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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/28/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-13 and 15-20 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.
The term “effective amount” in claim 1 is a relative term which renders the claim indefinite. The term “effective amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the specification states “effective amount” refers to “a sufficient amount of the active ingredient specified to provide the sought effect” on page 7, the Examiner will not be considering the limitation of an “effective amount” because it is unclear what the amount would be effective against or the identity of the sought effect. Clarification by amendment of claim 1 is required.
The phrase “R1, R2, R4, R5, R6, R7, R9, and R10 are a radical independently selected from the group consisting of H, hydroxy, amino, (C1-Ce)-alkyl, (C1-Ce)-alkoxy, (C1-Ce)-alkylamino, and (C1-Ce)-dialkylamino” renders claim 1 indefinite. It is not possible for all R groups simultaneously to have a radical, and it is unclear in both the claim and specification if only one group, multiple groups, or all groups have a radical. Additionally, it is not chemically possible for a hydrogen to be a radical. The structure as drawn also does not specify the presence of a radical at all. The Examiner will be interpreting the claim without the presence of a radical. Clarification by amendment of claim 1 is required.
Claims 2-13 and 15-20 are rejected for being dependent on an indefinite claim.
The phrase “R1, R2, R4, R5, R6, R7, R9, and R10 are a radical independently selected from the group consisting of H, hydroxy, amino, and methyl” renders claim 3 indefinite. It is not possible for all R groups simultaneously to have a radical, and it is unclear in both the claim and specification if only one group, multiple groups, or all groups have a radical. Additionally, it is not chemically possible for a hydrogen to be a radical. The Examiner will be interpreting the claim without the presence of a radical. Clarification by amendment of claim 3 is required.
Claim 5 is rejected for being dependent on indefinite claims.
The phrase “R1, R2, R4, R5, R6, R7, R9, and R10 are a radical independently selected from the group consisting of H, hydroxy, amino, (C1-Ce)-alkyl, (C1-Ce)-alkoxy, (C1-Ce)-alkylamino, and (C1-Ce)-dialkylamino” renders claim 15 indefinite. It is not possible for all R groups simultaneously to have a radical, and it is unclear in both the claim and specification if only one group, multiple groups, or all groups have a radical. Additionally, it is not chemically possible for a hydrogen to be a radical. The structure as drawn also does not specify the presence of a radical at all. The Examiner will be interpreting the claim without the presence of a radical. Clarification by amendment of claim 15 is required.
The term “effective amount” in claim 16 is a relative term which renders the claim indefinite. The term “effective amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the specification states “effective amount” refers to “a sufficient amount of the active ingredient specified to provide the sought effect” on page 7, the Examiner will not be considering the limitation of an “effective amount” because it is unclear what the amount would be effective against or the identity of the sought effect. Clarification by amendment of claim 16 is required.
The phrase “R1, R2, R4, R5, R6, R7, R9, and R10 are a radical independently selected from the group consisting of H, hydroxy, amino, and methyl” renders claim 17 indefinite. It is not possible for all R groups simultaneously to have a radical, and it is unclear in both the claim and specification if only one group, multiple groups, or all groups have a radical. Additionally, it is not chemically possible for a hydrogen to be a radical. The structure as drawn also does not specify the presence of a radical at all. The Examiner will be interpreting the claim without the presence of a radical. Clarification by amendment of claim 17 is required.
Claims 18-20 are rejected for being dependent on indefinite claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borchers et al. (WO 2017129432 A1) (hereinafter Borchers), in further view of Bertz et al. (WO 2005009341 A2) (hereinafter Bertz).
Regarding claim 1, Borchers teaches a cosmetic preparation that contains compound 1. Compound 1 reads on the claimed “Formula (I),” where “R’ is selected from H,” “R1, R2, R4, R5, R6, R7, R9, and R10 are independently selected from the group consisting of H,” and “R3 and R8 are independently selected from the group consisting of (C1-C6)-alkyl, (C1-C6)- alkoxy” (Claim 1, page 1). Borchers also teaches preparation contains one or more emulsifiers selected from the group of the compounds glyceryl stearate citrate, glyceryl stearate (self-emulsifying), stearic acid, stearate salts, polyglyceryl-3-methylglycose distearate, sodium cetearylsulfate, sodium staroylglutamate, polyglyceryl-10 stearate, cetearyl alcohol, cetearyl sulfosuccinate, potassium cetyl phosphate (page 4). It is noted that emulsifiers reads on the claimed “one or more pharmaceutically or cosmetically acceptable excipients or carriers.”
Regarding claim 2, Borchers teaches a cosmetic preparation that contains compound 1 (Claim 1, page 1). Compound 1 reads on the claimed “R’ is selected from H.”
Regarding claim 3, Borchers teaches a cosmetic preparation that contains compound 1 (Claim 1, page 1). Compound 1 reads on the claimed “R1, R2, R4, R5, R6, R7, R9, and R10 are independently selected from the group consisting of H.”
Regarding claim 4, Borchers teaches a cosmetic preparation that contains compound 1 (Claim 1, page 1). Compound 1 reads on the claimed “R2, R4, R7, and R9, are H.”
Regarding claim 5, Borchers teaches a cosmetic preparation that contains compound 1 (Claim 1, page 1). Compound 1 reads on the claimed “R', R1, R2, R4, R5, Rs, R7, R9, and R10 are H; R3 is tert-butyl and R8 is methoxyl.”
Regarding claims 7 and 13, Borchers teaches it is advantageous according to the invention if the cosmetic preparation contains compound 1 in a concentration of 0.1 to 6% by weight, based on the total weight of the preparation (page 3). It is noted that compound 1 reads on the claimed “Formula (I)” and “methoxyphenylethenyl t-butylbenzoate.”
Regarding claims 10 and 12, Borchers teaches the preparation according to the invention can advantageously contain one or more dialkyl adipates (page 3). Embodiments of the present invention which are advantageous according to the invention are characterized in that one or more dialkyl adipates are selected from the group of the compounds dimethyl adipate, diethyl adipate, dipropyl adipate, diisopropyl adipate (page 3).
Regarding claims 8 and 13, Borchers teaches according to the invention, particularly advantageous embodiments of the present invention are characterized in that the preparation contains one or more UV filters which are selected from the group of the compounds 2-phenylbenzimidazole-5-sulfonic acid and/or salts thereof; phenylene-1,4-bis (2-benzimidazyl) -3,3'-5,5'-tetrasulfonic acid salts; 1,4-di (2-oxo-10-sulfo-3-bomylidenemethyl) benzene and its salts; 4- (2-oxo-3-bomylidenemethyl) benzenesulfonic acid salts; 2-methyl-5- (2-oxo-3-bornylidenemethyl) sulfonic acid salts; 2,2'-methylenebis (6- (2H-benzotriazol-2-yl) -4- (1,1,3,3-tetramethylbutyl) -phenol); 2- (2H-Benzotriazol-2-yl) -4-methyl-6- [2-methyl-3- [1,3,3,3-tetramethyl-1 - [(trimethylsilyl) oxy] disiloxanyl] propyl] phenol ; 3- (4-methylbenzylidene) camphor; 3-benzylidenecamphor; ethylhexyl salicylate; terephthalidendicamphersulfonsäure; 2-ethylhexyl-2-cyano-3,3-diphenylacrylate; 2-ethylhexyl 4- (dimethylamino) benzoate; 4- (dimethylamino) benzoic acid amyl ester; Di (2-ethylhexyl) -4-methoxybenzalmalonate; 4-methoxycinnamate (2-ethylhexyl) ester; 4-methoxycinnamic acid isoamyl ester; 2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxy-4'-methylbenzophenone; 2,2'-dihydroxy-4-methoxybenzophenone; homomenthyl; 2-ethylhexyl 2-hydroxybenzoate; dimethicodiethylbenzalmalonate; 3- (4- (2,2-ethoxycarbonylvinyl) phenoxy) propenyl) methoxysiloxane/dimethylsiloxane copolymer; 4- (tert-butyl) -4'-methoxydibenzoylmethane; 2- (4'-diethylamino-2'-hydroxybenzoyl) benzoate; dioctylbutylamidotriazone (INCI: diethylhexyl-butamidotriazone); 2,4-bis- [5-1 (dimethylpropyl) benzoxazol-2-yl- (4-phenyl) -imino] -6- (2-ethylhexyl) -imino-1,3,5-triazine with the CAS no. 288254-16-0); 2,4-Bis - {[4- (2-ethyl-hexyloxy) -2-hydroxy] -phenyl} -6- (4-methoxyphenyl) -1, 3,5-triazine (INCI: bis-ethylhexyloxyphenol methoxyphenyl triazine) ; 4,4 ', 4 "- (1,3,5-triazine-2,4,6-triyltriimino) -tris-benzoic acid tris (2-ethylhexyl ester) (also: 2,4,6-tris [anilino] (p-carbo-2'-ethyl-1'-hexyloxy)] - 1, 3,5-triazine (INCI: ethylhexyl triazone); 2,4,6-tribiphenyl-4-yl-1,3,5-triazine; merocyanines; titanium dioxide; ainc oxide (page 4). Furthermore, examples 1-5 all include butyl methoxydibenzoylmethane (page 7). It is noted that the UV filters read on the claims “UV sunscreen active agent.” It is also noted that bis-ethylhexyloxyphenol methoxyphenyl triazines read on the claimed “UVA/UVB sunscreen active agent.” It is also noted that 2-ethylhexyl 2-hydroxybenzoate (INCI: ethylhexyl salicylate) reads on the claimed “UVB sunscreen active agent” and butyl methoxydibenzoylmethane reads on the claimed “UVA sunscreen agent.”
Regarding claim 15, Borchers teaches in sunscreens, 4- (tert-butyl) -4'-methoxydibenzoylmethane is usually used as UV filter (page 2). However, this UV filter has the known disadvantage of not being particularly photostable on its own, but slowly decomposing under UV-B radiation in particular (page 2). Borchers also teaches a new approach to solve this problem is to use chemical precursors of 4-(tert-butyl) -4'-methoxydibenzoylmethane that can covert under sunlight to 4-(tert-butyl) -4'-methoxydibenzoylmethane (page 2). However, a disadvantage of this approach is the fact that the precursors only relatively slowly and incompletely convert into the 4- (tert-butyl) -4'-methoxydibenzoylmethane (page 2). Borchers teaches a faster photochemical conversion is achieved when tricyclodecanmethyl isononanoate is added to a cosmetic formulation (page 2). It is noted that Borcher teaches the conversion of compound I to 4-(tert-butyl) -4'-methoxydibenzoylmethane, which reads on the claimed “Formula I to Formula II.” It is noted that 4- (tert-butyl) -4'-methoxydibenzoylmethane reads on the claimed “R' is selected from the group consisting of H,” “R1, R2, R4, R5, R6, R7, R9, and R10 are selected from the group consisting of H,” and “R3 and R8 are independently selected from the group consisting of (C1-C6)-alkyl and (C1-C6)- alkoxy.”
Regarding claim 16, Borchers teaches according to the invention, the use of the preparation according to the invention for protection against skin aging (in particular for protection against UV-induced skin aging) and as sunscreens (page 5). In addition, Borcher teaches the preparations according to the invention lead to a significantly reduced textile stain (yellowing), as is the case with preparations which contain an equivalent amount of 4- (tert-butyl) -4'-methoxydibenzoylmethane, if the preparations come into contact with textiles after use on the skin (page 2). It is noted that protection against UV-induced skin aging reads on the claimed “protecting a human or animal living body from UV radiation” and the use on the skin and use as sunscreens read on the claimed “treating said human or animal living body with the composition.”
Regarding claim 17, 4- (tert-butyl) -4'-methoxydibenzoylmethane reads on the claimed “R1, R2, R4, R5, R6, R7, R9, and R10 are selected from the group consisting of H.”
Regarding claim 18, 4- (tert-butyl) -4'-methoxydibenzoylmethane reads on the claimed “wherein R2, R4, R7, and R9 are H.”
Regarding claim 19, 4- (tert-butyl) -4'-methoxydibenzoylmethane reads on the claimed “wherein R', R1, R2, R4, R5, R6, R7, R9, and R10 are H; R3 is tert-butyl and R8 is methoxyl.”
However, Borchers does not teach a phenylethyl ester selected from the group consisting of phenethyl benzoate, 2-phenylethyl toluate, di-2-phenylethyl phthalate, and 1-phenylethyl benzoate of claims 1 and 15. Borchers also does not teach wherein the phenylethyl ester is phenethyl benzoate of claims 6 and 20. Borchers also does not teach the phenylethyl ester is in an amount from 0.1 wt.% to 40 wt.% of claims 7 and 13.
Bertz teaches a sunscreen composition containing UVA and/or UVB compounds solubilized by a phenylethyl ester, such as an aryl carboxylic ester of 2-phenylethyl alcohol, e.g. 2-phenylethyl benzoate, 2-phenylethyl toluate or di-2-phenylethyl phthalate (page 3). In preferred forms of the invention, the phenylethyl ester is 2-phenylethyl benzoate, toluate or phthalate (page 4). It is noted that 2-phenylethyl benzoate reads on the claimed “phenethyl benzoate.”
It would have been obvious for one of ordinary skill in the art to use 2-phenylethyl benzoate in the composition of Borchers to produce the claimed invention. It would have been obvious to do so because both Borchers and Bertz are commonly drawn to sunscreen compositions with aromatic sunscreen actives. Additionally, Bertz provides the motivation to do so by teaching that sunscreen containing aromatic compounds, such as avobenzone or benzophenone-3, require a solubilization agent to keep an emulsion and to prevent crystallization (page 1). Furthermore, Bertz identifies phenylethyl ester as a safe and effective solvent (page 3). Thus, an ordinary artisan would have followed this teaching motivation to yield the claimed invention with an effective amount of phenethyl benzoate (See MPEP 2143(I)(G)).
It also would have been obvious for one of ordinary skill in the art to optimize the amount of 2-phenylethyl benzoate in the modified composition of Borchers to produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Bertz provided the guidance to do so by teaching 2-phenylethyl benzoate in a 10 wt/wt% in the broad-spectrum UVA/UVB sunscreen formulation in Table 3 (page 17), which lies within the claimed range an amount from 0.1 wt.% to 40 wt.%. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of phenylethyl benzoate in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Furthermore, Borchers does not explicitly teach the UV sunscreen active agent is in an amount from 0.1 wt.% to 50 wt.% of claim 9. Borchers also does not explicitly teach the emollient other than the phenylethyl ester is in an amount from 0.5 wt.% to 35 wt.% of claim 11 or the dialkyl adipate is in an amount from 0.5 wt.% to 35 wt.% of claim 13. Borchers also does not explicitly teach the UVB absorber is in an amount from 0.1 wt.% to 25 wt.%, the UVA absorber is in an amount from 0.1 wt.% to 15 wt.%, and the UVA/UVB absorber is in an amount from 0.1 wt.% to 15 wt.% of claim 13. It is noted that the UV filters read on the claims “UV sunscreen active agent.” It is also noted that bis-ethylhexyloxyphenol methoxyphenyl triazines read on the claimed “UVA/UVB sunscreen active agent.” It is also noted that that 2-ethylhexyl 2-hydroxybenzoate (INCI: ethylhexyl salicylate) reads on the claimed “UVB sunscreen active agent” and butyl methoxydibenzoylmethane reads on the claimed “UVA sunscreen agent.” It is also noted that dialkyl adipate reads on the claimed “emollient.”
It would have been obvious for one of ordinary skill in the art to optimize the amount of UV filter in the composition of Borchers to produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Borchers provided the guidance to do so by teaching if the preparation contains both salicylates, it is advantageous according to the invention 2-ethylhexyl 2-hydroxybenzoate (INCI: ethylhexyl salicylate) in a concentration of 2 to 5% by weight, which overlaps with the claimed range 0.1 wt.% to 50 wt.% of claim 9 and the 0.1 wt.% to 25 wt.% amount of UVB absorber of claim 13. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the UV sunscreen active agent and UVB absorber in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
It would also have been obvious for one of ordinary skill in the art to optimize the amount of UV filter in the composition of Borchers to produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Borchers provided the guidance to do so by teaching bis-ethylhexyloxyphenol methoxyphenyl triazines in an amount of 2 to 5% by weight, which overlaps with the claimed range 0.1 wt.% to 15 wt.% of claim 13. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the UVA/UVB absorber in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
It would also have been obvious for one of ordinary skill in the art to optimize the amount of UV filter in the composition of Borchers to produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Borchers provided the guidance to do so by teaching examples 1-5 that comprise butyl methoxydibenzoylmethane in the amounts 0.50, 1.50, 2.50, and 5.00 wt%, which lie within the claimed range 0.1 wt.% to 15 wt.% of claim 13. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the UVA absorber in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
It would have been obvious for one of ordinary skill in the art to optimize the amount of dialkyl adipates in the composition of Borchers to produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Borchers provided the guidance to do so by teaching the total concentration of dialkyl adipates in the preparation is from 0.5 to 3% by weight, based on the total weight of the preparation, which overlaps with the claimed range 0.5 wt.% to 35 wt.% of claims 11 and 13. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the dialkyl adipate in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
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 was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
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/E.L.K./ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614