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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-28 are the original claims filed on 2/9/2023. In the preliminary amendment of 12/1/2023, Claims 1, 3-4, 7, 10-11, and 14-15 are amended and claims 16-28 are canceled. Claims 1-15 are all the claims. In the Response of 11/14/2025, Claims 1-2 are amended, claims 3-15 are canceled and new claims 29-33 are added.
Claims 1-2 and 29-33 are pending. The amendment of the claims raises new grounds for objection and rejection. The Office Action is final.
Priority
2. USAN 18/166,938, filed 02/09/2023, is a Continuation of 16/710,432, filed 12/11/2019, now U.S. Patent # 11607452, 16/710,432 is a Continuation of 16/411,276, filed 05/14/2019, now U.S. Patent # 11202829, 16/411,276 is a Continuation of 15/402,888, filed 01/10/2017, now U.S. Patent # 10314910 and having 1 RCE-type filing therein, 15/402,888 Claims Priority from Provisional Application 62/276,955, filed 01/10/2016.
Information Disclosure Statement
3. As of 12/22/2025, one (1) IDS is on file for this application: 11/14/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawal of Objections
Drawings
4. The objections to drawings for Figures 4-5 because each of the figures recites the terms “KETRUDA” and “ANYARA”, which is a trade name or a mark used in commerce, is withdrawn. Replacement figures rectify the deficiency.
Specification
5. The objection to the abstract of the disclosure is withdrawn in view of the amendment to delete the text:
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6. The objection to the disclosure because of informalities is withdrawn.
The specification is amended to rectify the improper use of the term, i.e., GenBank, NCBI, which is a trade name or a mark used in commerce.
Claim Objections
7. The objection to Claims 1-15 because of informalities is moot for the canceled claims and withdrawn for the pending claims.
a) Claims 1-15 are amended to delete the phrase “a first antigen” in Claim 1.
b) Claims 1-15 are amended to delete the phrase “capable of one or more of the following” in Claim 1.
c) Claim 13 is canceled.
Withdrawal of Rejections
Claim Rejections - 35 USC § 103
8. The rejection of Claims 1-15 under 35 U.S.C. 103 as being unpatentable over Eisen et al. (Curr. Oncol. Rep. 16:370-376 (2014)) as evidenced by www.medsafe.govt.nz/Profs/Datasheet/o/opdivoinf.pdf (product data sheet for nivolumab; pp. 1-47; printed 7/5/17) is moot for the canceled claims and withdrawn for the pending claims. The reference does not teach treating esophageal cancer with the SEA/E-120 superantigen (ANYARA)/ nivolumab combination.
9. The rejection of Claims 1-15 under 35 U.S.C. 103 as being unpatentable over Eisen et al. (Curr. Oncol. Rep. 16:370-376 (2014)) as applied to claims 1-15 above, and further in view of Shin et al. (Current Opinion in Immunol. 33:23-35 (April 2015): available online 1/23/2015)) is moot for the canceled claims and withdrawn for the pending claims. The references do not teach treating esophageal cancer with the SEA/E-120 superantigen (ANYARA)/ pembrolizumab combination.
Double Patenting
10. The rejection of Claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,314,910 in view of Eisen et al. (Curr. Oncol. Rep. 16:370-376 (2014); IDS of 11/29/19) and Shin et al. (Current Opinion in Immunol. 33:25-35 (2015): available online 1/23/2015)) is moot for the canceled claims and withdrawn for the pending claims. The terminal disclaimer filed on 11/14/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,314,910 has been reviewed and is accepted. The terminal disclaimer has been recorded.
11. The rejection of Claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11202829 is moot for the canceled claims and withdrawn for the pending claims. The terminal disclaimer filed on 11/14/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11202829has been reviewed and is accepted. The terminal disclaimer has been recorded.
12. The rejection of Claims 1-11 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11607452 is moot for the canceled claims and withdrawn for the pending claims. The terminal disclaimer filed on 11/14/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11607452 has been reviewed and is accepted. The terminal disclaimer has been recorded.
13. The provisional rejection of Claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 32-51 of copending Application No. 17610,897 (reference application US 20220213194) is moot for the canceled claims and withdrawn for the pending claims. The reference application is abandoned effective as of 7/31/2025.
Rejections Maintained
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
14. The provisional rejection of Claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15, 18, 20-21, 25-26, 28-31, 34-38, 40, 44-46, 49, and 53 of copending Application No. 17/909,212 (reference application US 20230085724) is moot for the canceled claims and maintained for the pending claims.
Claims 1-2 and 29-33 are drawn to:
A method of treating a cancer in a subject in need thereof, the method comprising: administering to the subject (i) an effective amount of a superantigen conjugate comprising a first protein chain comprising SEQ ID NO: 8 and a second protein chain comprising SEQ ID NO: 9 that together bind a 5T4 cancer antigen expressed by cancerous cells within the subject and (ii) an effective amount of an antibody selected from pembrolizumab, nivolumab, and MEDI4736 to treat the cancer, wherein the cancer is esophageal cancer.
Ref claims are drawn to:
1. (Original) A method of treating cancer in a subject in need thereof, the method comprising administering to the subject: (i) an effective amount of a superantigen conjugate comprising a superantigen covalently linked to a targeting moiety that binds a first cancer antigen expressed by cancerous cells within the subject; and (ii) an effective amount of an immune cell comprising an exogenous nucleotide sequence encoding a chimeric antigen receptor (CAR) that binds a second cancer antigen expressed by cancerous cells within the subject.
2. (Previously Presented) The method of claim 1, wherein the superantigen comprises Staphylococcal enterotoxin A or an immunologically reactive variant and/or fragment thereof.
3. (Previously Presented) The method of claim 1, wherein the superantigen comprises the amino acid sequence of SEQ ID NO: 3, or an immunologically reactive variant and/or fragment thereof.
4. (Previously Presented) The method of claim 1, wherein the targeting moiety is an antibody.
5. (Original) The method of claim 4, wherein the antibody is an anti-5T4 antibody.
6. (Original) The method of claim 5, wherein the anti-5T4 antibody comprises a Fab fragment that binds a 5T4 cancer antigen.
7. (Original) The method of claim 6, wherein the anti-5T4 antibody comprises a heavy chain comprising amino acid residues 1-458 of SEQ ID NO: 8 and a light chain comprising amino acid residues 1-214 of SEQ ID NO: 9.
8. (Previously Presented) The method of claim 1, wherein the superantigen conjugate comprises a first protein chain comprising SEQ ID NO: 8 and a second protein chain comprising SEQ ID NO: 9.
18. (Previously Presented) The method of claim 1, wherein the method further comprises administering to the subject a PD-1 based inhibitor.
20. (Previously Presented) The method of claim 18, wherein the PD-1 based inhibitor is an anti- PD-1 antibody or an anti-PD-L1 antibody.
21. (Previously Presented) The method of claim 20, wherein the PD-1 based inhibitor is an anti- PD-1 antibody selected from nivolumab pembrolizumab, and cemiplimab, or an anti-PD-L1 antibody selected from atezolizumab, avelumab, and durvalumab [MEDI4736].
53. (Previously Presented) The method of claim 1, wherein the cancer comprises a solid tumor.
The solid tumor in the method is taught in the ref specification at
[0203] “Moreover, the cancer that may be treated using the methods and compositions described herein may be based upon the body location and/or system to be treated, for example, but not limited to…esophageal cancer,”
MPEP 804 The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The reference is not afforded safe harbor under 35 USC because the ref claims share no continuity or restriction/ speciation with the claims of the instant application for an esophageal cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. The provisional rejection of Claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claim 37-40, 42, 48-52, 56-57, 64-65, 67-70 of copending Application No. 18/006,243 (reference application US 20230285588) is moot for the canceled claims and maintained for the pending claims.
Claims 1-2 and 29-33 are drawn to:
A method of treating a cancer in a subject in need thereof, the method comprising: administering to the subject (i) an effective amount of a superantigen conjugate comprising a first protein chain comprising SEQ ID NO: 8 and a second protein chain comprising SEQ ID NO: 9 that together bind a 5T4 cancer antigen expressed by cancerous cells within the subject and (ii) an effective amount of an antibody selected from pembrolizumab, nivolumab, and MEDI4736 to treat the cancer, wherein the cancer is esophageal cancer.
Ref claims are drawn to:
38. (Currently amended) A method of promoting infiltration of T-cells and/or reducing infiltration of regulatory T-cells (Tregs) into a tumor in a subject in need thereof, the method comprising administering to the subject: (i) an effective amount of a B-cell depleting agent; and then (ii) an effective amount of a superantigen conjugate comprising a superantigen covalently linked to a targeting moiety that binds a cancer antigen expressed by cancerous cells of the tumor, thereby to promote infiltration of T-cells and/or reduce infiltration of Tregs into the tumor.
42. (Original) A method of treating cancer in a subject in need thereof, the method comprising administering to the subject: (i) an effective amount of a B-cell depleting agent; and then (ii) an effective amount of a superantigen conjugate comprising a superantigen covalently linked to a targeting moiety that binds a cancer antigen expressed by cancerous cells of the tumor.
48. (Currently amended) The method of claim 38, wherein the superantigen comprises Staphylococcal enterotoxin A or an immunologically variant and/or fragment thereof.
49. (Currently amended) The method of claim 38, wherein the superantigen comprises the amino acid sequence of SEQ ID NO: 3, or an immunologically reactive variant and/or fragment thereof.
50. (Currently amended) The method of claim 38, wherein the cancer antigen is EpCAM or 5T4.
51. (Original) The method of claim 50, wherein the cancer antigen is 5T4.
52. (Currently amended) The method of claim 38, wherein the targeting moiety is an antibody.
56. (Currently amended) The method of claim 52, wherein the antibody is an anti-5T4 antibody comprising comprises a heavy chain comprising amino acid residues 1-222 of SEQ ID NO: 8 and a light chain comprising amino acid residues 1-214 of SEQ ID NO: 9.
57. (Currently amended) The method of claim 56 any one of claims 38-56, wherein the superantigen conjugate comprises a first protein chain comprising SEQ ID NO: 8 and a second protein chain comprising SEQ ID NO: 9.
64. (Currently amended) The method of claim 38 any one of claims 38-63, wherein the method further comprises administering to the subject an immunopotentiator.
65. (Currently amended) The method of any one of claim 64, wherein the immunopotentiator is a CTLA-4-based or a PD-1-based inhibitor, a PD-1 inhibitor or a PD-L1 inhibitor.
67. (Currently Amended) The method of claim 65, wherein the PD-1 inhibitor is an anti- PD-1 antibody.
68. (Currently amended) The method of claim 67, wherein the anti-PD-1 antibody is selected from nivolumab, pembrolizumab, and cemiplimab.
69. (Currently Amended) The method of claim [[66]] 65, wherein the PD-L1 inhibitor is an anti-PD-L1 antibody.
70. (Original) The method of claim 69, wherein the anti-PD-L1 antibody is selected from atezolizumab, avelumab, and durvalumab [MEDI4736].
The tumor in the method is taught in the ref specification at
[0215] “Moreover, the cancer that may be treated using the methods and compositions described herein may be based upon the body location and/or system to be treated, for example, but not limited to…esophageal cancer,”
MPEP 804 The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The reference is not afforded safe harbor under 35 USC because the ref claims share no continuity or restriction/ speciation with the claims of the instant application for an esophageal cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
16. The provisional rejection of Claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 17-19, 21 and 23 of copending Application No. 18/556,473 (reference application US 20240197784) is moot for the canceled claims and maintained for the pending claims.
Claims 1-2 and 29-33 are drawn to:
A method of treating a cancer in a subject in need thereof, the method comprising: administering to the subject (i) an effective amount of a superantigen conjugate comprising a first protein chain comprising SEQ ID NO: 8 and a second protein chain comprising SEQ ID NO: 9 that together bind a 5T4 cancer antigen expressed by cancerous cells within the subject and (ii) an effective amount of an antibody selected from pembrolizumab, nivolumab, and MEDI4736 to treat the cancer, wherein the cancer is esophageal cancer.
Ref claims are drawn to:
1. (Original) A method of reducing tumor volume in a subject with glioblastoma, the method comprising administering to the subject an effective amount of a 5T4-targeting agent.
2. (Original) A method of killing tumor cells in a subject with glioblastoma, the method comprising administering to the subject an effective amount of a 5T4-targeting agent.
3. (Original) A method of treating glioblastoma in a subject in need thereof, the method comprising administering to the subject an effective amount of a 5T4-targeting agent.
7. (Currently Amended) The method of any one of claim 3, wherein the 5T4-targeting agent is a superantigen conjugate comprising a superantigen covalently linked to an anti-5T4 antibody.
8. (Original) The method of claim 7, wherein the superantigen comprises Staphylococcal enterotoxin A or an immunologically variant and/or fragment thereof.
7. (Currently Amended) The method of any one of claim 3, wherein the 5T4-targeting agent is a superantigen conjugate comprising a superantigen covalently linked to an anti-5T4 antibody.
8. (Original) The method of claim 7, wherein the superantigen comprises Staphylococcal enterotoxin A or an immunologically variant and/or fragment thereof.
11. (Currently Amended) The method of any one of claim 7, wherein the anti-5T4 antibody comprises a heavy chain comprising amino acid residues 1-222 of SEQ ID NO: 8 and a light chain comprising amino acid residues 1-214 of SEQ ID NO: 9.
17. (Currently Amended) The method of any one of claim 3, wherein the method further comprises administering to the subject an immunopotentiator.
18. (Original) The method of claim 17, wherein the immunopotentiator is a CTLA-4- or a PD-1- based inhibitor.
19. (Currently Amended) The method of claim 18, wherein the PD-1-based inhibitor is an anti- PD-1antibody or an anti-PD-L1 antibody.
21. (Currently Amended) The method of claim 19, wherein the anti-PD-1 antibody is selected from nivolumab pembrolizumab, cemiplimab, spartalizumab, MEDI0680, pidilizumab, dostarlimab, sintilimab, toripalimab, camrelizumab, pimivalimab, tislelizumab, and prolgolimab.
23. (Currently Amended) The method of claim 19, wherein the anti-PD-L1 antibody is selected from atezolizumab, avelumab, durvalumab, CS1001, tagitanlimab, cosibelimab, TQB2450, envafolimab, SHR-1316, STI-A1014, BGB-A333, MSB2311, HLX-20, and BMS-936559.
The tumor in the method is taught in the ref specification at
[0215] “Moreover, the cancer that may be treated using the methods and compositions described herein may be based upon the body location and/or system to be treated, for example, but not limited to…esophageal cancer,”
MPEP 804 The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The reference is not afforded safe harbor under 35 USC because the ref claims share no continuity or restriction/ speciation with the claims of the instant application for an esophageal cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
New Grounds for Objection
Claim Objections
17. Claim 29 is objected to because of the following informalities:
Amend claim 29 to recite “The method of claim 1, wherein the superantigen and the antibody are administered to the subject simultaneously.
Appropriate correction is required.
New Grounds for Rejection
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.
18. Claims 1-2 and 29-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: a pretreatment step using soluble SEA. The affidavit of 11/14/2025 avers under section 11 “Numerous studies describe both the use of the OE-33 cell line as a pre-clinical model for esophageal cancer, and in vitro cytotoxicity assays with isolated T-cell and cancer cell lines.” The affidavit under section 7 describes the protocol for exposing PBMCs to the regimen that results in tumor cell adherence and viability following the regimen. The affidavit specifically states the use of soluble SEA in the method steps:
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The claimed method steps are silent with respect to a preincubation or pretreatment of the subject with a dose of SEA followed by the administration of the antibody and the superantigen conjugate. It is not clear or concise what role the soluble SEA adds to the success of those data shown in the affidavit.
Conclusion
18. No claims are allowed.
19. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached on Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached on 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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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643