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(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2014/0066843) in view of Toyohara (US 2015/0094648).
Regarding claim 1, Zhang discloses a microneedle array (Fig. 1, 100) comprising a non-biosoluble substance as a material (¶[0134]), wherein no drug is applied to the needle tip section apex (¶[0149]).
Zhang teaches a needle length of between 100 µm and 1200 µm (¶[0141]).
However, Zhang does not explicitly disclose the needle length being between 350 µm and 1500 µm
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Zhang from between 100 µm and 1200 µm to between 350 µm and 1500 µm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see ¶[0017], where other acceptable ranges are allowed).
Zhang does not specifically teach a diameter of a needle tip section apex of 15 µm or more and 100 µm or less, having a drug-applied portion.
Toyohara teaches a microneedle and microneedle array that includes a needle and a tip portion (Abstract). Toyohara teaches where the diameter of the tip of the micro needle is between 1 µm and 20 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Toyohara from between 1 µm and 20 µm to between 15 µm and 100 µm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see ¶[0017], where other acceptable ranges are allowed). This would be a well-known combination as the tip of Zhang is not a specified diameter and Toyohara does not modify the tip diameter for a specific reason other than to specify the diameter of apex of the microneedle and is a design change that does not impact functionality.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Zhang to include a tip diameter of between 1 µm and 20 µm from Toyohara as it is an overlapping range and a design choice modification.
Regarding claim 2, Zhang discloses a microneedle array (Fig. 1, 100) comprising a non-biosoluble polymer as a base(¶[0134]), wherein no drug is applied to the needle tip section apex (¶[0149]).
Zhang teaches a needle length of between 100 µm and 1200 µm (¶[0141]).
However, Zhang does not explicitly disclose the needle length being between 350 µm and 1500 µm
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Zhang from between 100 µm and 1200 µm to between 350 µm and 1500 µm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see ¶[0017], where other acceptable ranges are allowed).
Zhang does not specifically teach a diameter of a needle tip section apex of 15 µm or more and 100 µm or less, having a drug-applied portion.
Toyohara teaches a microneedle and microneedle array that includes a needle and a tip portion (Abstract). Toyohara teaches where the diameter of the tip of the micro needle is between 1 µm and 20 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Toyohara from between 1 µm and 20 µm to between 15 µm and 100 µm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see ¶[0017], where other acceptable ranges are allowed). This would be a well-known combination as the tip of Zhang is not a specified diameter and Toyohara does not modify the tip diameter for a specific reason other than to specify the diameter of apex of the microneedle and is a design change that does not impact functionality.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Zhang to include a tip diameter of between 1 µm and 20 µm from Toyohara as it is an overlapping range and a design choice modification.
Regarding claim 3, Zhang and Toyohara teach the microneedle array according to claim 1, Zhang further teaches wherein an upper end of the drug-applied portion is a position 30 µm or more lower than the needle tip section apex (¶[0149], where the distance 270 of the coating is at most 10 percent of the distance from the tip to the base which is between 10 µm and 120 µm).
Regarding claim 4, Zhang and Toyohara teach the microneedle array according to claim 3, Zhang further teaches wherein the drug-applied portion has a maximum diameter of 300 µm or less (¶[0142], where the aspect ratio of height to width is 2:1 to 5:1 which means the width at the base can be 600 µm to 20 µm which means that the width at the drug applied portion falls into the range of the claimed invention).
Regarding claim 5, Zhang and Toyohara teach the microneedle array according to claim 1, Zhang further teaches wherein the needle has an aspect ratio of 3 or more (¶[0142], where the aspect ratio can be between 2:1 and 5:1).
Regarding claim 6, Zhang and Toyohara teach the microneedle array according to claim 1, Zhang further teaches wherein the amount of the applied drug per needle is 0.001 to 30 µg (¶[0151], where the coating has an average amount of 0.01 to 2 µg per needle and falls within the claimed range).
Regarding claim 7, Zhang and Toyohara teach the microneedle array according to claim 2, Zhang further teaches wherein the non-biosoluble polymer is selected from the group consisting of nylon, polycarbonate, polylactic acid, poly(lactic acid-glycolic acid) copolymer, polyglycolic acid, polyethylene terephthalate, COP (cyclic olefin polymer), and mixtures thereof (¶[0134], [0137], where the material can be polycarbonate or other materials).
Regarding claim 8, Zhang and Toyohara teach the microneedle array according to claim 2, Zhang further teaches wherein the non-biosoluble polymer is selected from the group consisting of hyaluronic acid, dextran, polyvinylpyrrolidone, sodium chondroitin sulfate, hydroxypropyl cellulose, polyvinyl alcohol, and mixtures thereof (¶[0159], where the material can be hyaluronic acid, dextran, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl methyl cellulose, or combinations of these materials or others).
Regarding claim 9, Zhang and Toyohara teach the microneedle array according to claim 1, Zhang further teaches wherein the drug-applied portion concomitantly contains a water-soluble substance selected from the group consisting of hyaluronic acid, collagen, dextrin, dextran, sodium chondroitin sulfate, hydroxypropyl cellulose, ethyl cellulose, carboxymethyl cellulose sodium salt, alginic acid, glucose, sucrose, maltose, trehalose, and mixtures thereof (¶[0121], where multiple of the substances are listed in the group and combinations thereof).
Regarding claim 10, Zhang discloses a method for producing a microneedle array (Fig. 1, 100) in which no drug is applied to a needle tip section apex (Fig. 3, 100), the method comprising:
comprising a non-biosoluble polymer as a base (¶[0134]); and
drying the drug-containing application liquid with such a setting that an upper end of a drug-applied portion after a drying step is a position 30 µm or more lower than an upper end of a needle (¶[0149], where the distance 270 of the coating is at most 10 percent of the distance from the tip to the base which is between 10 µm and 120 µm & ¶[0161]-[0162], where there is a drying step).
Zhang teaches a solution viscosity of 500 to 30000 centipoise which is equivalent to 500 to 30000 mPa·s (25°C).
However, Zhang does not explicitly disclose the viscosity of 50 to 2,000 mPa·s (25°C).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the viscosity of Zhang from 500 to 30000 centipoise to between 50 to 2,000 mPa·s since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Zhang teaches a needle length of between 100 µm and 1200 µm (¶[0141]).
However, Zhang does not explicitly disclose the needle length being between 350 µm and 1500 µm
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Zhang from between 100 µm and 1200 µm to between 350 µm and 1500 µm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see ¶[0017], where other acceptable ranges are allowed).
Zhang does not specifically teach a diameter of a needle tip section apex of 15 µm or more and 100 µm or less, having a drug-applied portion.
Toyohara teaches a microneedle and microneedle array that includes a needle and a tip portion (Abstract). Toyohara teaches where the diameter of the tip of the micro needle is between 1 µm and 20 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Toyohara from between 1 µm and 20 µm to between 15 µm and 100 µm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see ¶[0017], where other acceptable ranges are allowed). This would be a well-known combination as the tip of Zhang is not a specified diameter and Toyohara does not modify the tip diameter for a specific reason other than to specify the diameter of apex of the microneedle and is a design change that does not impact functionality.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Zhang to include a tip diameter of between 1 µm and 20 µm from Toyohara as it is an overlapping range and a design choice modification.
Regarding claim 11, Zhang and Toyohara teach the microneedle array according to claim 2, Zhang further teaches wherein an upper end of the drug-applied portion is a position 30 µm or more lower than the needle tip section apex (¶[0149], where the distance 270 of the coating is at most 10 percent of the distance from the tip to the base which is between 10 µm and 120 µm).
Regarding claim 12, Zhang and Toyohara teach the microneedle array according to claim 11, Zhang further teaches wherein the drug-applied portion has a maximum diameter of 300 µm or less (¶[0142], where the aspect ratio of height to width is 2:1 to 5:1 which means the width at the base can be 600 µm to 20 µm which means that the width at the drug applied portion falls into the range of the claimed invention).
Regarding claim 13, Zhang and Toyohara teach the microneedle array according to claim 2, Zhang further teaches wherein the needle has an aspect ratio of 3 or more (¶[0142], where the aspect ratio can be between 2:1 and 5:1).
Regarding claim 14, Zhang and Toyohara teach the microneedle array according to claim 2, Zhang further teaches wherein the amount of the applied drug per needle is 0.001 to 30 µg (¶[0151], where the coating has an average amount of 0.01 to 2 µg per needle and falls within the claimed range).
Regarding claim 15, Zhang and Toyohara teach the microneedle array according to claim 2, Zhang further teaches wherein the drug-applied portion concomitantly contains a water-soluble substance selected from the group consisting of hyaluronic acid, collagen, dextrin, dextran, sodium chondroitin sulfate, hydroxypropyl cellulose, ethyl cellulose, carboxymethyl cellulose sodium salt, alginic acid, glucose, sucrose, maltose, trehalose, and mixtures thereof (¶[0121], where multiple of the substances are listed in the group and combinations thereof).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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