DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
The Amendment filed on 25Nov2025 in which claim(s) 18-19 is/are new is acknowledged.
Claim(s) 1-19 is/are currently pending and presented for examination on the merits.
Response to Amendment
The objection(s) to the specification have been withdrawn in view of the Amendment filed on 25Nov2025.
The rejection(s) of claim(s) 1-2, 4-17 under 35 U.S.C. § 102, and of claim(s) 3 under 35 U.S.C. § 103 have been withdrawn in view of the recent claim amendment filed on 25Nov2025, which added new limitation(s) requiring new rejection(s). Only argument(s) relevant to the new rejections are addressed herein.
New Rejections Necessitated by Claim Amendments
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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over by US 2021/0024601 A1 (hereinafter “US601”).
Regarding instant claims 1-3, 6, US601 teaches a method for the treatment of an autoimmune disease (e.g., autoimmune hepatitis) comprising administering to a subject an IL2 agent or a pharmaceutical composition comprising the IL-2 or IL2 variant fusion protein comprising amino acid substitutions H16N, V69A, AND Q74P [e.g., ¶ 0110-0111, 0235, 0236]. US601 teaches the subject is a human [e.g., ¶ 0660-0661]. US601 further teaches the IL2 variant fusion protein of the human IL2 sequence comprising SEQ ID NO: 1, which is the same as instant human IL2 SEQ ID NO: 1 (see alignment below) [e.g., ¶ 0200, 0343, 0347]. US601 teaches a “non-limiting” dose range of .1-30 mg/kg (e.g., 0.1 mg/kg = 100 μg/kg) [e.g., ¶ 0617]. US601 further teaches the IL2 fusion protein comprises amino acid substitutions including H16L, V69A, Q74P, and C125S [e.g., ¶ 0110, 0112, 0114].
Alignment of instant human IL2 of SEQ ID NO: 1 with US601 (Human mature IL-2 variant protein, SEQ ID 1):
Query Match 100.0%; Score 675; Length 133;
Best Local Similarity 100.0%;
Matches 133; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 APTSSSTKKTQLQLEHLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 APTSSSTKKTQLQLEHLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
Qy 61 EELKPLEEVLNLAQSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EELKPLEEVLNLAQSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
Qy 121 WITFSQSIISTLT 133
|||||||||||||
Db 121 WITFSQSIISTLT 133
Regarding instant claim 4, US601 teaches the IL2 fusion protein is administered once a week [e.g., para 0678].
Regarding instant claim 5, US601 further teaches the IL2 fusion protein may be administered subcutaneously [e.g., para 0611].
Regarding instant claim 7, US601 further teaches the IL2 variant further comprises the amino acid substitution T3A [e.g., para 0182].
Regarding instant claims 8, 18, US601 teaches IL2 variants comprising any of SEQ ID NOs: 5 or 1001, which match instant claimed IL2 SEQ ID NOs: 5 or 1001 (see alignments below) [e.g., para 0391, 0393].
Alignment of IL2 variant instant SEQ ID NO: 5 with US601 (Human mature IL-2 variant protein, SEQ ID 5):
Query Match 100.0%; Score 673; Length 133;
Best Local Similarity 100.0%;
Matches 133; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 APTSSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 APTSSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
Qy 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
Qy 121 WITFSQSIISTLT 133
|||||||||||||
Db 121 WITFSQSIISTLT 133
Alignment of IL2 variant instant SEQ ID NO: 1001 with US601 (Human mature IL-2 variant protein, SEQ ID 1001):
Query Match 100.0%; Score 672; Length 133;
Best Local Similarity 100.0%;
Matches 133; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 APASSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 APASSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
Qy 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
Qy 121 WITFSQSIISTLT 133
|||||||||||||
Db 121 WITFSQSIISTLT 133
Regarding instant claims 9-10, US601 further teaches the IL2 variant fusion proteins comprising an Fc region [e.g., ¶ 0202-0204, 0242, 0506].
Regarding instant claims 11, US601 further teaches the FC region is an IgG1 allotype m3 comprising an N297G substitution according to EU numbering [e.g., ¶ 202, 209-210].
Regarding instant claim 12, US601 further teaches the Fc region comprises the amino acid sequence of SEQ ID NO: 1006, which is the same as instant Fc region of SEQ ID NO: 1003 (see alignment below) [e.g., para].
Alignment of instant Fc region SEQ ID NOL: 1003 with US601 (Human mature IL-2 variant-linker-human IgG1 fusion protein, SEQ ID 1006)
Query Match 100.0%; Score 1233; Length 380;
Best Local Similarity 100.0%;
Matches 227; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 154 DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVD 213
Qy 61 GVEVHNAKTKPREEQYGSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 214 GVEVHNAKTKPREEQYGSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK 273
Qy 121 GQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 274 GQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDS 333
Qy 181 DGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 227
|||||||||||||||||||||||||||||||||||||||||||||||
Db 334 DGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 380
Regarding instant claims 13-15, US601 further teaches the IL2 fusion protein comprises from the N-terminus to C-terminus an IL2 variant and an FC region, or an IL2 variant, a linker, and an Fc region [e.g., para 0506]. US601 further teaches the linker is a (G4S)4 linker (SEQ ID NO: 48), which is the same as instant SEQ ID NO 48 [e.g., pg. 68, para 0722, “59.”, “61.”].
CLUSTAL O(1.2.4) multiple sequence alignment
790_Seq48 GGGGSGGGGSGGGGSGGGGS 20
US601_Seq48 GGGGSGGGGSGGGGSGGGGS 20
********************
Regarding instant claims 16, 19, US601 further teaches the fusion protein comprises an amino acid sequence from any of SEQ ID NOs: 1005, or 1008 which are the same as instant claimed IL2 fusion protein SEQ ID NOs: 1004-1009 (see alignments below) [e.g., para ].
Alignment of instant IL2 fusion protein SEQ ID NO: 1005 with US601 (Human mature IL-2 variant-linker-human IgG1 fusion protein, SEQ ID 1005):
Query Match 100.0%; Score 2017; Length 380;
Best Local Similarity 100.0%;
Matches 380; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 APASSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 APASSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
Qy 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
Qy 121 WITFSQSIISTLTGGGGSGGGGSGGGGSGGGGSDKTHTCPPCPAPELLGGPSVFLFPPKP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 WITFSQSIISTLTGGGGSGGGGSGGGGSGGGGSDKTHTCPPCPAPELLGGPSVFLFPPKP 180
Qy 181 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGSTYRVVSVLT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGSTYRVVSVLT 240
Qy 241 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTC 300
Qy 301 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 360
Qy 361 MHEALHNHYTQKSLSLSPGK 380
||||||||||||||||||||
Db 361 MHEALHNHYTQKSLSLSPGK 380
Alignment of instant IL2 fusion protein SEQ ID NO: 1008 with US601 (Human mature IL-2 variant-linker-human IgG1 fusion protein, SEQ ID 1008):
Query Match 100.0%; Score 2018; Length 380;
Best Local Similarity 100.0%;
Matches 380; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 APTSSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 APTSSSTKKTQLQLELLLLDLQMILNGINNYKNPKLTRMLTFKFYMPKKATELKHLQCLE 60
Qy 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EELKPLEEALNLAPSKNFHLRPRDLISNINVIVLELKGSETTFMCEYADETATIVEFLNR 120
Qy 121 WITFSQSIISTLTGGGGSGGGGSGGGGSGGGGSDKTHTCPPCPAPELLGGPSVFLFPPKP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 WITFSQSIISTLTGGGGSGGGGSGGGGSGGGGSDKTHTCPPCPAPELLGGPSVFLFPPKP 180
Qy 181 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGSTYRVVSVLT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGSTYRVVSVLT 240
Qy 241 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTC 300
Qy 301 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 360
Qy 361 MHEALHNHYTQKSLSLSPGK 380
||||||||||||||||||||
Db 361 MHEALHNHYTQKSLSLSPGK 380
Regarding instant claim 17, US601 further teaches the IL2 fusion protein forms a dimer [e.g., para 0227; fig. 1A].
US601 does not expressly teach that the IL2 agent is administered at a dose of 1 μg/kg to treat autoimmune disease (AID), wherein (a) the IL2 agent is administered weekly; (b) the IL2 agent is administered subcutaneously; (c) the AID is SLE, AIH, FSGS or AA; (d) the IL2 variant comprises a T3A substitution; (e) the IL2 variant comprises SEQ ID NO: 5 or 1001, (f) the IL2 agent comprises a fusion protein comprising the IL2 variant; (g) the IL2 fusion protein comprises an Fc region, wherein the fc region comprises (1) an IgG1 allotype m3 comprising N297G substitution or (2) the amino acid of SEQ ID NO: 1003; (h) the Fc region is fused to the C-terminus of the IL2 variant; (i) the IL2 fusion protein comprises a (G4S)4 linker; (j) the IL2 fusion protein comprises SEQ ID NO: 1005; (k) the IL2 fusion protein forms a dimer; (l) the IL2 variant comprises SEQ ID NO: 5; or (m) the IL2 fusion protein comprises SEQ ID NO: 1008.
In regard to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This is because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (i.e. dosage and intervals) optimization is obvious.
Further, it would have been obvious to a PHOSITA to modify the modified method of treating an autoimmune disease comprising administering a dose of 1ug/kg (see obviousness of dose optimization above) of an IL2 therapeutic of US601 (see above) to include that (a) the IL2 agent is administered weekly; (b) the IL2 agent is administered subcutaneously; (c) the AID is SLE, AIH, FSGS or AA; (d) the IL2 variant comprises a T3A substitution; (e) the IL2 variant comprises SEQ ID NO: 5 or 1001, (f) the IL2 agent comprises a fusion protein comprising the IL2 variant; (g) the IL2 fusion protein comprises an Fc region, wherein the fc region comprises (1) an IgG1 allotype m3 comprising N297G substitution or (2) the amino acid of SEQ ID NO: 1003; (h) the Fc region is fused to the C-terminus of the IL2 variant; (i) the IL2 fusion protein comprises a (G4S)4 linker; (j) the IL2 fusion protein comprises SEQ ID NO: 1005; (k) the IL2 fusion protein forms a dimer; (l) the IL2 variant comprises SEQ ID NO: 5; or (m) the IL2 fusion protein comprises SEQ ID NO: 1008, as taught by US601, because US601 teaches the base method and IL2 therapeutic molecules, as well as non-limiting dose ranges, and additional modifications to the base method, while the dose optimization is considered obvious (see above). There is an expectation of success for a PHOPSITA to substitute the modified method for treating autoimmune disease comprising 1ug/kg doses of an IL2 therapeutic as taught by US601 with the additional modified methods as taught by US601, because US601 teaches the base method, IL2 therapeutic molecules, non-limiting dose ranges (specific dose optimization is considered obvious, see above), and additional modifications to the base method. Therefore, the difference in the methods (all taught by one reference) are solely dose optimization, and therefore there would be a reasonable expectation of success. This rationale aligns with the principle of simple substitution of one known element for another to obtain predictable results, supporting a conclusion of obviousness (see MPEP § 2141).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues:
Amended claim 1 is directed to a method of treating an autoimmune disease comprising administering one or more doses, each ranging from 1 ug/kg to 30 ug/kg of an IL2 agent comprising amino acid substitutions H16L, V69A, and Q74P. The recited method cannot be obvious because the prior art does not teach repeated low-dose administration of the claimed IL2 agent. Applicant further argues US601 claimed doses are 3.5-50,000-fold greater than the amended claim 1 doses, and that US601 is silent on the amended dose range.
In response, US601 as applied in the new rejection teaches the method of claim 1, identical IL2 agents to those claimed, and a “non-limiting” dose including 0.1 mg/kg in paragraph 0617 (0.1 mg/kg = 100 ug/kg), suggesting that other doses not expressly listed may be used in the disclosed method could be obvious (see rejection above for details). It is noted that 100 ug/kg dose taught by US601 is 100-fold (2 orders of magnitude) greater than the bottom range of the instant claimed 1-30 ug/kg dose range, and roughly 3.3-fold greater than the instant claimed 30 ug/kg top range. Further, in response to Applicant argument that the prior art does not teach repeated low dose administration, (1) US601 teaches weekly (e.g., more than one dose) dose administration (see instant claim 4 rejection above); (2) instant claim 1 requires “one or more doses” and therefore does not require more than one single low dose administration but rather only requires one dose; and (3) dose optimization and intervals (e.g., frequency of administration) are considered routine optimization in the art and therefore the amended dose range (e.g., 1-30 ug/kg) and any dosing intervals (e.g., one or more) thereof are considered obvious (see rejection above for details).
Conclusion
No claims are currently 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 AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643