoadhesion, comprising a modified acrylic polymer and hydroxypropyl methylcellulose, wherein a weight ratio of the modified acrylic polymer: the hydroxtpropyl methylcellulose is 1:4 to 4:1 (Nassar ¶ 0120-0128); wherein the layered material is obtained by drying a layered material composition liquid comprising the modified acrylic polymer and the hydroxypropyl methylcellulose (Nassar ¶ 0016), wherein the layered material composition liquid has a solid content of 0.5 weight percent to 30 weight percent (Nassar ¶ 0092); and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Kim in view of Nassar fail to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer. Zolotarsky teaches microneedles comprising a modified acrylic polymer wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer (Zolotarsky ¶ 0082-0083, 0239, 0300). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the modified acrylic polymer of Kim in view of Nassar to be an acrylates/C10-30 alkyl acrylate crosspolymer as disclosed by Zolotarsky (Zolotarsky ¶ 0082-0083, 0239, 0300), wherein the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Nassar also teaches the weight ratio of the modified acrylic polymer: the hydroxypropyl methylcellulose is 1:1.5 to 4:1 (Nassar ¶ 0120). Kim in view of Nassar fail to teach wherein the hydroxypropyl methylcellulose has a viscosity of 1 cP to 100 cP. Liu teaches a patch comprising hydroxypropyl methylcellulose having a viscosity of 1 cP to 100 cP (Liu ¶ 0065 - teaching viscosity of about 3.6 cP to 5.1 cP). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of about 3.6 cP to 5.1 cP substantially overlaps and thus anticipates the claimed range of 1 cP to 100 cP. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the hydroxypropyl methylcellulose of Kim in view of Nassar have a viscosity of 1 cP to 100 cP where the teaching of 3.6 cP to 5.1 cP cP as disclosed by Liu is a range within, overlapping, or touching the claimed range and anticipates the prior art range due to not substantially deviating from the claimed range (Liu ¶ 0065).
In the present case, prior art Kim teaches a similar formulation for a layer comprising a vinyl polymer and hydroxypropyl methylcellulose (Kim ¶ 0040). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Furthermore, chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have replaced the backing layer of Kim with that of Nassar in view of Zolotarsky and Liu where the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art and, where chemical compounds having structural similarities and similar utility will likely have similar properties are obvious to one of ordinary skill in the art (MPEP 2144.09).
Response to Arguments
Applicant’s arguments filed 06/12/2026 with respect to drawing objections have been fully considered and are persuasive. The filing of updated drawings dated 06/12/2026 is accepted. Due to updates to the specification and drawings, objections to the drawings are hereinafter withdrawn.
Applicant’s arguments with respect to Claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Examiner concedes prior art Nassar fails to teach newly amended Claim 1 limitation “wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer.” However, Zolotarsky is now relied upon to teach wherein the modified acrylic polymer is an acrylates/C10-30 alkyl acrylate crosspolymer.
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive. At the bottom of Page 11 of the response, applicant argues Nassar et al. discloses the solid content of the hydrogel is greater than 85% (See Claim 10), so Nassar et al. is silent on the technical feature that "the layered material composition liquid has a solid content of 0.5 weight percent to 30 percent.” However, Nassar PGPub paragraph teaches “the concentration of the solution of HPMC in aqueous solvent is between 1% and 8% (w/w) and is preferably around 2% (w/w).” At the bottom of Page 14 leading into Page 15, applicant argues with regard to secondary reference Liu that “the adhesion efficacy (the adhesive time to the glass slide) demonstrated in Table 2 of the present invention is at least 1.3 hours (See Example A1) and the test method is to put the layered material in a PBS buffer, PHOSITA has no intention to take reference to the formula in Liu et al. for increasing the adhesion efficacy.” However, Liu is not relied upon to teach adhesion, only to teach hydroxypropyl methylcellulose having a viscosity of 1 cP to 10000 cP or 400 cP to 1000 cP. On Page 15 of the response, applicant’s arguments turn to the microneedle patch of prior art Kim. Applicant refers to the method of Kim for using its patch. However, the claims to the present case are not directed to a method of suing microneedles, only microneedle formulations and microneedle patches. As to prior art Kim, Kim is relied upon to teach the configuration of the patch only, not the formulation thereof or the method of using said patch.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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