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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “adhesive layer” and “supportive layer” of Claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nassar et al. (USPGPub 2024/0024234).
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), and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
Re Claim 2, Nassar teaches whe9rein 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).
Re Claim 3, Nassar teaches wherein the modified acrylic polymer is a hydrophobically-modified cross-linked acrylate copolymer (Nassar ¶ 0016).
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.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (USPGPub 2024/0024234) in view of Liu et al. (USPGPub 2023/0277431).
Re Claim 4, Nassar teaches all of the limitations of Claim 1. Nassar fails 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 pf 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).
Re Claim 5, Nassar 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 fails 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 pf 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).
Re Claim 6, Nassar in view of Liu teach all of the limitations of Claim 4. Nassar fails 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 pf 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 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 (Nassar ¶ 0120).
Nassar also fails 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 pf 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).
Re Claim 7, Nassar 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 fails 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 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 pf 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).
Claims 8 and 12-16 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).
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), and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
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 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), and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128).
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 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 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 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).
Re Claim 15, 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), and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128); and 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).
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 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 16, 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), and the layered material has a thickness of 0.0001 millimeters to 100 millimeters (Nassar ¶ 0128); and wherein the modified acrylic polymer is a hydrophobically-modified cross-linked acrylate copolymer (Nassar ¶ 0016).
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 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).
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 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), 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 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 pf 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 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), 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 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 pf 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 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 (Nassar ¶ 0120).
Nassar also fails 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 pf 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 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), 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 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 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 pf 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 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 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 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), 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 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 pf 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 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 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 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 fails 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 pf 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 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 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 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 pf 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 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 (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 pf 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 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). However, Kim fails to teach the adhesive layer comprising the layered material of Claim 7. Nassar 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 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 pf 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 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).
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781