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 .
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.
Claim Status
Applicant’s amendment of 04/27/2026 is acknowledged. Claims 1-2, 4-6, and 8 are amended, and claims 3, 7, and 9 are cancelled. Claims 1-2, 4-6, and 8 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/JP2021/005757 filed on 02/16/2021 and claims foreign priority to JP2020-024772 filed on 02/17/2020 as reflected in the filing receipt dated on 06/14/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Previous Rejections/Objections
Applicant’s arguments filed 04/27/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied as necessitated by Applicant’s amendment to the claims. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicant’s arguments insofar as they pertain to the present grounds of rejections and/or objections are addressed herein.
Claim Rejections - 35 USC § 112(b)
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 2 and 8 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.
Claim 2 recites the limitation “the stabilizer” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 2 depends from claim 1, which does not recite a stabilizer. Therefore, it is unclear to which stabilizer the claim is referring. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting “the stabilizer” to mean the glucosyl naringenin, as is consistent with Applicant’s claim 8, which recites a stabilizer comprising a glucosyl naringenin.
Claim 8 recites the limitation “adding a stabilizer comprising a glycosyl naringenin to (1) a starting material to be emulsified into the emulsion composition”. It is unclear whether the limitation “to be emulsified” applies to the starting material, to the glycosyl naringenin, or both. For example, the claim could mean that the glycosyl naringenin is the component “to be emulsified” and could be added to a starting material that is already emulsified to produce a final composition wherein the glycosyl naringenin is emulsified in the final emulsion composition. Alternatively, the claim could mean that the starting material is the component “to be emulsified”, in which case the starting material is not already emulsified. Therefore, the scope of the method step is indefinite. For the purposes of compact prosecution, the Examiner is interpreting the claim broadly to mean either interpretation meets the claim.
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 1-2, 4-6, and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hashizume et al. (US20220401761A1; effectively filed: 10/30/2019; published: 12/22/2022; PTO-892 of 01/27/2026).
Hashizume, throughout the reference, discloses skin external preparations containing at least one component selected from α-glucosyl hesperidin and α-glucosyl naringin [abstract and claims], wherein α-glucosyl naringin is a main component in a material known as “enzyme-treated naringin” [0044-0047, formula I].
Hashizume teaches that enzyme-treated naringin contains 80 wt.% or more of α-monoglucosyl naringin, particularly, 3"-α-monoglucosyl naringin based on the entire enzyme-treated naringin [0046-0047]. An enzyme-treated naringin comprising 80 wt.% 3"-α-monoglucosyl naringin would comprise 20 wt.% unmodified naringin, resulting in a mass ratio of 3"-α-glucosyl naringin to naringin of 80:20 (also written as 1:0.25), which lies within and thus anticipates the claimed range of 90:10 to 20:80 (also written as 1:0.11 to 1:4) as it relates to the instantly claimed glycosyl naringenin.
Regarding claim 1: Hashizume teaches an exemplary composition comprising: 2.0 wt.% α-glycosyl naringin (also called “third enzyme-treated naringin”); 2.5 wt.% glyceryl stearate; and 2.0 wt.% PEG-15 glyceryl stearate; among other ingredients [0111, second table]. Hashizume teaches that glyceryl stearate and PEG-15 glyceryl stearate are examples of non-ionic surfactants, which are expressly referred to as emulsifiers [0075-0077], and as discussed above, enzyme-treated naringin reads on the instantly claimed glycosyl naringenin. Hashizume further teaches that the composition is produced by adding aqueous components to oily components to emulsify, and then α-adding glycosyl naringin thereto and mixing therewith [0112]. Thus, the composition meets the limitation of an emulsion composition emulsified with a non-ionic surfactant.
Regarding the ratio of glycosyl naringenin to non-ionic surfactant: Hashizume expressly teaches that when α-glycosyl naringin is used, the content is preferably between 0.01 to 10 mass % [0063, claim 3]. Because Hashizume clearly contemplates embodiments wherein the content of α-glycosyl naringin is 10 wt.%, an ordinarily skilled artisan before the effective filing date of the claimed invention could readily envision an embodiment wherein Hashizume’s exemplary composition comprises 10 wt.% α-glycosyl naringin, which results in 2.2 parts by mass glycosyl naringenin to 1 part by mass of non-ionic surfactant, which lies within and thus reads on the instantly claimed ratio. Note: MPEP 2131.02. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage' the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
Regarding claim 2: Hashizume teaches that third enzyme-treated naringin contains 3”-α-monoglucosyl naringin and naringin, and can contain residual 4’-α-monoglucosyl naringin and 3”-4’-α-monoglucosyl naringin [0048], wherein 4’- and 3”-4’- α-glucosyl naringin read on two of the instantly claimed one or more components.
Regarding claims 4 and 5: Hashizume teaches that glyceryl stearate and PEG-15 glyceryl stearate are examples of glycerin fatty acid ester non-ionic surfactants [0077] and, thus, they read on the instantly claimed ester surfactant
Regarding claim 6: Hashizume teaches a limited number of suitable non-ionic surfactants, wherein polyoxyethylene alkyl phenyl ether is explicitly taught as an alternative to glycerin fatty acid ester non-ionic surfactants [0077]. Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the non-ionic surfactant in Hashizume’s exemplary composition is polyoxyethylene alkyl phenyl ether rather than glyceryl stearate and/or PEG-15 glyceryl stearate. Again, note: MPEP 2131.02. Further, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990).
Regarding claim 8: As discussed above, Hashizume teaches that its emulsion composition, which contains the claimed ratio of glycosyl naringenin to non-ionic surfactant, is produced by adding α-glycosyl naringin to an emulsified mixture of the oily and aqueous components and mixing therewith. Because Hashizume’s α-glycosyl naringin has the same chemical structure as the instantly claimed stabilizer, it meets the claim limitation. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Regarding the instantly claimed addition step, Applicant provides no limiting definition of the terms “starting material”, “intermediate product” or “manufactured”. Therefore, the terms are given the broadest reasonable interpretation. As such, the emulsified mixture of oily and aqueous components of Hashizume could be interpreted as (1) one of two starting materials (e.g., the mixture as one material and the α-glycosyl naringin “to be emulsified” as a second material) for an emulsion composition comprising the mixture and α-glycosyl naringin, (2) an intermediate product formed from the oily and aqueous starting materials used to produce a final emulsion composition comprising the oily components, the aqueous components, and α-glycosyl naringin, or (3) a stand-alone (i.e., manufactured) emulsion composition to which α-glycosyl naringin is added. Though only one of the three recited addition steps is required to meet the claim, the method of Hashizume reads each alternative of the method step as claimed.
The Examiner notes that the recitation “for enhancing the emulsion stability of an emulsion composition emulsified with a non-ionic surfactant” is an intended outcome of adding the stabilizer to a starting material, an intermediate product, or a manufactured emulsion composition as claimed. A recitation of the intended use of the claimed invention must 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 the structure of the α-glycosyl naringin of Hashizume is capable of achieving the intended outcome when practicing the method as claimed, then it meets the claim. Note: MPEP 2111.02.
Response to Arguments
Applicant’s arguments submitted on 04/27/2026 with respect to rejections under 35 U.S.C. 102 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that there is nothing in Hashizume et al. that teaches or suggests the presently claimed emulsion composition comprising the glycosyl naringenin in a ratio of from 2 to 10 parts by mass relative to 1 part by mass of the non-ionic surfactant as recited in amended claim 1. The Examiner respectfully disagrees. As discussed in the prior art rejections of record, Hashizume clearly contemplates embodiments wherein the content of α-glycosyl naringin is 10 wt.%. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the non-limiting exemplary composition of Hashizume comprises 10 wt.% α-glycosyl naringin, which results in 2.2 parts by mass glycosyl naringenin to 1 part by mass of non-ionic surfactant, which lies within and thus reads on the instantly claimed ratio. Note: MPEP 2131.02. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage' the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
Applicant further argues that the unexpected results obtained by changing to the claimed ratio would not have been obvious. Because Hashizume discloses embodiments within the scope of the instant claims, arguments of allegedly unexpected results are not considered at this time.
Applicant further argues that the exemplary composition of Hashizume incidentally comprises the glycosyl naringenin and the non-ionic surfactant in combination, that the reference fails to disclose any other examples of emulsion composition comprising the combination, and that the reference is entirely silent about emulsion stability. This argument was not found to be persuasive. The prior art is not required to disclose multiple examples in order to anticipate a claim. The reference still anticipates the instant invention(s) for at least the reasons set forth in the prior rejections of record. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., emulsion stability) is not recited in the rejected independent claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Even if emulsion stability were a claimed feature of the instant composition, the Examiner again directs Applicant’s attention to MPEP 2112.01. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present.
Applicant further argues that it would have never been easy for such a skilled person in the art to arrive at the presently claimed invention. This argument was not found to be persuasive. While Applicant does not specifically point out why it would not have been easy to arrive at the claimed invention, the Examiner reiterates that Hashizume clearly contemplates compositions within the scope of the claimed invention and, as such, the composition and method as claimed are anticipated by the prior art.
Applicant further argues that the dependent claims are not anticipated or made obvious over Hashizume for the same reasons as applied to independent claim 1. This argument was not found to be persuasive for the same reasons discussed in detail above.
In view of the foregoing, the prior art rejections of record are maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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