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 .
Claims 1, 3-9, 16 and 19 are examined; claims 2, 10-12, 14-15, 17-18 and 20-22 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-9, 16, and 19 in the reply filed on 23 April 2026 is acknowledged. Accordingly, claims 2, 10-12, 14-15, 17-18, and 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 16 is objected to because of the following informalities: “A pharmaceutically” in line 1 should be recited as --- The pharmaceutically --- since claim 1, from which it depends, already recites a pharmaceutically acceptable blend. Appropriate correction is required.
Claims 1, 9, and 19 are objected to because of the following informalities: “(w/w)” in each claim should be recited as --- w/w ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 contains the trademark/trade name METHOCEL®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe hydroxypropyl methylcellulose, and, accordingly, the identification/description is indefinite.
Claim 7 recites “(International Flavors & Fragrances, Inc.)” in the last line. The claim is indefinite because it is not clear whether such recitation is part of the claimed invention. Clarification is requested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, and 16 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Sakamoto et al. (JP 2015/027953 A, 12 February 2015) (hereinafter Sakamoto).
Sakamoto discloses skin cosmetic compositions, including an essence gel comprising: (i) 5 wt. % dimethylpolysiloxane; (ii) 0.3 wt. % xanthan gum, and 1.5 wt. % agar microgel; (iii) 3 wt. % cetyl octanoate; 0.01 wt. % citric acid, 0.1% sodium citrate; and (iv) more than 40 wt. % of water (example 36). Accordingly, Sakamoto discloses a pharmaceutically acceptable blend as claimed instantly.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-7, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (JP 2015/027953 A, 12 February 2015) (hereinafter Sakamoto).
Sakamoto discloses compositions for the skin, comprising 1 to 1000 parts by mass of water and 0.01 to 30 parts by mass of surfactant with respect to 10 parts by mass of oil-soluble component (p.47, ¶ 1) including silicone oil such as dimethylpolysiloxane (p.48, ¶ 3). The compositions may further comprise water-soluble polymer (p.49, last ¶) including xanthan gum, gellan gum, collagen, pectin, or agar, as well as cellulosic polymers such as cellulose, methyl cellulose, carboxymethyl cellulose, or methyl hydroxypropyl cellulose (p.50, ¶¶ 3-4). The ingredients may be emulsified with surfactants (p.46, last ¶). Exemplary amounts of agar include 0.8 and 1.5 mass% (Ex. 32 and 36). Exemplary amounts of cellulosic polymer include, for example, 0.5 mass% of cellulose (Ex. 13) and 1 mass% of hydroxyethyl cellulose (ex. 47). Exemplary amounts of dimethylpolysiloxane include 2 and 5 mass%, and exemplary viscosities thereof include 5, 6, or 100 mPa·s (Ex. 5, 7, 14, 32, 36, 46).
Accordingly, Sakamoto discloses compositions comprising dimethylpolysiloxane (i.e. claimed organopolysiloxane thickener); agar and/or methyl cellulose (i.e. instantly claimed hydrocolloid); surfactants (i.e. claimed emulsifier); and water. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the claimed amounts of organopolysiloxane thickener and hydrocolloid, the claimed amounts (i.e. 1% to 30% w/w or 0.5% to 8% w/w, respectively) would have been obvious to one of ordinary skill in the art since they appear to overlap with the ranges of the prior art (i.e. 2 or 5 mass%, or 0.8 or 1.5 mass%, respectively). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % w/w. "[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." See MPEP § 2144.05(II)(A).
Regarding the claimed amount of emulsifier or water, it would have been obvious to one of ordinary skill in the art to have selected an amount of emulsifier from the disclosed range of 0.01 to 30 parts by mass of surfactants, or an amount of water from the disclosed range of 1 to 1000 parts of water, which appear to overlap the instantly claimed amounts of emulsifier and water in percent by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate amount in parts would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % w/w. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 4, it would have been obvious to one of ordinary skill in the art to have selected a viscosity of dimethylpolysiloxane from the disclosed exemplary viscosity ranges of 5, 6, or 100 mPa·s, which appear to overlap the instantly claimed viscosity range in cSt (i.e. less than about 2,000,000 cSt at 25 °C). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate viscosity values would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed ranges of viscosity in cSt. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 5, it would have been prima facie obvious to one of ordinary skill in the art to have selected xanthan gum and agar microgel as the water soluble polymers, and since “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I).
Regarding claim 6, it would have been prima facie obvious to one of ordinary skill in the art to have selected methyl hydroxypropyl cellulose and cellulose as the water soluble polymers, and since “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I).
Regarding claim 7, it would have been prima facie obvious to one of ordinary skill in the art to have selected methyl cellulose and cellulose as the water soluble polymers, and since “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I).
Regarding claim 16, Sakamoto further discloses wherein the composition may comprise pH adjusters (p.52, ¶ 7).
Regarding claim 19, Sakamoto further discloses wherein the water-soluble polymers include alginic acid based polymers such as sodium alginate (p. 50, last ¶). Regarding the claimed amounts of alginate, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount (i.e. 1 to about 5% w/w) through routine experimentation based on the level of water-soluble polymers desired. "[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." See MPEP § 2144.05(II)(A).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (JP 2015/027953 A, 02/12/2015, IDS reference) (hereinafter Sakamoto) in view of Ansmann (US 4,798,682, 01/17/1989).
The disclosure of Sakamoto is discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing a viscosity of methyl hydroxypropyl cellulose.
However, Ansmann discloses compositions for the skin having good viscosity behavior, comprising hydrocolloids including water-soluble nonionic cellulose ether (col. 1, lines 49-61), such as methylhydroxypropyl cellulose (col. 2, lines 4-7). Suitable methylhydroxypropyl cellulose has a viscosity, when in the form of 2% by weight, of from 40 to 40,000 mPas at 20 °C, as measured with a Brookfield rotational viscosimeter at 30 r.p.m. (col. 2, lines 19-22).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a methyl hydroxypropyl cellulose with a viscosity value of from 40 to 40,000 mPas since it is a known and effective viscosity range suitable for skin compositions comprising water-soluble cellulose ethers as taught by Ansmann.
Regarding claim 9, it would have been obvious to one of ordinary skill in the art to have included the methyl hydroxypropyl cellulose in an amount of 2% by weight since it is a known and effective amount suitable for skin compositions as taught by Ansmann.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoehl et al. (EP 0407838 A1, 01/16/1991), directed to methods to produce hydrocolloids.
Marchant et al. (CN 108473652 A, 08/31/2018), directed to hydrogel compositions.
Brown et al. (US 2018/0303866 A1, 10/25/2018), directed to sol-gel compositions.
Gupta (US 2006/0110415 A1, 05/25/2006), directed to topical delivery system for cosmetic and pharmaceutical agents.
Baker et al. (US 2012/0064136 A1, 03/15/2012), directed to anti-aging nanoemulsion compositions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights