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 . Claims included in the prosecution are claims 13-32.
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.
1. Claims 13, 15-25 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Pelicci et al. (US 2006/0160897, Jul. 20. 2006) (hereinafter Pelicci) in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König).
Pelicci discloses a topical formulation for the protection from UV light and for the treatment of sun burn (¶ [0003]). The composition can comprise a thickening agent, preferably from about 0.1% to about 5% (¶ [0177]). Suitable thickening agents include hydroxypropyl methylcellulose (¶ [0190]) and xanthan gum (¶ [0192]). The composition may comprise a mixture of thickening agents (¶ [0197]). The topical composition may be an emulsion containing one or more of a hydrophobic component (¶ [0134] and [0135]). Suitable hydrophobic components include hydrogenated rapeseed oil (¶ [0148]) and isopropyl palmitate (¶ [0141]). The composition preferably comprises from about 1% to about 50% of the hydrophobic component (¶ [0136]). The emulsion may be an oil-in-water emulsion (¶ [0130]). The composition may comprise an emollient, such as carnauba wax (¶ [0201]). Optional components include ultraviolet light absorbers or scattering agents (¶ [0200]).
Pelicci differs from the instant claims insofar as not teaching wherein the hydrogenated rapeseed oil is free of glycerol tripalmitate.
However, Kömig discloses an oil-based cleansing product comprising lipids (¶ [0026]). Suitable lipids include hydrogenated rapeseed oil obtained from ADM under the tradename VGB 22 (¶ [0028]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated VGB 22 into the composition of Pelicci since the composition comprises hydrogenated rapeseed oil and this is a known and effective source of hydrogenated rapeseed oil as taught by Kömig. As noted in the instant specification on page 3, lines 1-3, VGB22 is free of glycerol tripalmitate.
In regards to instant claims 13, 15 and 16 reciting wherein the composition is free of certain compounds, Pelicci does not require those claimed compounds as shown in the examples and claims. As such, a composition free of those compounds would have been obvious.
In regards to instant claims 17-19, Pelicci discloses from about 0.1% to about 5% thickening agents and wherein thickening agents include hydroxypropyl methylcellulose and xanthan gum. Therefore, the claimed amounts would have been obvious from one of ordinary skill in the art selecting an amount of each compound from this range and the amount of each compound overlapping with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
2. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pelicci et al. (US 2006/0160897, Jul. 20. 2006) (hereinafter Pelicci) in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König), and further in view of Simonnet et al. (US 2011/0110989, May 12, 2011) (hereinafter Simonnet).
The teachings of Pelicci and König are discussed above. Pelicci and König do not teach wherein the composition comprises 4-(tert-butyl)-4’methyoxydibenzoylmethane.
However, Simonnet discloses wherein 4-tert-butyl-4’-methoxydibenzoylmethane is a UV-screening agent (¶ [0333] and [0342]).
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. Pelicci teaches wherein the composition comprises UV absorbers or scattering agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 4-(tert-butyl)-4’methyoxydibenzoylmethane into the composition of Pelicci since it is a known and effective UV absorber or scattering agent as taught by Simonnet.
3. Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Pelicci et al. (US 2006/0160897, Jul. 20. 2006) (hereinafter Pelicci) in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König), and further in view of Howe et al. (US 2008/0317687, Dec. 25, 2008) (hereinafter Howe).
The teachings of Pelicci and König are discussed above. Pelicci and König do not teach wherein the composition comprises di-n-butyl adipate.
However, Howe discloses an oil-in-water emulsion (abstract). Suitable oil phase components include esters of dicarboxylic acids (¶ [0052]). Suitable dicarboxylic esters include di-n-butyl adipate (¶ [0053]).
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. Pelicci teaches wherein the composition comprises one or more hydrophobic components. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated di-n-butyl adipate into the composition of Pelicci since it is a known and effective hydrophobic component for emulsions as taught by Howe.
4. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Pelicci et al. (US 2006/0160897, Jul. 20. 2006) (hereinafter Pelicci) in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König), and further in view of Deshayes et al. (US 2018/0110706, Apr. 26, 2018) (hereinafter Deshayes).
The teachings of Pelicci and König are discussed above. Pelicci and König do not teach wherein the composition comprises butylene glycol dicaprylate/dicaprate.
However, Deshayes discloses a topical sunscreen emulsion comprising an oil phase and a water phase (abstract). Suitable oils to be incorporated into the oil phase of the topical sunscreen emulsion include butylene glycol dicaprylate/dicaprate (¶ [0038]).
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. Pelicci teaches wherein the composition comprises one or more hydrophobic components. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated butylene glycol dicaprylate/dicaprate into the composition of Pelicci since it is a known and effective hydrophobic component for emulsions as taught by Deshayes.
5. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Pelicci et al. (US 2006/0160897, Jul. 20. 2006) (hereinafter Pelicci) in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König), and further in view of Mendrok-Edinger et al. (US 2017/0312192, Nov. 2, 2017) (hereinafter Mendrok-Edinger).
The teachings of Pelicci and König are discussed above. Pelicci and König do not teach wherein the composition has a viscosity of 2500-3000 mPas-1 after storage for 28 days at 40°C.
However, Mendrok-Edinger discloses a method of preserving the long - term thermal storage stability of a topical composition in the form of an oil - in water (O/W) emulsion comprising an oil phase dispersed in an aqueous phase in the presence of a polyglyceryl fatty ester surfactant, said method comprising the addition of a phosphate ester co – surfactant (claim 15). It is generally known that O/W emulsions with low viscosity often exhibit a stability problem upon storage, in particular at elevated temperatures. Thus, there is an ongoing need for agents that are able to reduce the viscosity of O/W emulsions without affecting the storage stability (¶ [0002]). The topical composition exhibits a viscosity of 50,000 mPas or less, such as 100 to 25,000 mPas (¶ [0021]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition of Pelicci to have a viscosity of 100 to 25,000 mPas since the composition is an O/W emulsion and this is a known and effective viscosity for such compositions as taught by Mendrok-Edinger. It would have been obvious to one of ordinary skill in the art to have the viscosity be within this range after 28 days at 40°C since thermal storage stability is desirable in the art and Mendrok-Edinger teaches how to obtain it.
6. Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Pelicci et al. (US 2006/0160897, Jul. 20. 2006) (hereinafter Pelicci) in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König), and further in view of Miller et al. (US 2006/0159645, Jul 20, 2006) (hereinafter Miller).
The teachings of Pelicci and König are discussed above. Pelicci and König do not teach wherein the composition is present in a LDPE tube.
However, Miller discloses a method of providing a lubricious characteristic to skin surfaces (abstract). The composition of the method may be in the form of an emulsion (¶ [0048]). The composition may be packaged in a container that is well known by an artisan of ordinary skill such as a low-density polyethylene tube with a dispensing tip head (¶ [0049]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have packaged the composition of Pelicci into a low-density polyethylene tube since this is a known and effective container for topical compositions as taught by Miller.
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 13-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-31 of copending Application No. 17/904,039 in view of König et al. (EP 3130329 A1, Feb. 15, 2017) (hereinafter König).
The pending claims differ from the copending claims insofar as reciting wherein the hydrogenated rapeseed oil is free of glycerol tripalmitate. However, Kömig discloses an oil-based cleansing product comprising lipids (¶ [0026]). Suitable lipids include hydrogenated rapeseed oil obtained from ADM under the tradename VGB 22 (¶ [0028]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated VGB 22 into the composition of pending claims since this is a known and effective source of hydrogenated rapeseed oil as taught by Kömig. As noted in the instant specification on page 3, lines 1-3, VGB22 is free of glycerol tripalmitate.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 13-32 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614