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 the species:
- Component (B): solid paraffin and stearyl alcohol;
- Component (C): polyoxyethylene cetyl ether; and
- Component (D): water and polyethylene glycol,
in the reply filed on 7/10/26 is acknowledged.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (two or more polyoxyalkylene alkyl ethers, and hydrophobic alkyl groups of the polyoxyalkylene alkyl ethers are the same as each other) there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/10/26
Claims Status
Claims 1-20 are pending.
Claims 13 is withdrawn.
Claims 1-12 and 14-20 are presented for examination as they read upon the elected subject matter.
Priority
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The foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 8/28/24 and 3/27/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shigeyama et al. (US20210205210; of record).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical topical emulsion scientist possesses specialized knowledge in physical chemistry, dermatology, compatible excipient selection and material science to design stable, safe, and effective skin-applied medical formulations like creams and lotions. They understand how to mix oil, water, active pharmaceutical ingredients and excipients into a uniform product that releases medicine properly through the skin. The ordinary artisan has knowledge of conventional emulsion components, formulation methods and analytical techniques for stability and performance.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-2, 4, 5, 7-9, and 16-20, Shigeyama et al. teach topical compositions comprising 30-60 weight % zinc chloride (component A) (Abstract; claims 1-2), solid paraffin and linear stearyl alcohol (component B) [0116], nonionic surfactant polyoxyethylene higher alcohol ethers such as polyoxyethylene lauryl ether (dodecyl C12) (component C) [0113] and exemplify polyoxyethylene(23) lauryl ether (Page 13, Table 1), which has an HLB between 8-17, in an amount of from 0.1 to 10% by weight [0115], which overlaps the claimed ranges of 12.7 wt% or less and 1-7.5 wt% of claims 4, 5, 16 and 17, water and polyethylene glycol (component D) (Claims 5-6). Shigeyama et al. teach oil-in-water type emulsions [0117], such as creams [0118]. Shigeyama et al. teach that the surfactants may be used in combination with two or more types [0114]. Shigeyama et al. teach mixing with PEG4000 [0131], which is naturally solid.
Regarding claims 10-11, Shigeyama et al. teach adding inorganic powder such as silicon dioxide, aluminum silicate, magnesium silicate, magnesium aluminum silicate, sodium magnesium silicate, calcium silicate (Claim 1). The instant specification teaches that “a silicic compound” includes silicon dioxide, aluminum silicate, magnesium silicate, magnesium aluminum silicate, sodium magnesium silicate, and calcium silicate [0056]. Shigeyama et al. teach that component B inorganic powder can suppress excessive viscosity to facilitate uniform mixing and to obtain good appearance or to prevent the topical composition from accidently flowing to other places [0049-0050]. Shigeyama et al. teach: “The content (total amount) of the component (B) in the topical composition of the present invention is not particularly limited, and can be appropriately determined
according to separation suppression and coloration suppression to be exerted.” [0054]
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Shigeyama et al. is that Shigeyama et al. do not expressly teach an oil in water emulsion composition wherein the non-ionic surfactant is polyoxyethylene cetyl ether and wherein a content of (B) with respect to 100 parts by weight of the total amount of the component (B) and the component (C) is 52 parts by weight or more, and a content of (B) with respect to 100 parts by weight of the total amount of the component (B) and the component (D) is 11.7 parts by weight or more or wherein a content of the component (D) with respect to 100 parts by weight of the total amount of the component (B), the component (C), and the component (D) is 42 parts by weight or more. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the oil-in-water emulsion of Shigeyama et al. with the non-ionic surfactant polyoxyethylene cetyl ether and optimize the relative parts by weight of the other components, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Shigeyama et al. suggest using nonionic surfactant polyoxyethylene higher alcohol ethers and exemplify polyoxyethylene lauryl ether (dodecyl C12). It is merely judicious selection of another nonionic surfactant polyoxyethylene higher alcohol ether such as polyoxyethylene cetyl ether (C16) with a reasonable expectation of success. Regarding the content of component (B) with respect to component (C) and component (D), this merely routine optimization of the emulsion components already taught by Shigeyama et al. See MPEP 2144.05 (II) (A): “[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)…see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."). The ordinary artisan would optimize the components to achieve a stable emulsion of the zinc chloride in an oily base with a higher alcohol with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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