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 5, 6, 8, 10, 11, 16, 17, 19, 21 and 22 have been amended. Claims 1-22 are pending and examined on the merits.
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 10 and 21 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.
Claims 10 and 21 are vague and indefinite because they are unclear if applicant intends that the carboxyl terminus is a region of the heavy chain, thus any lysine within that region can be deleted, or if applicant intends that only the last lysine of the heavy chain is to be deleted.
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.
Claims 1-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741, English Language translation). Kamii et al (translation) disclose a pharmaceutical composition comprising an ADC having the drug linker of formula I, wherein A represents a connecting position to an antibody which is conjugated to the drug-linker via a thioether bond(claim 1 of ‘741), which meets the structural limitations of instant claims 1 and 12 for the drug-linker. Kamii et al disclose that the antibody is an anti-B7H3 antibody (claim 7 of ‘741) comprising a heavy chain consisting of amino acid residues 20-471 of SEQ ID NO:7 and a light chain consisting of amino acid residues 21-233 of SEQ ID NO:4, or a variant thereof comprising the heavy chain wherein a lysine residue at the carboxyl terminus is deleted (claim 27 of ‘741) which meets the limitations of instant claims 10 and 21 for the deletion of a lysine residue at the carboxy terminus of the heavy chain; instant claims 5 and 16, wherein the heavy chain CDRs are at residues 50-54, 69-85 and 118-130 of SEQID NO: 3; the limitations of instant claims 6, 7, 17 and 18 wherein the heavy chain variable regions consists of residues 20-141 of SEQ ID NO:3 and the light chain variable region consists of residues 21-128 of SEQ ID NO:4; the limitations of instant claims 8, 9, 19 and 20 wherein the anti-B7H3 antibody consists of a heavy chain of amino acid residues 20-471 of SEQ ID NO:3 and a light chain of residues 21-233 of SEQ ID NO:4 because
SEQ ID NO: 7 of ‘483 is identical to the instant SEQ ID NO: 3:
GenCore version 6.5.2
Copyright (c) 1993 - 2025 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: December 11, 2025, 23:48:49 ; Search time 1 Seconds
(without alignments)
0.222 Million cell updates/sec
Title: AASEQ1_12112025_234844
Perfect score: 2533
Sequence: 1 MKHLWFFLLLVAAPRWVLSQ..........MHEALHNHYTQKSLSLSPGK 471
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 471 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-18-036-290-3.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2533 100.0 471 1 US-18-036-290-3 TREATMENT OF MESOT
ALIGNMENTS
RESULT 1
US-18-036-290-3
Query Match 100.0%; Score 2533; DB 1; Length 471;
Best Local Similarity 100.0%;
Matches 471; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYVMHWVRQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYVMHWVRQAP 60
Qy 61 GQGLEWMGYINPYNDDVKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARWGY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GQGLEWMGYINPYNDDVKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARWGY 120
Qy 121 YGSPLYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YGSPLYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV 180
Qy 181 SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVE 240
Qy 241 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 300
Qy 301 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 360
Qy 361 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 420
Qy 421 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 471
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 471
Search completed: December 11, 2025, 23:48:49
Job time : 1 secs
and SEQ ID NO: 8 of ‘483 is identical to the instant SEQ ID NO: 4:
GenCore version 6.5.2
Copyright (c) 1993 - 2025 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: December 11, 2025, 23:52:40 ; Search time 1 Seconds
(without alignments)
0.054 Million cell updates/sec
Title: AASEQ1_12112025_235238
Perfect score: 1211
Sequence: 1 MVLQTQVFISLLLWISGAYG..........EVTHQGLSSPVTKSFNRGEC 233
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 233 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-18-036-290-4.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1211 100.0 233 1 US-18-036-290-4 TREATMENT OF MESOT
ALIGNMENTS
RESULT 1
US-18-036-290-4
Query Match 100.0%; Score 1211; DB 1; Length 233;
Best Local Similarity 100.0%;
Matches 233; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MVLQTQVFISLLLWISGAYGEIVLTQSPATLSLSPGERATLSCRASSRLIYMHWYQQKPG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MVLQTQVFISLLLWISGAYGEIVLTQSPATLSLSPGERATLSCRASSRLIYMHWYQQKPG 60
Qy 61 QAPRPLIYATSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQWNSNPPTFGQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QAPRPLIYATSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQWNSNPPTFGQG 120
Qy 121 TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE 180
Qy 181 SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 233
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 233
Search completed: December 11, 2025, 23:52:40
Job time : 1 secs
Kamii et al disclose that the anti-B7H3 conjugate has an average number of drug-linker conjugated to the antibody of 3 to 5 (claim 28 of ‘741) which meets the limitations of “n” in instant claim 12, and 3.5-4.5 in instant claim 22.
It is noted that the limitation “for mesothelioma” in claim 1 occurs in the preamble.
A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-4, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claim 1 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent
Thus, Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741) anticipates the instant 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 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.
Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 20-23 and 40-52 of U.S. Patent No. 12,220,604. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claim 1 anticipates the drug-linker of instant claims 1 and 12, with the exception of the value of “n” in claim 12. Claim 7 as drawn to the conjugate comprising ananti-B7-H3 antibody in claim 7 and claim 20 anticipates the antibody of instant claims 1 and 12. Claim 21 disclosing the anti-B7-H3 antibody as comprising the heavy chain of residues 20-471 of SEQ ID NO: 7 and a light chain comprising residues 21-233 of SEQ ID NO: 8, meets the limitations of instant claims 5-9 and 16-20 because SEQ ID NO: 7 of ‘914 is identical to the instant SEQ ID NO: 3 and SEQ ID NO: 8 of ‘914 is identical to the instant SEQ ID NO: 4. Claim 22 discloses that the heavy chain consists of residues 20-470 of SEQ ID NO: 7 anticipates instant claims 10 and 21 for deletion of the terminal lysine residue. Claim 23 discloses that the ratio of drug to antibody is in the range of 3.5 to 4.5 meets the limitations of instant claims 11, and 22 and “n” in the structure of claim 12.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-4 and 13-15, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent
Thus, Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741) anticipates the instant claims.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 26-31, 43, 44 and 52-58 of copending Application No. 16/640,914(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘914 application anticipate the instant claims. Claim 1 of ‘914 anticipates the drug-linker of instant claims 1 and 12, with the exception of the value of “n” in claim 12. Claim 7 as drawn to the conjugate comprising ananti-B7-H3 antibody in claim 7 and claim 26 of ‘914 anticipates the antibody of instant claims 1 and 12. Claim 27 disclosing the anti-B7-H3 antibody as comprising the heavy chain of residues 20-471 of SEQ ID NO: 7 and a light chain comprising residues 21-233 of SEQ ID NO: 8, meets the limitations of instant claims 5-9 and 16-20 because SEQ ID NO: 7 of ‘914 is identical to the instant SEQ ID NO: 3 and SEQ ID NO: 8 of ‘914 is identical to the instant SEQ ID NO: 4. Claim 27 of ‘914 anticipates instant claims 10 and 21. Claim 28 of ‘914 meets the limitations of instant claims 11, and 22 and “n” in claim 12.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-4 and 13-15, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent
Thus, Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741) anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 20-23, 32-38, 51-54 of copending Application No. 19/001,254(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘001 application anticipate the instant claims. The claims of the ‘001 application anticipate the instant claims due to the identical structure of the drug-linker and the sequence of the anti-B7-H3 antibody of the antibody-drug conjugate.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding instant claims 2-4 and 13-15, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1 and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent.
Thus, said claims of the ‘254 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 20-23, 32-38, 51-54 of copending Application No. 19/353,836 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘836 application anticipate the instant claims. The claims of the ‘836 application anticipate the instant claims due to the identical structure of the drug-linker and the sequence of the anti-B7-H3 antibody of the antibody-drug conjugate.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding instant claims 2-4 and 13-15 the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1 and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent.
Thus, said claims of the ‘836 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 52, 65-68 of copending Application No. 18/440,920(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of the ‘920 application..
Claim 3 of the ‘920 application teaches a method of producing an ADC comprising the drug-linker of formula 19, which meets the structure of the instant ADC comprising the same drug-linker in instant claim 1. Claims 52 and 65 specify that the antibody of the ADC is an anti-B6-H3 antibody. Claims 66-67 of the ‘920 application teach that the anti-B6-H3 antibody comprising the identical heavy and light chains as the heavy chain of residues 20-471 of SEQ ID NO:3 paired with a light chain comprising residues 21-233 of SEQ ID NO: 4 in instant claims 8 and 9. Claims 66 and 68 of the ‘920 application include a heavy chain of residues 20-479n of SEQ ID NO: 7 paired with a light chain consisting of residues 21-233 of SEQ ID NO: 8 which meets the limitations of instant claim 10 wherein the terminal lysine of the heavy chain is deleted.
It is noted that the limitation “for mesothelioma” in claim 1 occurs in the preamble.
A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding instant claims 2-4, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claim 1 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent.
Thus, the instant therapeutic agent is obvious over the method of producing the antibody-drug conjugate of claims 3, 52, 65-68 of the ‘920 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643