/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624 DETAILED ACTION
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 the Claims
Claims 1-17 are pending.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/EP2021/059653, filed on April 14, 2021. This application also claims the benefits of foreign priority to EP20171853.3, filed on April 28, 2020.
Information Disclosure Statement
The information disclosure statement filed on May 15, 2024 lists the following foreign document number: EP3773422. A copy of this reference was not provided and, therefore, the Examiner did not consider this reference. It is also noted here that a copy of foreign document number WO2019224048A1 was received on May 15, 2024, however, the reference was not listed in the information disclosure statement filed on May 15, 2024.
Specification - Abstract
The abstract of the disclosure is objected to because the sheet presenting the abstract includes other parts of the application or other material. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Note on 35 USC § 103 Rejections
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.
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.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over:
Guelakis et al. (Guelakis) (WO2018113634A1; published June 28, 2018),
Molnar-Perl et al. (Molnar-Perl) (Molnar-Perl, I. et al. Inhibition of Browning by Sulfur Amino Acids. 3. Apples and Potatoes. J. Agric. Food Chem. 1990, 38, 1652-1656.)
Guelakis teaches a personal care composition (wherein the composition is a leave-on non-solid skin cosmetic composition; Guelakis, claim 10) comprising:
from about 0.001% to about 2% of cystine, (Guelakis, claim 1)
from about 0.01 to about 10% of a glutamate source (Guelakis, claim 1)
from about 0.001 to about 3% of a resorcinol of Formula I (Guelakis, claim 1)
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wherein R is an ethyl group optionally substituted with a phenyl or substituted phenyl group or C3 to C16 straight or branched alkyl group optionally substituted with a phenyl or substituted phenyl group (Guelakis, claim 1)
The resorcinol of Formula I can be 4-hexylresorcinol (Guelakis, claim 4), 4-ethylresorcinol (Guelakis, claim 5), or 4-isopropylresorcinol (Guelakis, claim 7),
a cosmetically acceptable carrier (Guelakis, claim 1)
The inventive composition preferably includes a skin lightening compound, in addition to resorcinols included herein, to obtain optimum skin lightening performance at an optimum cost. Illustrative substances are additional resorcinols (2,5-disubstituted, 4,5-disubstituted, and 4,6 di-substituted), placental extract, lactic acid, niacinamide, arbutin, kojic acid, ferulic acid, hydroquinone, resorcinol derivatives including disubstituted resorcinols and combinations thereof (pg. 14, lines 14-19).
Note: all amino acids used in the experiments and invention of Guelakis are L stereo isomers (pg. 22, line 25, last sentence). Also, the composition disclosed by Guelakis comprises L-cystine instead of L-cysteine because the “exposed sulfhydryl group of cysteine renders it unstable and reactive and also causes strong unpleasant odor” which is not ideal in a personal care composition (pg. 1, lines 31-32).
Guelakis does not teach the antioxidant properties of L-cysteine and N-acetyl-L-cysteine. Molnar-Perl is relied upon for this disclosure.
Note: Cystine is the disulfide form of cysteine (structures shown below). Molnar-Perl does not disclose information related to the disulfide form, cystine. However, the teachings of Molnar-Perl related to L-cysteine and N-acetyl-L-cysteine can be applied to the compounds’ disulfide forms.
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Molnar-Perl “compared the effectiveness of the following potential inhibitors in minimizing or preventing browning in apples and potatoes: L-cysteine, N-acetyl-L-cysteine (NAC), reduced glutathione (GSH), sodium bisulfite, sodium sulfhydrate, and sodium hydrosulfite. [Their] data suggest that NAC… may be as effective as sodium sulfite in some food applications” (pg. 1652, “Introduction” section, last two sentences). Given that the browning of fruit is an oxidative process (McEvily, A. J. et al. inhibition of enzymatic browning in foods and beverages. Crit. Rev. Food Sci. 1992, 32, 253-273.; pg. 255, Figure 2), N-acetyl-L-cysteine’s more efficient browning inhibition compared to L-cysteine (pg. 1656, left col., paragraph that starts with “In summary,…”, 2nd sentence) indicates that N-acetyl-L-cysteine is a more effective antioxidant than L-cysteine.
Regarding instant claims 1-17:
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to modify the stabilized composition taught by Guelakis by replacing cystine (from item (1)) with N,N’-diacetyl-L-cystine in order to yield a topical composition that can be applied to the skin and is made by combining the following components:
from about 0.001% to about 2% of N,N’-diacetyl-L-cystine,
from about 0.001 to about 3% of a resorcinol of Formula I (Guelakis, claim 1)
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wherein R is an ethyl group optionally substituted with a phenyl or substituted phenyl group or C3 to C16 straight or branched alkyl group optionally substituted with a phenyl or substituted phenyl group (Guelakis, claim 1)
The resorcinol of Formula I can be 4-hexylresorcinol (Guelakis, claim 4), 4-ethylresorcinol (Guelakis, claim 5), or 4-isopropylresorcinol (Guelakis, claim 7),
a cosmetically acceptable carrier (Guelakis, claim 1)
The inventive composition preferably includes a skin lightening compound, in addition to resorcinols included herein, to obtain optimum skin lightening performance at an optimum cost. Illustrative substances are additional resorcinols (2,5-disubstituted, 4,5-disubstituted, and 4,6 di-substituted), placental extract, lactic acid, niacinamide, arbutin, kojic acid, ferulic acid, hydroquinone, resorcinol derivatives including disubstituted resorcinols and combinations thereof (Guelakis, pg. 14, lines 14-19).
wherein the weight ratio of N,N’-diacetyl-L-cystine to a 4-substituted resorcinol derivative is within 10,000:1 to 1:10,000.
Even though Molnar-Perl does not compare the antioxidant properties of L-cystine and N,N’-diacetyl-L-cystine (the disulfide forms of L-cysteine and N-acetyl-L-cysteine, respectively), one of ordinary skill in the art would have been motivated to replace L-cystine within the composition disclosed by Guelakis with its N-acetylated form (i.e., N,N’-diacetyl-L-cystine) as a POSITA would have expected improved stabilization (i.e., oxidation prevention) of a 4-substituted resorcinol with N,N’-diacetyl-L-cystine instead of L-cystine (analogous to the greater antioxidant property of N-acetyl-L-cysteine as compared to L-cysteine).
Further, even though Molnar-Perl only teaches N-acetyl-L-cysteine (not its disulfide form) as an antioxidant, POSITA would have found it obvious to use N,N’-diacetyl-L-cystine instead of N-acetyl-L-cysteine in a cosmetic composition because N-acetyl-L-cysteine, like L-cysteine, has an exposed sulfhydryl which can cause an unpleasant odor that is not ideal for cosmetic compositions (as discussed in Guelakis, pg. 1, lines 31-32).
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 1-5, 7-9, and 13-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 4-6, and 10-13 of U.S. Patent Application No. 17919761 in view of
Guelakis et al. (Guelakis) (WO2018113634A1; published June 28, 2018) and
Sakiguchi et al. (Sakiguchi) (JP2009242321A; published October 22, 2009).
While the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim set from the co-pending application in view of the prior art. Specifically, either the instant claims are broader in scope and, therefore, encompass the more narrowly defined claims of the co-pending application or the claims of the co-pending application are broader in scope and, thus, encompass the more narrowly defined claims of the instant application.
The co-pending application claims a composition comprising:
0.001% to 2% by weight of the composition of cystine (co-pending application, claim 1)
0.01% to 5% by weight of the composition of N,N’-diacetyl-L-cystine (co-pending application, claim 1)
A cosmetically acceptable carrier (co-pending application, claim 1)
A skin benefit agent selected from the group consisting of vitamin B3 or a derivative thereof, 4- butylresorcinol, 4-hexylresorcinol, 4-isopropylresorcinol, 4-(1- phenylethyl)resorcinol, koiic acid, lactic acid, ferulic acid, hydroquinone, and mixtures thereof (co-pending application, claim 6)
wherein vitamin B3 or a derivative thereof is selected from the group consisting of niacinamide, nicotinic acid esters, non-vasodilating esters of nicotinic acid, nicotinyl amino acids, nicotinyl alcohol esters of carboxylic acids, nicotinic acid N-oxide, niacinamide N-oxide and mixtures thereof (co-pending application, claim 13)
In the co-pending application, the pH of the claimed composition is within a range of 3.5 to 8.5 (claim 1). Although the instant claim set does not mention the pH range of the claimed composition, it is presumed that the pH of the instantly claimed invention is “in a neutral pH range, which is the pH range required for topical application” (Guelakis, pg. 2, lines 11-12; also stated in instant specification, pg. 2, 12-13).
Although, the instant claim set does not explicitly claim a composition comprising cystine, Sakiguchi teaches a composition comprising 0.01 to 5 wt% of one or more antioxidants (that prevent the degradation of 4-substituted resorcinol) wherein the antioxidants can be a sulfur-containing compound such as cystine and/or α-tocopherol (Sakiguchi, claims 1-3). Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instantly claimed invention to also add one or more antioxidants in a composition which includes N,N’-diacetyl-L-cystine (as stated in the instant claim set) and 0.01 to 5 wt% of cystine (as stated in Sakiguchi). One of ordinary skill in the art would have been obvious to try and add more than one antioxidant into a composition because Sakiguchi has provided a working example of a cream comprising of two antioxidants: Cystine and α-tocopherol (English-translated document, pg. 36, para. 0080, 1st and 2nd lines; part of Example 10: O/W Cream).
Conclusion
Claims 1-17 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624