NOVEL T CELL RECEPTORS AND IMMUNE THERAPY USING THE SAME

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 . 1. 1-20 are pending and under consideration. Specification 2 The disclosure is objected to because of the following informalities: the section for the Brief Description of the Drawings is found on page 4, however the complete description of the drawings is found on pages 45-56. The complete description of the drawings should be in the section labeled Brief Description of the Drawings. See MPEP 608.01(a) and MPEP 608.01(f). Appropriate correction is required 3. The disclosure is objected to because of the following informalities: The current application was filed after July 1, 202, thus the WIPO Standard ST.26, Sequence Listing in XML format, applies to sequence disclosures. See 37 CFR § 1.831. An ST.26 Sequence Listing in XML must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids. See 37 CFR § 1.831(j). The specification contains sequences of three amino acids or less in length associated with SEQ ID NOs: 50, 74, 98 and 122. See p. 37- ¶¶ 00118 and 0019 and Table 1. These sequences are replaced with “000” in the Sequence Listing in XML because the sequences are less than 4 amino acid sequences. The SEQ ID NOs: 50, 74, 98 and 122 and replace the appropriate amino acid sequence should be deleted because the Sequence Listing in XML does not contain the short sequences. Appropriate correction is required. Additionally, the last line of paragraph [0120] on page 39 of the specification filed 07/05/2024 ends in two periods. Appropriate correction is required. Claim Objections 5. Claims 4-12 are objected to because of the following informalities: Claims 4-12 contain SEQ ID NO: 50 which is a single amino acids. This sequence is replaced with “000” in the Sequence Listing in XML because the sequence is less than 4 amino acid sequences in length. See 37 CFR § 1.831(j). SEQ ID NO: 50 in claims 4-12 should be deleted and replaced with the amino acid glycine (GLY or G). Appropriate correction is required. 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. 6. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,874,731 (Alten et al. Dec. 29, 2020). The ‘731 claims are drawn to: 1. A single chain T cell receptor (TCR) comprising SEQ ID NO: 49, SEQ ID NO: 51, SEQ ID NO: 55, and SEQ ID NO: 57, wherein each of SEQ ID NO: 49, SEQ ID NO: 51, SEQ ID NO: 55, and SEQ ID NO: 57 comprise at most one conservative amino acid substitution. 2. The single chain TCR according to claim 1, wherein said single chain TCR specifically and/or selectively binds to SEQ ID NO: 133. 3. The single chain TCR according to claim 1, comprising a TCR α variable chain comprising an amino acid sequence having at least 95% identity to SEQ ID NO: 52 and a TCR β variable chain comprising an amino acid sequence at least having 95% identity to SEQ ID NO: 58. 4. A nucleic acid encoding for the single chain TCR according to claim 1. 5. A vector comprising a nucleic acid according to claim 4. 6. A host cell comprising the single chain TCR according to claim 1. 7. A pharmaceutical composition comprising the single chain TCR according to claim 1. 8. A method of manufacturing the single chain TCR, comprising providing a suitable host cell, providing a genetic construct comprising a coding sequence encoding the single chain TCR according to claim 1, introducing into said suitable host cell said genetic construct, expressing said genetic construct by said suitable host cell. 9. The method according to claim 8, further comprising isolation and purification of the single chain TCR from the suitable host cell and, optionally, reconstitution of the single chain TCR in a T-cell. 10. The single chain TCR of claim 1, comprising a CDR1α chain comprising the amino acid sequence of SEQ ID NO: 49, a CDR2α chain comprising the amino acid sequence of SEQ ID NO: 50, a CDR3α chain comprising the amino acid sequence of SEQ ID NO: 51, a CDR1β chain comprising the amino acid sequences of SEQ ID NO: 55, a CDR2β chain comprising the amino acid sequence of SEQ ID NO: 56, and a CDR3β chain comprising the amino acid sequence of SEQ ID NO: 57, wherein each of SEQ ID NOs: 49 and 55 comprise at most one conservative amino acid substitution. 11. The single chain TCR of claim 1, comprising a CDR1α chain comprising the amino acid sequence of SEQ ID NO: 49, a CDR2α chain comprising the amino acid sequence of SEQ ID NO: 50, a CDR3α chain comprising the amino acid sequence of SEQ ID NO: 51, a CDR1β chain comprising the amino acid sequences of SEQ ID NO: 55, a CDR2β chain comprising the amino acid sequence of SEQ ID NO: 56, and a CDR3β chain comprising the amino acid sequence of SEQ ID NO: 57, wherein each of SEQ ID NOs: 50 and 56 comprise at most one conservative amino acid substitution. 12. The single chain TCR of claim 1, comprising a CDR1α chain comprising the amino acid sequence of SEQ ID NO: 49, a CDR2α chain comprising the amino acid sequence of SEQ ID NO: 50, a CDR3α chain comprising the amino acid sequence of SEQ ID NO: 51, a CDR1β chain comprising the amino acid sequences of SEQ ID NO: 55, a CDR2β chain comprising the amino acid sequence of SEQ ID NO: 56, and a CDR3β chain comprising the amino acid sequence of SEQ ID NO: 57, wherein each of SEQ ID NOs: 51 and 57 comprise at most one conservative amino acid substitution. 13. The single chain TCR of claim 1, comprising a CDR1α chain comprising the amino acid sequence of SEQ ID NO: 49, a CDR2α chain comprising the amino acid sequence of SEQ ID NO: 50, a CDR3α chain comprising the amino acid sequence of SEQ ID NO: 51, a CDR1β chain comprising the amino acid sequences of SEQ ID NO: 55, a CDR2β chain comprising the amino acid sequence of SEQ ID NO: 56, and a CDR3β chain comprising the amino acid sequence of SEQ ID NO: 57. 14. The single chain TCR according to claim 13, wherein said single chain TCR specifically binds to SEQ ID NO: 133. 15. The single chain TCR of claim 1, wherein the single chain TCR is a soluble TCR. Although the claims at issue are not identical, they are not patentably distinct from each other because the ’731 patent discloses the utility for the TCR claimed in the ‘731 patent that is now claimed in the instant claims. See e.g. column 29-line 40 to column 30-line 30 and column 31-line 44 to column 32-line 12. The U. S. Court of Appeals Federal Circuit (See Sun PNG media_image1.png 1 1 media_image1.png Greyscale Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797 (Fed. Cir. 2010) at 1800) has found in relation to double patenting : . . . we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. We held that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. See also Geneva PNG media_image1.png 1 1 media_image1.png Greyscale Pharmaceuticals PNG media_image1.png 1 1 media_image1.png Greyscale , Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] and Pfizer, Inc. v. Teva PNG media_image1.png 1 1 media_image1.png Greyscale Pharmaceuticals PNG media_image1.png 1 1 media_image1.png Greyscale USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008). Thus, the TCRs claimed in the ‘731 patent are not distinct from the method now claimed because the claimed method is disclosed in the ‘731 patent. 7. Claims 1-13 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 21 and 27-33 of U.S. Patent No. 10,702,609 B2 (Alten et al. July 7, 2020). The ‘609 claims are drawn to: 1. A method of treating a patient who has cancer, comprising administering to the patient a population of transformed CD8+ T cells expressing at least one vector encoding a T cell receptor (TCR), wherein the TCR comprises SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 7 and SEQ ID NO: 9, or SEQ ID NO: 13, SEQ ID NO: 15, SEQ ID NO: 19 and SEQ ID NO: 21, or SEQ ID NO: 25, SEQ ID NO: 27, SEQ ID NO: 31 and SEQ ID NO: 33, or SEQ ID NO: 37, SEQ ID NO: 39, SEQ ID NO: 43 and SEQ ID NO: 45, or SEQ ID NO: 49, SEQ ID NO: 51, SEQ ID NO: 55 and SEQ ID NO: 57, or SEQ ID NO: 61, SEQ ID NO: 63, SEQ ID NO: 67 and SEQ ID NO: 69, or SEQ ID NO: 73, SEQ ID NO: 75, SEQ ID NO: 79 and SEQ ID NO: 81, or SEQ ID NO: 85, SEQ ID NO: 87, SEQ ID NO: 91 and SEQ ID NO: 93, or SEQ ID NO: 97, SEQ ID NO: 99, SEQ ID NO: 103 and SEQ ID NO: 105, or SEQ ID NO: 109, SEQ ID NO: 111, SEQ ID NO: 115 and SEQ ID NO: 117, wherein each of SEQ ID NOs: 1, 3, 7, 9, 13, 15, 19, 21, 25, 27, 31, 33, 37, 39, 43, 45, 49, 51, 55, 57, 61, 63, 67, 69, 73, 75, 79, 81, 85, 87, 91, 93, 97, 99, 103, 105, 109, 111, 115, and 117 comprise at most one conservative amino acid substitution, wherein the TCR is capable of binding to a peptide consisting of the amino acid sequence of KVLEYVIKV (SEQ ID NO: 133) in a complex with an MHC class I molecule, and wherein the cancer is selected from non-small cell lung cancer, small cell lung cancer, renal cell cancer, brain cancer, gastric cancer, colorectal cancer, hepatocellular cancer, head and neck cancer, pancreatic cancer, prostate cancer, leukemia, breast cancer, Merkel cell carcinoma, melanoma, ovarian cancer, urinary bladder cancer, uterine cancer, gallbladder and bile duct cancer, esophageal cancer. 2. The method of claim 1, wherein the population of transformed cells are produced by a method comprising isolating a CD8+ T cell from a subject, transforming the cell with at least one vector encoding the TCR to produce a transformed cell, and expanding the transformed cell to produce the population of transformed cells. 3. The method of claim 2, wherein the subject is the patient. 4. The method of claim 2, wherein the subject is a healthy donor. 6. The method of claim 1, wherein the MHC class I molecule is HLA-A*02. 7. The method of claim 1, wherein the population of transformed cells are administered in the form of a pharmaceutical composition. 8. The method of claim 7, wherein the pharmaceutical composition comprises a chemotherapeutic agent selected from the group consisting of asparaginase, busulfan, carboplatin, cisplatin, daunorubicin, doxorubicin, fluorouracil, gemcitabine, hydroxyurea, methotrexate, paclitaxel, rituximab, vinblastine, and vincristine. 21. The method of claim 1, wherein the TCR comprises a CDR1α chain comprising the amino acid sequence of SEQ ID NO: 49, a CDR2α chain comprising the amino acid sequence of SEQ ID NO: 50, a CDR3α chain comprising the amino acid sequence of SEQ ID NO: 51, a CDR1β chain comprising the amino acid sequence of SEQ ID NO: 55, a CDR2β chain comprising the amino acid sequence of SEQ ID NO: 56, and a CDR3β chain comprising the amino acid sequence of SEQ ID NO: 57. 27. The method of claim 1, wherein the cancer is selected from the group consisting of non-small cell lung cancer and small cell lung cancer. 28. The method of claim 1, wherein the cancer is colorectal cancer. 29. The method of claim 1, wherein the cancer is pancreatic cancer. 30. The method of claim 1, wherein the cancer is prostate cancer. 31. The method of claim 10, wherein the cancer is selected from the group consisting of non-small cell lung cancer and small cell lung cancer. 32. The method of claim 11, wherein the cancer is selected from the group consisting of non-small cell lung cancer and small cell lung cancer. 33. The method of claim 12, wherein the cancer is selected from the group consisting of non-small cell lung cancer and small cell lung cancer. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patented claims relate to the same inventive concept, and the current claims would have been obvious in view of the patented claims which have are drawn to a method of treating a patient who has cancer, comprising administering to the patient a population of transformed CD8+ T cells expressing at least one vector encoding the claimed T cell receptor (TCR). 8. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,998,607 B2 (Alten et al. June 4, 2024). The ‘607 claims are drawn to: 1. An antigen recognizing construct, comprising a first T cell receptor (TCR) variable chain region comprising a complementarity determining region (CDR)1 comprising SEQ ID NO: 49, a CDR2, and a CDR3 comprising SEQ ID NO: 51, and a second TCR variable chain region comprising a CDR1 comprising SEQ ID NO: 55, a CDR2, and a CDR3 comprising SEQ ID NO: 57, wherein each of SEQ ID NO: 49, SEQ ID NO: 51, SEQ ID NO: 55, and SEQ ID NO: 57 comprises at most one conservative amino acid substitution. 2. The antigen recognizing construct of claim 1, wherein the antigen recognizing construct binds to a peptide of SEQ ID NO: 133 in a complex with an MHC class I molecule. 3. The antigen recognizing construct of claim 1, wherein the soluble antigen recognizing construct does not selectively bind any of the peptides set forth in SEQ ID NO: 143 to 152. 4. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR2 comprising SEQ ID NO: 50 and the second TCR variable chain region comprises a CDR2 comprising SEQ ID NO: 56. 5. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain comprising SEQ ID NO: 49, a CDR2α chain comprising SEQ ID NO: 50, and a CDR3α chain comprising SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain comprising SEQ ID NO: 55, a CDR2β chain comprising SEQ ID NO: 56, and a CDR3β chain comprising SEQ ID NO: 57, wherein each of SEQ ID NOs: 49 and 55 comprise at most one conservative amino acid substitution. 6. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain comprising SEQ ID NO: 49, a CDR2α chain comprising SEQ ID NO: 50, and a CDR3α chain comprising SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain comprising SEQ ID NO: 55, a CDR2β chain comprising SEQ ID NO: 56, and a CDR3β chain comprising SEQ ID NO: 57, wherein each of SEQ ID NOs: 50 and 56 comprise at most one conservative amino acid substitution. 7. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain comprising SEQ ID NO: 49, a CDR2α chain comprising SEQ ID NO: 50, and a CDR3α chain comprising SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain comprising SEQ ID NO: 55, a CDR2β chain comprising SEQ ID NO: 56, and a CDR3β chain comprising SEQ ID NO: 57, wherein each of SEQ ID NOs: 51 and 57 comprises at most one conservative amino acid substitution. 8. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain consisting of SEQ ID NO: 49, a CDR2α chain consisting of SEQ ID NO: 50, and a CDR3α chain comprising SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain consisting of SEQ ID NO: 55, a CDR2β chain consisting of SEQ ID NO: 56, and a CDR3β chain comprising SEQ ID NO: 57. 9. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain comprising SEQ ID NO: 49, a CDR2α chain consisting of SEQ ID NO: 50, and a CDR3α chain comprising SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain comprising SEQ ID NO: 55, a CDR2β chain consisting of SEQ ID NO: 56, and a CDR3β chain comprising SEQ ID NO: 57. 10. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain consisting of SEQ ID NO: 49, a CDR2α chain comprising SEQ ID NO: 50, and a CDR3α chain consisting of SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain consisting of SEQ ID NO: 55, a CDR2β chain comprising SEQ ID NO: 56, and a CDR3β chain consisting of SEQ ID NO: 57. 11. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain comprising SEQ ID NO: 49, a CDR2α chain comprising SEQ ID NO: 50, and a CDR3α chain consisting of SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain comprising SEQ ID NO: 55, a CDR2β chain comprising SEQ ID NO: 56, and a CDR3β chain consisting of SEQ ID NO: 57. 12. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises a CDR1α chain consisting of SEQ ID NO: 49, a CDR2α chain consisting of SEQ ID NO: 50, and a CDR3α chain consisting of SEQ ID NO: 51, and the second TCR variable chain region comprises a CDR1β chain consisting of SEQ ID NO: 55, a CDR2β chain consisting of SEQ ID NO: 56, and a CDR3β chain consisting of SEQ ID NO: 57. 13. The antigen recognizing construct of claim 1, wherein the antigen recognizing construct is an αβ-T cell receptor (TCR) or a derivative or fragment thereof, or a 76 TCR or a derivative or fragment thereof. 14. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 52 or the second TCR variable chain region comprises at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 58. 15. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises the amino acid sequence of SEQ ID NO: 52 or the second TCR variable chain region comprises the amino acid sequence of SEQ ID NO: 58. 16. A nucleic acid or nucleic acids encoding the antigen recognizing construct of claim 1. 17. An expression vector comprising the nucleic acid(s) of claim 16 operably linked to at least one promoter sequence. 18. A host cell transformed with the expression vector of claim 17. 19. A pharmaceutical composition comprising the antigen recognizing construct of claim 1. 20. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 52 or the second TCR variable chain region comprises at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 58. 21. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises at least 98% sequence identity to the amino acid sequence of SEQ ID NO: 52 and the second TCR variable chain region comprises at least 98% sequence identity to the amino acid sequence of SEQ ID NO: 58. 22. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region comprises at least 99% sequence identity to the amino acid sequence of SEQ ID NO: 52 and the second TCR variable chain region comprises at least 99% sequence identity to the amino acid sequence of SEQ ID NO: 58. 23. The antigen recognizing construct of claim 6, wherein the first TCR variable chain region comprises the amino acid sequence of SEQ ID NO: 52 and the second TCR variable chain region comprises the amino acid sequence of SEQ ID NO: 58. 24. The antigen recognizing construct of claim 1, wherein the first TCR variable chain region consists of the amino acid sequence of SEQ ID NO: 52 and the second TCR variable chain region consists of the amino acid sequence of SEQ ID NO: 58. 25. An antigen recognizing construct comprising a first TCR chain comprising the amino acid sequence of SEQ ID NO: 54 and a second TCR chain comprising the amino acid sequence of SEQ ID NO: 60. Although the claims at issue are not identical, they are not patentably distinct from each other because the ’607 patent discloses the utility for the TCR claimed in the ‘607 patent that is now claimed in the instant claims. See e.g. column 21-lines 33 to 43 and column 28-lines 1-38. The U. S. Court of Appeals Federal Circuit (See Sun PNG media_image1.png 1 1 media_image1.png Greyscale Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797 (Fed. Cir. 2010) at 1800) has found in relation to double patenting : . . . we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. We held that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. See also Geneva PNG media_image1.png 1 1 media_image1.png Greyscale Pharmaceuticals PNG media_image1.png 1 1 media_image1.png Greyscale , Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] and Pfizer, Inc. v. Teva PNG media_image1.png 1 1 media_image1.png Greyscale Pharmaceuticals PNG media_image1.png 1 1 media_image1.png Greyscale USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008). Thus, the TCRs claimed in the ‘607 patent are not distinct from the method now claimed because the claimed method is disclosed in the ‘607 patent. Conclusion 9. No claims allowed. 10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time. 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, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PETER J REDDIG/Primary Examiner, Art Unit 1646