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 .
Status of Claims
Claims 1 – 15 are pending.
Claims 1- 15 have been examined.
Claims 1 – 15 have been rejected.
Priority
Instant application 18/543,287, filed on 2023, Dec. 18, does not claim priority to any earlier filings.
Information Disclosure Statement
Applicant has elected to not submit an IDS for this invention.
Drawings
Applicant has not included any drawings to consider.
Specification
The disclosure is objected to for the following informalities:
“Labsphere” is a registered trademark and should be rewritten as “Labsphere ®” (paragraphs 0033 and 0165)
Registered trademarks throughout the entire disclosure should be properly labeled as such (e.g., TAYCA [paragraphs 0090, 0091].
The final table in the specification is missing a table heading. It should be called “Example 5 – SPF Testing”.
The ingredient listed as “Vitro SPF*” should be “in vitro SPF*” (the unnamed table at the end of the specification).
The ingredient listed as “Vitro SPF*” has no associated explanation as to what the asterisk means (the unnamed table at the end of the specification).
Appropriate action is required.
Claim Objections
Claim 11 is objected to because of the following informalities: The all-caps text should be rewritten in standard sentence case. 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 1, 7 and 12 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 1 recites the limitation "the booster". There is insufficient antecedent basis for this limitation in the claim. Examiner suggests rewriting it as “the at least one booster.”
Regarding claims 7 and 12, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 4, 7 – 13, and 15 are rejected under 35 USC 102(a)(1) and 35 USC 102(a)(2) as being anticipated by Deckner, et al. (US 2018/0263866 A1, published 2018, Sep. 20).
Regarding claims 1 – 4, Deckner teaches a sunscreen composition comprising an organic UVA absorber, UVB absorber, and photostabilizer (paragraph 0011), where said UVA absorber is selected from a group consisting of bemotrizinol (paragraph 0019, claims 1, 18, and 19) and said photostabilizer can increase the in vivo SPF efficacy of the composition 5 – 20 SPF units per 1 wt. % (paragraph 0079, Table 4). Additionally, Deckner discloses the SPF booster can be present in an amount of 1 – 10 wt. % of the composition (paragraphs 0077 and 0079), which falls within the range claimed by the current application.
Regarding claim 7, Deckner discloses an embodiment that includes a metal oxide (e.g., titanium dioxide or zinc oxide) (paragraph 0081).
Regarding claim 8, Deckner teaches a sunscreen composition that includes a UVA absorber selected from the group consisting of avobenzone (paragraph 0019), which can be used as a mixture with bemotrizinol. Additionally, Deckner teaches a sunscreen composition that includes a UVB absorber selected from the group consisting of octisalate (paragraph 0020), ensulizole (paragraph 0020), or homosalate (0020), which can be used in combination with bemotrizinol.
Regarding claim 9, Deckner teaches that the sunscreen composition is free of a metal oxide (e.g., titanium dioxide or zinc oxide), which are known to be mineral UV filters.
Regarding claim 10, Deckner teaches the bemotrizinol composition can use UVA absorbers and combinations thereof that are not comprised of oxybenzone (e.g., avobenzone or diethylamino hydroxybenzoyl methyl benzoate) (paragraph 0019). Additionally, Deckner teaches the bemotrizinol composition can use UVAB absorbers and combinations thereof that are neither oxybenzone nor octinoxate (enzacamene, octisalate, octyltriazone, homosalate, inter alia) (paragraph 0020).
Regarding claim 11, Deckner teaches the sunscreen composition can optionally be comprised of the following compounds:
drometrizole trisiloxane (paragraph 0019);
diethylhexyl butamido triazone (paragraph 0020);
polysilicone-15 (paragraph 20);
methylbenzylidene camphor (paragraph 0020).
The above products are only optionally selected from, which necessitates that some embodiments are free of them. Additionally, all disclosed embodiments are free of ethyl hexyl triazone, methylene bis-benzotriazolyl tetramethylbutyl phenol, diethylamino hydroxybenzoyl hexyl benzoate, isoamyl p-methoxycinnamate, disodium phenyl dibenzimidazole tetrasulfonate, and methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate.
Regarding claim 12, Deckner teaches photostabilizer/SPF booster is selected from a group consisting of ethylhexyl methoxycrylene (paragraph 0014, claims 6 and 7).
Regarding claim 13, Deckner teaches the aqueous sunscreen base is an oil-in-water emulsion or a water-in-oil emulsion (paragraph 0033).
Regarding claim 15, Deckner teaches a sunscreen composition comprising an active UVA absorber, an active UVB absorber, and a photostabilizer (paragraph 0011).
Claims 1, 2, and 5 – 15 are rejected under 35 USC 102(a)(1) as being anticipated by Spaulding et al. (WO 2015152865, published 2015, Oct. 08).
Regarding claim 1 – 2, Spaulding teaches a sunscreen composition comprising bemotrizinol (bis-ethylhexyloxyphenol methoxyphenyl triazine) (paragraph 0028, claim 6) and an embodiment that includes an SPF booster (paragraph 0086, claim 12).
Regarding claim 5 - 6, Spaulding teaches a sunscreen composition comprising bemotrizinol (bis-ethylhexyloxyphenol methoxyphenyl triazine), wherein said composition meets the 1/3 UVA ratio requirement of ISO 24443 (paragraph 0040, claim 19) and has an SPF of 15, 30, 50, and/or 50+ (paragraph 0016, claim 18).
Regarding claims 7 and 9, Spaulding discusses an embodiment that may or may not comprise photoactive agents, including zinc oxide and titanium dioxide (paragraph 0027. claim 2).
Regarding claim 8, Spaulding discusses embodiments that include avobenzone (paragraphs 0027, 0028 claim 6), octisalate (paragraphs 0027, 0028, claim 6), homosalate (paragraphs 0027, 0028, claim 6), and octocrylene (paragraphs 002, 0028, claim 2, claim 6).
Regarding claim 10, Spaulding discloses a composition that may or may not include both oxybenzone and octinoxate as photoactive agents, and therefore teaches a composition that is free from both (paragraph 0028, claim 2).
Regarding claim 11, Spaulding does not disclose any embodiment wherein ethylhexyl triazone, drometrizole trisiloxane, methylene bis-benzotriazolyl tetramethylbutyl phenol, diethylamino hydroxybenzoyl hexyl benzoate, diethylhexyl butamido triazone, isoamyl p-methoxycinnamate, 4-methylbenzylidene camphor, disodium phenyl dibenzimdazole tetrasulfonate or methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate are comprised. Additionally, polysilicone-15 is optionally included in some embodiments (claim 14), and all other embodiments are free of it.
Regarding claim 12, Spaulding teaches the use of ethylhexyl methoxycrylene in its sunscreen composition (paragraph 0089, claim 13).
Regarding claim 13, Spaulding teaches the use of an emulsifying agent (paragraph 0089, claims 12 and 13).
Regarding claim 14, Spaulding teaches the use of a coloring additive (paragraph 0086, claim 12).
Regarding claim 15, Spaulding teaches the use of photoactive agents to prepare a photoprotective composition (abstract, paragraph 0009, inter alia).
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 – 3, 5 – 7, and 13 – 15 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 – 5, 9 – 11 of co-pending application No. 18/543,130, filed 2023, Dec. 18. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claim 1 of the co-pending application recites a composition comprising bemotrizinol and zinc oxide. This corresponds to claims 1 of the instant application that recites a bemotrizinol composition consisting of at least one booster in an amount sufficient to increase SPF of the composition. This also corresponds with claim 7 of the instant application that recites the addition of mineral UV filters, preferably titanium dioxide and/or zinc oxide to the composition.
Claims 2 – 5 of the co-pending application recites the bemotrizinol composition having the same SPF properties as those in claims 2, 3, 5 and 6 of the instant application.
Claim 9 of the co-application recites that the composition can form an emulsion, reading on claim 13 of the instant application that recites the composition in the form of an emulsion.
Claim 10 of the co-application recites that the composition comprises at least one coloring agent, reading on claim 14 of the instant application that recites the composition comprising at least one coloring agent.
Claim 11 of the co-application recites that the composition comprises at least one active agent, reading on claim 15 of the instant application that recites the composition comprising at least one active agent.
Claims 1 – 3, 5, 6, 9, 10, 14, and 15 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 – 5, 10, 12, and 14 of co-pending application No. 18/543,618, filed 2023, Dec. 18. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claim 1 of the co-pending application recites a composition comprising bemotrizinol and an ecofriendly carrier, which reads on claim 1 of the instant application that recites a bemotrizinol composition consisting of at least one booster.
Claims 2 – 4 of the co-pending application recites the bemotrizinol composition having the same SPF properties as those in claims 2, 3, 5 and 6 of the instant application.
Claim 5 of the co-pending application recites the composition being free of mineral UV filters which reads on claim 9 of the instant application that recites the composition is free of mineral UV filters.
Claim 10 of the co-application recites the composition is free of oxybenzone and/or octinoxate, which reads on claim 10 of the instant application that recites the composition is free of oxybenzone and/or octinoxate.
Claim 12 of the co-application recites that the composition comprises at least one coloring agent, reads on claim 14 of the instant application that recites the composition comprising at least one coloring agent.
Claim 14 of the co-application recites that the composition comprises at least one active agent, reads on claim 15 of the instant application that recites the composition comprising at least one active agent.
Claims 1 – 3, 5, 6, 9, 10, and 15 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 10, 12, and 13 of co-pending application No. 18/543,860, filed 2023, Dec. 18. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claim 1 of the co-pending application recites a composition comprising bemotrizinol and at least one semi-crystalline polymer comprising at least one alkyl acrylate chain, and at least one scleroglucan gum, which corresponds to claim 1 of the instant application that recites a bemotrizinol composition consisting of at least one booster. Paragraphs 0057 and 0058 of the instant application disclose that the “booster” can include polymers.
Claim 6 and 8 of the co-pending application recites the composition having the same SPF properties as claims 2, 3, 5, and 6 of the instant application.
Claim 10 of the co-pending application recites the composition being free of mineral UV filters, which corresponds with claim 9 of the instant application that recites the composition being free of mineral UV filters.
Claim 12 of the co-application recites the composition is free of oxybenzone and/or octinoxate, which corresponds with claim 10 of the instant application that recites the composition is free of oxybenzone and/or octinoxate.
Claim 13 of the of the co-application recites that the composition comprises at least one active agent, corresponding to claim 15 of the instant application that recites the composition comprising at least one active agent.
Claims 1 – 3, 5, 6, 9, 10, 14, and 15 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 – 3, 7, and 9 – 11 of co-pending application No. 18/543,823, filed 2023, Dec. 18. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claim 1 of the co-application recites “an emulsion composition comprising bemotrizinol, at least one lipophilic acrylic polymer … and wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm, a UVAPF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher.” This reads on claims 1 and 5 of the instant application that recites a composition comprised of bemotrizinol and a booster. Paragraphs 0057 and 0058 of the instant application discloses that the “booster” can include polymers.
Claims 2 and 3 of the co-application also reads on claims 2, 3, and 6 of the instant application, which recites identical photoprotective properties.
Claim 7 of the co-application recites the composition being free of mineral UV filters, which reads on claim 9 of the instant application that recites the composition is free of mineral UV filters.
Claim 9 of the co-application recites the composition being free of oxybenzone and/or octinoxate, which reads on claim 10 of the instant application that recites the composition being free of oxybenzone and/or octinoxate.
Claim 10 of the co-application recites the composition comprising at least one coloring agent, which reads on claim 14 of the instant application that recites the composition comprising at least one coloring agent.
Claim 11 of the co-application recites the composition comprising at least one active agent, which reads on claim 15 of the instant application that recites the composition comprising at least one active agent.
Claims 1 – 10, 13 and 14 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 – 5, 7 – 9, 11, and 12 of co-pending application No. 18/543,343, filed 2023, Dec. 18. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claims 1 – 3 of the co-pending application recites a composition comprising bemotrizinol, avobenzone, and at least one additional UV filter, wherein the composition has one of more of the following properties: a critical wavelength of at least 370 nm; a UVAPF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher. This corresponds to the composition with identical SPF and photoprotective properties as recited in claims 1 – 3, 5, and 6 of the instant application.
Claim 4 of the co-pending application recites the composition having at least one additional UV filter that is at least one mineral UV filter, preferably titanium dioxide and/or zinc oxide, which reads on claim 7 of the instant application that recites the composition further comprising at least one mineral UV tiler, preferably titanium dioxide and/or zinc oxide.
Claim 5 of the co-pending application recites the bemotrizinol and the avobenzone are present in the composition in a weight percent ratio with respect to the mineral filter(s) present in the composition of about 3:1 to about 1:1, which reads on claim 4 of the instant application that recites the bemotrizinol and the at least one booster are present in the composition in a weight ratio from about 10:1 to about 1:1.
Claim 7 of the co-pending application recites the composition has at least one additional organic UV filter selected from the group consisting of PABA, Ensulizole, Meradimate, Padimate O, Octisalate, Ensulizole, Homosalate, Octocrylene, and mixtures thereof, which reads on claim 8 of the instant application that recites the composition has at least one additional organic UV filter selected from the group consisting of Avobenzone, Octisalate, Ensulizole, Homosalate, Octocrylene, and mixtures thereof.
Claim 8 of the co-pending application recites the composition is free of mineral UV filters, which reads on claim 9 of the instant application that recites the composition is free of mineral UV filters.
Claim 9 of the co-pending application recites the composition is free of oxybenzone, octocrylene and/or octinoxate, which reads on claim 10 of the instant application that recites the composition is free of oxybenzone and/or octinoxate.
Claim 11 of the co-pending application recites the composition is in the form of an emulsion, which reads on claim 13 of the instant application that recites the composition is in the form of an emulsion.
Claim 12 of the co-pending application recites the composition comprises at least one coloring agent, which reads on claim 14 of the instant application that recites the composition comprising at least one coloring agent.
Claims 1 – 3, 5, 6, and 13 – 15 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 – 3 and 7 – 9 of co-pending application No. 18/543,141, filed 2023, Dec. 18. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claims 1 – 3 of the co-pending application recites a composition comprising bemotrizinol, avobenzone, and at least one additional UV filter, wherein the composition has one of more of the following properties: a critical wavelength of at least 370 nm; a UVAPF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher. This corresponds to the composition with identical SPF and photoprotective properties as recited in claims 1 –3, 5, and 6 of the instant application.
Claim 7 of the co-application recites that the composition can form an emulsion, which reads on claim 13 of the instant application that recites the composition in the form of an emulsion.
Claim 8 of the co-application recites that the composition comprises at least one coloring agent, which reads on claim 14 of the instant application that recites the composition comprising at least one coloring agent.
Claim 9 of the co-application recites that the composition comprises at least one active agent, which reads on claim 15 of the instant application that recites the composition comprising at least one active agent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Arcoria whose telephone number is (571)272-8719. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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