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 .
Election/Restrictions
Applicant’s election without traverse of Group I (drawn to an RNAi oligonucleotide), and of the species SEQ ID NOs:1095 (target sequence), 780 (sense strand), and 815 (antisense strand), in the reply filed on 01/20/2026 is acknowledged.
Claims 84, 94, 102, and 104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Claims 84 and 94 do not encompass the elected species of SEQ ID NOs:1095 (target sequence), 780 (sense strand), and 815 (antisense strand). Election was made without traverse in the reply filed on 01/20/2026.
Claims Status
Claims 2-3, 5-8, 11-12, 14-16, 18-20, 22-26, 29-35, 37-39, 41, 43, 45, 47, 49-52, 54-55, 57-64, 68-83, 85-93, 95-100, 103 is/are cancelled. Claims 1, 4, 9-10, 13, 17, 21, 27-28, 36, 40, 42, 44, 46, 48, 53, 56, 65-67, 84, 94, 101, 102, 104 is/are currently pending with claims 84, 94, 102, 104 withdrawn. Claims 1, 4, 9-10, 13, 17, 21, 27-28, 36, 40, 42, 44, 46, 48, 53, 56, 65-67, 101 is/are under examination.
Claim Objections
Claim 46 is objected to because of the following informalities: “comprises a phosphate analog at 4’-carbon of the sugar” should read “comprises a phosphate analog at the 4’-carbon of the sugar” (lines 2-3). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4, 42, 44 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.
Claim 4 recites the following: “optionally wherein the antisense strand is 22 nucleotides in length, and wherein [the] antisense strand and the sense strand form a duplex region of at least 19 nucleotides in length, optionally at least 20 nucleotides in length.” It is unclear which limitations (in claim 4, three different length parameters) are alternatives of which other limitations, and thus the structures recited are unclear. Furthermore, the antecedent basis of these optional limitations is unclear: it is unclear whether “optionally at least 20 nucleotides in length” refers to an optional alternative length of the antisense strand, the sense strand, the duplex region, or a different structure, not referenced in claim 4. See MPEP §2173.05(h)(II).
Claims 42 and 44 recite limitations (claim 42 lines 4-7, claim 44 lines 3-6) which are unclear as to which are optional and which are required. It is clear that “the antisense strand is 22 nucleotides in length” (claim 42) is optional, but it is unclear if the subsequent limitations are optional or required. It is clear that “the sense strand is 20 nucleotides in length” (claim 44) is optional, but it is unclear if the subsequent limitations are optional or required. As such, the metes and bounds of claims 42 and 44 are unclear. The broadest reasonable interpretation is that the limitations subsequent to the term “optionally” in claims 42 and 44 are optional.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 9-10, 17, 21, 27-28, 36, 40, 42, 44, 46, 48, 53, 101 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khvorova (WO2021188626A1, of record).
Regarding claim 1, Khvorova teaches an RNAi oligonucleotide (a dsRNA) comprising a sense strand and an antisense strand, wherein the antisense strand comprises a sequence complementary to a MAPT nucleic acid sequence of SEQ ID NO:2 (SEQ ID NO:2 comprises a sequence 100% identical to instant SEQ ID NO:1095, see alignment below) (claim 1). Khvorova teaches that the sense strand is 15-25 nucleotides long (claim 7), and that the sense and antisense strands form a duplex (paragraph [0565]; claim 1, the sense and antisense strands form a double-stranded RNA). Khvorova teaches that the dsRNA is used for RNAi-mediated reduction of MAPT gene expression (claims 69-71, paragraph [0553]).
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Regarding claim 4, Khvorova teaches that the antisense strand is 15-25 nucleotides long (claim 6).
Regarding claim 9, Khvorova teaches that the sense and antisense strands are linked by a loop segment, forming a stem-loop structure (paragraphs [0585]-[0590]), wherein the sense strand can be 3’ or 5’ of the loop structure (paragraph [0588], if the antisense strand is 5’ or 3’ of the end of the stem, the sense strand must be 3’ or 5’, respectively, of the stem-loop).
Regarding claim 10, Khvorova teaches that the loop is a tetraloop (paragraph [0589]).
Regarding claim 17, Khvorova teaches that the dsRNA comprises a blunt end (claim 20).
Regarding claim 21, Khvorova teaches that the dsRNA comprises an overhang of at least one nucleotide (claims 21-24). Khvorova teaches that “the 3’ end of the antisense strand extends 1, 2, 3, 4, 5, 6, 7, or 8 nucleotides further than the 5’ end of the sense strand” (paragraph [0538]).
Regarding claim 27, Khvorova teaches that the dsRNA comprises at least one modified nucleotide (claim 26).
Regarding claim 28, Khvorova teaches that the modified nucleotide comprises a 2’ modification, wherein the 2’ modification may be a 2’-fluoro or 2’-O-methyl modification (claim 27).
Regarding claim 36, Khvorova teaches that the dsRNA may comprise any combination of 2’-fluoro and 2’-O-methyl modifications, in both the sense and antisense strands (paragraphs [0401], [0554], [0706]-[0715]).
Regarding claim 40, Khvorova teaches that the dsRNA comprises at least one modified internucleotide linkage, wherein the modified internucleotide linkage may be a phosphorothioate linkage (claims 28-29).
Regarding claims 42 and 44, Khvorova teaches that the dsRNA comprises a phosphorothioate linkage between nucleotides 1-8 of the 3’ end of the antisense strand and nucleotides 1-3 of the 5’ end of the antisense strand (paragraph [0779]).
Regarding claim 46, Khvorova teaches that the antisense strand comprises a phosphate analog in the 5’ nucleotide, wherein the phosphate analog is a vinyl phosphate (claims 43-44).
Regarding claims 48 and 53, Khvorova teaches that one or both strands of the dsRNA may be conjugated to targeting agents, including GalNAc (paragraphs [0555], [0671], [0675]; claims 52-56).
Regarding claim 101, Khvorova teaches a pharmaceutical composition comprising the dsRNA and a pharmaceutically acceptable carrier (claim 68).
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 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, 4, 9-10, 13, 17, 21, 27-28, 36, 40, 42, 44, 46, 48, 53, 65-67, 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khvorova (WO2021188626A1), in view of Brown (WO2020206350A1).
Regarding claim 1, Khvorova teaches an RNAi oligonucleotide (a dsRNA) comprising a sense strand and an antisense strand, wherein the antisense strand comprises a sequence complementary to a MAPT nucleic acid sequence of SEQ ID NO:2 (SEQ ID NO:2 comprises a sequence 100% identical to instant SEQ ID NO:1095, see alignment below) (claim 1). Khvorova teaches that the sense strand is 15-25 nucleotides long (claim 7), and that the sense and antisense strands form a duplex (paragraph [0565]; claim 1, the sense and antisense strands form a double-stranded RNA). Khvorova teaches that the dsRNA is used for RNAi-mediated reduction of MAPT gene expression (claims 69-71, paragraph [0553]).
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Regarding claim 4, Khvorova teaches that the antisense strand is 15-25 nucleotides long (claim 6).
Regarding claim 9, Khvorova teaches that the sense and antisense strands are linked by a loop segment, forming a stem-loop structure (paragraphs [0585]-[0590]), wherein the sense strand can be 3’ or 5’ of the loop structure (paragraph [0588], if the antisense strand is 5’ or 3’ of the end of the stem, the sense strand must be 3’ or 5’, respectively, of the stem-loop).
Regarding claim 10, Khvorova teaches that the loop is a tetraloop (paragraph [0589]).
Regarding claim 17, Khvorova teaches that the dsRNA comprises a blunt end (claim 20).
Regarding claim 21, Khvorova teaches that the dsRNA comprises an overhang of at least one nucleotide (claims 21-24). Khvorova teaches that “the 3’ end of the antisense strand extends 1, 2, 3, 4, 5, 6, 7, or 8 nucleotides further than the 5’ end of the sense strand” (paragraph [0538]).
Regarding claim 27, Khvorova teaches that the dsRNA comprises at least one modified nucleotide (claim 26).
Regarding claim 28, Khvorova teaches that the modified nucleotide comprises a 2’ modification, wherein the 2’ modification may be a 2’-fluoro or 2’-O-methyl modification (claim 27).
Regarding claim 36, Khvorova teaches that the dsRNA may comprise any combination of 2’-fluoro and 2’-O-methyl modifications, in both the sense and antisense strands (paragraphs [0401], [0554], [0706]-[0715]).
Regarding claim 40, Khvorova teaches that the dsRNA comprises at least one modified internucleotide linkage, wherein the modified internucleotide linkage may be a phosphorothioate linkage (claims 28-29).
Regarding claims 42 and 44, Khvorova teaches that the dsRNA comprises a phosphorothioate linkage between nucleotides 1-8 of the 3’ end of the antisense strand and nucleotides 1-3 of the 5’ end of the antisense strand (paragraph [0779]).
Regarding claim 46, Khvorova teaches that the antisense strand comprises a phosphate analog in the 5’ nucleotide, wherein the phosphate analog is a vinyl phosphate (claims 43-44).
Regarding claims 48 and 53, Khvorova teaches that one or both strands of the dsRNA may be conjugated to targeting agents, including GalNac (paragraphs [0555], [0671], [0675]; claims 52-56).
Regarding claims 65-67, Khvorova teaches that the antisense strand comprises a sequence complementary to SEQ ID NO:2, with up to three mismatches (SEQ ID NO:2 is 95.5% complementary to instant SEQ ID NO:815, with one mismatch, see alignment below), that the antisense and sense strands are 15-25 nucleotides long, and that the sense strand is complementary to the antisense strand (see alignment below) (claims 1, 3-4, 6-7; paragraph [0520]). SEQ ID NO:2 thus renders obvious instant SEQ ID NO:815 and nucleotides 1-21 of instant SEQ ID NO:780.
SEQ ID NO:2 and instant SEQ ID NO:815:
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SEQ ID NO:2 and instant SEQ ID NO:780:
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Regarding claim 101, Khvorova teaches a pharmaceutical composition comprising the dsRNA and a pharmaceutically acceptable carrier (claim 68).
However, Khvorova does not teach that the stem-loop sequence linking the 3’ end of the sense strand to the 5’ end of the antisense strand comprises the sequence of instant SEQ ID NO:1680.
Brown teaches a dsRNA for RNAi which comprises a sense strand and an antisense strand, wherein the sense and antisense strands comprise specific combinations of nucleotide modifications, and wherein the sense strand comprises, at its 3’ end, the stem-loop segment of instant SEQ ID NO:1680.
Regarding claims 13, 65, and 67, Brown teaches functional dsRNA comprising a sense strand and an antisense strand, “wherein the sense strand comprises at its 3’-end a stem-loop set forth as: S1-L-S2, wherein S1 is complementary to S2, wherein L is a tetraloop and comprises a sequence set forth as GAAA” (claim 1), and wherein S1 and S2 are up to 10 nucleotides long (paragraph [0121]). Brown further teaches that S1 may comprise the sequence GCAGCC and S2 may comprise the sequence GGCUGC (Fig. 23). Combined, Brown teaches that the sense strand comprises the stem-loop sequence GCAGCCGAAAGGCUGC (i.e., instant SEQ ID NO:1680). Brown thus renders obvious nucleotides 21-36 of instant SEQ ID NO:780 (see alignment below).
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Regarding claim 36, Brown teaches that a dsRNA may comprise the following sense strand modification pattern of nucleotides 1-22, wherein “mX” is a 2’-O-methyl-modified nucleotide, and “fX” is a 2’-fluoro-modified nucleotide, and wherein the superscript number indicates the nucleotide position of the preceding nucleotide:
(mX)1(mX)2(fX)3(mX)4(fX)5(mX)6(mX)7(fX)8(mX)9(fX)10(mX)11(fX)12(fX)13(mX)14(fX)15(mX)16(fX)17(mX)18(mX)19(mX)20(mX)21(mX)22 (Fig. 23). Brown teaches that a dsRNA comprising the afore-detailed sense strand modification pattern may comprise the following antisense strand modification pattern: (mX)1(fX)2(fX)3(fX)4(fX)5(mX)6(fX)7(mX)8(mX)9(fX)10(mX)11(mX)12(mX)13(fX)14(mX)15(fX)16(mX)17(mX)18(fX)19(mX)20(mX)21(mX)22 (Fig. 23).
Khvorova teaches that it may be desirable to deliver the dsRNA to the central nervous system (CNS) to reduce MAPT expression in the CNS (paragraphs [003], [0749], [0753], [0759], [0762], [0764], [0780]). However, Khvorova only teaches that the dsRNA should be designed such that they are capable of reducing MAPT gene expression in the CNS, and that delivery vehicles (such as viral vectors and pharmaceutical excipients) should be designed such that they facilitate delivery to the CNS. Brown teaches that oligonucleotides may be modified such that the oligonucleotide “cannot easily exit the CNS” (paragraph [0038]), and that the specific nucleotide modification patterns and stem-loop sequence described above (seen in Fig. 23) are exemplary “for use in the CNS” (paragraph [0071]). Brown also teaches that the particular stem-loop structure and modifications taught “improve activity, bioavailability, and/or minimize the extent of enzymatic degradation after in vivo administration to the central nervous system” (paragraph [0009]). It would have been obvious to an artisan at the time of filing that the particular nucleotide modifications and stem-loop structures taught by Brown should be applied to the dsRNA oligonucleotides of Khvorova in order to improve activity and stability in the central nervous system.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
18030230:
Claims 1, 4, 9-10, 13, 17, 21, 27-28, 36, 40, 42, 44, 46, 48, 53, 56, 65-67, 101 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 17, 22-23, 32, 38, 85, 88, 90, 108 of copending Application No. 18030230 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims recite a dsRNA for RNAi (claims 1, 10), with overlapping length parameters relative to the instant claims (claim 10), the same stem-loop structure (claim 17) (while the copending claims do not recite a sequence identical to instant SEQ ID NO:1680, SEQ ID NO:1680 is not required by instant claim 13), wherein the dsRNA targets any sequence within a MAPT gene, rendering obvious the target sequences of instant SEQ ID NOs:912-1295 (claim 38). The copending claims also recite that the dsRNA comprises at least one modified nucleotide (claim 23). Copending claim 108 recites that the dsRNA may be selected from Table A. Table A recites dsRNA comprising the GCAGCCGAAAGGCUGC stem-loop sequence, and the phosphorothioate, antisense 5’-modifications, and 2’-modification patterns required by the instant claims. As the copending claims render obvious target sequences of instant SEQ ID NOs:912-1295, the copending claims render obvious an antisense sequence of instant SEQ ID NO:815 and a sense sequence comprising nucleotides 1-22 of instant SEQ ID NO:780. Furthermore, as Table A of the copending application recites the stem-loop sequence of instant SEQ ID NO:1680, and instant SEQ ID NO:780 consists of 22 nucleotides complementary to instant SEQ ID NO:815 and of SEQ ID NO:1680, the copending claims and specification (as referenced by copending claim 108) render obvious a dsRNA comprising an antisense strand of instant SEQ ID NO:815 and a sense strand of instant SEQ ID NO:780.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19383237:
Claims 1, 4, 9-10, 13, 17, 21, 27-28, 36, 40, 42, 44, 46, 48, 53, 56, 65-67, 101 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-101 of copending Application No. 19383237 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims recite an “RNAi oligonucleotide for reducing MAPT gene expression” wherein the oligonucleotide comprises “a sense strand and an antisense strand, wherein the sense strand and the antisense strand form a duplex region, wherein the antisense strand comprises a region of complementarity to” SEQ ID NO:1095 (wherein SEQ ID NO:1095 is identical to instant SEQ ID NO:1095) (claim 1). The copending claims recite the same length parameters (claims 1-7, 19-20), stem-loop structures (claims 9-16), overhang parameters (claims 17-18, 21, 23), nucleotide and internucleotide linkage modifications (claims 27-64, 94-100), sense and antisense sequences (claims 65-100).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/AFRICA M MCLEOD/Examiner, Art Unit 1635
/KIMBERLY CHONG/Primary Examiner, Art Unit 1636