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 .
Priority
This Application filed on 05/23/2023 is a 371 of PCT/NZ2021/050194 filed on 11/04/2021.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed April 2, 2026 to the restriction requirement made on October 2, 2025.
Applicant's election without traverse of Group I, Claims 45-59, in the reply filed on April 2, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 8/22/24 and 4/2/26 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 45-48, 51-57 are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US2003/0236310).
Nathan et al. teaches a bioactive agent, rapamycin; monoglyceride is selected from the group consisting of monostearoyl glycerol, monopalmitoyl glycerol, monomyrisitoyl glycerol, monocaproyl glycerol, monodecanoyl glycerol, monolauroyl glycerol, monolinoleoyl glycerol and monooleoyl glycerol; water added immediately before administration; additionally, at least on additional polyol selected from the group consisting of ethylene glycol, 1,2-propylene glycol; polybasic acid or derivative thereof is selected from the group consisting of succinic acid, succinic anhydride, malic acid, tartaric acid, citric acid; alkyd polyester microdispersions of the present invention can be made more hydrophilic or amphiphilic by employing hydroxy acids, such as malic, tartaric and citric acids, or some oxadiacids, in the composition [0019].
While Nathan teaches the components of the formulation, an example of formulation is not specified.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange the components of Nathan. The motivation to interchange the components is because Nathan teaches the variables that are compatible for making the formulation include a bioactive agent, monoglyceride, water, polyols, polybasic acid, and hydroxy acids to make the composition more hydrophilic or amphiphilic . A skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results. With respect to the amounts, in 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). (MPEP § 2144.05(1)) Moreover, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(Il)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US2003/0236310), as applied to claims 45-48, 51-57 above in view of Wang et al. (EP3927410A1).
Nathan et al. is as discussed above.
While Nathan et al. teaches polyethylene glycol; the reference does not teach polyethylene glycol stearate.
Wang et al. teaches a therapeutic agent chosen from paclitaxel, docetaxel, taxol, their analogues, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, mTOR inhibitors, their analogues, and combinations thereof, a water- soluble additive such as sorbitol, monolaurin, monomyristin (see claim 11) and combinations thereof; surfactants in the mixture or the combination include PEG stearate; additives such as triethanolamine, organic acids such as citric acid.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate PEG stearate. The motivation to incorporate PEG stearate is because Wang teaches PEG stearate acts as a surfactant. A skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Claims 45-58 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (EP3927410A1).
Wang et al. teaches a therapeutic agent chosen from paclitaxel, docetaxel, taxol, their analogues, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, mTOR inhibitors, their analogues, and combinations thereof, a water- soluble additive such as sorbitol, monolaurin, monomyristin (see claim 11) and combinations thereof; surfactants in the mixture or the combination include PEG stearate; additives such as triethanolamine, organic acids such as citric acid.
While Wang teaches the components of the formulation, an example of formulation is not specified.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange the components of Wang. The motivation to interchange the components is because Wang teaches the variables that are compatible for making the formulation include a therapeutic agent, water- soluble additive, surfactants, and additives. A skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results. With respect to the amounts, in 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). (MPEP § 2144.05(1)) Moreover, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(Il)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US2003/0236310), as applied to claims 45-48, 51-57 above in view of Rudolph et al. (WO 2008089822 A2).
Nathan et al. is as discussed above.
Nathan et al. does not teach the preservatives of claim 59.
Rudolph et al. teaches preservatives or antimicrobial agents in catheters which contain liquid polymers. The preservatives or antimicrobial agents, such as for example phenoxyethanol, triclosan, 7-ethylbicyclooxazolidine, benzoic acid, bronopol, butylparaben, chlorphenesin, diazolidinyl urea, dichlorobenzyl alcohol, dimethyl oxazolidine, DMDM hydantoin, ethylparaben, hexamidine diisethionate, imidiazolidinyl urea, imidiazolidinyl urea NF, iodopropynyl butylcarbamate, isobutylparaben, methylparaben, potassium sorbate NF FCC, propylparaben, quaternium-15, sodium benzoate NF FCC, sodium caprylate, sodium dehydroacetate, sodium dehydroacetate FCC, sodium hydroymethylglycinate, sodium hydroxymethylglycinate.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate phenoxyethanol, diazolidinyl urea, potassium sorbate, or sodium hydroymethylglycinate. The motivation to incorporate henoxyethanol, diazolidinyl urea, potassium sorbate, or sodium hydroymethylglycinateis because Rudolph teaches they are used as preservatives or antimicrobial agents. A skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Claims 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (EP3927410A1), as applied to claims 45-58, above in view of Rudolph et al. (WO 2008089822 A2).
Wang et al. is as discussed above.
Wang et al. does not teach the preservatives of claim 59.
Rudolph et al. teaches preservatives or antimicrobial agents in catheters which contain liquid polymers. The preservatives or antimicrobial agents, such as for example phenoxyethanol, triclosan, 7-ethylbicyclooxazolidine, benzoic acid, bronopol, butylparaben, chlorphenesin, diazolidinyl urea, dichlorobenzyl alcohol, dimethyl oxazolidine, DMDM hydantoin, ethylparaben, hexamidine diisethionate, imidiazolidinyl urea, imidiazolidinyl urea NF, iodopropynyl butylcarbamate, isobutylparaben, methylparaben, potassium sorbate NF FCC, propylparaben, quaternium-15, sodium benzoate NF FCC, sodium caprylate, sodium dehydroacetate, sodium dehydroacetate FCC, sodium hydroymethylglycinate, sodium hydroxymethylglycinate.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate phenoxyethanol, diazolidinyl urea, potassium sorbate, or sodium hydroymethylglycinate. The motivation to incorporate henoxyethanol, diazolidinyl urea, potassium sorbate, or sodium hydroymethylglycinateis because Rudolph teaches they are used as preservatives or antimicrobial agents. A skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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