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 .
This action is in response to the amendment filed 11/03/2025, in which claims 29, 35, 36 and 56 were amended, claims 37-44 and 51-55 were previously presented and claims 1-28, 30-34 and 45-50 were previously canceled. Claims 29, 35-44 and 51-56 are currently pending.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn. This action is FINAL.
Response to Amendments - Claim Rejections - 35 USC § 102
The rejection of claims 29, 35-39, 41-43 and 56 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bancel et al (US 2015/0064236 A1) has been withdrawn in view of Applicant' s amendment to the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 29, 35-39, 40-44 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Dajee et al (WO 2006/03443 A2) in view of Hoge et al (US 2016/0194368 A1; Cited in a previous action). This is a NEW Rejection necessitated by the amendment filed on 11/03/2025.
Regarding claim 29, 35 and 36, Dajee teaches a composition for delivering polynucleotide to cell comprising a polynucleotide and ethanol at a concentration of about 1 % to 60% (p.11, 6th para.). The composition can be a gel, an aqueous solution, or aqueous suspension (p.11). The aqueous solution of Dajee is considered to meet a viscosity that is about the same as water of claim 43 (p. 12). Dajee teaches the formulation is for topical administration (p.2, p.25). Dajee exemplifies the ethanol concentration being about 2.5%, 5%, 10% where the percentage of ethanol taught by Dajee is by weight (p.11). The ethanol concentration of 1 %, 5% or 10% by weight can be converted to volume weight based on the weight of ethanol and water being 0.789g/ml and 1 g/ml, and they would be about 1.3%, 6.3% or 12.7% by volume. Dajee teaches that the term "polynucleotide" refers to any modified or unmodified RNA or DNA including for example, the polynucleotide defined herein including, not limited to, single-stranded and double-stranded DNA, a single-stranded and double-stranded region of DNA, single-stranded and double-stranded RNA, and RNA-containing single-stranded and double-stranded regions, hybrid molecules comprising DNA and RNA, the hybrid molecule can be single-stranded or double-stranded molecules are more common, or includes single-stranded and double-stranded regions as well as includes DNAs (including cDNAs) and RNAs that contain one or more modified bases (p.19, 2nd para.).
Dajee does not teach the polyribonucleotide is circular.
Hoge et al. teach a composition comprising circular RNA that encodes polypeptide including therapeutic proteins (para. 97-98). Hoge et al. teach that the composition can be a topical or transdermal formulation (paras. 725-726), and it can be in the form of creams or gels, lotion (para. 727-728). Hoge et al teaches that analysis of circRNA and their associated linear mRNAs revealed that the circRNA isoforms were highly stable, with transcript half-lives exceeding 48 hours, while the associated linear transcripts exhibited half-lives of less than 20 hours (Para. 0004).
It would have been obvious to a person skilled in the art to substitute the polynucleotide in the formulation taught by Dajee et al. with the circular mRNA as taught by Hoge et al. to provide a formulation capable of producing therapeutic proteins in a subject in need thereof with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated use the formulation of Dajee et al. for circular mRNA because the formulation of Dajee et al. is suitable for delivery of any polynucleotide including RNA and DNA, and thus, it would be considered as a suitable delivery tool for circular mRNA taught by Hoge et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Regarding claims 37-39, Dajee teaches a composition for delivering polynucleotide to cell comprising a polynucleotide and ethanol at a concentration of about 1 % to 60% (p.11, 6th para.).
Regarding claim 40, Dajee does not teach the circular polyribonucleotide encodes a cosmetic protein or peptide selected from the group consisting of collagen, keratin, elastin and botulinum toxin or any fragment thereof.
Hoge teaches the use of circular RNA for cosmetic composition purpose [0725-0726].
Hoge teaches the cosmetic composition contains ethanol [0644]. Hoge teaches the use of botulinum in the cosmetic composition for delivery to the skin for improvement in the skin [0865]. Hoge teaches that the cosmetic composition is effective for treatment of multiple conditions/diseases such as psoriasis, wounds, wrinkles and eczema [0867].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Dajee to include a protein or peptide as a cosmetic composition that would help improve the skin of an individual taught by Hoge because Dajee teaches it is within the ordinary skill in the art to use a composition comprising a mixture of circular polyribonucleotide encoding a polypeptide and an alcohol, wherein the alcohol constitutes 1&, 2.5%, 5% and/or 10% v/v of the mixture and Hoge teaches the use of a circular RNA polynucleotide along with ethanol as a cosmetic composition with the addition of botulinum toxin to be administered to individuals for skin improvement.
One would have been motivated to make such a modification in order to receive the expected benefit of adding a known protein successful in improvement of the skin, such as for wound healing, as taught by Hoge.
Regarding claim 41, Dajee teaches a composition for delivering polynucleotide to cell comprising a polynucleotide and ethanol at a concentration of about 1 % to 60% (p.11, 6th para.). The composition can be a gel, an aqueous solution, or aqueous suspension (p.11).
Regarding claim 42, Dajee teaches that the term "polynucleotide" refers to any modified RNA or DNA including for example, the polynucleotide defined herein including, not limited to, single-stranded and double-stranded RNA, and RNA-containing single-stranded and double-stranded regions, hybrid molecules comprising DNA and RNA, the hybrid molecule can be single-stranded or double-stranded molecules are more common, or includes single-stranded and double-stranded regions as well as includes DNAs (including cDNAs) and RNAs that contain one or more modified bases (p.19, 2nd para.).
Dajee does not teach the polyribonucleotide is circular.
Hoge et al. teach a composition comprising circular RNA that encodes polypeptide including therapeutic proteins (para. 97-98). Hoge et al. teach that the composition can be a topical or transdermal formulation (paras. 725-726), and it can be in the form of creams or gels, lotion (para. 727-728). Hoge et al teaches that analysis of circRNA and their associated linear mRNAs revealed that the circRNA isoforms were highly stable, with transcript half-lives exceeding 48 hours, while the associated linear transcripts exhibited half-lives of less than 20 hours (Para. 0004). Due to Hoge et al teaching the use of circular RNA, the construct is covalently closed and therefore would not have a 5’ cap.
It would have been obvious to a person skilled in the art to use the formulation taught by Dajee et al. utilizing ethanol for delivery of the circular mRNA wherein the circular RNA lacks a 5’ cap as taught by Hoge et al to produce therapeutic proteins in a subject in need thereof with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated use the formulation of Dajee et al. for circular mRNA because the formulation of Dajee et al. is suitable for delivery of any polynucleotide including RNA and DNA, and thus, it would be considered as a suitable delivery tool for circular mRNA taught by Hoge et al. in the absence of any evidence that the circular nucleic acid is not being delivered by the formulation of Dajee et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Regarding claim 43, Dajee teaches a composition for delivering polynucleotide to cell comprising a polynucleotide and ethanol at a concentration of about 1 % to 60% (p.11, 6th para.). The composition can be a gel, an aqueous solution, or aqueous suspension (p.11). The aqueous solution of Dajee is considered to meet a viscosity that is about the same as water of claim 43 (p. 12). Dajee teaches the formulation is for topical administration (p.2, p.25). Dajee exemplifies the ethanol concentration being about 2.5%, 5%, 10% where the percentage of ethanol taught by Dajee is by weight (p.11). The ethanol concentration of 1 %, 5% or 10% by weight can be converted to volume weight based on the weight of ethanol and water being 0.789g/ml and 1 g/ml, and they would be about 1.3%, 6.3% or 12.7% by volume.
Regarding claim 44, Dajee does not teach the composition is an anti-wrinkle composition.
Hoge teaches the use of circular RNA for cosmetic composition purpose [0725-0726]. Hoge teaches the cosmetic composition contains ethanol [0644]. Hoge teaches the use of botulinum in the cosmetic composition for delivery to the skin for improvement in the skin [0865]. Hoge teaches that the cosmetic composition is effective for treatment of multiple conditions/diseases such as psoriasis, wounds, wrinkles and eczema [1019].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Dajee to include a protein or peptide as a cosmetic composition that would help improve the skin of an individual taught by Hoge because Dajee teaches it is within the ordinary skill in the art to use a composition comprising a mixture of circular polyribonucleotide encoding a polypeptide and an alcohol, wherein the alcohol constitutes 1&, 2.5%, 5% and/or 10% v/v of the mixture and Hoge teaches the use of a circular RNA polynucleotide along with ethanol as a cosmetic composition with the addition of botulinum toxin to be administered to individuals for skin improvement.
One would have been motivated to make such a modification in order to receive the expected benefit of adding a known protein successful in improvement of the skin, such as for anti-wrinkle ability, as taught by Hoge.
Regarding claim 56, Dajee teaches a composition for delivering polynucleotide to cell comprising a polynucleotide and ethanol at a concentration of about 1 % to 60% (p.11, 6th para.). The composition can be a gel, an aqueous solution, or aqueous suspension (p.11). The aqueous solution of Dajee is considered to meet a viscosity that is about the same as water of claim 43 (p. 12). Dajee teaches the formulation is for topical administration (p.2, p.25). Dajee exemplifies the ethanol concentration being about 2.5%, 5%, 10% where the percentage of ethanol taught by Dajee is by weight (p.11). The ethanol concentration of 1 %, 5% or 10% by weight can be converted to volume weight based on the weight of ethanol and water being 0.789g/ml and 1 g/ml, and they would be about 1.3%, 6.3% or 12.7% by volume. Dajee teaches that the term "polynucleotide" refers to any modified or unmodified RNA or DNA including for example, the polynucleotide defined herein including, not limited to, single-stranded and double-stranded DNA, a single-stranded and double-stranded region of DNA, single-stranded and double-stranded RNA, and RNA-containing single-stranded and double-stranded regions, hybrid molecules comprising DNA and RNA, the hybrid molecule can be single-stranded or double-stranded molecules are more common, or includes single-stranded and double-stranded regions as well as includes DNAs (including cDNAs) and RNAs that contain one or more modified bases (p.19, 2nd para.). Dajee teaches the dsODN molecule comprises two oligodeoxynucleotide strands that are covalently attached to each other at either the 3' or the 5' end, or both, resulting in a dumbbell structure, or a circular molecule (p. 12, 6th para.).
Dajee does not teach the polyribonucleotide is circular.
Hoge et al. teach a composition comprising circular RNA that encodes polypeptide including therapeutic proteins (para. 97-98). Hoge et al. teach that the composition can be a topical or transdermal formulation (paras. 725-726), and it can be in the form of creams or gels, lotion (para. 727-728). Hoge et al teaches that analysis of circRNA and their associated linear mRNAs revealed that the circRNA isoforms were highly stable, with transcript half-lives exceeding 48 hours, while the associated linear transcripts exhibited half-lives of less than 20 hours (Para. 0004). Due to Hoge et al teaching the use of circular RNA, the construct is covalently closed and therefore would not have a 5’ cap.
It would have been obvious to a person skilled in the art to use the formulation taught by Dajee et al. utilizing ethanol for delivery of the circular mRNA wherein the circular RNA lacks a 5’ cap as taught by Hoge et al to produce therapeutic proteins in a subject in need thereof with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated use the formulation of Dajee et al. for circular mRNA because the formulation of Dajee et al. is suitable for delivery of any polynucleotide including RNA and DNA, and thus, it would be considered as a suitable delivery tool for circular mRNA taught by Hoge et al. in the absence of any evidence that the circular nucleic acid is not being delivered by the formulation of Dajee et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 51-55 are rejected under 35 U.S.C. 103 as being unpatentable over Dajee et al (WO 2006/03443 A2) in view of Hoge et al (US 2016/0194368 A1; Cited in a previous action), as applied to claims 29, 35-39, 40-44 and 56 above, and further in view of Glenn et al (US 6,797,276 B1; Cited in a previous action). This is a NEW Rejection necessitated by the amendment filed on 11/03/2025.
The combined teachings of Dajee and Hoge are described above and applied to the claims as above.
Regarding claims 51-55 directed to the kit comprising the first application tool to apply a sterilizing agent (alcohol) such as a wipe comprising alcohol, and the second application tool to apply the composition to the surface area of the subject (e.g. skin), Dajee and Hoge do not teach the limitations.
However, it is well known in the art that a cosmetic composition for topical delivery involves sterilizing the skin surface by using alcohol wipes and apply the composition with any known applicator. For example, Glenn teaches a transcutaneous system for the topical application of an adjuvant and an antigen or nucleic acid encoding for an antigen to skin, and the procedures require alcohol swabbing with an isopropyl pad, and then the composition is applied to the back of the mice using a pipette and tip (col. 24, lines 4-15; Example 1).
It would have been obvious to a person skilled in the art to prepare a kit comprising the topical composition of Dajee along with alcohol/isopropyl wipes and an applicator (e.g. pipette tip) for the delivery of the topical composition of Dajee. A person of ordinary skilled in the art would have been motivated to do so because it is well known in the art that topical delivery of a composition accompanies with cleaning the skin with alcohol wipes and applicators for applying the composition to the skin as taught by Glenn.
Response to Amendments - Claim Rejections - 35 USC § 103
The rejection of claims 40 and 44 under 35 U.S.C. 103 as being obvious over Bancel et al (US 2015/0064236 A1) in view of Hoge et al (US 2016/0194368 A1; Cited in a previous action) has been withdrawn in view of Applicant' s amendment to the claims.
The rejection of claims 51-55 under 35 U.S.C. 103 as being obvious over Bancel et al (US 2015/0064236 A1) in view of Glenn et al (US 6,797,276 B1) has been withdrawn in view of Applicant' s amendment to the claims.
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 Langi, 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 CPR l.32l(c) or l.32l(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 CPR l.32l(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. l.
For a reply to a non-final Office action, see 37 CPR 1.11 l(a). For a reply to final Office action, see 37 CPR 1.113( c ). A request for reconsideration while not provided for in 37 CPR 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 autoprocessed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www. uspto. gov /patents/apply I appl ying-online/ eterminal-disclaimer.
Claims 29, 35-44 and 51-55 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5, 6, 8, 9, 20-25, 35 and 36 of copending Application No. 17 /433,658 in view of Yang et al (Previously cited).
Claim 8 of ‘658 anticipates claim 29, 35-38 of current application.
Claim 1 of ‘658 is drawn to a composition comprising a mixture of a polyribonucleotide and ethanol, wherein the ethanol constitutes: at least about 0.3% v/v to about 75% v/v of the mixture.
Claim 1 does not require the polyribonucleotide to be circular. However, Yang teaches circular RNA and the benefit of circular RNA producing increased expression of Stat3 and Dnmt3a which lead to increased cell adhesion, migration, proliferation, survival and wound repair (Abstract). Yang teaches that circular RNAs are crucial in tissue remodeling as well as circRNA such as circ-Foxo3 which is important for regulating cell cycle progression, cell senescence, cardiovascular protection and tumor formation (Page 2062; Column 1).
One would have been motivated to make such a modification in order to receive the expected benefit of increased cell proliferation leading to improved wound healing as taught by Yang.
Instant claims 29,35-39 are not patentably distinct from claim 1 of 658.
Claim 35 of 658 recite "The pharmaceutical composition of claim 1, comprising a mixture of a polyribonucleotide and ethanol, wherein the ethanol constitutes at least about 1 % v/v to about 75% v/v", therefore instant claim 35 is not patentably distinct from claim 35 of the 658 application.
Claim 36 of 658 recites "The pharmaceutical composition of claim 1, comprising a mixture of a polyribonucleotide and ethanol, wherein the ethanol constitutes at least about 5% v/v to about 75% v/v", therefore instant claim 36 is not patentably distinct from claim 36 of the 658 application. Claim 5 of 658 would include the "fragments thereof' in the instant claim 40 therefor they are not patentably distinct.
Claim 6 of 658 recites "The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a liquid, gel, lotion, paste, cream, foam, or stick", therefore instant claim 41 is not patentably distinct from claim 6 of the 658 applications.
Claim 9 of 658 recites "The pharmaceutical composition of claim 1, wherein the pharmaceutical composition: (i) has a pH of about 7; and/or (ii) has a viscosity that is about the same as water; and/or (iii) is substantially free of hydrophobic or lipophilic groups; and/or (iv) is substantially free of hydrocarbons; and/or (v) is substantially free of cationic liposomes; and/or (vi) is substantially free of fatty acids, lipids, liposomes, cholesterol, or any combination thereof', therefore instant claim 43 is not patentably distinct from claim 9 of the 658 application.
Claim 20 of 658 recites "A kit comprising an application tool and the pharmaceutical composition of claim 1, wherein the application tool is configured to apply the pharmaceutical composition to a surface area of a subject", therefore instant claim 51 is not patentably distinct from claim 20 of the 658 application.
Claim 21 of 658 recites "A kit comprising a first application tool, a second application tool, a sterilizing agent, and a composition free of any carrier comprising the polyribonucleotide and diluent, wherein the first application tool is configured to apply a sterilizing agent to a surf ace area of a subject and the second application tool is configured to apply the composition to the surface area of the subject", therefore instant claim 52 is not patentably distinct from claim 21 of the 658 application.
Claim 22 of 658 recites "The kit of claim 21, wherein the sterilizing agent is an alcohol, UV light, laser light, or heat", therefore instant claim 53 is not patentably distinct from claim 22 of the 658 application.
Claim 23 of 658 recites "The kit of claim 22, wherein the alcohol is selected from the group consisting of: methanol, ethanol, isopropanol, butanol, pentanol, cetyl alcohol, ethylene glycol, propylene glycol, denatured alcohol, benzyl alcohol, specially denatured alcohol, glycol, stearyl alcohol, cetearyl alcohol, menthol, polyethylene glycols (PEG)-400, ethoxylated fatty acids, and hydroxyethylcellulose", therefore instant claim 54 is not patentably distinct from claim 23 of the 658 application.
Claim 25 of 658 recites "The kit of claim 20 or21, wherein first application tool is (i) a device that applies UV light or laser light; (ii) a device that applies heat; or (iii) a wipe comprising the sterilizing agent", therefore instant claim 55 is not patentably distinct from claim 25 of the 658 application.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments – Double Patenting
The double patenting rejection stated in the Office Action filed on 01/31/2025 is maintained.
Applicant stated in the Remarks filed on 04/30/2025 that a terminal disclaimer may be filed when the claims were found allowable. The rejection has not been overcome by amendment, substantive argument or a proper terminal disclaimer. Thus, the rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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/ALEXANDRA ROSE LIPPOLIS/ Examiner, Art Unit 1637
/Jennifer Dunston/ Supervisory Patent Examiner, Art Unit 1637