DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Claim Status
Applicant’s amendment of 11/18/2025 is acknowledged. Claim 1 is amended, and claim 3 remains cancelled. Claims 1-2 and 4-8 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.
Withdrawn Objections and Rejections
The previous 103 rejections are withdrawn in favor of the new grounds of rejection presented herein. Applicant’s arguments insofar as they pertain to the new/revised grounds of rejection are addressed herein.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the limitation “wherein the emulsion stability is the property to maintain…”, which contains a grammatical error and should read “wherein the emulsion stability is a property to maintain…”.
Appropriate correction is required.
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 4-6 and 8-9 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 4 recites the limitations “ester type surfactant”, “ether type surfactant”, “amido type surfactant”, “ester-ether type surfactant”, “polyoxyethylene type surfactant” and “alkyl-polyglucoside type surfactant”. Note: MPEP 2173.05(b)(III)(E). The addition of the word "type" to an otherwise definite expression extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). It is unclear whether the claimed surfactant is required to be, for example, an ester surfactant. If it is not, what are the metes and bounds of what is considered an ester “type” of surfactant?
Claims 5 and 6 are rejected by virtue of their dependency on claim 4, as they fail to resolve the ambiguity in question.
Claim 5 recites the limitations “ester type surfactant”, “glycerin fatty acid ester type surfactant”, “sorbitan fatty ester type surfactant”, and “sucrose fatty ester type surfactant”. Note: MPEP 2173.05(b)(III)(E). The addition of the word "type" to an otherwise definite expression extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). It is unclear whether the claimed surfactant is required to be an ester surfactant. If it is not, what are the metes and bounds of what is considered an ester “type” of surfactant?
Claim 6 recites the limitations “ether type surfactant”, “polyoxyethylene alkyl ether type surfactant”, “polyoxyethylene alkyl phenyl ether type surfactant”, and “polyoxyethylene-polyoxypropylene glycol type surfactant”. Note: MPEP 2173.05(b)(III)(E). The addition of the word "type" to an otherwise definite expression extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). It is unclear whether the claimed surfactant is required to be an ether surfactant. If it is not, what are the metes and bounds of what is considered an ether “type” of surfactant?
Claim 8 recites a method “for enhancing an emulsion stability of an emulsion composition emulsified with a non-ionic surfactant”, which is an intended outcome of practicing the method as claimed. However, the method step of having the stabilizer according to claim 1 contained in a starting material of the emulsion composition does not require that a non-ionic surfactant be present. Therefore, it is unclear how one can achieve the intended outcome of enhancing an emulsion stability of an emulsion composition emulsified with a non-ionic surfactant by practicing the method step as claimed, which renders the scope of the claim indefinite.
Claim 9 is rejected by virtue of its dependency on claim 8, as it fails to resolve the ambiguity in question.
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 and 4-9 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 instant action).
Hashizume, throughout the reference, discloses skin external preparations containing at least one component selected from α-glucosyl hesperidin and α-glucosyl naringin (Abstract), wherein α-glucosyl naringin is a main component in a material known as “enzyme-treated naringin” (Paragraphs 0044-0047 and formula [I]).
Regarding claim 1: Hashizume teaches an enzyme-treated naringin containing 80 wt.% or more of α-monoglucosyl naringin, particularly, 3"-α-monoglucosyl naringin based on the entire enzyme-treated naringin (Paragraph 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 instantly claimed range of 90:10 to 20:80 (also written as 1:0.11 to 1:4). Because the enzyme-treated naringin of Hashizume comprises the exact same structure as the instantly claimed stabilizer, it anticipates the claim.
The Examiner notes that although claim 1 is drawn to a “stabilizer” as an “active ingredient”, the term is only given patentable weight to the extent that it structurally distinguishes the claimed invention from the prior art. Note: 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.
Similarly, the Examiner notes that the recitations “for enhancing the emulsion stability of an emulsion composition emulsified with a non-ionic surfactant” and “to enhance the emulsion stability, wherein the emulsion stability is the property to maintain the emulsified state of the emulsified composition” recited in claim 1 are intended uses of the claimed stabilizer. Importantly, the claim as written does not claim an emulsion composition or a non-ionic surfactant, only a stabilizer. 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 enzyme-treated naringin of Hashizume is capable of performing the recited intended uses, then it meets the claim. Note: MPEP 2111.02.
Regarding claim 2: Hashizume teaches that enzyme-treated naringin contains three kinds of α-mono/diglucosyl naringin, including 3”-α-monoglucosyl naringin, 4’-α-monoglucosyl naringin, and 3”-4’-α-monoglucosyl naringin (Paragraph 0046-0048), 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 an exemplary composition comprising: 2.0 wt.% α-glycosyl naringin (same as “third enzyme-treated naringin”, which as established contains 3”-α-monoglucosyl naringin and naringin, and can contain residual 4’-α-monoglucosyl naringin and 3”-4’-α-monoglucosyl naringin (Paragraph 0048)); 2.5 wt.% glyceryl stearate; and 2.0 wt.% PEG-15 glyceryl stearate; among other ingredients. Hashizume teaches that glyceryl stearate and PEG-15 glyceryl stearate are examples of glycerin fatty acid ester non-ionic surfactants (Paragraph 0077) and, thus, they read on the instantly claimed ester type surfactant.
The Examiner emphasizes, however, that claims 4 and 5 ultimately depend from claim 1, which is directed to only a stabilizer, whereas claims 4 and 5 are directed to a non-ionic surfactant, which does not further limit the structure of the claimed stabilizer. As such, the claims do not have patentable weight but have been examined herein in the interest of compact prosecution. If Applicant intends for the claims to have patentable weight, Applicant must claim a composition comprising both the stabilizer and the non-ionic 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 (Paragraph 0077). Therefore, an ordinarily skilled artisan before the effective filing date of the claimed invention could at once envisage an embodiment wherein the non-ionic surfactant in the exemplary composition of Hashizume is polyoxyethylene alkyl phenyl ether rather than glyceryl stearate and/or PEG-15 glyceryl stearate. 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)). 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).
The Examiner emphasizes, however, that claim 6 ultimately depends from claim 1, which is directed to only a stabilizer, whereas claim 6 is directed to a non-ionic surfactant, which does not further limit the structure of the claimed stabilizer. As such, the claim does not have patentable weight but has been examined herein in the interest of compact prosecution. If Applicant intends for the claim to have patentable weight, Applicant must claim a composition comprising both the stabilizer and the non-ionic surfactant.
Regarding claim 7: The ratio of the enzyme-treated naringin relative to the non-ionic surfactants in the exemplary composition of Hashizume is 0.44 parts mass to 1 part mass, which lies within and thus anticipates the instantly claimed range.
The Examiner emphasizes, however, that claim 7 ultimately depends from claim 1, which is directed to only a stabilizer, whereas claim 7 is directed to an emulsion composition, which does not further limit the structure of the claimed stabilizer. As such, the claim does not have patentable weight but has been examined herein in the interest of compact prosecution. If Applicant intends for the claim to have patentable weight, Applicant must claim a composition comprising both the stabilizer and the non-ionic surfactant.
Regarding claim 8: Hashizume teaches a production method for its compositions wherein aqueous components are added to oily components to emulsify, and then α-glycosyl naringin is added thereto and mixed therewith (Paragraph 0112). Because the stabilizer is contained in the starting material of the emulsified composition, e.g. before its addition, in an intermediate of the composition when stirring, and in the final manufactured composition, the production method of Hashizume anticipates the method as claimed.
The Examiner notes that the recitation “for enhancing the emulsion stability of an emulsion composition emulsified with a non-ionic surfactant” recited in claim 8 is an intended outcome of using the claimed stabilizer. Importantly, the claim as written does not claim an emulsion composition or a non-ionic surfactant, only a stabilizer. 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 enzyme-treated naringin of Hashizume is capable of achieving the intended outcome when the method step is carried out as claimed, then it meets the claim. Note: MPEP 2111.02.
Regarding claim 9: Because the production method of Hashizume is used to produce the exemplary composition, which as discussed in detail above anticipates the instantly claimed ratio of glycosyl naringenin relative to non-ionic surfactant, the claim is anticipated.
The Examiner emphasizes, however, that claim 9 ultimately depends from claims 1 and 8, which are directed to only a stabilizer, whereas claim 9 is directed to an emulsion composition, which does not further limit the structure of the claimed stabilizer. As such, the claim does not have patentable weight but has been examined herein in the interest of compact prosecution. If Applicant intends for the claim to have patentable weight, Applicant must claim a composition comprising both the stabilizer and the non-ionic surfactant.
Response to Arguments
Applicant’s arguments submitted on 11/18/2025 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s arguments drawn to alleged unexpected results and/or the technical effect of “enhancing the emulsion stability…”, because Hashizume teaches the identical chemical structure to the claimed stabilizer, the properties Applicant discloses and/or claims are necessarily present and are, therefore, not a limiting feature. Note: MPEP 2145. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991); see also In re Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir. 1990) (obviousness rejection affirmed where using claimed elements in the manner suggested by the prior art necessarily resulted in claim-recited effect). Since nothing in the instant claims or specification indicate how the prior art structure would differ from that instantly claimed, the instant claims are not distinguished from the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 4-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/553882 in view of Hashizume et al. (US20220401761A1; effectively filed: 10/30/2019; published: 12/22/2022; PTO-892 of instant action).
The claims of App. ‘882 are drawn to a composition comprising a glycosyl naringenin, among other ingredients.
The claims of App. ‘882 differ from the instant claims in that the claims of App. ‘882 are drawn to a composition for promoting GLP-1 secretion, which is merely an intended use of the composition, and the claims of App. ‘882 do not explicitly recite that the glycosyl naringenin comprises 3”-α-monoglucosyl naringin and naringin at the mass ratio recited in instant claim 1, the further limitations of instant claims 2 and 4-7, or the method of claims 8-9. Importantly, the composition claimed in App. ‘882 is recited using the open claim language “comprising”, which allows for the inclusion of additional, unrecited elements.
The teachings of Hashizume are as set forth above and further incorporated herein.
Regarding claim 1: It would have been obvious to one of ordinary skill in the art to substitute the glycosyl naringenin recited in the claims of App. ‘882 with any glycosyl naringenin known in the art, such as the enzyme-treated naringin of Hashizume, which is a glycosyl naringenin comprising 3”-α-monoglucosyl naringin relative to naringin at the instantly claimed mass ratio, to yield the predictable result of a composition comprising a glycosyl naringenin with a reasonable expectation of success. Note: MPEP 2143.
The Examiner notes that although instant claim 1 is drawn to a “stabilizer” as an “active ingredient”, the term is only given patentable weight to the extent that it structurally distinguishes the claimed invention from the prior art. Note: 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.
Similarly, the Examiner notes that the recitations “for enhancing the emulsion stability of an emulsion composition emulsified with a non-ionic surfactant” and “to enhance the emulsion stability, wherein the emulsion stability is the property to maintain the emulsified state of the emulsified composition” recited in instant claim 1 are intended uses of the claimed stabilizer. Importantly, the claim as written does not claim an emulsion composition or a non-ionic surfactant, only a stabilizer. 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 glycosyl naringenin taught by the combination of App. ‘882 claims and Hashizume is capable of performing the recited intended uses, then it meets the claim. Note: MPEP 2111.02.
Regarding claim 2: Hashizume teaches that enzyme-treated naringin contains three kinds of α-mono/diglucosyl naringin, including 3”-α-monoglucosyl naringin, 4’-α-monoglucosyl naringin, and 3”-4’-α-monoglucosyl naringin (Paragraph 0046-0048), wherein 4’- and 3”-4’- α-glucosyl naringin read on two of the instantly claimed one or more components.
Regarding claims 4-6: It would have been obvious to one of ordinary skill in the art to modify the composition taught by the combination of App. ‘882 claims and Hashizume by further including a non-ionic surfactant, such as the glyceryl stearate, PEG-15 glyceryl stearate, and/or polyoxyethylene alkyl phenyl ether of Hashizume, because the reference teaches that these non-ionic surfactants are useful emulsifiers in compositions comprising a glycosyl naringenin (Paragraphs 0075-0077).
The Examiner emphasizes, however, that instant claims 4-6 ultimately depend from instant claim 1, which is directed to only a stabilizer, whereas instant claims 4-6 are directed to a non-ionic surfactant, which does not further limit the structure of the claimed stabilizer. As such, the claims do not have patentable weight.
Regarding claim 7: It would have been obvious to one of ordinary skill in the art to modify the composition taught by the combination of App. ‘882 claims and Hashizume by including the glycosyl naringenin and non-ionic surfactant(s) at a relative ratio of 0.44 parts mass to 1 part mass, which lies within and thus renders obvious the claimed range, because Hashizume teaches that these amounts are useful from the viewpoint of the stability of the composition (Paragraphs 0063 and 0081).
The Examiner emphasizes, however, that instant claim 7 ultimately depends from instant claim 1, which is directed to only a stabilizer, whereas instant claim 7 is directed to an emulsion composition, which does not further limit the structure of the claimed stabilizer. As such, the claim does not have patentable weight.
Regarding claims 8 and 9: It would have been obvious to one of ordinary skill in the art to use an art-recognized method to produce the composition taught by the claims of App. ‘882 and Hashizume, such as that taught by Hashizume wherein the glycosyl naringenin is contained in the starting material of the composition, e.g. before its addition, in an intermediate of the composition when stirring, and in the final manufactured composition, in order to yield the predictable result of an emulsion composition comprising a glycosyl naringenin and non-ionic surfactant(s) at a relative ratio of 0.44 parts mass to 1 part mass, which lies within and thus renders obvious the claimed range.
The Examiner notes that the recitation “for enhancing the emulsion stability of an emulsion composition emulsified with a non-ionic surfactant” recited in instant claims 8 and 9 is an intended outcome of using the claimed stabilizer. Importantly, the claim as written does not claim an emulsion composition or a non-ionic surfactant, only a stabilizer. 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 glycosyl naringenin taught by the combination of App. ‘882 claims and Hashizume is capable of achieving the intended outcome when the method step is carried out as claimed, then it meets the claim. Note: MPEP 2111.02.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the claims of App. ‘882 with the prior art as proposed because all ingredients, concentrations, and methods are known in the art to be routinely used for producing compositions comprising a glycosyl naringenin.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616