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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Acknowledgment is made of applicant’s claim for priority based on the instant application being a continuation of an application filed as PCT/CN2023/140808 on 12/22/2023.
Acknowledgment is made of applicant’s request for priority to two foreign applications filed as CN202311453875.2 on 11/02/2023 and CN202211663018.0. However, due to the foreign priority documents are not in English, all claims are given the priority date of the PCT 371 application filed as PCT/CN2023/140808 on 12/22/2023.
Therefore, all claims are given the priority date of 12/22/2023.
Application Status
Receipt is acknowledged of amendment, filed 12/21/2025. Claims 1, 3, 4, 6, 7, 9, 10, 13, 18, 19, 21, 22, 25-31, 36, 53 and 54 are currently pending.
Election/Restriction
Applicant’s election of Group I, drawn to claims 1, 3, 4, 6, 7, 9, 10, 13, 18, 19, 21, 22, 25-31 and 36 in the reply filed on 12/31/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant's election of the TALEHPT8 (identified as SEQ ID NO: 343) or TALEHPT12 (identified as SEQ ID NO: 344) as the DNA binding domain; the ZIM3 (identified as SEQ ID NO: 26) as the transcriptional repressor domain; V48 (identified as SEQ ID NO: 345 for the amino acid sequence and SEQ ID NO: 353 for the nucleic acid sequence) or V49 (identified as SEQ ID NO: 346 for the amino acid sequence and SEQ ID NO: 354 for the nucleic acid sequence); and After protein translation, V48 and V49 use self-cleaving peptide P2A to produce scFv-ZIM3 and DNMT3A-hDNMT3L-(TALE HPT8 or TALE HPT12)-1xGCN4. Thus, the applicant elects SEQ ID NO: 53 corresponding to the fusion protein of scFv-ZIM3, and SEQ ID NO: 361 corresponding to the fusion protein of DNMT3A-hDNMT3L-TALE HPT8-1 xGCN4 and SEQ ID NO: 362 corresponding to the fusion protein of DNMT3A-hDNMT3L-TALE HPT12-1 xGCN4, in the reply filed on 12/31/2025 is acknowledged Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 53 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/31/2025.
Claims 1, 3, 4, 6, 7, 9, 10, 13, 18, 19, 21, 22, 25-31 and 36 are currently under consideration.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 06/23/2025 have been received and all references have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specifically, the specification recites “amino acid sequences” but then recites SEQ ID NOs that are not amino acid sequences. As well as, the specification recites “a nucleic acid sequence” but then recites SEQ ID NOs that are not nucleic acid sequences. The specification also recites sequences with sequence identifiers that are not the same as the sequences listed in the Sequence Listing.
For example, embodiments recite limitations such as “wherein the first fusion and/or the second fusion comprises an amino acid sequence as set forth in any one of SEQ ID NOs: 51-76, 78-124 and 361-364”, wherein SEQ ID NOs: 53, 361 and 362 were elected, however, some of those sequences are nucleic acid sequences and not amino acid sequences as required by the claim; “comprising an amino acid sequence as set forth in any one of SEQ ID NOs: 133-168, 345 and 346-348”, wherein SEQ ID NOs: 345 and 346 were elected, however, those sequences are nucleic acid sequences and not amino acid sequences as required by the claim; and “A nucleic acid encoding the complex of claim 1, wherein the nucleic acid comprising a nucleic acid sequence set forth in any one of SEQ ID NOs: 169-335 and 349-360”, wherein SEQ ID NOs: 353 and/or 354 were elected, however, those sequences are amino acid sequences not nucleic acid sequences as required by the claim. As well as, SEQ ID NO: 26 was elected for the species election as “ZIM3”, however the sequence listing corresponds to “ZFN264” transcriptional repressor instead as per the sequence listing.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 includes abbreviations, such as “TALE”, “tetR” and “Cas”. The first instance of an abbreviation must be written out followed by the abbreviation in parathesis.
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 30, 31 and 36 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 30 is vague and indefinite in that the metes and bounds of the claim’s limitations are unclear. The claim’s limitations are unclear in that the claim recites “wherein the first fusion and/or the second fusion comprises an amino acid sequence as set forth in any one of SEQ ID NOs: 51-76, 78-124 and 361-364”, wherein SEQ ID NOs: 53, 361 and 362 were elected, however, those sequences are nucleic acid sequences and not amino acid sequences as required by the claim. It would be remedial to replace the phrase “amino acid sequences” with “nucleic acid sequences” or replace the sequences selected with the corresponding amino acid sequences.
Claim 31 is vague and indefinite in that the metes and bounds of the claim’s limitations are unclear. The claim’s limitations are unclear in that the claim recites “comprising an amino acid sequence as set forth in any one of SEQ ID NOs: 133-168, 345 and 346-348”, wherein SEQ ID NOs: 345 and 346 were elected, however, those sequences are nucleic acid sequences and not amino acid sequences as required by the claim. It would be remedial to replace the phrase “amino acid sequences” with “nucleic acid sequences” or replace the sequences selected with the corresponding amino acid sequences.
Claim 36 is vague and indefinite in that the metes and bounds of the claim’s limitations are unclear. The claim’s limitations are unclear in that the claim recites “A nucleic acid encoding the complex of claim 1, wherein the nucleic acid comprising a nucleic acid sequence set forth in any one of SEQ ID NOs: 169-335 and 349-360”, wherein SEQ ID NOs: 353 and/or 354 were elected, however, those sequences are amino acid sequences not nucleic acid sequences as required by the claim. It would be remedial to replace the amino acid sequence elected with the corresponding nucleic acid sequence.
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.
Claims 1, 3, 4, 6, 7, 9, 10, 13, 18, 19, 21, 22 and 25-31 are rejected under 35 U.S.C. 103 as being unpatentable over Maeder et al (WO 2022/140577 A2; Priority to 12/22/2020) in view of Plueger et al (Genome Res. 2018 Aug; 28 (8); Pgs. 1193-1206).
Regarding claims 1, 3 and 4, the claim does not limit that the two fusions are separate or on separate molecules. The claim recites the limitation “wherein the recruitment domain A and the recruitment A’ are capable of interacting, such that the fusion of one of the first fusion and the second fusion or a portion thereof is capable of being recruited to the vicinity of the other fusion”. Therefore, the claim is interpreted that the two fusions can be/are bound by a linker comprising the recruitment domains.
Maeder teaches a fusion protein comprising, from N-terminus to C-terminus, DNMT3A (a DNA methylation domain), dSpCas9 (nucleic acid binding domain), a linker comprising an affinity binding domain, such as scFv or GCN (wherein the affinity binding domain has the same function as a recruitment domain), a transcriptional repressor, such as ZFN264 and a second linker comprising an affinity binding domain, such as scFv or GCN (wherein the affinity binding domain has the same function as a recruitment domain) ([0004, 0007 and 0381] and Page 453, Figures 6a and 6b). Maeder teaches a linker comprising an affinity domain having specific binding affinity to an epigentic effector domain (also referred to as the programmable DNA binding domain such as, dCas9) [0381]. Maeder teaches that the linker may comprise a Suntag for the fusion of the proteins [0382].
Maeder does not specifically teach the suntag must be used as the two recruitment domains.
Pflueger teaches that suntag is a repeating array of short repeat peptide sequences fused to dCas9, thus acting as an epitope docking station that allows multiple proteins to be recruited to a desired target site wherein the suntag comprises an array of scFv-GCN4 fused together with additional domains, such as the dCas9 and another domain, fused to either side of the scFv-GCN4 (suntag) (Page 1195, Column 1 bridging Column 2).
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 Maeder to include the suntag that is capable of recruiting the two fusion proteins together as taught by Pflueger because Mader teaches it is within the ordinary skill in the art to use recruitment domains/affinity binding domains, a DNA binding domain and a transcriptional repressor domain in multiple configurations for the fusion protein complex and Pflueger teaches the suntag, comprising the scFv-GCN4 fused together with additional domains, such as the dCas9 and another domain, fused to either side of the scFv-GCN4 (suntag), for the recruitment of multiple proteins together.
One would have been motivated to make such a modification in order to receive the expected benefit of epitope docking station that allows multiple proteins to be recruited to a desired target site as taught by Pflueger.
Regarding claims 6 and 7, Maeder teaches the structure of the fusion proteins can vary with multiple configurations such that, from the N-terminus to the C-terminus, the fusion comprises N']-[DBD]-[ repression domain]-[-C', wherein the connecting structure ]-[ is an affinity binding domain [0396]. Therefore, the configuration would read N’-affinity binding domain (also referred to as recruitment binding domain)-DNA binding domain-transcriptional repressor domain-C’.
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 Maeder to include the specific configuration of the fusion protein complex because Maeder teaches it is within the ordinary skill in the art to use recruitment domains/affinity binding domains, a DNA binding domain and a transcriptional repressor domain in multiple configurations for the fusion protein complex. Therefore, one would have been reasonable expectation of success to include the specific configuration of the fusion protein complex for the variety of the intended gene targets.
Regarding claims 9, 10 and 18, Maeder teaches a fusion protein comprising, from N-terminus to C-terminus, DNMT3A/L (DNA methylation domain made up of both DNMT3A linked to DNMT3L), dSpCas9 (nucleic acid binding domain), a linker comprising an affinity binding domain, such as scFv or GCN (wherein the affinity binding domain has the same function as a recruitment domain), a transcriptional repressor, such as ZFN264 and a second linker comprising an affinity binding domain, such as scFv or GCN (wherein the affinity binding domain has the same function as a recruitment domain) ([0004, 0007 and 0381] and Page 453, Figures 6a and 6b). Maeder teaches a linker comprising an affinity domain having specific binding affinity to an epigentic effector domain (also referred to as the programmable DNA binding domain such as, dCas9) [0381].
Regarding claim 13, Maeder teaches the DNA binding domain comprises CRISPR-Cas
protein bound to the guide polynucleotide [0009].
Regarding claim 19, the election filed by applicant chose SEQ ID NOs: 343 and 344 which were said to correspond to TALE HPT8 and TALE HPT12 respectively. However, the sequence listing, and subsequent sequence searches, identifies the SEQ ID NOs as V15’ fusion and V16’ fusion which corresponds to a Cas9 DNA binding domain. Therefore, without knowing the proper sequence to correspond to the TALE DNA binding domains as elected, the claims will be interpreted as requiring either SEQ ID NO: 343 or 344 as it reads on a Cas9 DNA binding domain wherein the term “an amino acid sequence” is interpreted as two or more consecutive nucleic acids with 100% identity and does not require the entire length of the sequence.
Maeder teaches the DNA binding domain as a dCas9 with the sequence of SEQ ID NO: 3 which is 100% identical to two or more amino acids in instant SEQ ID NO: 343 (Page 245; See Appendix I).
Regarding claims 21 and 29, Maeder teaches a fusion protein comprising, from N-terminus to C-terminus, DNMT3A/L (DNA methylation domain made up of both DNMT3A linked to DNMT3L), dSpCas9 (nucleic acid binding domain), a linker comprising an affinity binding domain, such as scFv or GCN (wherein the affinity binding domain has the same function as a recruitment domain), a transcriptional repressor, such as ZFN264 and a second linker comprising an affinity binding domain, such as scFv or GCN4 (wherein the affinity binding domain has the same function as a recruitment domain) ([0004, 0007 and 0381] and Page 453, Figures 6a and 6b). Maeder teaches a linker comprising an affinity domain having specific binding affinity to an epigentic effector domain (also referred to as the programmable DNA binding domain such as, dCas9) [0381]. Mader teaches the linkers comprise an affinity domain that specifically binds a component of an epigenetic effector such as a scFv [0381]. Maeder teaches the effector domain regulates acetylation of a histone associated with the target gene [0357]. Maeder teaches the use of GCN4 as part of the effector domain as an affinity binding domain [0357].
Maeder does not specifically teach the domain of one of the recruitment domain A and the recruitment domain A’ is a GCN4, and wherein the other domain is a scFv.
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 Maeder to include a GCN4 as a recruitment domain (also referred to as an affinity binding domain) on one fusion protein and a scFv as a second recruitment domain (also referred to as an affinity binding domain) one another fusion protein because Maeder teaches it is within the ordinary skill in the art to use recruitment domains/affinity binding domains for the purpose of specifically binding a component of an epigenetic effector. Therefore, one would have been reasonable expectation of success to include the two recruitment domains/affinity binding domains on the two fusion proteins for recruitment of the DNA binding domains to the intended targets.
Regarding claims 22, 25 and 26, Maeder teaches the DNMT3A linked to the DNMT3L as the DNA methylation domain (Page 453, Figures 6a and 6b). Maeder teaches the sequence of DNMT3L as SEQ ID NO: 38 which is 100% identical to instant SEQ ID NO: 21 (Page 259; See Appendix II).
Regarding claims 27 and 28, the election filed by Applicant chose SEQ ID NO: 26 which were said to correspond to ZIM3. However, the sequence listing, and subsequent sequence searches, identifies instant SEQ ID NO: 26 as ZFN264 (also referred to as ZNF264). Therefore, without knowing the proper sequence to correspond to the ZIM3 transcriptional repressor domain as elected, the election is interpreted as SEQ ID NO: 26 corresponding to ZFN264.
Maeder teaches the repressor domain is ZNF264 where the sequence of ZNF264 is identified as SEQ ID NO: 83 which is 100% identical to instant SEQ ID NO: 26 (Page 147 and 266; See Appendix III).
Regarding claim 30, the election filed by Applicant chose SEQ ID NOs: 53, 361 and 362 which were said to correspond to scFv-ZIM3, DNMT3A-hDNMT3L-TALE HPT8-1XGCN4 and DNMT3A-hDNMT3L-TALE HPT12-1XGCN4, respectively. However, the sequence listing, and subsequent sequence searches, identifies instant SEQ ID NO: 53 as a linker, such as “linker7_XTEN1”; identifies SEQ ID NO: 361 as “V76 mRNA”; and identifies SEQ ID NO: 362 as “V77 mRNA”. Further, SEQ ID NOs: 361 and 362 are nucleic acid sequences and not amino acid sequences. Therefore, without knowing the proper sequence to correspond to the elected species as stated in the Applicants remarks, the election is interpreted as SEQ ID NO: 53 corresponding to a linker sequence wherein the term “a nucleic acid sequence” or “an amino acid sequence” is interpreted as two or more consecutive nucleic acids or amino acids with 100% identity and does not require the entire length of the sequence.
Maeder teaches the linker sequence identified as SEQ ID NO: 687 which is 100% identicial to two or more consecutive amino acids in instant SEQ ID NO: 53 (Page 308; See Appendix IV).
Regarding claim 31, the election filed by Applicant chose SEQ ID NOs: 345 and 346 which were said to correspond to V48 and V49, respectively. However, the sequence listing, and subsequent sequence searches, identifies instant SEQ ID NO: 345 as “V7’ DNA” and identifies SEQ ID NO: 346 as “V8’ DNA”. Further, SEQ ID NOs: 345 and 346 are nucleic acid sequences and not amino acid sequences. Therefore, without knowing the proper sequence to correspond to the elected species as stated in the Applicants remarks, the election is interpreted as a nucleic acid sequence of SEQ ID NO: 345 or 346 corresponding to the complex of claim 1 wherein the term “a nucleic acid sequence” is interpreted as two or more consecutive nucleic acids with 100% identity and does not require the entire length of the sequence.
Maeder teaches the nucleic acid sequence that encodes the Cas9 protein sequence as SEQ ID NO: 1 which is 100% identical to two or more consecutive nucleic acids of instant SEQ ID NO: 345 (Pages 243-244; See Appendix V).
Regarding claim 36, the election filed by Applicant chose SEQ ID NOs: 353 and 354 which were said to correspond to V48 and V49, respectively. However, the sequence listing, and subsequent sequence searches, identifies instant SEQ ID NO: 353 as “TALE 8” and identifies SEQ ID NO: 354 as “TALE 6”. Further, SEQ ID NOs: 353 and 354 are amino acid sequences and not nucleic acid sequences for which the claim limitations require a nucleic acid sequence. Therefore, without knowing the proper sequence to correspond to the elected species as stated in the Applicants remarks, the election is interpreted as an amino acid sequence of SEQ ID NO: 353 or 354 corresponding to a DNA binding domain within the complex of claim 1 wherein the term “an amino acid sequence” is interpreted as two or more consecutive amino acids with 100% identity and does not require the entire length of the sequence.
Maeder teaches the DNA binding domain as a dCas9 with the sequence of SEQ ID NO: 3 which is 100% identical to two or more amino acids in instant SEQ ID NO: 353 (Page 245; See Appendix VI).
Conclusion
No claims are allowed.
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
/CELINE X QIAN/Primary Examiner, Art Unit 1637