DETAILED ACTION
Claims 1-3, 5, 7-8, 12, 14-15, 21-22, 29-30, 36, and 42 are pending in the instant application.
Claims 43, 50, 54, 73, and 75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02/17/2026.
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 of Group I: claims 1-3, 5, 7-8, 12, 14-15, 21-22, 29-30, 36, and 42 drawn to NK cells comprising an integrated nucleic acid sequence encoding a catalytically inactive Cas9 (dCas9) protein; populations of NK cells comprising an integrated nucleic acid sequence encoding a catalytically inactive Cas9 (dCas9) protein; and methods of preparing NK cells comprising an integrated nucleic acid sequence encoding a catalytically inactive Cas9 (dCas9) protein in the reply filed on 2/17/2026 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 1-3, 5, 7-8, 12, 14-15, 21-22, 29-30, 36, and 42 are being examined on the merit.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Specifically, the examiner refers to the following references listed in the specification:
page 7, paragraph [0036];
page 11, paragraphs [0046], [0047];
page 15, paragraph [0057];
page 17, paragraph [0063];
page 28, paragraph [0091];
page 41, paragraph [0129];
page 79, paragraph [0300];
page 80, paragraph [0302];
page 81, paragraph [0303];
page 89, paragraph [0357], lines 3, 5-8;
page 93, paragraph [0365], Table 2 under “Oligonucleotides”;
page 101, paragraph [0409];
page 103, paragraph [0417];
page 106, paragraph [0432];
page 106-107, paragraph [0436];
page 108, paragraph [0445];
page 110, paragraph [0452];
page 111, paragraphs [0457], [0460];
page 112, paragraphs [0462]-[0463];
page 113, paragraphs [0465]-[0466], [0468];
page 114, paragraphs [0469], [0472];
page 115, paragraph [0476];
page 116, paragraph [0483].
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Specifically, the Examiner is referring to the hyperlinks embedded in:
Page 18, paragraph [0067];
Page 19, paragraph [0072];
Page 92-93 under “Oligonucleotides”;
Page 93 under “Software and algorithms”;
Page 98, paragraph [0389].
The disclosure is objected to because of the following informalities. Examples of pages requiring such corrections in the instant application include, but are not limited to, the following:
“LentidCas9-VP64-GFP” should read “Lenti-dCas9-VP64-GFP” (page 4, paragraph [0024]);
“dCAS9- VP64-GFP” should read “dCas9-VP64-GFP” (page 5, paragraph [0024]);
“dCAS9” should read “dCas9” (page 5, paragraphs [0024], [0025], [0027]; page 6, paragraphs [0028], [0029], [0030]; page 7, paragraphs [0035], [0036]; Figure 7B, 7C, 17; etc.);
“CAS9” should read “Cas9” (page 5, paragraph [0027]);
“dCas99-VP64-GFP” should read “dCas9-VP64-GFP” (Fig. 19A);
“GPF” should read “GFP” (page 8, paragraph [0039], lines 2, 7-8);
“DRAB” should read “KRAB” (page 8, paragraph [0039]);
“Interleukin-15e” should read “Interleukin-15” (page 20, paragraph [0073];
“dcas9” should read “dCas9” (page 62, paragraph [0190]);
“B/T-ALL ),” should read “B/T-ALL,” (page 81, paragraph [0304];
“Lenti-CAS9_EGFP” and “dCAS9-VP64_GFP” should read “Lenti-CAS9-EGFP” and “dCAS9-VP64-GFP”, respectively (page 81, paragraph [0308]);
“sgRFP_ipUSEPR” should read “sgRFP-ipUSEPR” (page 81, paragraph [0309]);
“Cutsmart” should read “CutSmart®” (page 99, paragraph [0395], Table 9);
Appropriate correction is required.
The use of the term Polybrene®, LipofectamineTM, Lenti-XTM, SYBR®, Nucleospin®, SuperscriptTM, GeneJETTM, CellTraceTM, NucleoBond®, GlutaMAX®, CutSmart®, HyPureTM, FlowJoTM, Steriflip®, ProFlex® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is directed to correct the Specification as noted by the Examiner. Examples of pages requiring such corrections in the instant application include, but are not limited to, the following:
Polybrene (page 81, paragraph [0310]; page 82, paragraph [0324]);
Lipofectamine (page 82, paragraphs [0312], [0324]; page 83, paragraph [0330]; page 91, paragraph [0365], Table 2; etc.);
Lenti-X (page 82, paragraphs [0313], [0314], [0324]; page 83, paragraphs [0326], [0330]; page 84, paragraph [0330], [0335], [0336]; page 91, paragraph [0365], Table 2; page 92, paragraph [0365], Table 2; etc.);
SYBR (page 83, paragraph [0326]; page 91, paragraph [0365], Table 2; page 92, paragraph [0365], Table 2);
Nucleospin (page 83, paragraph [0326]; page 91, paragraph [0365], Table 2, etc.);
Superscript (page 83, paragraph [0326]; page 91, paragraph [0365], Table 2, etc.);
GeneJET (page 90, paragraph [0365], Table 2; page 99, paragraph [0396]; etc.);
CellTrace (page 91, paragraph [0365], Table 2);
NucleoBond (page 91, paragraph [0365], Table 2; etc.);
GlutaMAX (page 91, paragraph [0365], Table 2; page 94, paragraph [0366], Table 3; page 95, paragraph [0368], Table 4; page 95, paragraph [0370], Table 5, etc.);
CutSmart (page 91, paragraph [0365], Table 2);
HyPure (page 92, paragraph [0365], Table 2);
FlowJo (page 93, paragraph [0365], Table 2; page 103, paragraph [0417]; etc.);
Steriflip (page 94, paragraph [0365], Table 2);
ProFlex (page 94, paragraph [0365], Table 2);
Claim Interpretation
The phrase “substantially pure population of NK cells” recited in instant claims 8, 12, 14, and 21 will be interpreted as “a population of cells wherein at least about 10% to 100% of cells in the population are NK cells” as disclosed in page 50, paragraph [0159] of the specification.
Regarding claims 1-3, 5, 7-8, 12, 14-15, 21-22, 29-30, 36, and 42 as defined by the instant specification on page 26, paragraph [0089] and page 30, paragraph [0100], “Cas9” will be interpreted as wildtype Cas9, dCas9, CRISPR associated protein 9, Csn1, Cas9 protein, etc.
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.
Claims 1-3, 5, 7-8, 12, 14, 22, 29-30, 36, and 42 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wang et al (WO2019014390 A1, priority to July 12, 2017, IDS entered on 10/29/2025; hereinafter Wang).
Regarding instant claims 1, 5, 7-8, 12, 14-15, 21, and 42, Wang teaches a system for regulating expression of a target gene in a cell, wherein the cell is a natural killer (NK) cell, comprising an expression cassette comprising a nucleic acid sequence encoding a gene modulating polypeptide (GMP) placed under the control of a promoter, wherein the GMP comprises (i) an actuator moiety wherein the actuator moiety is an RNA-guided actuator moiety that complexes with one or more guide-RNAs (e.g. sgRNAs), wherein the RNA-guided actuator moiety is dCas9 (page 3, paragraph [0005]; page 5, paragraphs [0009] and [0012]; page 63, paragraph [00209]; page 126, paragraph [00313]). Additionally, Wang teaches that the promoter that controls the expression of GMP comprises a constitutively active promoter, and upon transcriptional activation of the promoter, the expression of the GMP comprising dCas9 can complex with a constitutively-expressed guide RNA to regulate the expression of a target gene (page 120, paragraph [00294]; page 188, paragraph [00492], Example 1).
Regarding instant claims 2 and 3, Wang teaches that the expression cassette is integrated into the cell genome via lentivirus, wherein the virus can infect and transduce the cell in vivo, ex vivo, or in vitro (page 15, paragraph [0047]; page 47-48, paragraph [00162]; page 187, paragraph [00487]).
Regarding instant claims 22, 29-30 and 36, Wang teaches contacting cells with an expression cassette comprising a nucleic acid encoding the dCas9 protein, wherein the nucleic acid encoding dCas9 is integrated into the genome of the cell as discussed above. Additionally, Wang teaches that the expression of the GMP comprising dCas9 is linked to VPR (a transcriptional activator) or KRAB (a transcriptional repressor), which can complex with a constitutively-expressed guide RNA to regulate the expression of a target gene (page 188, paragraph [00492], Example 1). Furthermore, Wang teaches that one or more desired cell types can be enriched by any suitable method, non-limiting examples of which include treating a population of cells to trigger expansion, purification of a desired cell type(e.g. purification on an affinity column to retain desired cell type on the basis of one or more cell surface markers), wherein the enriched population of cells is a population of cells enriched in cytotoxic lymphocytes, wherein the cytotoxic lymphocytes are natural killer cells (page 167, paragraph [0419]).
Claims 8, 12, 14, 22, and 29 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ma et al (PGPUB No. US20180187149 A1, Priority to 10/1/2015; hereinafter Ma).
Regarding instant claims 8, 12, and 14, Ma teaches using CRISPR/Cas Nucleases to target CD45 in NK cells, wherein gene-specific sgRNAs were cloned into a lentiviral vector (Lenti U6-sgRNA-SFFV-Cas9-puro-wpre) expressing human Cas9 and puromycin resistance genes linked with an E2A self-cleaving linker, wherein the U6-sgRNA cassette is in front of the Cas9 element and the expression of sgRNA and Cas9-puro is driven by the promoters U6 and SFFV, respectively (page 92-93, paragraphs [0307]-[0308]). Additionally, Ma further teaches that the SFFV promoter of the expression vector leads to a stronger expression than other constitutive promoters, e.g. EF1 or CAG promoters, and that the expression remains high for at least 10 days post-transduction (instant claim 14; page 79, paragraph [0118]-[0119]; page 95, paragraph [0329]).
Regarding instant claims 8, 12, and 14 in regards to a “substantially pure population of NK cells”, Ma teaches that lentiviruses that carried gene-specific sgRNAs were used to transduce NK-92 cells wherein the loss of CD45 expression on NK-92 cells were assessed by flow cytometry analysis. Ma further teaches that the CD45 negative population of NK-92 cells was sorted and expanded, wherein 99.20% of the cells were expressing the expression cassette (page 93, paragraph [0309]; Figure 25), which is a substantially pure population of NK cells according to the definition disclosed in the instant specification.
Regarding instant claims 22 and 29, Ma teaches transducing NK-92 cells with lentiviruses carrying the gene-specific sgRNAs (Lenti U6-sgRNA-SFFV-Cas9-puro-wpre), wherein the cells were sorted through flow cytometry analysis and expanded to generate CD45-negative NK-92 cells (page 92-93, paragraphs [0307]-[0309]).
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (WO2019014390 A1, priority to July 12, 2017, IDS entered on 10/29/2025; hereinafter Wang) and further in view of Ma et al (PGPUB No. US20180187149 A1, Priority to 10/1/2015; hereinafter Ma).
Regarding instant claims 15 and 21, the teachings of Wang are discussed above in the 102 rejection. Wang also teaches that the subject system disclosed is expressed in a cell population, wherein the cells are immune cells, e.g. lymphocytes including NK cells (page 166, paragraph [00416]).
However, Wang does not explicitly teach a substantially pure population of NK cells, wherein the NK cells comprise an integrated nucleic acid sequence encoding dCas9 protein, wherein the dCas9 protein is constitutively expressed.
The deficiency is resolved by Ma.
The teachings of Ma are discussed above in the 102 rejection.
Regarding instant claims 15 and 21, it would have been obvious for a person having ordinary skill in the art at the time of filing to take the NK cells comprising an integrated nucleic acid sequence encoding dCas9 protein, wherein the dCas9 protein is constitutively expressed as taught by Wang, and include that the NK cells are a substantially pure population of NK cells wherein a substantially pure population of NK cells comprise a population of cells wherein at least 10% of cells in the population are NK cells comprising an integrated nucleic acid sequence encoding a dCas9 protein as taught by Ma. This is obvious because, Wang teaches a system for regulating expression of a target gene in a cell, wherein the cell is an NK cell comprising an expression cassette comprising an RNA-guided actuator moiety dCas9, wherein the promoter that controls the expression cassette comprises a constitutively active promoter, and upon transcriptional activation of the promoter, dCas9 can complex with a constitutively-expressed guide RNA to regulate the expression of a target gene, wherein the expression cassette achieves 10-50% expression efficiency in Jurkat cells after transduction, and Ma teaches that lentiviruses that carried gene-specific sgRNAs were used to transduce NK-92 cells wherein the loss of CD45 expression on NK-92 cells were assessed by flow cytometry analysis, resulting in 99.20% of cells expressing the expression cassette after sorting. Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to take the NK cells comprising an integrated nucleic acid sequence encoding dCas9 protein, wherein the dCas9 protein is constitutively expressed as taught by Wang and include that the NK cells are a substantially pure population of NK cells wherein a substantially pure population of NK cells comprise a population of cells wherein at least 10% of cells in the population are NK cells comprising an integrated nucleic acid sequence encoding dCas9 protein as taught by Ma to form the instant substantially pure population of NK cells, wherein the instant NK cells comprise an integrated nucleic acid sequence encoding a catalytically inactive Cas9 (dCas9) protein, wherein the instant dCas9 protein is constitutively expressed.
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.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 15, and 18 of copending Application No. 18/271,026 (hereinafter ‘026) in view of Ma et al (PGPUB No. US20180187149 A1, Priority to 10/1/2015; hereinafter Ma).
This is a provisional nonstatutory double patenting rejection.
Regarding instant claim 8, ‘026 teaches a method for preparing Cbl-bneg NK cells, the method comprising obtaining a population of NK cells, reducing or eliminating Cbl-b expression in the NK cells, and culturing the NK cells (claim 2), wherein the step of reducing or eliminating Cbl-b expression comprises genetically modifying the NK cells (claim 3), wherein the genetic modification is deletion of all or a portion of the Cbl-b gene using CRISPR/CAS9 (claims 4 and 18), thus reducing the expression of Cbl-b (claim 15).
However, ‘026 does not teach NK cells comprising an integrated nucleic acid sequence encoding a Cas9 protein.
The deficiency is resolved by Ma et al.
The teachings of Ma are discussed above in the 102 rejection.
Regarding instant claim 8, it would have been obvious for a person having ordinary skill in the art at the time of filing to take the method for preparing Cbl-bneg NK cells, the method comprising (i) obtaining a population of NK cells; (ii) reducing or eliminating Cbl-b expression in the NK cells; and (iii) culturing the NK cells, wherein the step of reducing or eliminating Cbl-b expression comprises genetically modifying the NK cells, wherein the genetic modification is deletion of all or a portion of the Cbl-b gene using CRISPR/CAS9, thus reducing the expression of Cbl-b as taught by ‘026 and modify it to include that the NK cells comprise an integrated nucleic acid sequence encoding a Cas9 protein as taught by Ma. This is obvious because, ‘026 teaches a method for preparing Cbl-bneg NK cells, the method comprising (i) obtaining a population of NK cells; (ii) reducing or eliminating Cbl-b expression in the NK cells; and (iii) culturing the NK cells, wherein the step of reducing or eliminating Cbl-b expression comprises genetically modifying the NK cells, wherein the genetic modification is deletion of all or a portion of the Cbl-b gene using CRISPR/CAS9, thus reducing the expression of Cbl-b, and Ma teaches using CRISPR/Cas Nucleases to target a gene in NK cells by transducing NK cells with lentiviruses carrying the gene-specific sgRNAs (Lenti U6-sgRNA-SFFV-Cas9-puro-wpre), wherein the cells are sorted through flow cytometry analysis and expanded to generate NK cells comprising the integrated nucleic acid sequence encoding the Cas9 protein. Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to take the method for preparing Cbl-bneg NK cells, the method comprising (i) obtaining a population of NK cells; (ii) reducing or eliminating Cbl-b expression in the NK cells; and (iii) culturing the NK cells, wherein the step of reducing or eliminating Cbl-b expression comprises genetically modifying the NK cells, wherein the genetic modification is deletion of all or a portion of the Cbl-b gene using CRISPR/CAS9, thus reducing the expression of Cbl-b as taught by ‘026 and modify it to include that the NK cells comprise an integrated nucleic acid sequence encoding a Cas9 protein as taught by Ma to form the instant method of preparing a plurality of NK cells each comprising an integrated nucleic acid sequence encoding a Cas9 protein.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jieun Ham whose telephone number is (571)272-7779. The examiner can normally be reached Monday - Friday 7-2.
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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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/J.H./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
Prosecution Insights