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 .
Claim Objections
Claims 1, 4, 14, and 15 are objected to because of the following informalities: the amounts in each claim lack indication of --- by weight ---. Appropriate correction is required.
Claims 1 and 17 are objected to because of the following informalities: “salts of these” in part (d.), line 2 of claim 1 and last line of claim 17 should each be recited as --- salts thereof ---. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “ratio” in line 2 of component (b.) should be recited with --- weight ratio ---. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “metabisifulite” in line 2 should be recited as --- metabisulfite ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “The method composition” in line 1 should be recited as --- The composition ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “HPLC” in the last line should be recited as --- high performance liquid chromatography (HPLC) ---. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: immediately after “ppm” in line 1 there should be recited --- of ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the antioxidant" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 11, from which it depends, does not recite an antioxidant. It appears claim 7 should depend from claim 6. Clarification is requested.
Claim 19 recites “ferulic acid ethoxydiglycol” in line 3 of the claim. It is not clear whether it is intended as one entity or two separate entities of ferulic acid and ethoxydiglycol. To obviate this issue, it is suggested for the claim to recite ethoxydiglycol as a separate component. Clarification is requested.
Claim 20 is rejected since it depends from claim 19 and does not further clarify the subject matter.
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 1-4, 6, 8-10, 12-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng).
Regarding claims 1, 2, 12, 14, Deng discloses cosmetic compositions (abs) comprising: one or more hydrotrope ([0028]) including sodium salicylate ([0030]) and vitamin B3, including niacinamide ([0031]), in amounts of about 0.01% - 25% wt. of the composition ([0032]); one or more actives including ferulic acid and p-coumaric acid ([0049]) in amounts of about 0.05% - 2.5% wt. each ([0053]); one or more solvent including propylene glycol, alcohol and water ([0043]) in amounts of from about 0% - 90% wt. of the composition ([0044]); and water ([0046]). The pH of the composition may be between 2-12 ([0047]), for example a pH of less than 7 ([0007]). The composition were assessed for signs of any undesirable crystallization which would indicate instability, and were found to show stability for up to or more than 8 weeks ([0071]).
Together these would provide a composition as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 1 reciting an amount of vitamin B3 an amount of a coumaric acid, and an amount of glycol co-solvent, the claimed ranges (i.e. about 0.1% to about 10%, about 0.1% to about 10%, and less than 25%, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. about 0.01-25% wt., about 0.05-2.5% wt., and about 0-90% wt.). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate amount percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in percent. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 1 and 8 reciting a pH range, the claimed ranges (i.e. less than 5.0 and about 2.0 to about 4.5, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e., between 2 and 12, particularly less than 7). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate pH values would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed pH values. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 1 and 12 reciting wherein the composition is free of HCA crystals, since Deng discloses wherein the composition does not show signs of undesirable crystallization, it would have been obvious to one of ordinary skill in the art that the composition is free of HCA crystals.
Regarding claims 3, 17 and 18, as discussed above, Deng discloses wherein the composition comprises sodium salicylate (i.e. salt of salicylic acid).
Regarding claim 4 and 15, Deng further discloses wherein the one or more solvents may be from about 0 to about 16 weight percent ([0045]). Accordingly, the claimed ranges (i.e. less than 17%) would have bene obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 6, Deng further discloses wherein the composition may comprise an antioxidant (claim 12), which is known to inhibit oxidation reactions ([0002]). Regarding the claimed amount of antioxidant, although Deng does not explicitly disclose a specific amount of antioxidant, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount (i.e. about 1-20% by weight) through routine experimentation based on the level of oxidation inhibition desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 9, Deng does not explicitly disclose a coumaric acid degradation amount according to the HPLC method. However, since the compositions of Deng do not exhibit undesirable crystallization, and comprise substantially the same vitamin B3 compound, coumaric acid, propylene glycol, salt of salicylic acid and water in substantially the same amounts at substantially the same pH, one of ordinary skill in the art would reasonably expect the compositions of Deng to possess substantially the same properties as the claimed invention, such as exhibiting a coumaric acid degradation of less than 25% according to the HPLC method. Moreover, as noted by p. 5, line 31 – p. 6, line 5 of the instant Specification, a lower pH can reduce the rate at which HCA is oxidized/degraded, and inclusion of an antioxidant can also help further reduce oxidation and/or degradation of the HCA. Accordingly, since the compositions of Deng are formulated at a low pH and comprises an antioxidant to inhibit oxidation reactions, alternatively one of ordinary skill in the art would reasonably expect the compositions of Deng to exhibit less than 25% coumaric acid degradation according to the HPLC method.
Regarding claim 10, although Deng does not explicitly disclose an amount of 4-vinylphenol, as noted by p. 28, lines 17-20 of the instant Specification, 4-vinylphenol is a byproduct that is produced when a hydroxycinnamic acid degrades. As noted above, the instant Specification notes wherein a lower pH and/or inclusion of an antioxidant can reduce oxidation and/or degradation of an HCA. Table 6 of the instant Specification further notes wherein a composition comprising 1% of an HCA and 5% of niacinamide at a pH of between 3.56 and 4.57 would be expected to have a 4-vinylphenol value of between 380 and 700. Accordingly, since the composition of Deng, comprising about 0.01% - 25% wt. of vitamin B3 including niacinamide, about 0.05-2.5% wt. each of ferulic acid and p-coumaric acid, antioxidants, and an exemplary pH of below 7, and do not exhibit undesirable crystallization (i.e. stable), one of ordinary skill in the art would reasonably expect the composition of Deng to comprise less than 1000 ppm of 4-vinylphenol like the claimed invention.
Claims 5, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng) as applied to claims 1-4, 6, 8-10, 12-15, and 17-18, in view of Faig et al. (US 2021/0401696 A1, filed 06/30/2020) (hereinafter Faig).
The disclosure of Deng has been discussed in detail above, and differs from instant claims 5, 16, and 19 insofar as not explicitly disclosing wherein the alcohol includes ethoxydiglycol.
However, Faig discloses compositions for improving the health and visual appearance of skin, including slowing skin damage and reducing the effects of aging ([0004]). The composition comprises one or more solvents including polyhydric alcohols including propylene glycol and diethylene glycol monoethyl ether (i.e. ethoxydiglycol) ([0085]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have selected propylene glycol and diethylene glycol monoethyl ether as the one or more solvents of Deng since “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I). Moreover, in any case, the selection of appropriate solvents would appear to require no more than the relative skills of one of ordinary skill in the art, and so alternatively it would have been obvious to have included diethylene glycol monoethyl ether since each is a known and effective solvent suitable for skin care as taught by Faig. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng) as applied to claims 1-4, 6, 8-10, 12-15, and 17-18, in view of Carle et al. (US 2021/0346275 A1, 11/11/2021, IDS reference) (hereinafter Carle).
Regarding claim 7, the disclosure of Deng has been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing wherein the antioxidant includes sodium bisulfite.
However, Carle discloses compositions to reduce skin damage from free radicals and/or aging process (§Background, (B.)). The compositions may include cosmetic ingredients and pharmaceutical active ingredients ([0057]) including antioxidants such as sodium bisulfite ([0066]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included sodium bisulfite since it is a known and effective antioxidant suitable for topical compositions as taught by Carle. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Claim 11 rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng) as applied to claims 1-4, 6, 8-10, 12-15, and 17-18, in view of Damodaran et al. (US 2019/0307664 A1, 10/10/2019) (hereinafter Damodaran).
The disclosure of Deng has been discussed in detail above. Deng further discloses wherein the one or more actives may include humectants, alpha hydroxy acid, anti-oxidant compounds ([0049]).
Deng differs from instant claim 11 insofar as not explicitly disclosing wherein the alpha hydroxy acid includes lactic acid and their salts.
However, Damodaran further discloses wherein the composition may comprise hydroxycarboxylic acids like lactic acid and their salts e.g. sodium lactate ([0077]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included lactic acid and sodium lactate in the composition of Deng since it is a known and effective lactic acid and corresponding salt thereof suitable for topical compositions as taught by Damodaran.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng) as applied to claims 1-4, 6, 8-10, 12-15, and 17-18, in view of Faig et al. (US 2021/0401696 A1, filed 06/30/2020) (hereinafter Faig), further in view of Damodaran et al. (US 2019/0307664 A1, 10/10/2019) (hereinafter Damodaran).
The disclosures of Deng and Faig have been discussed in detail above. Deng further discloses wherein the one or more actives may include humectants, alpha hydroxy acid, anti-oxidant compounds ([0049]).
Deng and Faig differ from instant claim 20 insofar as not explicitly disclosing wherein the alpha hydroxy acid includes lactic acid and their salts.
However, as discussed above, Damodaran discloses wherein the composition may comprise hydroxycarboxylic acids like lactic acid and their salts e.g. sodium lactate ([0077]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included lactic acid and sodium lactate in the composition of Deng since it is a known and effective lactic acid and corresponding salt thereof suitable for topical compositions as taught by Damodaran.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,144,882. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite substantially the same composition as the pending claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,280,132. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a more specific embodiment of the pending claims (i.e. 0.1-1% of HCA comprising coumaric and ferulic acid; 0.1-3% of hydrotrope; water; pH 3.5-4.5, and remaining free of HCA crystals after 2 freeze/thaw cycles).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,409,119 in view of Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng), Faig et al. (US 2021/0401696 A1, filed 06/30/2020) (hereinafter Faig), Carle et al. (US 2021/0346275 A1, 11/11/2021, IDS reference) (hereinafter Carle), and Damodaran et al. (US 2019/0307664 A1, 10/10/2019) (hereinafter Damodaran).
The patented claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, such as instantly claimed hydrotropes. However, these feature are known in the art. As noted in the current rejections, the teachings of Deng render obvious claims 1-4, 6, 8-10, 12-15, and 17-18. Furthermore, the combined teachings of Deng and Faig render obvious claims 5, 16, and 19; the combined teachings of Deng and Carle render obvious claim 7; the combined teachings of Deng and Damodaran render obvious claim 11; and the combined teachings of Deng, Faig, and Damodaran render obvious claim 20.
Therefore, as claims 1-20 of U.S. Patent No. 12,409,119, Deng, Faig, Carle, and Damodaran all teach compositions comprising a hydroxycinnamic acid such as coumaric or ferulic acid, it would have been prima facie obvious to one of ordinary skill in the art to have modified the patented claims and to include the teachings of Deng, Faig, Carle, and Damodaran as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/084,910 (reference application) in view of Deng et al. (US 2019/0159989 A1, 05/30/2019) (hereinafter Deng), Faig et al. (US 2021/0401696 A1, filed 06/30/2020) (hereinafter Faig), Carle et al. (US 2021/0346275 A1, 11/11/2021, IDS reference) (hereinafter Carle), and Damodaran et al. (US 2019/0307664 A1, 10/10/2019) (hereinafter Damodaran).
The copending claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, such as instantly claimed combination of coumaric acid and ferulic acid. However, these feature are known in the art. As noted in the current rejections, the teachings of Deng render obvious claims 1-4, 6, 8-10, 12-15, and 17-18. Furthermore, the combined teachings of Deng and Faig render obvious claims 5, 16, and 19; the combined teachings of Deng and Carle render obvious claim 7; the combined teachings of Deng and Damodaran render obvious claim 11; and the combined teachings of Deng, Faig, and Damodaran render obvious claim 20.
Therefore, as claims 1-15 of copending Application No. 19/084,910, Deng, Faig, Carle, and Damodaran all teach compositions comprising a hydroxycinnamic acid such as coumaric or ferulic acid, it would have been prima facie obvious to one of ordinary skill in the art to have modified the copending application and to include the teachings of Deng, Faig, Carle, and Damodaran as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/733,216 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a more specific embodiment of the pending claims (i.e. the copending claims recite additional specific components such as a low-pH tolerant polymer thickener in addition to the recited components in the instant claims).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights