DETAILED ACTION
Status of Claims
Claims 16-35 are currently pending. Claims 16-34 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 Non-elected claim 35 are withdrawn from consideration.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 16-34) in the response filed on December 17, 2025 (to the September 17, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claim of Group II is withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 traverse is based on applicant’s argument:
Applicants respectfully disagree with the Office's position and analysis. “Examiners are reminded that unity of invention analysis (not an independent and distinct analysis) is applicable in national stage applications submitted under 35 U.S.C. 371.” M.P.E.P. § 1893.03(d) (emphasis added). Further, “unity of invention only exists wherein there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features,” and “[t]he expression ‘special technical features’ is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art.” M.P.E.P. § 1850(11).[12/17/2025 Remarks, p. 2, par. 5, cont. on p. 3]
Respectfully, Applicants submit that no lack of unity of invention has been established. Further, the Office has failed to show that Groups I and II do not share a special technical relationship based on at least one common or corresponding special technical feature.[12/17/2025 Remarks, p. 3, par. 1]
12/17/2025 Remarks, p. 2, par. 5, cont. on p. 3, to p. 3, par. 1. In response: since the instant claims are not patentable over PAN I (WO 2017/172523 A1, Publ. Oct. 5, 2017; on 10/30/2023; hereinafter, “Pan I) and PAN II (US 2018/0116950 A1, Publ. May 3, 2018; hereinafter, “Pan II”), as discussed below, the claims lack “unity of invention,” and restriction is still deemed proper.
Accordingly, the September 17, 2025 Requirement for Restriction is made FINAL, and claims 16-34 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 16-34 are rejected under 35 U.S.C. § 103 as being unpatentable over PAN I (WO 2017/172523 A1, Publ. Oct. 5, 2017; on 10/30/2023; hereinafter, “Pan I), in view of PAN II (US 2018/0116950 A1, Publ. May 3, 2018; hereinafter, “Pan II”).
Pan I is directed to:
Title: COSMETIC COMPOSITIONS AND METHODS FOR PROVIDING BROAD AND FULL SPECTRUM PHOTO PROTECTION
Abstract: The present disclosure relates to compositions and methods for providing broad and full spectrum photo protection to skin. The compositions and methods use one or more antioxidants; optionally, one or more solubilizers; and a cosmetically acceptable carrier. UV filters may also optionally be included to provide additional protection from UV light. Non-limiting examples of antioxidants include baicalin, polydatin, silymarin, venuceane™, ferulic acid, punica granatum extract, mango leaf extract, soliprin, catechin, hesperetin, astilbin, DHC, Vitamin C, and mixtures thereof. Useful solubilizers include hydrotropes. Additional components, such as, additional active ingredients, emulsifiers, and silicone oils may also be used.
Pan I, title & abstract. In this regard, Pan I exemplifies an serum containing silymarin:
Example 15
(Serum)
A serum was prepared containing silymarin and the additional antioxidants vitamic C and Ferulic acid. The components of the serum are shown in the table below.
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The components of Phase A except for the alcohol were combined and mixed at 60°C then cooled to room temperature. Once at room temperature, the alcohol was added. The components of Phase B were separately combined and mixed. The mixture was heated to 65°C in order to dissolve the laureth-23. Phase A was added into phase B and mixed until the composition had a uniform consistency.
Pan I, p. 56, ln. 1-11, Ex. 15.
Regarding independent claims 16 and 34 and the requirements:
16. ([…]) A cosmetic composition comprising:
a) from about 0.1% to about 1.8% of Silybum Marianum Extract;
b) at least one compound chosen from salicylic acid, ascorbic acid, cinnamic acid derivatives, or mixtures thereof;
c) at least one surfactant;
d) from about 3% to about 18% of propylene glycol;
e) from about 3% to about 18% of dipropylene glycol; and
f) water;
wherein the composition has a pH of less than or equal to about 5; and
wherein all percentages are by weight, based on the total weight of the cosmetic composition.
[…]
34. ([…]) A cosmetic composition comprising:
a) from about 0.1% to about 1.8% of Silybum Marianum Extract;
b) from about 0.1% to about 2% of salicylic acid;
c) from about 2% to about 20% of ascorbic acid;
d) at least one surfactant;
e) propylene glycol;
f) dipropylene glycol; and
g) water;
wherein the weight ratio of propylene glycol to dipropylene glycol ranges from about 1:6 to about 1:1;
wherein the composition has a pH of less than or equal to about 5; and
wherein all percentages are by weight, based on the total weight of the cosmetic composition.
Pan I clearly teaches a serum containing silymarin (Pan I, p. 56, ln. 1-11, Ex. 15 & Table), WHEREBY it is noted:
0.5 wt.% “Silymarin” (Pan I, p. 56, Ex. 15 & Table) is “a) from about 0.1% to about 1.8% of Silybum Marianum Extract” of claims 16 and 34, as well as the requirements of claim 3 for:
33. ([…]) The cosmetic composition of claim 16, wherein the Silybum Marianum Extract is extracted from the fruit/seed of the Silybum Marianum plant.
(see also Pan II, par. [0037], as evidence that “Silymarin” is extract of “ Silybum Marianum”);
10 wt.% “Vitamin C” (Pan I, p. 56, Ex. 15 & Table) is:
“b) at least one compound chosen from […], ascorbic acid, […]” of claim 16, and
“c) from about 2% to about 20% of ascorbic acid” of claim 34;
as well as the requirements of claim 30 for:
30. ([…]) The cosmetic composition of claim 29, comprising salicylic acid in an amount ranging from about 0.1% to about 2% by weight, based on the total weight of the cosmetic composition.
3 wt.% “laureth-23” (Pan I, p. 56, Ex. 15 & Table) is
“c) at least one surfactant” of claim 16, and
“d) at least one surfactant” of claim 34;
as well as the requirements of claim 22-23 for:
22. ([…]) The cosmetic composition of claim 16, wherein the total amount of surfactants ranges from about 1% to about 10% by weight, based on the total weight of the cosmetic composition.
23. ([…]) The cosmetic composition of claim 16, comprising at least one surfactant chosen from alkoxylated fatty alcohols.
(and par. [0071]-[0072] listing “laureth-23” as a fatty alkoxylated alcohol surfactant);
10 wt.% “Propylene Glycol” (Pan I, p. 56, Ex. 15 & Table) is:
“d) from about 3% to about 18% of propylene glycol” of claim 16, and
“e) propylene glycol” of claim 34,
as well as the requirements of claim 20 for:
20. ([…]) The cosmetic composition of claim 16, wherein the total amount of propylene glycol ranges from about 5% to about 12% by weight, based on the total weight of the cosmetic composition.
10 wt.% “Dipropylene Glycol” (Pan I, p. 56, Ex. 15 & Table):
“e) from about 3% to about 18% of dipropylene glycol” of claim 16, and
“f) dipropylene glycol” of claim 34;
as well as the requirements of claim 21 for:
21. ([…]) The cosmetic composition of claim 16, wherein the total amount of dipropylene glycol ranges from about 8% to about 15% by weight, based on the total weight of the cosmetic composition.
55 wt.% “Water” (Pan I, p. 56, Ex. 15 & Table) is:
“f) water” of claim 16, and
“g)water” of claim 34;
as well as the requirements of claim 25 for:
25. ([…]) The cosmetic composition of claim 16, wherein the total amount of water ranges from about 35% to about 90% by weight, based on the total weight of the cosmetic composition.
wherein 10 wt.% “Propylene Glycol” and 10 wt.% “Dipropylene Glycol” (Pan I, p. 56, Ex. 15 & Table) meets “wherein the weight ratio of propylene glycol to dipropylene glycol ranges from about 1:6 to about 1:1” of claim 34, as well as the requirements of claim 17 for:
17. ([…]) The cosmetic composition of claim 16, wherein the weight ratio of propylene glycol to dipropylene glycol ranges from about 1:6 to about 1:1.
Regarding the range requirements of the instant claims, 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).” However, Pan I DOES NOT TEACH the pH requirements of claims 16, 24 and 34:
“wherein the composition has a pH of less than or equal to about 5” (claims 16 and 34), and
24. ([…]) The cosmetic composition of claim 16, wherein the composition has a pH ranging from about 3 to about 4.5.
which is well within the purview of the ordinarily skilled artisan.
Pan II, for instance, is directed to
COMPOSITIONS CONTAINING PHENOLIC COMPOUNDS HAVING SYNERGISTIC ANTIOXIDANT BENEFITS
ABSTRACT
Compositions comprising at least one polyphenol selected from the group consisting of Silybum Marianum extract, Origanum Vulgare leaf extract, and Coptis Chinensis root extract, and baicalin, and Vitamin E, all present in amounts sufficient to produce synergistic antioxidant activity and provided for cosmetic and other uses.
Pan II, title & abstract. In this regard, Pan II teaches a suitable pH range “generally between 2 and 12, or between 3 and 9”:
[0062] The pH of the compositions is not limited but is generally between 2 and 12, or between 3 and 9. The pH can be adjusted to the desired value by addition of a base (organic or inorganic) to the composition, for example ammonia or a primary, secondary or tertiary (poly)amine, such as monoethanolamine, diethanolamine, triethanolamine, isopropanolamine or 1,3-propanediamine, or alternatively by addition of an inorganic or organic acid, advantageously a carboxylic acid, such as, for example, citric acid.
Pan II, par. [0062].
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Pan I’s serum containing silymarin (Pan I, p. 56, ln. 1-11, Ex. 15 & Table) in a pH range “generally between 2 and 12, or between 3 and 9,” as taught by Pan II (Pan II, par. [0062]). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of a suitable pH range for a composition containing “Silybum Marianum extract” (Pan I, p. 56, ln. 1-11, Ex. 15 & Table; Pan II, abstract). See MPEP § 2144.07 stating that the selection of a known material based on its suitability for its intended use is prima facie obvious, which cites Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
Thus, the prior art renders claims 16-17, 20-25, 31 and 33-34 obvious.
Regarding claims 18, 26-30 and 32, and the requirements:
18. ([…]) The cosmetic composition of claim 16, comprising a total amount of salicylic acid, ascorbic acid, and/or cinnamic acid derivatives ranging from about 0.1% to about 20% by weight, based on the total weight of the cosmetic composition.
[…]
26. ([…]) The cosmetic composition of claim 16, comprising at least one cinnamic acid derivative.
27. ([…]) The cosmetic composition of claim 16, comprising ferulic acid.
28. ([…]) The cosmetic composition of claim 27, wherein the total amount of ferulic acid ranges from about 0.1% to about 1% by weight, based on the total weight of the cosmetic composition.
29. ([…]) The cosmetic composition of claim 16, comprising salicylic acid and/or ascorbic acid.
30. ([…]) The cosmetic composition of claim 29, comprising salicylic acid in an amount ranging from about 0.1% to about 2% by weight, based on the total weight of the cosmetic composition.
[…]
32. ([…]) The cosmetic composition of claim 16, comprising salicylic acid, ascorbic acid, and ferulic acid.
Pan I teaches a composition containing 0.5 wt.% “Ferulic Acid” and 10 wt.% “Vitamin C” (Pan I, p. 56, Ex. 15 & Table), thereby meeting the requirement of claims 18 and 26-27. With regard to “salicylic acid,” Pan I teaches “salicylic acid” among suitable “skin active ingredient” that may be present “from about 0.001 to about 10 wt.%, based on the total weight of the composition” (Pan I, p. 21, ln. 7-17), whereby it would be obvious to rearrange Pan I’s exemplary composition for the incorpoation thereof, per Pan I’s broader disclosure. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, the prior art renders claims 18, 26-30 and 32 obvious.
Regarding claim 19, and the requirements:
19. ([…]) The cosmetic composition of claim 16, further comprising at least one glycol other than propylene glycol or dipropylene glycol.
Pan I teaches suitable carriers, inter alia, “propylene glycol, dipropylene glycol, buylene glycol” (Pan I, p. 8, ln. 12-23), wherein “buylene glycol” is “at least one glycol other than propylene glycol or dipropylene glycol” of claim 19. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, the prior art renders claim 19 obvious.
Claim Rejections - Nonstatutory 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 16-34 are rejected on the ground of nonstatutory double patenting over claims 1-6 of US Patent 11,446,233 B2 to Brieva et al., hereinafter “‘233 Patent,” matured from copending Application No. 17/038,977, in view of the disclosure of PAN I (WO 2017/172523 A1, Publ. Oct. 5, 2017; on 10/30/2023; hereinafter, “Pan I).
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a Silybum Marianum extract composition with salicylic acid, ascorbic acid, alkoxylated fatty alcohol surfactants, prolylene glycol, dipropylen glycol, water and overlapping pH requirements. To the extent the ‘233 Patent DOES NOT RECITE ferulic acid per the requirements of the instant claims, the incorporation thereof would be obvious in order to obtain the advantage of a suitable antioxidant.
Thus, the ‘233 Patent per Pan I render claims 16-34 obvious.
Conclusion
Claims 16-34 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