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 .
Status of Claims
Amendment filed on 12/09/2025 is acknowledged.
Claims 1-15 are amended. Claims 1-15 are pending and being examined on merits herein.
Priority
This instant application 18257731, filed on 06/15/2023, is a 371 of PCT/JP2021/046658, filed on 12/10/2021, claims foreign priority of Japan 2020-212331, filed on 12/22/2020, and also claims foreign priority of France 2100495, filed on 01/19/2021.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 09/23/2025 that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 12/09/2025.
Maintained Claim Rejections - 35 USC § 103
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 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023), in view of Agnes (ES2324830, 08/17/2009, in record of 09/23/2025).
Marat teaches a cosmetic process for depigmenting, lightening and/or bleaching keratin materials (corresponding to instant claim 13), in particular the skin, comprising the application of a cosmetic composition comprising, in physiologically acceptable medium, at least one compound of formula (I) as defined below (e.g., Pg. 2, Lines 1-5; Claim 1) (corresponding to instant claim 14).
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The compound with formula (I) that Marat teaches (Pg. 2, line 25 -Pg. 3, line 5; Claim 1) constitutes the exact structures and radicals as in instant claims (corresponding to compound of formula (I) as recited in instant claims 1 and 15).
Marat also teaches the compounds of formula (I) preferably have the following meanings:
R1 denotes a radical chosen from
a hydrogen atom;
a saturated linear C1-C4 alkyl radical and preferably methyl; and
R2 denotes a radical chosen from:
a hydrogen atom;
a saturated linear C1-C6 alkyl group;
a saturated branched C3-C6 alkyl group.
as described (Pg. 4, lines 11-20; Claim 2) (corresponding to instant claim 2).
More particularly, Marat teaches that the compounds of formula (I) have the following meanings:
R1 denotes a radical chosen from
a hydrogen atom;
a methyl; and
R2 denotes a radical chosen from:
a hydrogen atom;
a saturated linear C1-C4 alkyl group;
a saturated branched C3-C4 alkyl group,
as presented (Pg. 4, lines 25-34; Claim 3) (corresponding to instant claim 3).
Marat teaches the specific compounds 1-4 (e.g., Pg. 7, top table, compound structures and names; Claims 4 and 5) used preferably in the composition, and also salts thereof, solvates thereof, and racemates thereof, alone or as a mixture, with the compound structures exactly the same as compounds 1-4 in instant claim 4 and compounds 1-2 in instant claim 5.
Marat teaches that the composition may be in any galenical form normally used in the cosmetics field, such as a two-phase dispersion, and an water-in-oil (W/O) emulsion is preferred (Pg. 12, line 38 -Pg. 13, line 2) (corresponding to instant claims 1 and 15), and the compound of formula (I) is present, alone or as a mixture, in the composition, in an amount between 0.01 % and 10% by weight, relative to the total weight of the composition (e.g., Pg. 9, lines 21-22 ; Claim 6) (overlapping with range from 0.01% to 20% in instant claim 6). Marat indicates that the composition comprises at least one adjuvant chosen from the group made up of water (corresponding to instant claim 1), organic solvents, in particular silicone oils, waxes, pigments, filler dyes, surfactants, emulsifiers (corresponding to instant claims 11-12), cosmetic or dermatological active agents, UV screening agents, polymers, hydrophilic or lipophilic gelling agents (corresponding to instant claim 10), thickeners, preservatives, fragrances, bactericides, ceramides, odor absorbers, antioxidants, C1-C6 alcohols and C2-C10 carboxylic acid esters (Pg. 9, lines 1-10; Claim 7) (corresponding to oil in instant claims 1 and 7). Marat teaches that cosmetic adjuvants, i.e., water, can present in the composition from 0.001% to 80% by weight (Pg. 10, lines 12-14) (overlapping to range from 10% to 80% in instant claim 9).
Marat does not explicitly teach the composition comprises a continuous oil phase and a discontinuous aqueous phase with weight ratio of the aqueous phase to the oil phase is 1.0 to 10.0 as recited in instant claims 1 and 15. Marat also does not teach emulsifying species silicone elastomer in instant claim 11.
Agnes teaches a cosmetic composition in W/O emulsion form containing at least two different silicone elastomer emulsifiers for cosmetic make-up or care process for keratin materials, involving applying the composition to the keratin materials (e.g., Abstract). Agnes teaches that the W/O emulsion with a continuous oily phase [0004] and the weight ratio of the oil phase to the aqueous phase is between 0.5 and 2.5, and preferably between 0.7 and 2, and preferably between 1 and 2 (e.g., [0124]), in other words, aqueous phase to oil phase weight ratio between 0.4 and 2 (overlapping with weight ratio of aqueous phase to oil phase 1.0 to 10.0 as recited in instant claims 1 and 15).
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the emulsifier species and weight ratio of aqueous phase to oil phase taught by Agnes into the Marat composition to arrive at current invention. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because Marat suggests that W/O emulsion with emulsifiers are proper for the keratin care (bleaching or whitening) composition, while Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates.
This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 15, to the extent that the claim is drawn to a method, it does not provide active or structural steps in addition to the composition. Since prior art teaches the composition, stabilizing the compound of formula (I) in the composition is inherent property of the composition.
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 1-15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-8, 12, 16, 18-21 of copending Application No. 17844949 (reference application, hereafter US’949), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). The claims at issue are not identical, but they are not patentably distinct from each other.
US’949 recites an oil-in-water cosmetic composition comprising at least one compound of formula (I), a tautomer of formula (I’), their salts, their optional isomers, racemates, solvates, or a mixture thereof:
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Based on the above structure description in US’949 (Claim 1), when R1 is hydrogen or a saturated linear C1-C6 alkyl group, and R2 denotes a linear C1-C12 hydrocarbonated group with substituent of iii) -C(O)-O-R3, the resulting compound reads on instant claims 1 and 15 of compound of formula (I). US’949 indicates the radical R1 of formula (I) and (I’) represents a hydrogen atom or a linear C1-C10 alkyl group or branched C3-C10 group (Claim 2), R2 represents a hydrogen atom or a linear C1-C10 alkyl group or branched C3-C10 alkyl group (Claim 3), R2 represents a linear C1-C10 alkyl group or branched C3-C10 alkyl group with defined substituents according to claim 1 (Claim 4), R2 represents a C3-C8 cycloalkyl group or C5-C12 aryl group with optional substituents (Claim 5), R3 represents a hydrogen atom or a saturated linear C1-C10 or branched C3-C10 alkyl group (Claim 6), R1, R2, R3 can be a hydrogen atom and other alternatives (Claim 7), specific compounds 1 to 24 (Claim 8) (all structural specifics and compounds overlap with instant compound structures in instant claims 1-5 and 15). US’949 indicates the compound is about 0.01 to about 10 wt.% (Claim 12) (overlapping with instant claim 6), oil phase is present from about 2 to about 25 wt.% based on total weight of the cosmetic composition (Claim 16), and the oil-in-water composition comprising about 0.01 to about 10 wt.% the compound selected from formula (I), a tautomer of formula (I’), as defined, their salts, their optical isomers, racemates, solvates or a mixture thereof, and oils (Claim 18), a method of using the cosmetic composition comprising applying the composition to a skin surface (Claim 19), a process for depigmenting, lightening and/or bleaching keratin materials (Claim 20) (corresponding to instant claims 13-14), one compound is compound 20 (Claim 21), which resembling compound 1 in instant claims 5 and 6. US’949 recites polyglyceryl fatty acid esters in addition to oils in the composition (Claims 1, 13, 15), which is known as emulsifiers in the field, corresponding to instant claim 12.
US’949 does not recite W/O emulsion with the specific weight ratio of aqueous phase and oil phase, and US’949 does not recite oil amount, water amount, lipophilic gelling agent, or silicone elastomer as emulsifier.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil amount, water amount overlapping with instant claimed amounts, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’949 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to change the emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 15, to the extent that the claim is drawn to a method, it does not provide active or structural steps in addition to the composition. Since prior art teaches the composition, stabilizing the compound of formula (I) in the composition is inherent property of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 11-12, 14-16, and 19-21 of copending Application No. 18031267 (reference application, hereafter US’267), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’267 recites method of using composition for skin of face and/or body (Claim 19) comprising compounds of formula (I) or (I’), when R2 is v) -COOR3 (Claims 11-12, Claims 14 and 20), and salts, solvates, optical isomers or racemates (Claim 15), they read on instant claims 1 and 15 formula (I) and compounds in instant claims 2-5. US’267 recites the relevant compound of formula (I) or (I’) in the composition in a range from 0.1% to 5.0% (Claim 16) or from 0.5% to 3.0% (Claim 21)(overlapping to instant claim 6).
US’267 does not recite the composition is W/O emulsion with continuous oil phase with discontinuous aqueous phase in specific weight ratio of the two phase amounts, and US’267 does not recite oil, water amounts, emulsifiers, lipophilic gelling agent in the composition.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil amount, water amount overlapping with instant claimed amounts, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’267 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 15, to the extent that the claim is drawn to a method, it does not provide active or structural steps in addition to the composition. Since prior art teaches the composition, stabilizing the compound of formula (I) in the composition is inherent property of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-6 and 10-15 of copending Application No. 18267333 (reference application, hereafter US’333), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’333 recites a composition for a keratin substance whitening (Claims 13-14) (corresponding to instant claims 13-14) and for stabilizing the compound as described as formula (I) (Claim 15) (corresponding to instant claim 15), comprising compounds of formula (I), and salts, solvates, optical isomers or racemates, defined radicals R1, R2, and specific compounds 1-4 according to formula (I) (Claims 1-5), they read on instant claims 1-5 and 15. US’333 recites the relevant compound of formula (I) in the composition in a range from 0.01% to 20% (Claim 6) (same as instant claim 6), or from 0.5% to 3.0% (Claim 21)(overlapping to instant claim 6). US’333 recites fatty acids (Claims 1, 7-9) (which can be emulsifiers as known in the field, corresponding to instant claim 12), oil (Claim 10), and water (Claim 11) (corresponding to instant claims 1, 8-9, 15), one surfactant (Claim 12).
US’333 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and US’333 does not recite oil, water amounts, emulsifiers, lipophilic gelling agent in the composition.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil amount, water amount overlapping with instant claimed amounts, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’333 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick an emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-9 of copending Application No. 18874676 (reference application, hereafter US’676), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’676 recites a method for stabilizing the compound as described as formula (I) (Claim 15) (corresponding to instant claim 15), and a composition comprising compounds of formula (I) (Claim 1), and salts, solvates, optical isomers or racemates according to formula (I) (Claim 8), with defined radicals R1 and R2 (Claims 2-6), when R2 as iii) -C(O)-OR3 (Claims 1 and 7), they read on instant claims 1-5 and 15. US’676 recites the relevant compound of formula (I) in the composition in a range from 0.01% to 10% (Claim 9) (overlapping with range in instant claim 6).
US’676 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and US’676 does not recite oil or water with amounts, emulsifiers, lipophilic gelling agent in the composition, and also does not recite the composition is for applying to keratin substance and for whitening keratin.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil amount, water amount overlapping with instant claimed amounts, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’676 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick an emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-9 and 12-15 of copending Application No. 18874784 (reference application, hereafter US’784), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’784 recites a method for stabilizing a compound described as formula (I) and (I’) (Claim 15) (corresponding to instant claim 15), and a composition for applying to keratin substance (Claim 14) and whitening keratin substance (Claim 13) (corresponding to instant claims 13-14), comprising compounds of formula (I) and (I’) (Claim 1), and salts, solvates, optical isomers or racemates according to formula (I) and (I’) (Claims 1 and 8), with defined radicals R1 and R2 (Claims 2-6), when R2 as iii) -C(O)-OR3 (Claims 1 and 7), they read on instant claims 1-5 and 15. US’784 recites the relevant compound of formula (I) in the composition in a range from 0.01% to 10% (Claim 9) (overlapping with range in instant claim 6), water from 20% to 99% by weight in the composition (Claim 12).
US’784 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and US’784 does not recite oil with amount, emulsifiers, lipophilic gelling agent in the composition.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil amount overlapping with instant claimed amount, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’784 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick an emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-9 and 14 of copending Application No. 18875814 (reference application, hereafter US’814), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’814 recites a method for stabilizing a compound described as formula (I) and (I’) (Claim 15) (corresponding to instant claim 15), and a composition comprising compounds of formula (I) and (I’) (Claim 1), and salts, solvates, optical isomers or racemates according to formula (I) and (I’) (Claims 1 and 8), with defined radicals R1 and R2 (Claims 2-6), when R2 as iii) -C(O)-OR3 (Claims 1 and 7), they read on instant claims 1-5 and 15. US’814 recites the relevant compound of formula (I) in the composition in a range from 0.01% to 10% (Claim 9) (overlapping with range in instant claim 6).
US’814 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and US’814 does not recite oil with amount, water and amount, emulsifiers, lipophilic gelling agent in the composition. US’814 also does not recite the composition is for applying to keratin substance and for keratin whitening.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil and water with amounts overlapping with instant claimed amount, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’814 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick an emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-13 and 15-19 of U.S. Patent No. 12226506 (Hereafter P506) in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
P506 recites oil-in-water (O/W) cosmetic compositions comprising compounds with formula (I) and (I’) and salts, solvates, optical isomers or racemates thereof, and compound examples (Claims 1, 8, and 16), with defined radicals R1 and R2 (Claims 2-6), when R2 as iii) -C(O)-OR3 (Claims 1 and 7), they read on instant claims 1-5 and 15. P506 indicates that the oil-in-water cosmetic composition physically stable (Claim 1) (corresponding to a method for stabilizing the compound in instant claim 15). P506 recites the compound in the composition in a range from about 0.01% to about 10% (Claim 9) (overlapping with range in instant claim 6). P506 recites at least two or more emulsifiers with amount range in the composition (Claims 10-13) (corresponding to instant claims 11-12). P506 recites a method for treating skin comprising applying the cosmetic composition to the skin (Claim 17), a process for depigmenting, lightening and/or bleaching keratin materials (Claim 18) (corresponding to instant claims 13-14). P506 exemplifies compound 20 (Claim 19) which is the instant claimed compound 1 in instant claims 4-5.
P506 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and P506 does not recite oil with amount, water and its amount, emulsifier silicone elastomer, lipophilic gelling agent in the composition.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil and water with amounts overlapping with instant claimed amount, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with P506 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to change the emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-8 of U.S. Patent No. 9138392 (Hereafter P392) in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
P392 recites a cosmetic process for depigmenting, lightening and/or bleaching keratin materials and applying to keratin material an effective amount of at least one compound of formula (I) (Claim 1 ) (corresponding to instant claims 13-14). P392 recites the cosmetic composition comprising compound with formula (I) or a salt with defined structural details (Claim 1), and further defined radicals R1 and R2 (Claims 2-4), compound examples (Claim 5-6), when R2 as iii) -C(O)-OR3 (Claims 1 and 2), they read on instant claims 1-5 and 15. P392 recites the compound in the composition in a range from 0.01% to 10% (Claim 7) (overlapping with range in instant claim 6). P392 recites at least one adjuvant selected from the group consisting of water, an organic solvent, a carbon-based and/or silicone oil, of mineral, animal and/or plant origin, a wax, a pigment, a filler, a dye, a surfactant, an emulsifier, a co-emulsifier, and others (Claim 8) (corresponding to ingredients in instant claims 1, 7, 9, 11-12).
P392 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and P392 does not recite oil with amount, water and its amount, emulsifier silicone elastomer, lipophilic gelling agent in the composition.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil and water with amounts overlapping with instant claimed amount, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with P392 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick an emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 15, to the extent that the claim is drawn to a method, it does not provide active or structural steps in addition to the composition. Since prior art teaches the composition, stabilizing the compound of formula (I) in the composition is inherent property of the composition.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-52 of copending Application No. 16061908 (reference application, hereafter US’908), in view of Marat et al. (WO2017102349, 06/22/2017 or earlier, IDS of 06/15/2023) and Agnes (ES2324830, 08/17/2009, in record of 09/23/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’908 recites a method for depigmenting, lightening and/or bleaching keratin materials comprising applying to keratin materials a cosmetic composition comprising at least one compound chosen from compounds 1-4 (Claims 34 and 49) as same compounds shown in instant claims 4-5, and these specific compounds represent specific radicals of R1 and R2 in instant claims (corresponding to instant claims 13-14, and compounds in instant claims 1-5 and 15). US’908 recites the cosmetic composition comprises compound, at least one tautomer, one salt, or mixtures of two or more thereof (Claims 35-38) (corresponding to instant claims 1, 4-5, and 15). US’908 recites the total amount of specific compounds in the composition in the range from 0.01% to 10% (Claims 39, 41, 43, 45, and 47) or from 0.5% to 3% (Claims 40, 42, 44, 46, and 48) (overlapping with range in instant claim 6). US’908 recites the method comprising compounds of formula (I) and formula (I’) with defined radicals R1 and R2 (Claims 50-53), which read into instant claims, e.g., 1-3 and 15.
US’908 does not recite the composition as W/O composition with weight ratio of the oil phase and aqueous phase as defined in instant invention, and US’908 does not recite oil with amount, water and its amount, emulsifier silicone elastomer, lipophilic gelling agent in the composition.
As discussed in detail above and incorporated herein, Marat and Agnes teach the W/O cosmetic composition comprising the instant claimed compound with formula (I), oil, and water with ratio weight of aqueous phase and oil phase overlapping with claimed range, and also teach oil and water with amounts overlapping with instant claimed amount, as well as lipophilic gelling agent and silicone elastomer as proper ingredients in the cosmetic composition for keratin whitening.
It would have been prima facie obvious for a person with ordinary skills in the art to incorporate Marat and Agnes teaching with US’908 compound formula to arrive at current invention. Because Marat teaches that emulsion types including W/O and O/W are proper for the specific compounds, with the adjuvants and emulsifiers taught by Marat and Agnes, it would be convenient for artisans in field to pick an emulsion type and select the proper ingredients. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Since Agnes teaches the composition comprising the emulsifiers and with the oil phase and water phase weight ratio constituting a comfortable, creamy texture and a soft feeling when taken with the fingers, and the composition stretches well and spreads easily without causing a greasy or sticky sensation during application (e.g., [0010]-[0011]), artisans in the field would have reasonable expectation of success to combine these elements for the benefits Agnes indicates. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, oil, water, and weight ratio overlap with those in prior art as discussed above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 15, to the extent that the claim is drawn to a method, it does not provide active or structural steps in addition to the composition. Since prior art teaches the composition, stabilizing the compound of formula (I) in the composition is inherent property of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s Remarks/Arguments filed on 12/09/2025 have been fully considered, but they are not persuasive.
Art Rejections
Applicant asserts that claim 1 is patentable over the cited prior art because data has shown in Declaration under 37 CRF 1.132 filed on 12/09/2025, that the weight ratio of the aqueous phase to the oil phase between 1:1 to 10:1 is critical, although prior art range between 0.4 and 2 overlaps with the scope. Applicant presents data of Ex. 1 W/O emulsion with aqueous phase to oil phase ratio is 1.96, Comparative Ex. 3 the ratio is about 0.85 (less than 1), both are within the prior art range, but only Example 1 provides the surprising result of stability of thiopyridinone/composition.
The conclusion that the claimed range (1:1 to 10:1) is critical over the prior art range (0.4:1 to 2:1) is not mature, because the results are drawn from the comparison based upon Ex. 1 (ratio 1.96) exhibiting superior stability over Comparative Ex. 3 (ratio about 0.85). One single data point to show criticality of a claimed range is not commensurate in scope. MPEP 716.02(d) states “[W]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”; further, MPEP 716.02 (d) II states “[T]o establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960)”. Response to the Declaration is presented below in separate session.
Applicant alleges that secondary prior art Agnes is silent regarding stability of thiopyridinone/ composition.
The rejection is based upon combined teaching of Marat and Agnes, not Agnes alone. Current claim set is a composition application, as presented in the office action, Marat and Agnes teaches the claimed composition. Stability as the property of the composition, which has already been taught by prior art, would necessarily be present as the inherent property of the composition. This is consistent with the rejection presented in office action regarding instant claim 15 scope of “a method for stabilizing”, the claim does not provide any structural steps, as presented in office action and copied for reference herein: “Regarding claim 15, to the extent that the claim is drawn to a method, it does not provide active or structural steps in addition to the composition. Since prior art teaches the composition, stabilizing the compound of formula (I) in the composition is inherent property of the composition. “.
Double Patenting Rejections
Applicant requests the rejections to be held in abeyance until such time that allowable subject matter is indicated.
A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP §714.02 and 37 CFR 1.111(b)). Thus, the double patenting rejections of record have been maintained as no action regarding these rejections has been taken by Applicants at this time.
Declarations Under 37 CFR 1.132
Makoto Saito provided a declaration under 37 C.F.R. 1.132, filed on 12/09/2025.
The declaration meets the formal requirements.
A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations:
1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art,
Examiner has fully considered the declaration and acknowledges that the declaration presents side-by-side comparisons of the ratio of aqueous phase/oil phase, ratio 1.96 as a data point representing claim 1 scope 1:1 to 10:1, compared to ratio 0.85, as data point representing the closest prior art Agnes range from 0.4:1 to 2:1. Therefore, the data presents a side-by-side comparison to the closest prior art.
3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)),
The data is not commensurate in scope with the scope of the ratio range 1:1 to 10:1 in claim. As presented above, MPEP 716.02(d) states “[W]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”; further, MPEP 716.02 (d) II states “[T]o establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960)”. The results are drawn from the comparison based upon Ex. 1 (ratio 1.96) exhibiting stability over Comparative Ex. 3 (ratio about 0.85). One single data point to show criticality of a claimed range is not commensurate in scope.
4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)),
The Declaration shows results in Table 2 that Ex. 1 presents slightly better outcome compared to Comp. Ex. 3, e.g., 0.491 vs. 0.488 of thiopyridinone 45C 1M amount %, 96.27 vs. 96.25 % thiopyridinone remaining ratio, 0.467 vs. 0.450 55C 1M/amount % , 91.57 vs. 88.76 of thiopyridinone remaining ratio %. Further, the stability was visually evaluated as well, results show in Table 3 that 45C or 55C 2 weeks, Comp. Ex. 3 shows phase separation, while in RM 1M, both shows good stability (no phase separation). The data as presented in Table 2 does not show significant difference between the two tested ratios, because the data only presents merely a difference in degree, exhibiting all compared values differ under 0.02 or 3% range. Plus, there is no statistical analysis to show significance. Regarding visual observation result shown in Table 3, even though at higher temperatures, the results show kind of difference, e.g., no phase separation vs. phase separation. However, because at room temperature, the composition does not show difference, and compositions are generally used by users at room temperature, the observed results are not deemed significant for the intended use. In conclusion, the ratio of aqueous phase to oil phase weight at 1.96 is not significantly better than 0.85, and the results do not provide support the allegedly criticality.
5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The prima facie case is sufficiently strong as presented in office action. Because Marat and Agnes teaches the composition, and stability is the property of the composition which has been taught by prior art, the composition based on prior art would have the stability as inherent property. Since the claimed ratio range overlaps with range taught by prior art, even if there is significant difference between the tested Ex. 1 ratio 1.96 vs. Comp. Ex. 3 ratio 0.85, ratio 1.96 is also in the prior art taught range 0.4 to 2, and therefore, any allegedly superior results generated from ratio 1.96 would be further confirmation that the composition taught by prior art constitutes such superior property.
In conclusion, the declaration under 37 CFR 1.132 is insufficient to overcome the rejection based upon as set forth in this Office action.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616