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 Status
Claims 1-13 are pending.
Claims 1-13 have been examined.
Claims 1-13 are rejected.
Drawings
The present application contains no drawings.
Claim Objections
[1] Claim 7 lists the organic filter ensulizole twice within the same group. The claim should be amended to remove the duplicative listing.
[2] In Claim 7, the phrase “further at least one additional organic UV filter” should be amended to read “further comprising at least one additional organic UV filter”
Specification Objections
[3] The disclosure is objected to because of the following informalities:
In para. [0033], Labsphere is a registered trademark; the mark should appear as Labsphere®, consistent with the listing in para. [0036].
In paragraph [0045], the phrase “using vitro methods” should be amended to read “using in vitro methods.”
In paragraph [0045], the phrase “or vitro SPF” should be amended to read “or in vitro SPF.”
In paragraph [0066], the phrase “may also ‘free of’” should be amended to read “may also be ‘free of’.”
Page 42, this is a blank page and should be removed.
Appropriate correction is required.
[4] The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (Paragraph [0034], Paragraph [0037], and Paragraph [0038]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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.
[5] Claims 2 and 4 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation "two or more of the properties", and the claim also recites “preferably all three of the properties” which is the narrower statement of the range/limitation.
Similarly, claim 4 recites the broad recitation "at least one mineral UV filter", and the claim also recites “preferably titanium dioxide and/or zinc oxide” which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102(a)(1)
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.
[6] Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johncock and Claus (Patent US11723850B2, published 08/15/2023).
With regard to claims 1-4 and 7, the prior art teaches sunscreen compositions comprising bemotrizinol, avobenzone, PABA (p-Aminobenzoic acid, see PABA, published 08/07/2023), meradimate, padimate O (2-ethylhexyl 4-dimethylaminobenzoate, see Padimate O, published 08/05/2022), octisalate, ensulizole, homosalate, octocrylene, titanium dioxide, and zinc oxide, or any combination thereof (reference claims 1, 6, and 22; col. 30, ln. 33 ; col. 31, lns. 29-30; col. 32, ln. 2, inter alia), having the same photoprotective properties and SPF values (reference claims 8-9; Examples 1-4, inter alia).
With regard to claims 5 and 6, the prior art teaches that the combined total amount by weight, or weight percent ratio, of bemotrizinol (0.1 to 10% by weight) and avobenzone (0.1 to 10% by weight) may exceed the total amount by weight, or weight percent ratio, of the mineral UV filter(s) (0.1 to 35% by weight) present in the composition (reference col. 31, last para., col. 32, paras. 2-3).
With regard to claim 8, the prior art teaches that the UV absorbing system may comprise any combination of the recited UV filters (reference claims 1, inter alia). Accordingly, one of ordinary skill in the art would readily envisage embodiments comprising bemotrizinol and avobenzone, and at least one additional UV filter without the inclusion of mineral UV filters, thereby meeting the limitation of claim 8, which requires that UV absorbing system is free of mineral UV filters.
With regard to claim 9, the prior teaches optional inclusion of UV filters (reference col. 30, lns. 56-60; col. 33, lns. 55-61, inter alia), embodiments omitting oxybenzone, octocrylene, and/or octinoxate are also envisaged, thereby meeting the limitation of claim 9.
With regard to claims 10-12, the prior art teaches anhydrous compositions (i.e., sticks; instant application [para. 0055]) (reference col. 59, Example 14, inter alia), in the form of an emulsion (reference claims 13-14 and 20) and comprising at least one coloring agent (reference claim 6; col. 46, para. 1, ln. 11, inter alai). Instant application identifies coloring agents as including dyes and pigments (para. [0118]).
With regard to claim 13, the prior art teaches a composition comprising a variety of active agents (reference claim 1, inter alia). The specification of the instant application as filed teaches that the term “UV filters,” as used therein, refers to sunscreen active agents approved by a governmental regulatory agency, such as the U.S. Food and Drug Administration (FDA) or the EU Commission, and includes organic UV filters such as avobenzone, and octocrylene, as well as mineral UV filters such as iron oxide, zinc oxide and titanium dioxide (para. 0024). Accordingly, a UV filter such as avobenzone would be understood by one of ordinary skill in the art to constitute an active agent, as taught by Johncock and Claus.
[7] Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spaulding et al. (Patent WO2014168773A1, published 10/16/2014).
With regard to claims 1-4 and 7, Spaulding et al. teaches a sunscreen composition comprising bemotrizinol (bis-ethylhexyloxyphenol methoxy triazine, see Spaulding et al., para. [0050]), octisalate, homosalate, octocrylene, avobenzone, titanium dioxide, and zinc oxide, or any combination thereof (claim 2, inter alia), having the same photoprotective properties and SPF values (paras. [0070] - [0071], [0075] - [0077], [0079]; Tables 3, 5-8; Figure 1).
With regard to claims 5 and 6, the prior art teaches that the combined total amount by weight, or weight percent ratio, of bemotrizinol (≤ 2.0 wt.%) and avobenzone (≤ 5.0 wt.%) may exceed the total amount by weight, or weight percent ratio, of the mineral UV filter(s) (≤ 5.0 wt.%) present in the composition (reference para., [0050], inter alia).
Spaulding et al. expressly teaches that the UV absorbing system may comprise any combinations of the listed UV filters (claim 2, inter alia). As such, one of ordinary skill in the art would readily envisage embodiment comprising bemotrizinol and avobenzone without the inclusion of mineral UV filters such as titanium dioxide and/or zinc oxide, thereby meeting the limitation of claim 8, which recites “the composition is free of mineral UV filters.”
Similarly, because Spaulding et al. teaches optional inclusion of UV filters and expressly permits “any combination thereof,” embodiments omitting oxybenzone, octocrylene, or octinoxate are also envisaged, thereby meeting the limitation of claim 9, which recites that “the composition is free of oxybenzone, octocrylene and/or octinoxate.” Furthermore, Spaulding et al. is silent with respect to octinoxate, the “and/or” language of claim 9 is satisfied by embodiment omitting octinoxate alone.
With regard to claims 10-12, Spaulding et al. teaches that the composition is anhydrous (claim 23; paras. [0013], [0017], and [00105], inter alia), in the form of an emulsion (paras. [0014]and [0093]), and comprising at least one coloring agent (claim 13; para. [00106]).
With regard to claim 13, Spaulding et al. teaches a composition comprising variety of active agents (claims 2, inter alia). The specification of the instant application as filed teaches that the term “UV filters,” as used therein, refers to sunscreen active agents approved by a governmental regulatory agency, such as the U.S. Food and Drug Administration (FDA) or the EU Commission, and includes organic UV filters such as avobenzone, and octocrylene, as well as mineral UV filters such as zinc oxide and titanium dioxide (para. 0024). Accordingly, a UV filter such as avobenzone would be understood by one of ordinary skill in the art to constitute an active agent, as taught by Spaulding et al.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
[8] Claims 1-4, 7, 9-11 and 13 of the instant application are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-12 of copending Application No. 18/985642 (the “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other, as discussed below.
The reference application teaches compositions comprising bemotrizinol, organic UV filter(s) including avobenzone (claims 1 and 5), and mineral UV filters (claims 1 and 6), having the same photoprotective properties and SPF value recited in instant claims 1-3 (see reference claims 2-4), corresponding to instant claims 1-4 and 7. Instant application claim 4 teaches mineral UV filters to include titanium oxides and zinc oxides.
Further the reference application teaches compositions free of oxybenzone and/or octinoxate (reference claim 9), anhydrous compositions, emulsions, and compositions comprising at least one active agent (reference claims 10-12), corresponding to instant claims 9-11 and 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[9] Claims 1-4, 7 and 9-13 of the instant application are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8 of copending Application No. 18/543756 (the “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other, as discussed below.
The reference application teaches a composition comprising bemotrizinol, avobenzone, optionally octinoxate, additional organic UV filters, and additional UV filters (reference claims 1 and 3-4), corresponding to instant claims 1, 4 and 7. Instant claims 1-3 recite photoprotective properties and SPF value associated with the claimed composition, which are achieved using the same combination of ingredients disclosed in the reference application. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The reference application also teaches optional exclusion of octinoxate (reference claim 1), compositions in the form of emulsion (reference claim 5), a stick (i.e., anhydrous) (reference claim 6), comprising at least one coloring agent (reference claim 7), and at least one active agent (reference claim 8), corresponding to instant claims 10-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[10] Claims 1-4, 7, 9-11 and 13 (instant application) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7 and 10 -13 of copending Application No. 18/543375 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other, as discussed below.
The reference application teaches a composition comprising bemotrizinol, titanium oxide, and additional organic UV filter (reference claims 1, 2, and 5), as well as mineral UV filters (reference claims 7), having same photoprotective properties and SPF value recited in instant claims 1 and 3 (reference claims 2-4), corresponding to instant claims 1-4 and 7.
Further, the reference application teaches compositions free of oxybenzone, octinoxate, and octocrylene (reference claim 10), compositions in the form of a stick (i.e., anhydrous) (reference claim 11), emulsion (reference claim 12) and compositions comprising at least one active agent (reference claim 13), corresponding to instant claims 9-11 and 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[11] Claims 1-4 and 7-13 of the instant application are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-13 of copending Application No. 18/543309 (the “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other, as discussed below.
The reference application teaches a compositions comprising bemotrizinol, avobenzone, organic UV filter, and mineral UV filters (reference claims 1, 4 and 5), having the same photoprotective properties and SPF value cited in instant claims 1-3 (reference claims 1-3), corresponding to instant claims 1-4 and 7.
The reference also teaches that the compositions free of mineral UV filters (reference claim 8), free of oxybenzone and/or octinoxate (reference claim 9), anhydrous compositions (reference claim 10), emulsions (reference claim 11), compositions comprising at least one coloring agent (reference claim 12), and compositions comprising at least one active agent (reference claim 13), corresponding to instant claims 8-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[12] Claims 1-4, 7-9 and 11-13 of the instant application are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-10 and 13-15 of copending Application No. 18/543287 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other, as discussed below.
The reference application teaches a compositions comprising bemotrizinol, organic UV filter including avobenzone, and mineral UV filters (reference claim 1 and 7-8), having the same photoprotective properties and SPF value recited in instant claims 1-3 (reference claims 5 and 6), corresponding to instant claims 1-4 and 7.
The reference application also teaches compositions free of mineral UV filters (reference claim 9), free of oxybenzone and/or octinoxate (reference claim 10), in the form of an emulsion (reference claim 13), comprising at least one coloring agent (reference claim 14), and comprising at least one active agent (reference claim 15), corresponding to instant claims 8-9 and 11-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[13] Claims 1- 7 and 9-13 of the instant application are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-10, and 12-13 of copending Application No. 18/543157 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other, as discussed below.
The reference application teaches compositions comprising bemotrizinol, organic UV filter(s) including avobenzone, and mineral UV filters (reference claims 1 and 5-6), having the same photoprotective properties and SPF value recited in instant claims 1-3 (reference claims 1-3), corresponding to claims 1-4 and 7. For reference, copending application teaches mineral UV filters to include zinc oxides and titanium oxides in paragraph [0059].
Claim 4 of the reference application teaches bemotrizinol and an additional organic UV filter in a ratio of about 1:3 to about 1:5, which can be modeled as a:b = 0.25:1, with b dominating a+b. Claim 5 of the instant application adds a mineral filter, which can be modeled as a:b:c = 0.25:1:1.25, corresponding to (a+b):c [Symbol font/0xBB] 1:1, while b continues to dominate a+b. Because the relative proportions of bemotrizinol and the additional organic UV filter remain unchanged, the inclusion of the mineral filter does not proportionally alter the composition. Accordingly, claims 5 and 6 of the instant application embody the same inventive concept.
The reference application further teaches composition free of UV filters including oxybenzone, octocrylene and octinoxate (reference claim 8), anhydrous composition (reference claim 9), in the form of an emulsion (reference claim 10), compositions comprising at least one coloring agent (reference claim 12), and compositions comprising at least one active agent (reference claim 13), corresponding to instant claims 9-13
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/ALI MUSTAFA ALAOUIE/Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614