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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 4-7, and 9-10) in the reply filed on 17 February 2026 is acknowledged.
Claims 3, 8, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 February 2026.
Claims 1-2, 4-7, and 9-10 are under current consideration.
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.
Claim(s) 1-2, 4-7, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patron et al. (US 2017/0087199 A1; published 30 March 2017; filed 10 February 2016).
Regarding claim 1, Patron et al. discloses compositions for delivering a cooling sensation (title) wherein the composition can comprise skin penetration enhancers such as polysorbate, beta-cyclodextrin, and menthol (paragraphs [0081], [0083]) and can comprise vehicles such as poloxamers (paragraph [0074]) and can comprise ingredients known to be useful for personal care products such as PEG-35 castor oil (paragraph [0164]) and can comprise viscosity-adjusting agents such as polyethylene glycol and hydroxypropylmethylcellulose (paragraph [0097]) and can comprise tonicity adjustors such as mannitol (paragraph [0075]).
Further regarding claim 1, although Patron et al. does not disclose an example including all elements as discussed above, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Patron et al. as discussed above and to make the composition of Patron et al. comprising polysorbate, beta-cyclodextrin, and menthol as skin penetration enhancers, poloxamers as vehicles, PEG-35 castor oil (i.e., polyoxyl 35 castor oil) as an ingredient known to be useful for personal care products and suitable for the composition, polyethylene glycol and hydroxypropylmethylcellulose (i.e., a cellulose derivative) as viscosity-adjusting agents, and mannitol (i.e., a polyol) as a tonicity adjustor, with a reasonable expectation of success. Such composition reads on the claimed composition comprising polysorbate, poloxamer, cyclodextrin, polyoxyl castor oil, polyethylene glycol, polyol, cellulose derivative, and menthol.
Regarding claim 2, Patron et al. discloses that polysorbate can be polysorbate 80 (paragraph [0164]) and that poloxamers can be poloxamer 188 and poloxamer 407 (paragraph [0024]) and that cyclodextrins can be beta-cyclodextrin and hydroxypropyl-gamma-cyclodextrin (paragraph [0024]) and that polyethylene glycol can be polyethylene glycol 400 (paragraph [0024]).
Further regarding claim 2, although Patron et al. does not disclose an example including all elements as discussed above, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Patron et al. as discussed above and to make the composition of Patron et al. as discussed above wherein the polysorbate is polysorbate 80, the poloxamers are poloxamer 188 and poloxamer 407, the cyclodextrin is hydroxypropyl-gamma-cyclodextrin, and the polyethylene glycol is polyethylene glycol 400, with a reasonable expectation of success. Such composition reads on the claimed composition wherein the polysorbate is polysorbate 80, the poloxamers are poloxamer 188 and poloxamer 407, the cyclodextrin is hydroxypropyl-gamma-cyclodextrin, the polyoxyl castor oil is polyoxyl 35 castor oil, the polyethylene glycol has a molecular weight from about 200-20,000 Daltons, and the polyol is mannitol.
Regarding claim 4, Patron et al. discloses that tonicity adjustors can include sodium chloride (paragraph [0075]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Patron et al. as discussed above and to make the composition of Patron et al. as discussed above further comprising sodium chloride as a tonicity adjustor, with a reasonable expectation of success. Such composition reads on the claimed composition wherein the polysorbate is polysorbate 80, the poloxamers are poloxamer 188 and poloxamer 407, the cyclodextrin is hydroxypropyl-gamma-cyclodextrin, the polyoxyl castor oil is polyoxyl 35 castor oil, the polyethylene glycol is polyethylene glycol 400, the polyol is mannitol, tonicity adjustors include sodium chloride, viscosity-adjusting agents include hydroxypropylmethylcellulose, and skin penetration enhancers include menthol.
Regarding claim 5, Patron et al. discloses that the composition can comprise 5% w/w skin penetration enhancer (paragraph [0088]) wherein skin penetration enhancers can be polysorbate, cyclodextrin, and menthol (paragraphs [0081], [0083]) and that the composition can comprise 0.7% w/w or 1% w/w or 2% w/w viscosity adjusting agent (paragraph [0098]) wherein viscosity adjusting agents can be polyethylene glycol and hydroxypropylmethylcellulose (paragraph [0097]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Patron et al. as discussed above and to make the composition of Patron et al. as discussed above further comprising 5% w/w of skin penetration enhancers polysorbate, cyclodextrin, and menthol, resulting in up to about 5% w/w of each of the polysorbate 80, hydroxypropyl-gamma-cyclodextrin, and menthol therein, and 0.7% w/w or 1% w/w viscosity adjusting agent polyethylene glycol 400, and 1% w/w viscosity adjusting agent hydroxypropylmethylcellulose, with a reasonable expectation of success. Such concentrations of up to about 5% w/w of each of the polysorbate 80, hydroxypropyl-gamma-cyclodextrin, and menthol overlap the claimed concentrations of about 0.5-1.5% w/w, about 0.5-3% w/w, and about 0.1-1.75 millimolar, respectively, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I). It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the vehicle of the composition of Patron et al. as discussed above by varying the concentration of poloxamer 188 and poloxamer 407 therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patron et al. discloses that poloxamer 188 and poloxamer 407 are used as vehicles therein. It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the personal care product ingredients of the composition of Patron et al. as discussed above by varying the concentration of PEG-35 castor oil therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patron et al. discloses that PEG-35 castor oil is used as personal care product ingredient therein. It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the tonicity of the composition of Patron et al. as discussed above by varying the concentrations of mannitol and sodium chloride therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patron et al. discloses that mannitol and sodium chloride are used as tonicity adjustors therein.
Regarding claim 6, Patron et al. discloses that suitable excipients include potassium sorbate (paragraph [0024]) and the composition may include citrate as buffer (paragraph [0076]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Patron et al. as discussed above and to make the composition of Patron et al. as discussed above further comprising potassium sorbate as an excipient and citrate as a buffer, with a reasonable expectation of success.
Regarding claims 7 and 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the excipients and pH/buffer of the composition of Patron et al. as discussed above by varying the concentrations of potassium sorbate and citrate buffer therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patron et al. discloses that potassium sorbate is used as an excipient therein and citrate is used as a buffer therein.
Regarding claim 9, see above regarding claim 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617