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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to a formulation for use as a cosmetic mask, classified in A61K 8/0212
II. Claim 17, drawn to a method of treating a portion of the skin of an individual, classified in A61Q 19/00
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the formulation of claim 1 can be used as a wound-dressing for protection of wounds, fixation of drugs and the like.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
. the inventions have acquired a separate status in the art in view of their different classification.
. the inventions have acquired a separate status in the art due to their recognized divergent subject matter.
. the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Mr. David Kohn (attorney for applicant) on December 17, 2025, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-16. Affirmation of this election must be made by applicant in replying to this Office action. Claim 17 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claims 1-16 are 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.
Both claims 1 and 2 recite the limitation "the semi-solid starting formulation" in line 7 and line 1, respectively. There is insufficient antecedent basis for this limitation in the claim.
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 recites that the amount of purified water is present in an amount that is greater than 50 wt%. It is unclear from the claim language what the amount is based on.
Claim 15 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 15 recites that the formulation of claim 1 further comprises an amount under 2 wt% of hydrolyzed collagen. It is unclear from the claim language what the amount is based on.
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.
Claim(s) 1-7, 9, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tsujihata (US 2010/0239621 A1).
Tsujihata teaches ([0010]) a gel sheet comprising a hydrogel, the hydrogel comprising a water-soluble divalent metal salt and an anionic polymer compound. Tsujihata teaches ([0003], [0030] and [0184]-[0186]) that a cosmetic preparation in sheet form may be formed from the gel sheet of its invention, and such cosmetic preparation in sheet form is particularly useful as a facial mask. Specifically, in Example 3 (see Table 1), Tsujihata teaches a hydrogel formulation containing k-carrageenan (Tsujihata’s anionic polymer compound – see [0042] and [0046]), magnesium ascorbyl phosphate (Tsujihata’s water-soluble divalent metal salt – see [0035] and [0038]), glucomannan (Tsujihata’s viscosity-increasing polysaccharide ([0077]) – instant thickener), 1,3-butanediol (Tsujihata’s polyhydric alcohol compound ([0080] and [0082]) - instant solvent), 1 wt.% collagen tripeptide (instant under 2 wt% of hydrolyzed collagen of claim 15), 85.8 wt.% of water and O/W emulsion. The O/W emulsion (included in Tsujihata’s Example 3 formulation) contains tocopherol (vitamin E of instant claim 14) and glycerin (instant humectant of claim 4) (see [0190]-[0199]).
With respect to instant agar and instant acid, as shown above Tsujihata uses k-carrageenan as its anionic polymer ([0042] and [0046]) in its hydrogel formulation of Example 3. Tsujihata furthermore teaches ([0043]) that two or more anionic polymer compounds may be used in a mixture in its formulation and teaches ([0045]-[0046]) carrageenan, agar and hyaluronic acid among preferred and particularly preferred examples for its anionic polymer compound in view of simultaneously achieving water retention capability, gel strength and syneresis property. Based on Tsujihata’s teaching, it would have been obvious to one skilled in the art to use a mixture of carrageenan (already present in Example 3 formulation), agar and hyaluronic acid (instant acid of claim 6) as anionic polymer compounds in Tsujihata’s formulation of Example 3 with a reasonable expectation of simultaneously achieving water retention capability, gel strength and syneresis property.
Thus, Tsujihata renders obvious instant formulation for use as a cosmetic mask comprising instant components (a)-(f).
With respect to instant limitation “wherein the semi-solid starting formulation forms a hydrogel when heated”, Tsujihata teaches ([0200]-[0202]) that the ingredients shown in Table 1 are heated then cooled to form the hydrogel. Thus, Tsujihata teaches instant limitation.
Thus, Tsujihata renders obvious instant claims 1, 4, 6, 7 and 15.
With respect to instant claim 2, claim 2 recites an intended use of the claimed invention, which does not result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since Tsujihata (which teaches instant formulation of claim 1) teaches that a cosmetic preparation in sheet form formed from the gel sheet of its invention can be used as a facial mask, Tsujihata renders obvious instant claim 2 as well.
With respect to instant claim 3, as discussed above, Tsujihata’s hydrogel formulation of Example 3 contains 1,3-butane diol as its polyhydric alcohol compound (a solvent). Tsujihata further teaches ([0080] and [0082]) the equivalence of 1,3-butanediol and 1,2-propanediol both as particularly preferred polyhydric alcohol compounds that can be used in its formulation. Thus, it would have been obvious to one skilled in the art to use 1,2-propanediol (instant solvent of claim 3) in place of 1,3-butanediol in Tsujihata’s Example 3 with a reasonable expectation of success. Thus, Tsujihata renders obvious instant claim 3.
With respect to instant claim 5, Tsujihata teaches ([0090]) the use of organic or inorganic fine particles in its hydrogel formulation in order to improve dimensional stability. Among preferred examples for the inorganic fine particles, Tsujihata teaches silica. It would have been obvious to one skilled in the art to use silica in Tsujihata’s hydrogel formulation of Example 3 with a reasonable expectation of improving dimensional stability. Thus, Tsujihata renders obvious instant claim 5.
With respect to instant claim 9, Tsujihata teaches ([0125], [0136]) that various additives, which examples include various extracts, may be added to its formulation depending on the purpose of use of the gel sheet of it invention. Among examples for the various extracts, Tsujihata teaches a cucumber fruit extract (instant Cucumis sativus of claim 9). It would be obvious to one skilled in the art to include an additive, such as cucumber fruit extract, in Tsujihata’s formulation of Example 3 with a reasonable expectation of success. Thus, Tsujihata renders obvious instant claim 9.
With respect to instant claim 14, as shown above, Tsujihata’s hydrogel formulation of Example 3 already contains tocopherol (vitamin E of instant claim 14). Tsujihata further teaches ([0119] and [0131]) that its hydrogel formulation may further contain an organic acid so as to control pH, and among specific examples for such organic acid, Tsujihata teaches ascorbic acid (instant vitamin C). It would have been obvious to one skilled in the art to further add ascorbic acid to Tsujihata’s hydrogel formulation of Example 3 with a reasonable expectation of controlling pH of the formulation. Thus, Tsujihata renders obvious instant claim 14.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tsujihata (US 2010/0239621 A1) in view of Stosz et al (5,418,156).
Although Tsujihata does not expressly state that agar is derived from Gelidium cartilagineum, as evidenced by Stosz et al (col.2, lines 4-10), it is known in the art that in the United States, agar is mainly extracted from Gelidium cartilagineum. Thus, it would be obvious to one skilled in the art to use agar derived from Gelidium cartilagineum which is available the United States. Thus, Tsujihata in view of Stosz renders obvious instant claim 8.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tsujihata (US 2010/0239621 A1) in view of Gerstein (5,139,771).
As discussed above in relation to instant claim 9, Tsujihata teaches the use of various additives, such as extracts, which examples include a cucumber fruit extract (instant Cucumis sativus of claim 9). Tsujihata does not teach instant amount “no more than 2% of the total formulation” for such extract. As evidenced by Gerstein (see Examples 5 and 7), it is known in the art that in face mask compositions, plant extracts (such as aloe and citrus) can be used in the amount of 1% and 0.5%, respectively. Under such guidelines, instant amount for the Cucumis sativus would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Thus, Tsujihata in view of Gerstein renders obvious instant claim 10.
Claim(s) 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tsujihata (US 2010/0239621 A1) in view of Tamareselvy et al (US 2013/0183361 A1).
With respect to instant claim 11, Tsujihata teaches ([0075]-[0077]) that polysaccharides efficient in viscosity increase and gelation such as galactomannan may be used in its formulation to improve handleability and gel strength. Furthermore, Tamareselvy teaches ([0251], [0263], [0265]) that locust bean gum (a galactomannan) is used as an auxiliary thickener in cosmetics such as facial masks. It would have been obvious to one skilled in the art to use locust bean gum (which is a galactomannan) in Tsujihata’s formulation of Example 3 as an auxiliary thickener with a reasonable expectation of further improving handleability and gel strength. Thus, Tsujihata in view of Tamareselvy renders obvious instant claim 11.
With respect to instant claim 12, Tamareselvy further teaches ([0204], [0263] and [0265) that copper chlorophyllin complex can be used as a deodorant in cosmetic compositions such as facial masks. It would be obvious to one skilled in the art to use copper chlorophyllin complex as a deodorant in Tsujihata’s formulation with a reasonable expectation of deodorizing the facial mask. Thus, Tsujihata in view of Tamareselvy renders obvious instant claim 12.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tsujihata (US 2010/0239621 A1) in view of Son et al (US 2018/0193236 A1).
Tsujihata does not teach the use of a synthetic form of epidermal growth factor. Son teaches ([0118]) a composition for skin surface modification such as a facial mask, and teaches ([0068]) that epidermal growth factor (EGF) is used as an additive to prevent or improve wrinkles on skin. Since EGF can be either natural or synthetic, it would be obvious to one skilled in the art to use a synthetic (lab-created) EGF in Tsujihata’s formulation with a reasonable expectation of improving wrinkles on skin. Thus, Tsujihata in view of Son renders obvious instant claim 13.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tsujihata (US 2010/0239621 A1) in view of Peterson (US 2018/0085303 A1).
Tsujihata’s formulation does not contain activated charcoal. Peterson teaches ([0065]) that an enhancing agent such as activated charcoal powder is especially useful in detoxifying cosmetic products, such as facial masks. It would be obvious to one skilled in the art to use an activated charcoal powder in Tsujihata’s formulation in order to achieve detoxification of the skin. Thus, Tsujihata in view of Peterson renders obvious instant claim 16.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 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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/SIN J LEE/
Primary Examiner, Art Unit 1613
December 27, 2025