DETAILED ACTION
Status of the Claims
Claims 1, 8-11 and 14-29 are pending in the instant application. Claims 14, 20-22 and 26 have been withdrawn based upon Restriction/Election. Claims 1, 8-11, 15-19, 23-25 and 27-29 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The U.S. effective filing date has been determined to be 11/15/2018, the filing date of PCT/EP2018/081476. Applicant's claim for a priority date of, 11/15/2017, the filing date of document FR1760729, is acknowledged, however no English translation of said priority document has been provided such that the examiner can verify 112(a) support. Accordingly, priority to this document cannot be afforded at this time.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 8-11, 15-19, 23-25 and 27-29 remain rejected under 35 U.S.C. 103 as being unpatentable over LORANT (WO 2007/141142 A1; published December, 2007) in view of L’ALLORET (US 2004/0228815; published November, 2004); HASE (US 4,128,635; published December, 1978) and as evidenced by Meaudre et al. (“New formulation technology to boost sun protection,” 2023; Wiley, International Journal of Cosmetic Science, Vol. 45, pp. 802-814).
Applicants Claims
Applicant claims an oil-in-water composition comprising at least:
(a) from 0.2% to 8% by weight, relative to the total weight of the composition, of one or more polymers selected from copolymers of behenyl acrylate and 2-hydroxyethyl acrylate having a number-average molecular weight Mn ranging from 2000 to 9000 g/mol, and wherein the weight ratio of the 2-hydroxyethyl acrylate to the behenyl acrylate ranges from 1:30 to 1:1, and wherein the sum of the total units of the 2-hydroxyethyl acrylate and behenyl acrylate is 100% by weight of the weight of the one or more polymers,
(b) from 1 to 45% by weight, relative to the total weight of the composition, of one or more UV-screening agents, and
(c) from 0.1% to 10% of one or more copolymers of acrylamido-2-methylpropanesulfonic acid and of one or more nonionic monomers chosen from at least one member of the group of copolymers of acrylamido-2-methylpropanesulfonic acid and of vinylpyrrolidone; crosslinked acrylamide/sodium acrylamido-2-methylpropanesulfonate copolymers; copolymers of acrylamido-2-methylpropanesulfonic acid and of hydroxyethyl acrylate; and acrylamido-2-methylpropanesulfonic acid/cetearyl methacrylate copolymers ethoxylated with 25 mol of ethylene oxide (instant claim 1).
Applicant further claims the content of polymer (a) is from 0.5% to 5% by weight, relative to the total weight of said composition (instant claim 8). Applicant further claims the content of polymer (c) is from 0.2% to 5% by weight, relative to the total weight of said composition (instant claim 15). Applicant further claims the weight ratio of the 2-hydroxyethyl acrylate to the behenyl acrylate ranges from 1:15 to 1:1 (claims 27-28) or 1:10 to 1:4 (claim 29).
Applicants elected the following species (i) first polymer is behenyl acrylate/2-hydroxyethyl acrylate copolymers as the species drawn to the polymer comprising A and B ((instant claim 1, item (a)); (ii) a species of UV screening agent is the hydrophobic butylmethoxydibenzoylmethane (syn. w/Avobenzone)(instant claim 1, item (b)); and (iii) a copolymer of acrylamido-2-methylpropanesulfonic acid and of one or more nonionic monomers is ammonium acryloyl dimethyl taurate/VP (i.e. vinylpyrrolidone) copolymers (e.g., Aristoflex® AVC)(instant claim 1, item c), in the response filed 02/24/2022. The examiner notes that behenyl acrylate is C22-acrylate, that is the alkyl chain has 22 carbon atoms.
Determination of the scope
and content of the prior art (MPEP 2141.01)
LORANT teaches oil-in-water emulsions containing hydrophilic polymer and a semi-crystalline polymer (title, see whole document), and particularly that: “The invention relates to a composition for topical application, in the form of an O/W emulsion containing at least one crosslinked 2-acrylamido-2-methylpropane- sulfonic acid polymer comprising at least one hydrophobic unit, and at least one semicrystalline polymer. The composition obtained has very good stability, and also good cosmetic properties. The present invention also relates to the uses of the said composition in cosmetics and dermatology, especially for caring for, protecting and/or making up facial or bodily skin, and/or the lips, and/or for skincare, and more especially for treating dry and/or sensitive skin and for treating the signs of ageing of the skin.” (abstract).
LORANT teaches that “In the cosmetics field, the addition of waxes or of similar fatty substances to skincare compositions makes it possible to obtain products that are particularly suitable for treating dry skin and aged skin. Waxes especially contribute towards nourishing the skin and smoothing out wrinkles and fine lines. They may be introduced either into W/O emulsions or O/W emulsions. Generally, in the cosmetics field, O/W emulsions are preferred to W/O emulsions on account of their cosmetic qualities that are judged to be superior since they are often lighter and fresher, and also on account of their greater flexibility of formulation. However the presence of waxes in standard O/W emulsions results in impairment in the stability of these emulsions, whereas their introduction into W/ emulsions poses no problems. Moreover, the cosmetic properties of O/W emulsions containing waxes are often judged to be insufficient; the are especially often found to have an excessively thick consistency, to be difficult to spread and to produce a greasy film after application to the skin.” (p. 1, lines 2nd paragraph). And that: “There is thus still a need for O/W emulsions that nourish the skin, and thus that contain skin-nourishing fatty substances such as waxes, while at the same time having textures that are easy to apply and pleasant to use, and that are neither greasy, tacky nor potentially irritant. This type of product is particularly advantageous for treating dry skin, and also for fragile and sensitive skin due to the fact that it may be free of surfactants, to which sensitive skin is particularly reactive. Furthermore, freshness effects and easy application are particularly soothing dry and reactive skin.” (p. 2, 3rd paragraph).
LORANT teaches that: “The Applicant has discovered, unexpectedly, that the use of a combination of particular hydrophilic polymers and of particular lipophilic polymers makes it possible to solve the underlying problem of the invention and to obtain a stable O/W emulsion that has good cosmetic properties, even in the presence of fatty substances such as waxes, and that may be advantageously free of emulsifying surfactant conventionally used in O/W emulsions or contain only a very small amount thereof, and thus be well tolerated by any skin type.” (p. 2, last paragraph). And that: “These compositions may contain fatty substances, including waxy and pasty fatty substances, while at the same time having good stability and surprising sensory pleasantness, i.e. a feel that is both rich and fresh. These surprising properties are demonstrated in various tests presented later.” (p. 3, 1st paragraph).
LORANT teaches that: “These sensory qualities combining richness in fatty substances, freshness and easy application are very surprising, all the more so since their consistency is thick, and they participate both towards the pleasantness of the compositions according to the invention and to their efficacy in treating the skin, especially in treating dry and/or sensitive skin.” (p. 3, lines 19-26). And that: “Another surprising characteristic of the products according to the invention is that of combining the qualities of "waxy" products (very specific feel) with sensation of freshness. Specifically, the known a products that have a "waxy" feel never have a freshness effect.” (p. 3, lines 28-33).
LORANT teaches that: “One subject of the invention is thus a composition for topical application, in the form of an O/W emulsion comprising an oily phase dispersed in an aqueous phase, characterized in that it contains at least one crosslinked polymer of 2-acrylamido-2-methylpropane-sulfonic acid comprising at least one hydrophobic unit, and at least one semi-crystalline polymer.” (paragraph bridging pp. 3-4), and claims “Composition for topical application, in the from of an O/W emulsion comprising an oily phase dispersed in an aqueous phase, characterized in that it contains at least one crosslinked 2-acrylamido-2-methylpropane-sulfonic acid polymer comprising at least one hydrophobic unit, and at least one semi-crystalline polymer.” (p. 33, claims 1 & 14-16)(instant claim 1, “An oil-in-water emulsion”; instant claim 23).
LORANT teaches that: “The hydrophilic polymers used in the composition of the invention are crosslinked 2-acrylamido-2-methylpropanesulfonic acid (AMPS) polymers comprising at least one hydrophobic group; they are hydrophobic modified AMPS crosslinked polymers. They are copolymers based on at least one AMPS hydrophilic monomer and on at least one hydrophobic monomer. These polymers are water-soluble or water-dispersible, in form. They neutralized or are preferably partially neutralized totally neutralized. Since the polymers are water-soluble or water-dispersible, they are generally introduced into the aqueous phase of the emulsion.” (paragraph bridging pp. 4-5). And that: “Polymers of this type that may be mentioned more especially include the product sold under the name Aristoflex HMS by the company Clariant, which is an AMPS/ethoxylated (25 EO) stearyl methacrylate crosslinked copolymer, for which in formula (IV) n is 25 and R is C16 -C18 , or the product sold under the name Aristoflex HMB by the company Clariant, which is an AMPS/ethoxylated (25 EO) behenyl methacrylate crosslinked copolymer, for which in formula (IV) n is 25 and R is C22. A mixture of these polymers may also be used.” [emphasis added](pp. 5-10, particularly p. 10, lines 12-22)(instant claim 1, item (a), elected species of item (a) - (i) first polymer is behenyl acrylate/2-hydroxyethyl acrylate copolymers as the species drawn to the polymer comprising A and B (e.g., Aristoflex® HMB). And further that: “The amount of AMPS polymer containing a hydrophobic unit in the composition of the invention may range, for example, as active material, from 0.1% to 5% by weight, preferably from 2% to 5% by weight and better still from 0.2% to 3% by weight relative to the total weight of the composition.” (p. 10, lines 24-29)(instant claim 1, item c; instant claim 15). The examiner notes that the instant Specification discloses that: “AMPS/cetearyl methacrylate copolymers ethoxylated with 25 mol of ethylene oxide, crosslinked with trimethylolpropane triacrylate (TMPTA), sold by Clariant under the name Aristoflex HMS.” (p. 12, lines 20-22)(instant claim 1, item c; claims 11, 15, 25).
LORANT teaches that “The composition according to the invention contains at least one semi-crystalline polymer, preferably derived from acrylic or methacrylic acid. The term "semicrystalline crystallizable polymer" portion, means polymers comprising a crystallizable side chain or a crystallizable block in the skeleton, and an amorphous portion in the skeleton and having a first order reversible phase-change temperature, in particular of melting (solid-liquid transition) When the crystallizable portion is in the form of a crystallizable block of the polymer skeleton, the amorphous portion of the polymer is in the form of an amorphous block; in this case, the semi-crystalline polymer is a block copolymer, for example, of the diblock, triblock or multiblock type.” (paragraph bridging pp. 10-11). The examiner notes that Meaudre et al. characterizes AAHCP as a semi-crystalline material (polymer) with “INCI name: C12-22 alkyl acrylate/hydroxyethylacrylate copolymer” (p. 803, col. 2, §Materials).
LORANT teaches that: “Advantageously, the semi-crystalline polymer (s) of the composition of the invention have a number-average molecular mass Mn greater than or equal to 2000, for example ranging from 2000 to 800 000, preferably from 3000 to 500 000, for example from 4000 to 150 000 and better still from 4000 to 99 000.” (p. 11, lines 10-15). And that: “For the purposes of the invention, the term "crystallizable chain or block" means a chain or block which, if it were alone, would pass reversibly from the amorphous state to the crystalline state, depending on whether it is above or below its melting point. For the purposes of the invention, a chain is a group of atoms, which is pendent or lateral relative to the polymer backbone. A block is a group of atoms belonging to the backbone, this group constituting one of the repeating units of the polymer.” (p. 11, lines 22-31).
LORANT teaches that: “Preferably, the crystallizable blocks or chains of the semi-crystalline polymers represent at least 30% and better still at least 40% of the total weight of each polymer. The semi-crystalline polymers containing crystallizable blocks used according to the invention are block or multiblock polymers. They may be obtained by polymerization of monomers containing reactive double (or ethylenic bonds) or by polycondensation. When the polymers of the invention are polymers containing crystallizable side chains, they are advantageously in random or statistical form.” (p. 12, lines 7-17). And “The crystallizable side chains or blocks are hydrophobic.” (p. 12, lines 29-30).
LORANT teaches that: “crystallizable side chain chosen from alkyl chains(s) containing at least 11 carbon atoms and not more than 40 carbon atoms and better still not more than 24 carbon atoms. They are especially alkyl chains containing at least 12 carbon atoms, and are preferably alkyl chains containing from 14 to 24 carbon atoms […].” (p. 12, line 36 through p. 13, line 2).
LORANT teaches that: “According to one particular embodiment of the invention, the semi-crystalline polymer is chosen from polymers derived from at least one monomer with a crystallizable chain chosen from C14-C24 alkyl (meth) acrylates […] and copolymers of these monomers obtained by copolymerization of these monomers with a hydrophilic monomer, which is preferably other than methacrylic acid, for instance N-vinylpyrrolidone, hydroxyethyl acrylate, […]. Such copolymers may be, for example, copolymers of C14-C24 alkyl acrylate […] with N-vinylpyrrolidone, hydroxyethyl acrylate […].” [emphasis added](p. 13, lines 13-31).
LORANT teaches that: “The amount of semi-crystalline polymer(s) in the
composition of the invention may range, for example, from 0.1% to 5% by weight, preferably from 0.5% to 5% by weight and better still from 1% to 3% by weight relative to the total weight of the composition.” (p. 15, 1st paragraph)(instant claim 1, item a; instant claims 8 & 27 – amounts of item a).
LORANT teaches inclusion of sunscreens including organic UV-screening agents such as “Dibenzoylmethane derivatives, and especially butyl methoxydibenzoylmethane sold in particular under the trade name Parsol 1789 by Hoffmann LaRoche;” (p. 22, lines 24-26 & 30-32)(instant claim 1, item b; instant claim 9).
LORANT teaches that: “The composition may that contain one or more active used agents. Active agents that may especially be used include vitamins and derivatives thereof, especially esters thereof, such as retinol (vitamin A) and its esters (for example retinyl palmitate), ascorbic acid (vitamin C) and its esters […].” (p. 22, 2nd paragraph)(instant claims 16-18).
LORANT teaches that: “The amount of the active agents depends on the desired aim. The active agent(s) may be present, for example, in a concentration ranging from 0.01% to 20%, preferably from 0.05% to 10% and better still from 0.1% to 5% by weight relative to the total weight of the composition.” (p. 24, 1st paragraph)(instant claim 19).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of LORANT is that LORANT does not expressly teach (1) the inclusion of the species a copolymer of acrylamido-2-methylpropanesulfonic acid and of one or more nonionic monomers is ammonium acryloyl dimethyl taurate/VP (i.e. vinylpyrrolidone) copolymers (e.g., Aristoflex® AVC)(instant claim 1, item c); (2) the amount of the UV-screening agents; or (3) the weight ratio of the 2-hydroxyethyl acrylate to the behenyl acrylate units (instant claims 27-29).
L’ALLORET teaches “photoprotective compositions comprising at least one aqueous phase, at least one oily phase, at least one water-soluble or water-dispersible, partially or completely neutralized, crosslinked or non-crosslinked acrylamido-2-methylpropanesulfonic acid polymer and at least one UV radiation-screening system, which screening system comprises at least one UV-A screening agent of the 4,4-diarylbutadiene type.” ([0003]). And that: “anti-sun compositions are often provided in the form of an emulsion of the oil-in-water type ([…]) or of the water-in-oil type ([…]), which contains, in various concentrations, one or more conventional fat-soluble organic screening agents and/ or conventional water soluble organic screening agents capable of selectively absorbing harmful UV radiation, these screening agents (and their quantities) being selected according to the desired sun protection factor, […]. In such emulsions, the hydrophilic screening agents are present in the aqueous phase and the lipophilic screening agents are present in the fatty phase.” ([0008]).
L’ALLORET teaches that: “Acrylamido-2-methylpropanesulfonic acid (AMPS) polymers are particularly suited for their cosmetic properties and their flexibility in terms of formulation, compared with the polymeric derivatives of the carboxylic acid (Carbopols supplied by Noveon). They may indeed be formulated at pH values of between 4 and 6 without their gelling properties being reduced.” ([0009]). And that: “These acrylamido-2-methylpropanesulfonic acid polymers are particularly suitable in the manufacture of emulsions. They make it possible to obtain stable formulations within a broad range of texture and consistency ranging from milks to thickened creams.” ([0012]). And further that: “It thus appears necessary to have emulsions based on acrylamido-2-methylpropanesulfonic acid polymers which are stable and which may contain organic screening agents which are active in UV-A with comparable efficacy to that of 1,4-benzene[di(3-methylidene-10-camphorsulfonic)] acid and its different salts without the disadvantages listed above.” ([0015]). L’ALLORET defines the term “stable” in paragraph [0016].
L’ALLORET teaches that: “It has now surprisingly and unexpectedly been determined that emulsions comprising at least one partially or completely neutralized, crosslinked or non-crosslinked acrylamido-2-methylpropanesulfonic acid polymer and at least one UV-A-screening agent of the 4,4-diarylbutadiene type ameliorate or avoid those disadvantages and drawbacks indicated above.” ([00017]).
L’ALLORET teaches the water-soluble or water-dispersible polymers include “copolymers obtained from AMPS and one or more hydrophilic or hydrophobic ethylenically unsaturated monomers and, if they are crosslinked, one or more crosslinking agents.” ([0034], [0037]). “The water-soluble or water-dispersible AMPS copolymers according to the invention contain water-soluble, ethylenically unsaturated monomers, hydrophobic monomers or mixtures thereof.” ([0044]) “The water-soluble comonomers may be ionic or nonionic.” ([0045]). And “Among the nonionic water-soluble comonomers, there may be mentioned, for example: […] N-vinyllactams containing a cyclic alkyl group having from 4 to 9 carbon atoms, such as N-vinylpyrrolidone […].” ([0061], [0067]). And further: “As water-soluble or water-dispersible copolymers obtained from AMPS and ethylenically unsaturated water-soluble monomers, there may be mentioned, for example, those obtained from AMPS […] There may also be mentioned the copolymers of AMPS and vinylpyrrolidone or vinylformamide, such as the products ammonium acryloyldimethyltaurate/VP copolymer (INCI name) marketed under the name ARISTOFLEX AVC by CLARIANT.” [emphasis added](instant claim 1, item c, elected species: ammonium acryloyl dimethyl taurate/VP (i.e. vinylpyrrolidone) copolymers; instant claim 25 “copolymers of acrylamido-2-methylpropanesulfonic acid and of vinylpyrrolidone”).
L’ALLORET teaches that: “The AMPS polymers in accordance with the invention are generally present in quantities as active material ranging from 0.01 % to 20% by weight, more preferably from 0.1 % to 10% by weight, still more preferably from 0.1 % to 5% by weight and more particularly still from 0.5% to 2% by weight relative to the total weight of the composition.” ([0140])(instant claim 1, item (c), instant claim 15).
L’ALLORET teaches inclusion of additional screening agents for UV-A and/or UV-B regions ([0205]) including butyl methoxydibenzoylmethane ([0219]). And that: “The additional screening agents according to the invention are generally present in the compositions according to the invention in an amount ranging from 0.1 % to 30% by weight, and preferably from 0.5% to 15% by weight, relative to the total weight of the composition.” ([0293])(instant claim 1, item b; instant claims 9-10, and 24).
HASE teaches polymeric emulsifiers which is a copolymer composed, in the molar ratio of (I) to (II) of 2:1 to 20:1 of units of the general formulae:
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253
431
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wherein X is hydrogen or a methyl radical, R1 is an alkyl radical having 6 to 24 carbon atoms and R2 is a radical selected from the group consisting of -CH2-CH2OH, […].” (col. 2, lines 25-50). The examiner notes that 2-hydroxyethyl acrylate has the following structure:
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200
400
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and the ratio formulae II (encompassing 2-hydroxyethyl acrylate) to formulae I (C6-C24 alkyl chains) is 1:2 to 1:20 which encompasses the claimed ratio range of 1:1 to 1:30 (claim 1, lines 5-6), 1:1 to 1:15 (claims 27-28), 1:4 to 1:10 (claim 29). HASE teaches including from 2% to 20% by weight relative to the total weight of the emulsion (col. 2, lines 28-31; claim 1)( amount of item (a); instant claims 1 and 27). 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-I).
HASE further teaches that: “The monomeric starting compounds from which the polymer units (II) of the copolymers of the invention are derived are the esters of acrylic acid or methacrylic acid with ethylene glycol […]. In part, these monomers are commercially available products, such as 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate […].” (col. 3, lines 9-15). HASE further teaches that: “The monomeric starting compounds from which the polymer units (I) of the copolymers of the invention are derived have the formula (III):
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125
291
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wherein X is a hydrogen or methyl, and R1 is an alkyl radical having 6 to 24, more preferably 8 to 14, carbon atoms.” And further that: “Among the monomeric starting compounds of the formula (III) above may be mentioned […] behenyl acrylate […] behenyl methacrylate.” (col. 3, lines 20-39; claim 1).
HASE teaches that: “The copolymers of the invention have average molecular weights between 2,000 and 100,000. Those having average molecular weights between 3,000 and 20,000 are particularly suitable in view of their easy processability and the quality of the emulsions obtained.” (col. 3, last paragraph; claims 3-4)(instant claim 1, “acrylate having a number average molecular weight Mn ranging from 2000 to 9000 g/mol.”).
HASE teaches that: “In general, the emulsions in accordance with the present invention can also be used by persons having a sensitive skin. Since they do not have any appreciable characteristic odor, they do not require heavy perfuming, which in turn, has an advantageous effect upon the compatibility and also reduces costs.” And further that: “the emulsions according to the invention are characterized by low sensitivity to acid, thus rendering it possible to incorporate acidic raw materials therein, such as organic acids. Another very favorable property of the emulsions according to the invention is their high temperature stability, which enables them to withstand a thermal stress of 50° C for 6 weeks without any detrimental effects.” (col. 5, lines 27-40).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a oil-in-water cosmetic emulsion including a at least one crosslinked 2-acrylamido-2-methylpropane sulfonic acid polymers comprising at least on hydrophobic unit and at least one semi-crystalline polymer, as taught by LORANT, and to substitute or combine the AMPS polymer of L’ALLORET for their cosmetic properties and flexibility of formulation, and to utilize the polymeric emulsifier of HASE in an oil-in-water emulsion, as suggested by LORANT, and produce the instantly claimed invention because the inclusion of the polymeric emulsifier would have been expected to provide improved moisturizing effect on the users skin due to the polymeric emulsifier, along with improved properties in use such as stable against organic acids and high temperature stability, and further to include a skin whitening agent such as Vitamin C (derivatives).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Response to Arguments:
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Applicant argues that: “The present inventors have found that compositions comprising UV-screening agents, certain copolymers of behenyl acrylate and 2-hydroxyethyl acrylate and acrylamido-2-propanesulfonic acid copolymers surprisingly make it possible to obtain stable compositions having high SPF and improved cosmetic properties. After application to the skin, there is no shiny effect, and the skin is neither greasy nor tacky.” (p. 7, 3rd paragraph).
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that: “In addition, Lorant fails to disclose the copolymers of behenyl acrylate and 2-hydroxyethyl acrylate employed according to the present invention having a number-average molecular weight Mn ranging from 2000 to 9000 g/mol, a weight ratio of the 2-hydroxyethyl acrylate to the behenyl acrylate ranges from 1 :30 to 1: 1, and wherein the sum of the total units of the 2- hydroxyethyl acrylate and behenyl acrylate is 100% by weight of the weight of the one or more polymers.” (paragraph bridging pp. 8-9).
In response the examiner argus that LORANT clearly teaches that: “According to one particular embodiment of the invention, the semi-crystalline polymer is chosen from polymers derived from at least one monomer with a crystallizable chain chosen from C14-C24 alkyl (meth)acrylates, […] and copolymers of these monomers obtained by copolymerization of these monomers with a hydrophilic monomer, which is preferably other than methacrylic acid, for instance N-vinylpyrrolidone, hydroxyethyl acrylate, hydroxyethyl methacrylate or acrylic acid. Such copolymers may be, for example, copolymers of (C14-C24)alkyl acrylate, […] with N-vinylpyrrolidone, hydroxyethyl acrylate, hydroxyethyl methacrylate or acrylic acid, or mixtures thereof.” [emphasis added](p. 13, 3rd paragraph). The examiner notes that behenyl is (C22) and behenyl acrylate is therefore C22 alkyl acrylate which is expressly suggested as copolymerized with a hydrophilic monomer that includes hydroxyethyl acrylate. And further teaches that: “LORANT teaches that: “Advantageously, the semi-crystalline polymer (s) of the composition of the invention have a number-average molecular mass Mn greater than or equal to 2000, for example ranging from 2000 to 800 000, preferably from 3000 to 500 000, for example from 4000 to 150 000 and better still from 4000 to 99 000.” [emphasis added](p. 11, lines 10-15). And that: “For the purposes of the invention, the term "crystallizable chain or block" means a chain or block which, if it were alone, would pass reversibly from the amorphous state to the crystalline state, depending on whether it is above or below its melting point. For the purposes of the invention, a chain is a group of atoms, which is pendent or lateral relative to the polymer backbone. A block is a group of atoms belonging to the backbone, this group constituting one of the repeating units of the polymer.” (p. 11, lines 22-31). LORANT teaches that: “Preferably, the crystallizable blocks or chains of the semi-crystalline polymers represent at least 30% and better still at least 40% of the total weight of each polymer. The semi-crystalline polymers containing crystallizable blocks used according to the invention are block or multiblock polymers. They may be obtained by polymerization of monomers containing reactive double (or ethylenic bonds) or by polycondensation. When the polymers of the invention are polymers containing crystallizable side chains, they are advantageously in random or statistical form.” (p. 12, lines 7-17). And “The crystallizable side chains or blocks are hydrophobic.” (p. 12, lines 29-30). That is the C22 alkyl (behenyl) acrylate is considered the crystallizable blocks and is suggested to be at least 30% and still better at least 40% of the copolymer which implies a lower range for the hydrophilic block which is suggested to be hydroxyethyl acrylate. Therefore, while LORANT does not expressly teach behenyl acrylate / 2-hydroxyethyl acrylate copolymer this species including the molecular weight and the ratio of hydrophilic block (2-hydroxyethyl acrylate) to the hydrophobic block (C22 alkyl (behenyl) acrylate) is implicit (MPEP §2144.01).
Applicant further argues that: “Also, Lorant does not disclose that the semi-crystalline polymers are employed in the compositions as emulsifiers.” And that: “Furthermore, Examples 1, 2 and 6 of Lorant do not include a surfactant and are stable according to the invention therein.” And further that: “As mentioned above, Lorant discloses that the compositions may be free of emulsifying surfactants conventionally used in O/W emulsions or contain only a very small amount thereof.”
(p. 9, lines 4-8).
In response the examiner argues that: LORANT teaches that: “The amount of semi-crystalline polymer(s) in the composition of the invention may range, for example, from 0.1% to 5% by weight, preferably from 0.5% to 5% by weight and better still from 1% to 3% by weight relative to the total weight of the composition.” (p. 15, 1st paragraph)(instant claim 1, item a; instant claims 8 & 27 – amounts of item a). And “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP §2112.01(II). Additionally, the fact that LORANT clearly suggests copolymers including hydrophobic blocks and hydrophilic blocks, as discussed above would have clearly suggested to one of ordinary skill that it would have acted as an emulsifier because emulsifiers (or surfactants) include hydrophilic and hydrophobic groups where the hydrophilic groups are water-soluble and the hydrophobic groups are oil-soluble. Additionally, the instant claims are open to any “conventionally used” emulsifier or lack thereof, and further “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” (MPEP §2123).
Applicant argues that: “L'Alloret further discloses at paragraph [00193] that the emulsions prepared with the AMPS polymers and/or copolymers according to the invention therein may contain only 1 % by weight or less, and may even be free of emulsifying surfactants, while being stable during storage.” (p. 9, last paragraph). And that: “Therefore, the Examiner relied upon Hase for the disclosure of certain statistical copolymers of alkyl(meth) acrylates and hydroxyalkyl (meth)acrylates including copolymers of 2-hydroxyethylacrylate/behenyl acrylate as emulsifiers.” (p. 10, 3rd paragraph). And further that: “Hase is concerned solely with water-in-oil emulsions and the use of the copolymers of alkyl(meth) acrylates and hydroxyalkyl (meth)acrylates as water-in-oil emulsifiers. For instance, Hase explicitly distinguishes between oil-in-water emulsions and water-in-oil emulsions. For instance, see column 1, lines 15-21, which state the following: "In contrast to the production of oil-in-water emulsions, only a limited number of emulsifying agents are available for producing cosmetic emulsions of the water-in-oil type and, moreover, the best of these emulsifying agents are becoming increasingly scarce."” (p. 11, 2nd paragraph). And further that: “Also, see column 1, lines 53-58, which state the following: "One object of the present invention is the development of a cosmetic emulsion or cream of the water-in-oil type which can be prepared easily and safely from inexpensive materials without need for costly emulsifying equipment."” (p. 11, 3rd paragraph). And further that: “In addition, and directly opposite of Hase, the present invention is concerned with oil-in-water emulsions employing a defined anionic surfactant in the oil-in-water emulsifier system. In an attempt to justify adding the copolymers of copolymers of 2-hydroxyethylacrylate/behenyl acrylate from Hase, the Examiner suggested on page 20, to utilize the polymeric emulsifier of Hase in an oil-in-water emulsion, as suggested by Lorant, and produce the instantly claimed invention because the inclusion of the polymeric emulsifier would
have been expected to provide improved moisturizing effect on the users skin due to the polymeric emulsifier, along with improved properties in use such as stable against organic acids and high temperature stability, and further to include a skin whitening agent such as Vitamin C (derivatives).” (p. 11, paragraphs 4-5).
In response the examiner notes that the AMPS polymers and/or copolymers according to L’ALLORET correspond to item (c) of the instant claims (“The terms "AMPS" and "acrylamido-2-methylpropanesulfonic (acid)" are used equivalently in the present patent application.” – instant Specification, p. 5, lines 1-2). Where the amount of
In response the instantly rejected claims include not recite any specific amount of water distinguishing over HASE. And while oil-in-water is defined as an emulsion in which the oil is the dispersed phase, and water is the continuous phase therefore fairly implying at least greater than 50% water, HASE teaches that: “The amount of water to be incorporated can be 20% to 75% by weight, preferably 45% to 65% by weight, relative to the total cosmetic emulsion.” Applicants Declaration includes 45 % by weight relative to the total composition of WATER.
Additionally the examiner argues that it is clear from the teaching of LORANT that semi-crystalline polymers, such as the claimed copolymers of behenyl acrylate and 2-hydroxyethyl acrylate, are suitably used in oil-in-water emulsions. Therefore, the examiner maintains that one of ordinary skill in the art before the time of the claimed invention would have considered the combination of (a) one or more copolymers of behenyl acrylate and 2-hydroxyethyl acrylate, and (c) one or more copolymers of acrylamido-2-methylpropanesulfonic acid and one or more nonionic monomers, in a oil-in-water cosmetic composition as prima facie obvious per the teachings/disclosure of the cited prior art.
Furthermore, the examiner maintains that a person having an ordinary level of skill in the art is a person of ordinary creativity and is presumed to have known the relevant art at the relevant time (MPEP §2141-II(C)). In the instant case one of ordinary level of skill in the art pertaining to (cometic) emulsions would have clearly understood that an emulsifier such as the polymeric emulsifier of HASE could have been utilized in any emulsion system as an emulsifier as per LORANT. The examiner argues that it would have been prima facie obvious to include the polymeric emulsifiers taught by HASE in any emulsion system for the advantages conferred by the same. This is clearly evidenced by the LORANT reference which clearly teaches the alkyl acrylate polymers in oil-in-water emulsions. Therefore, this argument alone is considered insufficient to overcome the prima facie case of obviousness.
RANDEN is no longer relied upon and is therefore not relevant to the instant grounds of rejection. LORANT clearly teaches the copolymers according to instant claim 1 item (a) can be used in an oil-in-water emulsion – LORANT teaches oil-in-water emulsions containing hydrophilic polymer and a semi-crystalline polymer (title, see whole document), the “semi-crystalline polymer” being copolymers according to instant claim 1 item (a).
Applicant further argues that: “Furthermore, nothing in Hase would have led or motivated a person having ordinary skill in the art concerned with problems addressed by the present invention to add a water-in-oil copolymer emulsifier from Hase to the compositions of Lorant and have a reasonable expectation of achieving results obtainable by the present invention.” (p. 15, 3rd paragraph).
In response LORANT clearly discloses copolymers of C14-24 acrylate with hydroxyethyl acrylate (p. 13, 3rd paragraph) as a semi-crystalline copolymer species and that: “Specifically, even when they are rich in thickeners and waxy and/or pasty fatty substances and when they have a high viscosity with the consistency of a thick balm, these compositions provide a freshness effect that is experienced immediately on application, and, in addition, they do not leave any greasy or tacky residue on the skin after penetration.” (p. 3, lines 10-16). HASE clearly teaches the species 2-hydroxyethyl acrylate/behenyl acrylate 2:1 (Example 2, Table). Where behenyl acrylate is has a C22 carbon chain consistent with the disclosure of LORANT discussed above. The "specific disclosure, even in a list, makes this case different from cases involving disclosure of a broad genus." Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005).
Applicant further argues that “The cited art does not provide a reasonable expectation of reaching the present invention of providing the improved and unexpected results achievable by the present invention.” (p. 15, last paragraph). And particularly that: “Nevertheless, the Declaration under 37 CFR § 1.132 by Dr. Martin JASSO (hereinafter also referred to as the "Jasso Declaration") and the test data in the specification, demonstrate that the results achievable by the present invention are unexpected and surprising. As requested in the Office Action, attached is a more legible copy of the Jasso Declaration. Also attached is the legible copy of the Table to the Declaration.” (p. 17, 1st paragraph). Applicant specifically argues that: “Test 10 comprises Aristoflex HMS and test 14 comprises Sepinov EMT-10, which are according to the present invention. Test 13 comprises Synthalen K, which is a comparative example. As verified by the Jasso Declaration, the compositions according to the invention (tests 10 and 14) are stable at 2 months 4°C and room temperature, but the comparative composition (test 13) was not stable. Surprisingly, significant improved stability (acceptable limit) at 2 months 45°C was achieved for the present invention compared to instability for the comparative example as stated in paragraph 11 of the Declaration.” (paragraph bridging pp. 15-16).
In response the examiner firstly appreciates Applicants providing a legible copy. According to the instant Specification Aristoflex HMS is INCI name: Ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer (p. 11, last paragraph). Sepinov EMT-10 does not appear to be disclosed however, “Simulgel NS® by the company SEPPIC (CTFA name: Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer” (paragraph bridging pp. 9-10) is described and appears to be consistent with “Sepinov EMT-10” (Applicant should confirm how tradenames correspond to Species in Declaration Table, and how exactly these species correspond to the instant claims).
In response to the result, the examiner first argues that the results are clearly not commensurate with the claims because the claims are not limited to these species and Applicant has not explained how the results should be considered to extend to a reasonable number of species within the scope of the claims supporting the same, and the amounts of the indicated species is only 0.5 weight percent of the total composition where these items correspond to item (c) the “one or more copolymers of acryloamido-2-methylpropanesulfonic acid and of one or more nonionic monomers”. And secondly, the results showing stability do not appear to be surprising or unexpected, particularly as L’ALLORET teaches that: “These acrylamido-2-methylpropanesulfonic acid polymers are particularly suitable in the manufacture of emulsions. They make it possible to obtain stable formulations within a broad range of texture and consistency ranging from milks to thickened creams.” ([0012]). Additionally, LORANT teaches: “The invention relates to a composition for topical application, in the form of an O/W emulsion containing at least one crosslinked 2-acrylamido-2-methylpropane- sulfonic acid polymer comprising at least one hydrophobic unit, and at least one semicrystalline polymer. The composition obtained has very good stability, and also good cosmetic properties.” [emphasis added](abstract).
Applicant further argues that: “The tacky, shiny and greasy effects of the compositions are evaluated by a panel of sensory experts. Each composition is applied to the forearm at a dose of 2 mg/cm2. The product is spread by circular movements until it has penetrated (approximately 30 seconds). The tacky, shiny and greasy effects are evaluated after 2 minutes of drying, by applying the back of the hand to the treated area, according to a scale ranging from 1 to 15 in which 1 constitutes a reference that is not very tacky or not very shiny or not very greasy, and 15 constitutes a reference that is very tacky or very shiny or very greasy.” (p. 16, 4th paragraph). And that: “By way of example, please see the comparison of invention Example 5 to Examples 6 and 7 at pages 39-42 of the specification. Example 5 contains a polymer a) comprising a copolymer of behenyl acrylate and 2-hydroxyethyl acrylate according to the present invention was compared with compositions comprising either another polymer (Example 6) or a surfactant system (Example 7).” (paragraph bridging pp. 18-19). And further that: “Composition 5 according to the invention is fine, smooth, homogeneous and glossy. It does not show any crystals under polarized light. It is stable over time (2 months of storage at 45°C). Contrary to this Compositions 6 and 7 are non-compliant at T0: they show release of oil. Also, Composition 5 has excellent bioavailability of the resveratrol.” (p. 19, 3rd paragraph).
In response the examiner argues that LORANT clearly teaches that their invention results in stable O/W emulsions that have good cosmetic properties (p. 2, last paragraph), and specifically “they do not leave any greasy or tacky residue on the skin after penetration” (p. 3, lines 15-16) therefore the results do not appear
MPEP 716.02(d) requires that any unexpected results be commensurate in scope with the claimed invention. Where the examiner cannot determine exactly what “Polymer 1” is, and more particularly where in the scope of claim 1 item (a) the Polymer 1 falls. Similarly for Applicants declaration is not clear which species of “one or more polymers selected from copolymers of behenyl acrylate and 2-hydroxyethyl acrylate having a number-average molecular weight Mn ranging from 2000 to 9000 g/mol, and wherein the weight ratio of the 2-hydroxyethyl acrylate to the behenyl acrylate ranges from 1:30 to 1:1” is exemplified. And the amounts of items (a) and (c) claim 1 are 3.00 and 0.5/0.6 weight percent relative to the total compositions whereas in claim 1, item (a) is from 0.2% to 8% and item (c) is 0.1% to 10%. Therefore, results are clearly not commensurate with the claims.
Additionally, each of the cited references is clearly directed at skin-contacting products including cosmetics and/or personal care products, therefore the emulsifiers are prima facie combinable based on the common use in skin-contacting products. A reasonable expectation of success is just that: “Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness.” (MPEP §2143.02). In the instant case a person having ordinary skill in the art would have clearly recognized that emulsifiers have the function of emulsification in emulsions in skin-contacting products. Therefore, predictability is not lacking in the instant case as Applicants are using an emulsifier to emulsify (cosmetic) oil-in-water (emulsion) composition. Additionally, the prior art references or combinations of the same need not teach Applicants actual results to support a prima facie case of obviousness with a reasonable expectation of success in their combination as any motivation, including motivation(s) other than applicants can support a prima facie case of obviousness (MPEP §2144-IV) and the simple recognition of latent properties in a composition of the prior art (i.e. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” - MPEP §2145-II)(Applicant argues that: “The cited art fails to provide a reasonable expectation of reaching the present invention of providing the improved and unexpected results achievable by the present invention.” - p. 13, 4th paragraph).
Although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989); Richardson-Vicks, Inc., v. The Upjohn Co., 122 F.3d 1476, 1484, 44 USPQ2d 1181, 1187 (Fed. Cir. 1997). Applicant is reminded that the submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed. Cir. 1987).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 8-11, 15-19, 23-25 and 27-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 29-48 of U.S. Patent No. 6,905,674 (hereafter ‘674) in view of in view of HASE (US 4,128,635; published December, 1978) and LORANT (WO 2007/141142 A1; published December, 2007).
Instant claim 1 is discussed above.
‘674 claim 1 recites a photoprotective composition comprising at least one aqueous phase, at least one oily phase, at least one partially or completely neutralized, crosslinked or non-crosslinked water-soluble or water-dispersible acrylamido-2-methylpropanesulfonic acid (AMPS) polymer and at least one UV radiation-screening system, said at least one screening system comprising at least one 4,4-diarylbutadiene UV-A-screening agent. ‘674 claim 14 recites the photoprotective composition as defined by claim 13, the water-dispersible copolymer of AMPS being selected from among ammonium acryloyldimethyltaurate/VP copolymer (instant claim 1, item c). The claims of ‘674 further include a UV-A sunscreening agent (claim 40) including dibenzoylmethane derivatives (claim 41), and particularly butyl methoxydibenzoylmethan (claim 41). And further claims the compositions are oil-in-water compositions (claim 48).
The difference between the instantly rejected claims and the claims of ‘674 is that the claim of ‘674 do not expressly claim the inclusion a polymeric emulsifier such as taught by HASE.
LORANT teaches O/W emulsions comprising an oily phase dispersed in an aqueous phase, characterized in that it contains at least one crosslinked polymer of 2-acrylamido-2-methylpropane-sulfonic acid comprising at least one hydrophobic unit, and at least one semi-crystalline polymer, as discussed above and incorporated herein by reference.
HASE teaches polymeric emulsifiers including 2-hydroxyethyl acrylate and behenyl acrylate monomers, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of ‘674 because the claims include the same UV-screening agent(s) in combination with one or more polymers of acrylamido-2-methylpropanesulfonic acid and of one or more nonionic monomers (instant claim 1, items b & c). The skilled artisan would have been motivated to modify the claims of ‘674 and produce the instantly rejected claim because HASE/LORANT teaches the improved skin moisturization of their polymeric emulsifiers which would have been useful in formulating an oil-in-water emulsion. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill in the art to simply combine in an oil-in-water emulsion the constituents of HASE/LORANT with the claims of ‘674 to produce the same.
Response to Arguments:
Applicant's arguments filed 10/14/2024 have been fully considered but they are not persuasive.
Regarding the obvious-type double patenting rejection over U.S. 6,905,674, Applicant argues that: “Therefore, the above discussions of Lorant, L'Alloret, and Hase are incorporated herein by reference in the spirit of linguistic brevity. Accordingly, this rejection should be withdrawn for at least those reasons as to why independent claim 1 and claims dependent thereon are patentable over these references.” (p. 25, 5th paragraph). In response the examiner has addressed Applicants arguments over the obviousness rejection above. Applicant further makes arguments regarding addition of extra work to “a know, successfully marketed formulation” which is not consistent with any evidence of record (p. 25, last paragraph).
Conclusion
Claims 1, 8-11, 15-19, 23-25 and 27-29 are pending and have been examined on the merits. Claims 1, 8-11, 15-19, 23-25 and 27-29 remain rejected under 35 U.S.C. 103; and claims remain rejected based on Obvious-type Double Patenting over claims of U.S Patent Nos. 6,905,674. No claims allowed at this time.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619