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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9 September 2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed 9 September 2026.
Claim 13 is canceled.
Claims 20 and 21 are added.
Claims 1-12 and 14-21 are presently pending in this application.
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 1-11, 17, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tokumoto et al. (US Patent Publication No. 20110288485 A1), hereinafter Tokumoto, in view of Pruitt et al. (US Patent Publication No. 20050063913 A1), hereinafter Pruitt, in further view of Hashimoto et al. (US Patent Publication No. 20160107189 A1).
Regarding claim 1, Tokumoto discloses a microneedle array (Tokumoto: Fig. 2, microneedle device 1) having microneedles (Fig. 2, microneedles 3) coated with a composition (Fig. 2, coating 5 is a liquid composition; para. 0042) comprising: a pharmaceutical particle (physiologically active ingredients; para. 0039 and 0042), 2% to 20% by weight of a binding agent (coating carrier is 10-65% by weight; para. 0041), and 60% by weight or more of water (The composition comprises water. If the coating agent is 10-65% by weight and the active ingredient is 10-30% by weight, then water is 5-80% by weight; para. 0039 and 0042).
Tokumoto does not expressly disclose the poorly water-soluble or water-insoluble particle with a mean particle size of 1 um or less.
Pruitt teaches a poorly water-soluble or water-insoluble particle (Pruitt: metaxalone is poorly soluble; para. 0181) with a mean particle size of 1 um or less (average particle size of less than 200 nm; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the poorly water-soluble or water-insoluble particle of Tokumoto such that the poorly water-soluble or water-insoluble particle has a mean particle size of 1 um or less as taught by Pruitt in order to provide nanoparticles of anti-inflammatory agents, allowing for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Tokumoto in view of Pruitt does not expressly disclose a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less.
Hashimoto teaches a coefficient of variation (CV) in an amount of a particle (variation coefficient of a drug coating microneedle; para. 0050) loaded on the microneedles is 10% or less (10% or less; para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the array of Tokumoto in view of Pruitt such that a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less as taught by Hashimoto in order to suppress variations in drug amount coating the microneedles and to allow stable production in aseptic environment (Hashimoto; para. 0050).
Regarding claim 2, Tokumoto in view of Pruitt and Hashimoto discloses the array above, wherein the binding agent (Tokumoto: coating carrier) comprises one or more selected from the group consisting of a saccharide or a derivative thereof (coating carrier consists of sucrose; para. 0040).
Regarding claim 3, Tokumoto in view of Pruitt and Hashimoto discloses the array above, the saccharide or a derivative thereof (Tokumoto: para. 0040) comprises sucrose (para. 0040).
Regarding claims 4-6, Tokumoto, in view of Pruitt and Hashimoto discloses the array above.
Tokumoto does not expressly disclose that the poorly water-soluble or water-insoluble particle has a mean particle size of 700 nm or less and 50 nm or more.
Pruitt teaches poorly water-soluble or water-insoluble particle (Pruitt: metaxalone is poorly soluble; para. 0181) has a mean particle size of 700 nm or less and 50 nm or more (average particle size of less than 200 nm; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the poorly water-soluble or water-insoluble particle of Tokumoto such that the poorly water-soluble or water-insoluble particle has a mean particle size of 700 nm or less and 50 nm or more as taught by Pruitt in order to allow for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036 and 0040).
Regarding claim 7, Tokumoto in view of Pruitt and Hashimoto discloses the array above.
Tokumoto does not expressly disclose the poorly water-soluble or water-insoluble particle comprises at least one drug selected from indomethacin, diclofenac, flurbiprofen, etodolac, fentanyl, lidocaine, apomorphine, donepezil, buprenorphine, naproxen, meloxicam, estradiol, progesterone, Metaxalone, cyclosporine, celecoxib, cilostazol, ciprofloxacin, and a salt thereof.
Pruitt teaches a poorly water-soluble or water-insoluble particle is Metaxalone (Pruitt: metaxalone is poorly soluble; para. 0181).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the composition of Tokumoto such that the poorly water-soluble or water-insoluble particle is a drug selected from indomethacin, diclofenac, flurbiprofen, etodolac, fentanyl, lidocaine, apomorphine, donepezil, buprenorphine, naproxen, meloxicam, estradiol, progesterone, Metaxalone, cyclosporine, celecoxib, cilostazol, ciprofloxacin, or a salt thereof as taught by Pruitt in order to provide nanoparticles of anti-inflammatory agents, allowing for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Regarding claim 8, Tokumoto in view of Pruitt and Hashimoto discloses the array above.
Tokumoto does not expressly disclose the wherein the poorly water-soluble or water-insoluble particle is pre-milled particle.
Pruitt teaches a poorly water-soluble or water-insoluble particle (Pruitt: metaxalone is poorly soluble; para. 0181) is pre-milled particle (metaxalone is milled; para. 0181).
It would have been obvious to one of ordinary skill in the art before the effective filing date to mill the poorly water-soluble or water-insoluble particle of Tokumoto as taught by Pruitt in order to reduce the particle size to the desired average particle size allowing for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Regarding claim 9, Tokumoto in view of Pruitt and Hashimoto discloses the array above.
Tokumoto does not expressly disclose the amount of the poorly water-soluble or water-insoluble particle is 60% or more relative to the total amount of the composition excluding water.
Pruitt teaches an amount of a poorly water-soluble or water-insoluble particle (Pruitt: metaxalone is poorly soluble; para. 0181) is 60% or more relative to the total amount of the composition excluding water (Claim 43, metaxalone can comprise 0.5-90% by weight of the dry ingredients).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the composition of Tokumoto such that the amount of the poorly water-soluble or water-insoluble particle is 60% or more relative to the total amount of the composition excluding water in order to provide nanoparticles of anti-inflammatory agents at an optimal amount of depending on factors such as melting point, surface tension, etc. (Pruitt: para. 0174).
Regarding claim 10, Tokumoto discloses a method of manufacturing a microneedle array (Tokumoto: 1), which comprises: preparing a pharmaceutical compound (physiologically active ingredients; para. 0039 and 0042), preparing a composition (5) comprising the pharmaceutical compound (physiologically active ingredients; para. 0039 and 0042), 60% by weight or more of water (The composition comprises water. If the coating agent is 10-65% by weight and the active ingredient is 10-30% by weight, then water is 5-80% by weight; para. 0039 and 0042) and 2% to 20% by weight of a binding agent (coating carrier is 10-65% by weight; para. 0041), and coating the composition on microneedles (Fig. 2, coating 5 is coated on the microneedles 3).
Tokumoto does not expressly disclose milling the poorly water-soluble or water-insoluble compound until the mean particle size of the compound is 1 um or less.
Pruitt teaches milling (Pruitt: metaxalone is milled; para. 0181) a poorly water-soluble or water-insoluble compound (metaxalone is poorly soluble; para. 0181) until the mean particle size of the compound is 1 um or less (average particle size of less than 200 nm; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Tokumoto such that it including milling the poorly water-soluble or water-insoluble compound until the mean particle size of the compound is 1 um or less as taught by Pruitt in order to provide nanoparticles of anti-inflammatory agents, allowing for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Tokumoto in view of Pruitt does not expressly disclose a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less.
Hashimoto teaches a coefficient of variation (CV) in an amount of a particle (variation coefficient of a drug coating microneedle; para. 0050) loaded on the microneedles is 10% or less (10% or less; para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the array of Tokumoto in view of Pruitt such that a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less as taught by Hashimoto in order to suppress variations in drug amount coating the microneedles and to allow stable production in aseptic environment (Hashimoto; para. 0050).
Regarding claim 11, Tokumoto in view of Pruitt and Hashimoto discloses the method above,
Tokumoto does not expressly disclose the milling of the poorly water-soluble or water-insoluble compound is wet milling with a bead mill.
Pruitt teaches milling (metaxalone is milled; para. 0181) of a poorly water-soluble or water-insoluble compound (metaxalone is poorly soluble; para. 0181) is wet milling with a bead mill (wet milling with a DYNO Mill KDL, which is a bead mill; para. 0201).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Tokumoto such that the milling of the poorly water-soluble or water-insoluble compound is wet milling with a bead mill as taught by Pruitt in order to reduce the particle size to the desired average particle size (Pruitt: para. 0181).
Regarding claim 17, Tokumoto discloses a microneedle array (Tokumoto: 1) having microneedles (3) incorporating a pharmaceutical particle (physiologically active ingredients; para. 0039 and 0042) and 2% to 20% by weight of a binding agent (coating carrier is 10-65% by weight; para. 0041).
Tokumoto does not expressly disclose the poorly water-soluble or water-insoluble particle with a mean particle size of 1 um or less.
Pruitt teaches a poorly water-soluble or water-insoluble particle (Pruitt: metaxalone is poorly soluble; para. 0181) with a mean particle size of 1 um or less (average particle size of less than 200 nm; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the poorly water-soluble or water-insoluble particle of Tokumoto such that he poorly water-soluble or water-insoluble particle has a mean particle size of 1 um or less as taught by Pruitt in order to provide nanoparticles of anti-inflammatory agents, allowing for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Regarding claim 19, Tokumoto in view of Pruitt and Hashimoto discloses the array above.
Tokumoto does not expressly disclose the poorly water-soluble or water insoluble particle comprises indomethacin.
Pruitt teaches a poorly water-soluble or water-insoluble particle that comprises indomethacin (the composition can be combined with NSAIDs such as indomethacin; para. 0118-0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the array of Tokumoto in view of Hashimoto such that the poorly water-soluble or water insoluble particle comprises indomethacin as taught by Pruitt in order to provide a formulation with greater benefits with acute musculoskeletal problems than just analgesic alone (Pruitt: para. 0191).
Regarding claim 20, Tokumoto in view of Pruitt and Hashimoto discloses the array above.
Tokumoto in view of Hashimoto does not expressly disclose the composition comprises 1% to 30% by weight of the poorly water-soluble or water-insoluble particle, and the poorly water-soluble or water-insoluble particle has a mean particle size of 500 nm or less.
Pruitt teaches a composition comprising 1% to 30% by weight of the poorly water-soluble or water-insoluble particle (Pruitt: Claim 43, metaxalone can comprise 0.5-90% by weight of the dry ingredients), and the poorly water-soluble or water-insoluble particle has a mean particle size of 1 um or less (average particle size of less than 200 nm; para. 0081)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the composition of Tokumoto in view of Hashimoto such that the composition comprises 1% to 30% by weight of the poorly water-soluble or water-insoluble particle, and the poorly water-soluble or water-insoluble particle has a mean particle size of 500 nm or less as taught by Pruitt in order to provide an anti-inflammatory agent at an optimal amount of depending on factors such as melting point, surface tension, etc. (Pruitt: para. 0174), and allow for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Regarding claim 21, Tokumoto in view of Pruitt and Hashimoto discloses the array above, wherein the binding agent comprises hydroxypropyl cellulose and sucrose (Tokumoto: hydroxypropyl cellulose and sucrose; para. 0039).
Claims 12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ronnander et al. (US Patent Publication No. 20200206489 A1), hereinafter Ronnander, in view of Pruitt, in further view of Hashimoto.
Regarding claim 12, Ronnander discloses a method of manufacturing a microneedle array (Ronnander: preparation of a polymeric microneedle array; para. 0051), which comprises: pouring a composition comprising 60% by weight or more of water (water is the preferred solvent. The solution comprises 15-40 wt.% binder, less than 2 wt.% humectant, less than 2 wt.% surfactant, 1-15 wt.% compound. Therefore, the solution comprises 59-84 wt.% water; para. 0027 and 0051) and 2% to 20% by weight of a binding agent (water soluble polymer as a binder. Binder comprises 15-40% by weight; para. 0027 and 0044) into a mold with a concave portion forming the form of microneedles (liquid polymer solution is poured into negative molds; para. 0051), evaporating water to form a microneedle array (microneedle array is dried; para. 0051), and removing the formed microneedle array from the mold (microneedle array can be peeled from the mold after drying; para. 0051).
Ronnander does not expressly disclose that the composition comprises a poorly water-soluble or water-insoluble particle with a mean particle size of 1 um or less.
Pruitt teaches a composition (nanoparticulate composition; para. 0025) comprising a poorly water-soluble or water-insoluble particle (Pruitt: metaxalone and other NSAIDs such as diclofenac are poorly soluble; para. 0119 and 0181) with a mean particle size of 1 um or less (average particle size of less than 200 nm; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the poorly water-soluble or water-insoluble particle of Ronnander such that he poorly water-soluble or water-insoluble particle has a mean particle size of 1 um or less as taught by Pruitt in order to provide nanoparticles of anti-inflammatory agents, allowing for faster onset of action, smaller doses to obtain the same pharmacological effect, and increased dissolution (Pruitt: para. 0036, 0040, and 0112).
Ronnander, in view of Pruitt does not expressly disclose a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less.
Hashimoto teaches a coefficient of variation (CV) in an amount of a particle (variation coefficient of a drug coating microneedle; para. 0050) loaded on the microneedles is 10% or less (10% or less; para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the array of Ronnander in view of Pruitt such that a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less as taught by Hashimoto in order to suppress variations in drug amount coating the microneedles and to allow stable production in aseptic environment (Hashimoto; para. 0050).
Regarding claim 14, Ronnander in view of Pruitt and Hashimoto discloses the method above.
Ronnander does not expressly disclose milling a poorly water-soluble or water-insoluble compound to obtain the poorly water-soluble or water-insoluble particle with a mean particle size of 1 um or less before pouring the composition into the mold.
Pruitt teaches milling a poorly water-soluble or water-insoluble compound (Pruitt: metaxalone is milled; para. 0181) to obtain the poorly water-soluble or water-insoluble particle (metaxalone is poorly soluble; para. 0181) with a mean particle size of 1 um or less (average particle size of less than 200 nm; para. 0081) before preparing the composition (para. 0179).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Ronnander such that it including milling the poorly water-soluble or water-insoluble compound until the mean particle size of the compound is 1 um or less as taught by Pruitt in order to reduce the particle size to the desired average particle size (Pruitt: para. 0181).
Regarding claim 15, Ronnander in view of Pruitt and Hashimoto discloses the method above.
Ronnander does not expressly disclose the milling of the poorly water-soluble or water-insoluble compound is wet milling with at least one mill selected from the group of a jet mill, a bead mill and a planetary mill.
Pruitt teaches milling (metaxalone is milled; para. 0181) of a poorly water-soluble or water-insoluble compound (metaxalone is poorly soluble; para. 0181) is wet milling with a bead mill (wet milling with a DYNO Mill KDL, which is a bead mill; para. 0201).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Pruitt such that the milling of the poorly water-soluble or water-insoluble compound is wet milling with a bead mill as taught by Pruitt in order to reduce the particle size to the desired average particle size (Pruitt: para. 0181).
Regarding claim 16, Ronnander in view of Pruitt and Hashimoto discloses the method above, wherein a microneedle array is manufactured by the method above (Ronnander: preparation of a polymeric microneedle array; para. 0051).
Claims 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tokumoto, in view of Pathak et al. (US Patent No. 10624865), hereinafter Pathak, in further view of Hashimoto.
Regarding claim 1, Tokumoto discloses a microneedle array (Tokumoto: Fig. 2, microneedle device 1) having microneedles (Fig. 2, microneedles 3) coated with a composition (Fig. 2, coating 5 is a liquid composition; para. 0042) comprising: a pharmaceutical particle (physiologically active ingredients; para. 0039 and 0042), 2% to 20% by weight of a binding agent (coating carrier is 10-65% by weight; para. 0041), and 60% by weight or more of water (The composition comprises water. If the coating agent is 10-65% by weight and the active ingredient is 10-30% by weight, then water is 5-80% by weight; para. 0039 and 0042).
Tokumoto does not expressly disclose the poorly water-soluble or water-insoluble particle with a mean particle size of 1 um or less.
Pathak teaches a poorly water-soluble or water-insoluble particle (Pathak: drug is insoluble; col 49, ln 36-38) with a mean particle size of 1 um or less (particle size of 0.1um to 500 um; col 49, ln 36-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the poorly water-soluble or water-insoluble particle of Tokumoto such that the poorly water-soluble or water-insoluble particle has a mean particle size of 1 um or less as taught by Pruitt in order to provide a drug solution that can disperse and precipitate drug crystals/solids, allow for slow dissolution (col 6, ln 29-38).
Tokumoto, in view of Pathak does not expressly disclose a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less.
Hashimoto teaches a coefficient of variation (CV) in an amount of a particle (variation coefficient of a drug coating microneedle; para. 0050) loaded on the microneedles is 10% or less (10% or less; para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the array of Tokumoto in view of Pathak such that a coefficient of variation (CV) in the amount of the particle loaded on the microneedles is 10% or less as taught by Hashimoto in order to suppress variations in drug amount coating the microneedles and to allow stable production in aseptic environment (Hashimoto; para. 0050).
Regarding claim 18, Tokumoto in view of Pathak and Hashimoto discloses the array above.
Tokumoto does not expressly disclose the poorly water-soluble or water insoluble particle excludes metaxalone.
Pathak teaches poorly water-soluble or water insoluble particle (col 49, ln 36-48) that does not include metaxalone.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the array of Tokumoto such that the poorly water-soluble or water insoluble particle excludes metaxalone as taught by Pathak in order to have a desired therapeutic effect (col 12, ln 42-60).
Response to Arguments
Applicant's arguments filed 9 September 2026 have been fully considered but they are not persuasive.
Regarding claims 1-11 and 17, applicant argues that Tokumoto in view of Pruitt does not teach a poorly water-soluble compound in particle form with a mean size of 1 um or less.
As cited above, Pruitt teaches a poorly water-soluble compound in particle form with a mean size of 1 um or less (Pruitt: para. 0081 and 0181). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Pruitt is merely relied upon to teach the usage of such a compound with that particle size, and, therefore, one of ordinary skill in the art would have reasonably able to combine the invention of Tokumoto with that of Pruitt’s compound to come to the present invention.
Furthermore, applicant argues that the coating system and mechanism of achieving uniformity of Hashimoto is fundamentally different than that of the present invention and, therefore, would not constitute a mere routine design modification.
As cited above, Hashimoto teaches the specified coefficient of variation of the present application in order to suppress variations in drug amount coating the microneedles and to allow stable production in an aseptic environment (Hashimoto; para. 0050). Hashimoto was merely relied upon to teach a coefficient of variation of 10% or less, and need not demonstrate the entirety of the present invention, as one of ordinary skill in the art would reasonably be able to interpret and use the coefficient of variation of Hashimoto. As described above, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, applicant’s argument is not persuasive, as merely describing the usefulness of the limitation does not present an argument for non-obviousness.
Applicant also argues that the range of about 2% to about 20% by weight of a binding agent is a critical range to achieve key physical properties by which the present invention must operate. Specifically, applicant discloses that a weight percent of above 20% results in a “tendency” to fail in coating the composition on the microneedles.
As cited above, Tokumoto discloses a range of 10-65% by weight. The “tendency” does not expressly exclude or outright prevent the invention of Tokumoto to achieve the same result as the present application and, therefore, while there would be motivation to optimize the weight percent to prevent the “tendency” to fail coating, as the applicant describes, it is clear that Tokumoto discloses a range overlapping the present invention.
Regarding claims 12 and 14-16, applicant argues that Ronnander does not disclose poorly water-soluble or water-insoluble particles incorporated into the microneedles. Specifically, there would be no motivation to modify its drug-containing polymer solution to incorporate such particles because the invention of Ronnander is a method of manufacturing a microneedle array that dissolves after insertion into the skin to release the incorporated drug. There would be no motivation to modify in view of Pruitt, as Pruitt does not disclose manufacturing a microneedle array, and the disclosed reasons of reducing particle size as taught by Pruitt would not be obvious.
As discussed above, Pruitt teaches a poorly water-soluble compound in particle form with a mean size of 1 um or less (para. 0081 and 0181). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Pruitt is merely relied upon to teach the usage of such a compound with that particle size, and, therefore, one of ordinary skill in the art would have reasonably been motivated to combine the invention of Ronnander with that of Pruitt’s compound to come to the present invention with a reasonable expectation of success. Pruitt need not demonstrate the entire invention of Ronnander, as the motivation to combine is clear to introduce small particle anti-inflammatory agents to allow for faster onset of action (Pruitt: para. 0036, 0040, and 0112).
Regarding claim 1 and 18, applicant argues that Pathak does not address the influence of particle size on surface structure nor coating/loading uniformity of microneedles and, therefore, Pathak does not provide adequate motivation to control the mean particle size of the poorly water-soluble or water-insoluble particles.
Pathak was merely relied upon to teach the disclosed particle and particle size, with a clear motivation of providing a drug solution that can disperse and precipitate drug crystals/solids and allow for slow dissolution (Pathak: col 6, ln 29-38). Pathak need not disclose the entirety of the invention, as one of ordinary skill in the art would be motivated and reasonably expect success from merely including a solution that does not comprise metaxalone. As described above, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Therefore, the rejections are maintained.
Conclusion
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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