DETAILED ACTION
Status of Claims
Claims 1-15 are currently pending. Claims 1-10 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 11-15 are withdrawn from consideration. 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 Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-10) in the response filed on October 13, 2025 (to the August 13, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claim 11) and Group III (claims 12-15) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I with traverse. The traversal is based on applicant’s argument:
Restriction is only proper if the claims of the restricted groups are independent or patentably distinct and there would be a serious burden placed on the Examiner if restriction is not required (MPEP §803). The burden is on the Examiner to provide reasons and/or examples to support any conclusion in regard to patentable distinction (MPEP §803). Moreover, when citing lack of unity of invention in a national stage application, the Examiner has the burden of explaining why each group lacks unity with each other group specifically describing special technical features in each group (MPEP § 1893.03(d)).
The Office has asserted that Groups I - III do not relate to a single general inventive concept under PCT Rule 13. l because under PCT Rule 13.2, the Examiner alleges that the claims lack the same or corresponding special technical features and cites WO 2014/098267 A1 as disclosing a composition which precludes the provision of a special technical feature by the present disclosure.
Annex B of the Administrative Instructions under the PCT at (b) Technical Relationship states:
“The expression "special technical features" is defined in Rule 13.2 as meaning those technical features that defines a contribution which each of the inventions, considered as a whole, makes over the prior art. The detennination is made on the contents of the claims as interpreted in light of the description and drawings (if any).”
In applying this definition Applicants respectfully submit that the Examiner has misinterpreted the phrase "contribution which each of the inventions, considered as a whole, makes over the prior art" as relating to patentable claims. While Applicants submit that their claims are patentable, at this early stage of prosecution they have not been examined nor rejected, nor has Applicant had a chance to respond to any rejection and/or amend their claims. It is thus incorrect to use the Examiner's interpretation of the phrase “contribution which each of the inventions, considered as a whole, makes over the prior art” as relating to decidedly patentable claims, as doing so denies Applicant due process.
Furthermore, Applicants respectfully submit that the Examiner has not provided any indication that the contents of the claims interpreted in light of the description was considered in making the assertion of a lack of unity and therefore has not met the burden necessary to support the assertion.
Therefore, Applicants respectfully submit that the burden necessary according to MPEP § 1893.03(d) to sustain the conclusion that the groups lack of unity of invention has not been met.
10/13/2025 Response. pp. 2-3. In response: the establishment of burden on the Office applies to US cases only. The instant application is a national stage entry of an international application under 35 U.S.C. § 371. As a result, lack of unity practice is observed for restriction purposes. Since the claims drawn to the instant composition over US 2019/0365628 A1 by Koide et al., restriction is still deemed proper.
Also in the response dated October 13, 2025, applicant elected the following species:
Specie i) C5-10 glycol: pentylene glycol;
Specie ii) a linear unsaturated C18-30 monoalcohol: oleyl alcohol;
Specie iii) a hydrophilic cosmetic ingredient: hydroxypropyl tetrahydropyrantriol.
and identified claims 1-8 and 10 as reading on the elected species. In searching for art on the elected invention, the examiner found and applied art, which reads on the broader scope of the elected claims, namely relating to the elected species for “Specie iii) a hydrophilic cosmetic ingredient,” which is broadened in scope in order to include niacinamide.
Accordingly, the August 13, 2025 Requirement for Restriction is made FINAL, and claims 1-10 are examined as follows.
Claim Rejections – 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-10 are rejected under 35 U.S.C. § 103 as being unpatentable over KOIDE (US 2019/0365628 A1, Publ. Dec. 5, 2019; File Nov. 28, 2016; on 04/24/2023 IDS; hereinafter, “Koide”).
Koide, is directed to:
COMPOSITION IN THE FORM OF NANO- OR MICRO- EMULSION
ABSTRACT
The present invention relates to a composition in the form of a nano- or micro-emulsion, comprising: (a) at least one oil; (b) at least one nonionic surfactant with an HLB value of from 8.0 to 14.0, preferably from 9.0 to 13.5, and more preferably from 10.0 to 13.0; (c) at least one ceramide compound; (d) at least one compound selected from Vitamin B3 and derivatives thereof; and (e) water. The composition according to the present invention can be used as a cosmetic composition and can enhance or improve the penetration of a ceramide compound into a keratin substance such as the skin.
Koide, title & abstract. In this regard, Koide teaches a claim embodiment drawn to a nano- or micro-emulsion, comprising at least one oil, at least one HLB 8.0 to 14.0 nonionic surfactant, at least one ceramide compound, at least one Vitamin B3 compound, and water:
16. A composition in the form of a nano- or micro-emulsion, comprising:
at least one oil;
at least one nonionic surfactant having an HLB value ranging from 8.0 to 14.0;
at least one ceramide compound;
at least one compound selected from Vitamin B3 or derivatives thereof; and
water.
17. The composition according to claim 16, wherein the at least one oil is chosen from ester oils, hydrocarbon oils, fatty alcohols, or mixtures thereof.
18. The composition according to claim 16, wherein the at least one oil is present in an amount ranging from 0.1 to 30% by weight, relative to the total weight of the composition.
19. The composition according to claim 16, wherein the at least one oil is present in an amount ranging from 0.5 to 20% by weight, relative to the total weight of the composition.
[…]
30. The composition according to claim 16, wherein the at least one compound selected from Vitamin B3 or derivatives thereof is niacinamide.
31. The composition according to claim 16, wherein the at least one compound selected from Vitamin B3 or derivatives thereof is present in an amount ranging from 0.01 to 20% by weight, relative to the total weight of the composition.
32. The composition according to claim 16, wherein the at least one compound selected from Vitamin B3 or derivatives thereof is present in an amount ranging from 0.05 to 15% by weight, relative to the total weight of the composition.
Koide, claims 16-19 and 30-32.
Regarding independent claims 1 and 9 and the requirements:
1. ([…]): A composition for skincare, comprising in a hydrophilic phase:
(i) at least one C5-C10 glycol;
(ii) at least one linear unsaturated C18-C30 monoalcohol; and
(iii) at least one hydrophilic cosmetic active ingredient.
[…]
9. ([…]): The composition according to claim 1, comprising in a hydrophilic phase, relative to the total weight of the composition:
(i) from 0.5% to 3% by weight of pentylene glycol;
(ii) from 2% to 8% by weight of oleyl alcohol; and
(iii) from 10% to 35% by weight of at least one hydrophilic cosmetic active ingredient selected from proxylane, niacinamide, and a mixture thereof.
Koide clearly teaches a nano- or micro-emulsion, comprising at least one oil, at least one HLB 8.0 to 14.0 nonionic surfactant, at least one ceramide compound, at least one Vitamin B3 compound, and water (Koide, claims 16-19 and 30-32), WHEREBY it is noted:
“at least one oil” (Koide, claim 16) encompassing “fatty alcohols” (Koide, claim 17) relates to “(ii) at least one linear unsaturated C18-C30 monoalcohol” of claim 1, and “oleyl alcohol” of claim 9, but for a particular fatty alcohol;
“at least one compound selected from Vitamin B3 or derivatives thereof” (Koide, claim 16) encompassing “niacinamide” (Koide, claim 30) is encompassed by “(iii) at least one hydrophilic cosmetic active ingredient” of claim 1, and the broadened elected species for (iii) “niacinamide” of claim 9; and
“water” (Koide, claim 16) is a “hydrophilic phase” of claims 1 and 9, as well as “water” of claim 10:
10. ([…]): The composition according to claim 1, wherein the hydrophilic phase comprises at least one solvent selected from the group consisting of water and C2-C4 glycol.
wherein “the composition according to the present invention is in the form of an O/W emulsion, the (a) oil in the composition according to the present invention can form dispersed fatty phases in the O/W emulsion” (Koide, par. [0131]), wherein the continuous phase is water per the requirements of claims 1 and 9 for a “hydrophilic phase” comprising the recited components.
However, it is noted that:
although Koide teaches the incorporation of a “Polyol” such as “pentyleneglycol”:
[0340] (Polyol)
[0341] The composition according to the present invention may further comprise at least one polyol. A single type of polyol may be used, but two or more different types of polyol may be used in combination.
[0342] The term “polyol” here means an alcohol having two or more hydroxy groups, and does not encompass a saccharide or a derivative thereof. The derivative of a saccharide includes a sugar alcohol which is obtained by reducing one or more carbonyl groups of a saccharide, as well as a saccharide or a sugar alcohol in which the hydrogen atom or atoms in one or more hydroxy groups thereof has or have been replaced with at least one substituent such as an alkyl group, a hydroxyalkyl group, an alkoxy group, an acyl group or a carbonyl group.
[0343] The polyol may be a C2-C12 polyol, preferably a C2-C9 polyol, comprising at least 2 hydroxy groups, and preferably 2 to 5 hydroxy groups.
[0344] The polyol may be a natural or synthetic polyol. The polyol may have a linear, branched or cyclic molecular structure.
[0345] The polyol may be selected from glycerins and derivatives thereof, and glycols and derivatives thereof. The polyol may be selected from the group consisting of glycerin, diglycerin, polyglycerin, ethyleneglycol, propyleneglycol, dipropyleneglycol, butyleneglycol, pentyleneglycol, hexyleneglycol, 1,3-propanediol, 1,5-pentanediol, caprylyl glycol, polyethyleneglycol (5 to 50 ethyleneoxide groups), and sugars such as sorbitol.
[0346] The polyol may be present in an amount ranging from 0.01 to 30% by weight, and preferably 50 from 0.1 to 25% by weight, such as from 1 to 20% by weight, relative to the total weight of the composition.
(Koide, par. [0340]-[0346]), which is the elected species of “(i) at least one C5-C10 glycol” of claim 1, and (i) “pentylene glycol” of claim 9, Koide DOES NOT EXPRESSLY TEACH an exemplary embodiment thereof; and
although Koide teaches suitable “fatty alcohol[s],” inter alia, “oleyl alcohol”:
[0120] As examples of the fatty alcohol, mention may be made of lauryl alcohol, cetyl alcohol, stearyl alcohol, isostearyl alcohol, behenyl alcohol, undecylenyl alcohol, myristyl alcohol, octyldodecanol, hexyldecanol, oleyl alcohol, linoleyl alcohol, palmitoleyl alcohol, arachidonyl alcohol, erucyl alcohol, and mixtures thereof.
(Koide, par. [0120]), which is a particular “C18-C30 monoalcohol” of claim 1, and the elected species of (ii) “oleyl alcohol” of claim 9, as well as claim 4-5:
4. ([…]): The composition according to claim 1, wherein the linear unsaturated C18-C30 monoalcohol is of structure R-OH with R denoting a linear alkenyl group comprising from 18 to 30 carbon atoms.
5. ([…]): The composition according to claim 1, wherein the linear unsaturated C18-C30 monoalcohol is selected from linear monoalcohols having from 18 to 24 carbon atoms.
Koide DOES NOT EXPRESSLY TEACH an exemplary embodiment thereof.
Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious, in light of Koide’s broader disclosure. In this regard, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange the disclosed above cited components of Koide in order to arrive at Koide clearly teaches a nano- or micro-emulsion (Koide, claims 16-19 and 30-32) containing:
a “Polyol” (Koide, par. [0340]-[0346]) such as “pentyleneglycol” (Koide, par. [0345]);
“at least one oil” (Koide, claim 16) encompassing “fatty alcohols” (Koide, claim 17) such as “oleyl alcohol” (Koide, par. [0120]); and
“niacinamide” (Koide, claim 30).
Regarding the range requirements of claim 9, as well as the requirements of claims 3 and 6-7 for:
3. ([…]): The composition according to claim 1, wherein the C5-C10 glycol is present in an amount ranging from 0.1% to 10%, relative to the total weight of the composition.
[…]
6. ([…]): The composition according to claim 1, wherein the linear unsaturated C18-C30 monoalcohol is present in an amount ranging from 0.1% to 10% relative to the total weight of the composition.
7. ([…]): The composition according to claim 1, wherein the hydrophilic cosmetic active ingredient is present in an amount ranging from 0.1% to 40% relative to the total weight of the composition.
it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” Therefore, it would be obvious to formulate Koide’s nano- or micro-emulsion (Koide, claims 16-19 and 30-32) per Koide’s broader disclosure, in order to contain:
a “Polyol” (Koide, par. [0340]-[0346]) such as “pentyleneglycol” (Koide, par. [0345]), wherein “[t]he polyol may be present in an amount ranging from 0.01 to 30% by weight, and preferably 50 from 0.1 to 25% by weight, such as from 1 to 20% by weight, relative to the total weight of the composition” (Koide, par. [0346]);
“at least one oil” (Koide, claim 16) encompassing “fatty alcohols” (Koide, claim 17) such as “oleyl alcohol” (Koide, par. [0120]), wherein “wherein the at least one oil is present in an amount ranging from 0.1 to 30% by weight, relative to the total weight of the composition” (Koide, claim 18); and
“niacinamide” (Koide, claim 30), wherein “wherein the at least one compound selected from Vitamin B3 or derivatives thereof is present in an amount ranging from 0.01 to 20% by weight, relative to the total weight of the composition” (Koide, claim 31).
Thus, Koide renders claims 1-7 and 9-10 obvious.
Regarding claim 8 and the requirements:
8. ([…]): The composition according to claim 1, further comprising conventional cosmetic adjuvants or additives selected from the group consisting of fragrances, chelating agents, preserving agents, bactericides, surfactants, thickeners, fillers, pH regulators, and mixtures thereof.
Koide teaches the incorporation of “Other Optional Ingredients,” inter alia, “fragrances”:
[0362] (Other Optional Ingredients)
[0363] The composition according to the present invention may also comprise an effective amount of other optional ingredients, such as various common adjuvants, antiageing agents, whitening agents, anti-greasy skin agents, sequestering agents such as EDTA and etidronic acid, UV screening agents, preserving agents, vitamins or provitamins, for instance, panthenol, opacifiers, fragrances, plant extracts, cationic polymers and so on.
(Koide, par. [0362]-[0363]), which are encompassed by “fragrances” and “conventional cosmetic adjuvants or additives” of claim 8.
Thus, Koide renders claim 8 obvious.
Conclusion
Claims 1-10 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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