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 .
Priority
This application is a CON of 17304181 filed 06/16/2021 (ABN).
17204181 is a CON of 16662917 filed 10/24/2019 (ABN).
16662917 is a CON of 15816026 filed 11/17/2017 (PAT 10500152).
15816026 is a CON of 14640328 filed 03/06/2015 (PAT 9849077).
14640328 has PRO of 62088812 filed 12/08/2014 and PRO of 61950517 filed 03/10/2014.
However, the subject matter of ammonium acryloyldimethyltaurate/VP copolymer of claim 51 is not present in Provisional (PRO) application of 61950517. Thus, claim 51 will not receive priority filing date of Provisional (PRO) application of 61950517.
Furthermore, the subject matter of claim 60 is not present in any of the prior applications of 17204181, 16662917, 15816026, and 14640328, as well as, Provisional (PRO) applications of 62088812 and 61950517. Thus, claim 60 will not receive priority filing date benefit of prior applications of 17204181, 16662917, 15816026, and 14640328, as well as, Provisional (PRO) applications of 62088812 and 61950517.
Accordingly, claims 47-50 and 52-59 are afforded the effective filing date of 03/10/2014; claim 51 is afforded the effective filing date of 12/08/2014; and claim 60 is afforded the effective filing date of 09/27/2024 (actual filing date).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/17/2025 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to preliminary papers filed 11/21/2024 in which claims 1-46 were canceled; and claims 47-60 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 47-60 are under examination.
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 60 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 60 introduces new matter as the claim recites the limitation: “the Leontopodium alpinum extract reduces uneven skin tone and/or lightens the skin without requiring another compound.” There is no support in the specification for this limitation.
After a thorough review of the disclosure from the specification including the drawings and examples, as well as, the original claims, there appeared to be no support for the claimed limitation of “the Leontopodium alpinum extract reduces uneven skin tone and/or lightens the skin without requiring another compound.”
While paragraphs [0006]-[0013], [0044]-[0045], and [0082], as well as, Example 3 and Tables 4-2 disclosed topical skin compositions/formulations containing Leontopodium alpinum extract, there is no disclosure anywhere in the specification that indicate that “Leontopodium alpinum extract reduces uneven skin tone and/or lightens the skin without requiring another compound” as claimed.
MPEP §2163.06 states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claim 60 at the time of filing of the instant application.
Claim Rejections - 35 USC § 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 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.
Claim(s) 47-50 and 55-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP2522330A1 in view of Gohla et al (US 2013/0287714 A1).
Regarding claim 47, EP2522330A1 teaches a method for smoothening skin color irregularities, for reducing melanin formation in the human skin, for lightening/brightening human skin and/or for treatment of pigmentation disorders, the method comprising topically applying to appropriate skin area of a person in need thereof, a composition comprising Leontopodium alpinum extract, water, glycerin, propylene glycol (a propanediol), citric acid, tocopherol, and disodium EDTA (Abstract; [0001]-[0058]; Examples 2-15; claims 1-11).
However, EP2522330A1 does not teach the sodium benzoate of claim 47.
Regarding the sodium benzoate of claim 47, Gohla teaches a cosmetic or dermatological preparation for protection of the skin comprising Leontopodium alpinum extract, water, glycerin, propylene glycol, disodium EDTA, sodium benzoate, and tocopherol (Abstract; [0006]-[0105], [0131]-[0148]; Examples 1-4).
It would have been obvious to one of ordinary skill in the art include sodium benzoate in the composition of EP2522330A1, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gohla provided the guidance to so by teaching that sodium benzoate is a known preservative commonly added to cosmetic or dermatological preparation containing Leontopodium alpinum extract. Thus, an ordinary artisan would have looked to known preservatives including sodium benzoate commonly included in skin care composition, as preservatives are one of the usual additives included in the skin care composition of EP2522330A1 ([0029]-[0030]), and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 48 and 49, EP2522330A1 teaches the composition is used for treating hyperpigmentation (Abstract; [0044]-[0049], [0056], [0058]), thereby is applied to dark spot or hyperpigmented skin.
Regarding claim 50, EP2522330A1 teaches the composition reduces melanin formation in the skin (Abstract; [0001], [0046], [0069]; claim 7; ), thereby reduces melanogenosis in the skin.
Regarding claims 55-57, EP2522330A1 teaches the composition is in the form of an emulsion such as O/W emulsion or W/O emulsion ([0023])
Regarding claim 58, Gohla teaches and provide the guidance for formulating the composition of EP2522330A1 in the form of a serum (Examples 1 and 4).
Regarding claim 59, EP2522330A1 teaches the composition is in the form of an ointment ([0024] and [0028]).
Regarding claim 60, EP2522330A1teaches Leontopodium alpinum extract alone reduces melanogenosis in the skin and thereby, provides skin lightening activity ([0069]).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP2522330A1 in view of Gohla et al (US 2013/0287714 A1), as applied to claim 47 above, and further in view of Schnittger et al (US 2010/0203077 A1) and Hines et al (US 2011/0044920 A1).
The composition of claim 47 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 51, EP2522330A1 teaches the composition further contains hexanediol, and a crosslinked polyacrylate polymer (i.e., carbomer and Acrylate/C10-30 Alkyl Acrylate Crosspolymer) ([0031], [0040]; Examples 4, 8-12, and 14).
However, EP2522330A1 does not teach ammonium acryloyldimethyltaurate/VP copolymer and a butyl alcohol of claim 51,
Regarding the ammonium acryloyldimethyltaurate/VP copolymer of claim 51, Schnittger teaches a skin care composition for use in whitening skin or treating skin disorders associated with pigmentation such as uneven pigmentation, skin mottling, or age spots, wherein the skin care composition contains at least one viscosity enhancing synthetic polymer including Ammonium acryloyldimethyltaurate/VP copolymer and crosslinked polyacrylate polymers (i.e., carbomer and Acrylate/C10-30 Alkyl Acrylate Crosspolymer) (Abstract; [0011]-[0028]; Examples 1-2; claims 1-19).
I would have been obvious to one of ordinary skill in the art to include ammonium acryloyldimethyltaurate/VP copolymer in the composition of EP2522330A1, and produce the claimed invention. One of ordinary skill in the art would have been motivated do so because Schnittger provided the guidance to do so by teaching that aside crosslinked polyacrylate polymers (i.e., carbomer and Acrylate/C10-30 Alkyl Acrylate Crosspolymer) disclosed in EP2522330A1, ammonium acryloyldimethyltaurate/VP copolymer can also be included as viscosity enhancing polymers so as to thicken and stabilize the skin care composition (Schnittger: [0026]). Thus, an ordinary artisan would have looked to including ammonium acryloyldimethyltaurate/VP copolymer in the composition of EP2522330A1 so as to stabilize the composition, as well as, achieve a resultant skin care composition having a desired viscosity, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding the butyl alcohol of claim 51, Hines teaches a skin care composition for use in lightening skin or evening skin tone comprising cosmetic ingredients including glycerin, disodium EDTA, caprylic/capric triglyceride, butylene glycol, butyl alcohol, potassium sorbate, ethylhexylglycerin, pentylene glycol, hexylene glycol, and thickening agents (i.e., crosslinked polyacrylate polymers) (Abstract; [0008]-[0036], [0045]-[0097]; Example 3; Tables 1-14).
It would have been obvious to one of ordinary skill in the art to include butyl alcohol in the composition of EP2522330A1, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Hines provided the guidance to do by teaching that skin care composition for use in lightening skin or evening skin tone can contain cosmetic ingredients including solvents such as butyl alcohol. Thus, an ordinary artisan would have to including commonly used cosmetic additives including solvents such as butyl alcohol as one of the solvents in the composition of EP2522330A1, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 52-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP252230A1 in view of Gohla et al (US 2013/0287714 A1), as applied to claim 47 above, and further in view of Hines et al (US 2011/0044920 A1).
The composition of claim 47 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 52-54, EP2522330A1 teaches a method for smoothening skin color irregularities, for reducing melanin formation in the human skin, for lightening/brightening human skin and/or for treatment of pigmentation disorders, the method comprising topically applying to appropriate skin area of a person in need thereof, a composition comprising Leontopodium alpinum extract, water, glycerin, carbomer, propylene glycol (a propanediol), citric acid, caprylic/capric triglyceride, tocopherol acetate, and disodium EDTA (Abstract; [0001]-[0058]; Examples 2-15; claims 1-11).
However, EP2522330A1 and Gohla do not teach the ethylhexylglycerin, pentylene glycol, squalane, xanthan gum, avocado oil, cocoa extract, butylene glycol, and potassium sorbate, respectively, of claims 52-54
Regarding the ethylhexylglycerin, pentylene glycol, squalane, xanthan gum, avocado oil, cocoa extract, butylene glycol, and potassium sorbate, respectively, of claims 52-54, Hines teaches a skin care composition for use in lightening skin or evening skin tone comprising cosmetic ingredients including glycerin, disodium EDTA, caprylic/capric triglyceride, butylene glycol, butyl alcohol, potassium sorbate, ethylhexylglycerin, pentylene glycol, hexylene glycol, ethylhexyl glycerin, squalane, xanthan gum, avocado oil, cocoa extract, potassium sorbate, and thickening agents (i.e., crosslinked polyacrylate polymers) (Abstract; [0008]-[0036], [0045]-[0097]; Example 3; Tables 1-14).
It would have been obvious to one of ordinary skill in the art to include ethylhexylglycerin, pentylene glycol, squalane, xanthan gum, avocado oil, cocoa extract, butylene glycol, and potassium sorbate in the composition of EP2522330A1, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Hines provided the guidance to do so by teaching that cosmetic ingredients including ethylhexylglycerin, pentylene glycol, squalane, xanthan gum, avocado oil, cocoa extract, butylene glycol, and potassium sorbate are usual additives included in a topical skin care composition for lightening skin or evening skin tone. Thus, an ordinary artisan would have looked including cosmetic ingredients including ethylhexylglycerin, pentylene glycol, squalane, xanthan gum, avocado oil, cocoa extract, butylene glycol, and potassium sorbate in the composition of EP2522330A1 so as to achieve a desired topical skin care composition for lightening skin or evening skin tone, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 47-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 9849077 in view of EP2522330A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in Patent ‘077 significantly overlap with the subject matter of the instant claims i.e., methods of lightening skin comprising topically applying to skin in need thereof a composition comprising Leontopodium alpinum extract, water, glycerin, a propanediol (propylene glycol), disodium EDTA, sodium benzoate, and tocopherol.
While the claims in the Patent ‘077 does not recite citric acid, it would have been obvious to include citric acid in the composition used in the methods of Patent ‘077 in view of the guidance from EP2522330A1 (Abstract; [0001]-[0058]; Examples 2-15; claims 1-11).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 9849077 in view of EP2522330A1.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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