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 1-10 are pending.
Claims 1-10 have been examined.
Claims 1-10 are rejected.
Drawings
The present application contains no drawings.
Specification Objections
[1] The disclosure is objected to because of the following informalities:
In paragraph [0036], “Labsphere” is identified as a registered trademark. The mark should be presented as “Labsphere®,” consistent with its presentation in paragraph [0039].
In paragraph [0027], the expression “(often expressed as “delta ____”)” is unclear and should be clarified.
In paragraph [0047], the phrase “using vitro methods” should be amended to read “using in vitro methods.”
In paragraph [0047], the phrase “or vitro SPF” should be amended to read “or in vitro SPF.”
[2] The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (paragraphs [0037] and [0040]). 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.
[3] Claim 2 is 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. The claim is 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
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.
[4] Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spaulding et al. (Patent WO2015152865A1, published 10/08/2015).
With regard to claims 1-3, the reference teaches a sunscreen composition comprising bemotrizinol (bis-ethylhexyloxyphenol methoxyphenyl triazine or BEMT, see instant application paragraph [0011]) and zinc oxide (reference claim 2, inter alia), and having the same photoprotective properties and SPF values (reference claims 18 and 19; paragraph [0016], [0083] and [0084], inter alia).
With regard to claims 4 and 6-8, the reference teaches a composition that is non-greasy (reference paragraph [00101]), non-whitening (reference claim 1, inter alia), anhydrous (reference claim 27, inter alia), in the form of an emulsion (reference paragraphs [0012], [0041]), and comprising at least one coloring agent (e.g., dyes and pigments; see instant application paragraph [0134]) (reference claim 12; paragraph [0086]).
With regard to claim 9, the reference teaches a compositions comprising a variety of active agents (reference claim 2, inter alia). The instant specification teaches that active agents approved by a governmental regulatory agency, such as the U.S. Food and Drug Administration (FDA) or the EU Commission, include zinc oxide (instant application paragraph [0026]). Accordingly, zinc oxide would have been understood by one of ordinary skill in the art to constitute an active agent, as taught by the reference.
[5] Claims 1-3, 5, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sohn et al. (Patent WO2023036749A1, published 03/16/2023).
With regard to claims 1-3 and 10, the reference teaches a daily care sunscreen composition comprising bemotrizinol (bis-ethylhexyloxyphenol methoxyphenyl triazine or BEMT, see instant application paragraph [0011]) and zinc oxide, wherein the sunscreen composition is free of a further additional UV filter (reference claim 23, inter alia). The reference further teaches photoprotective properties and SPF values as recited in instant claims 1-3 (reference Tables 5 and 6a; claims 9 and 19, inter alia).
With regard to claim 5, the reference teaches embodiments wherein the zinc oxide has a number-average elementary particle diameter of 5 to 150 nm (reference page 13, lines 36-40), which encompasses the claimed range of about 10 to about 35 nm.
With regard to claim 9, the reference teaches compositions comprising a variety of active agents (reference claim 23, inter alia). The instant specification teaches that active agents approved by a governmental regulatory agency, such as the U.S. Food and Drug Administration (FDA) or the EU Commission, include zinc oxide (instant application paragraph [0026]). Accordingly, zinc oxide would have been understood by one of ordinary skill in the art to constitute an active agent, as taught by the reference.
[6] Claims 1-3 and 5-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Ikebe et al. (US20140161848A1, published 06/12/2014).
With regard to claims 1-3 and 5-6, the reference teaches UV-protective cosmetic composition comprising bis-ethylhexyloxyphenol methoxyphenyl triazine (bemotrizinol or BEMT, see instant application paragraph [0011]) and zinc oxide having an average particle diameter of 35 to 80 nm, wherein the composition has SPF of 30 or greater and a critical wavelength of 370 nm or greater (reference claims 1 and 3; abstract; paragraphs [0021]-[0022], inter alia). The reference further teaches embodiments wherein the zinc oxide has an average particle diameter 20-30 nm (reference Tables 1-2, inter alia). The reference does not expressly teach a UVAPF/SPF ratio of at least 1/3 or a UVA1/UV ratio of 0.7 or higher; however, “[p]roducts 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). Accordingly, the claimed UVAPF/SPF ratio and UVA1/UV ratio are inherent properties of the composition taught by the reference, and claims 1-3 and 5-6 are anticipated.
With regard to claims 7-8, the reference teaches the composition in the form of an emulsion (reference claim 8, inter alia) and further teaches inclusion of coloring agent (e.g., dyes and pigments; see instant application paragraph [0134]) (reference claims 2 and 7, inter alia). Accordingly, claims 7-8 are anticipated by the reference.
With regard to claim 9, the reference teaches compositions comprising one or more active agents (reference claim 1, inter alia). The instant specification teaches that active agents approved by a governmental regulatory agency, such as the U.S. Food and Drug Administration (FDA) or the EU Commission, include zinc oxide (instant application paragraph [0026]). Accordingly, zinc oxide would have been understood by one of ordinary skill in the art to constitute an active agent, as taught by the reference. Accordingly, claim 9 is anticipated by the reference.
With regard to claim 10, the reference teaches a UV-protective cosmetic composition comprising: (a) one or more UV-absorbing agents and (b) zinc oxide (instant claim1). This disclosure anticipates a UV-absorbing system consisting essentially of zinc oxide and bemotrizinol, as claimed. Accordingly, claim 10 is anticipated by the reference.
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.
[7] Claims 1-3, 6-7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 10-12 of co-pending Application No. 18/985642 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/985642 teaches a composition comprising bemotrizinol and zinc oxide (reference claims 1 and 6) with the same properties and SPF value as listed in instant claims 1-3 (reference claims 2-4), corresponding to instant claims 1-3, and further teaches that the composition is anhydrous, an emulsion, and comprises at least one active agent (reference claims 10-12), corresponding to instant claims 6, 7, and 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[8] Claims 1-3 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 10-13 of co-pending Application No. 18/543343 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/543343 teaches a composition comprising bemotrizinol and zinc oxide (reference claims 1 and 4) with the same properties and SPF value as listed in instant claims 1 and 3 (reference claims 1-3), corresponding to instant claims 1-3, and further teaches that the composition is anhydrous, an emulsion, comprises at least one coloring agent, and comprises at least one active agent (reference claims 10-13), corresponding to instant claims 6-9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[9] Claims 1-3 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 10-13 of co-pending Application No. 18/543309 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/543309 teaches a composition comprising bemotrizinol and zinc oxide (reference claims 1 and 4) with the same properties and SPF value as listed in instant claims 1 and 3 (reference claims 1-3), corresponding to instant claims 1-3, and further teaches that the composition is anhydrous, an emulsion, comprises at least one coloring agent, and comprises at least one active agent (reference claims 10-13), corresponding to instant claims 6-9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[10] Claims 1-3 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7 and 13-15 of co-pending Application 18/543287 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/543287 teaches a composition comprising bemotrizinol and zinc oxide (reference claims 1 and 7) with the same properties and SPF value as listed in instant claims 1 and 3 (reference claims 5-6), corresponding to instant claims 1-3, and further teaches that the composition is an emulsion, comprises at least one coloring agent, and comprises at least one active agent (reference claims 13-15), corresponding to instant claims 7-9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[11] Claims 1-3 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-9 of co-pending Application 18/543657 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/543657 teaches a composition comprising bemotrizinol and zinc oxide (see reference application paragraph [0024], which teaches that the at least one active agent includes zinc oxide) (reference claims 1) with the same properties and SPF value as listed in instant claims 1 and 3 (reference claims 1-3), corresponding to instant claims 1-3, and further teaches that the composition is anhydrous, an emulsion, and comprises at least one coloring agent (reference claims 7-9), corresponding to instant claims 6-8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[12] Claims 1-3, 6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9, and 11-13 of co-pending Application 18/543618 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/543618 teaches a composition comprising bemotrizinol and zinc oxide (see reference application paragraph [0062], which teaches that the passivated mineral UV filters includes zinc oxide) (reference claims 1 and 9) with the same properties and SPF value as listed in instant claims 1 and 3 (reference claims 2-4), corresponding to instant claims 1-3, and further teaches that the composition is anhydrous, comprises at least one coloring agent, and comprises at least one active agent (reference claims 11-13), corresponding to instant claims 6, and 8-9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[12] Claims 1-3 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 9-10, and 12-13 of co-pending Application 18/543157 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending application 18/543157 teaches a composition comprising bemotrizinol and zinc oxide (see reference application paragraph [0025], which teaches that the mineral UV filters includes zinc oxide) (reference claims 1 and 6) with the same properties and SPF value as listed in instant claims 1 and 3 (reference claims 1-3), corresponding to instant claims 1-3, and further teaches that the composition is anhydrous, an emulsion, comprises at least one coloring agent, and comprises at least one active agent (reference claims 9-10 and 12-13), corresponding to instant claims 6-9.
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 ALI M ALAOUIE whose telephone number is 571-272-0844. The examiner can normally be reached Flextime: (M-TH) 7:30 am 6:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALI M. ALAOUIE/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614