DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendments filed on 06/18/2025 are acknowledged.
3. Claims 1-10 and 19 are canceled.
Claims 11-18 and 20-29 are currently pending and under examination.
4. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims the benefit of U.S. Provisional application 62/278,648 filed on January 14, 2016. Claims 11-18 and 20-29 have an effective filing date of 1/14/2016.
Previous Objections/Rejections Withdrawn
5. In view of applicant’s amendments, the objection to claims 19 and 20, set forth in the 12/20/2024 office action, is hereby withdrawn because instant claim 11 has been amended to define abbreviated term IFN as interferon; further, claim 19 has been canceled.
6. In view of applicant’s amendments, the indefiniteness rejections of claims 16-18 and 21-29 under 35 U.S.C. 112(b), set forth in the 12/20/2024 office action, are hereby withdrawn for the following reasons:
Claims 16-18 and 21-24, as currently amended, no longer lack antecedent basis.
Claim 24, as currently amended, further limits claim 21.
Claim 25, as currently amended, explicitly recites that the chimeric polypeptide is the same peptide recited in independent claim 11.
7. In view of applicant’s amendments, the rejection of claims 11, 16, 17, 21 and 24 under 35 U.S.C. 103, set forth in the 12/20/2024 office action, is hereby withdrawn because newly amended independent claim 11 incorporates the limitation of interferon (IFN) alpha 2a, making the claimed invention novel and rendering prior art rejection moot.
Double Patenting (Rejections Maintained)
8. 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.
9. Claims 11-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,919,950 B2 (listed in the IDS filed 05/27/2021; referred to as US’950B2 in subsequent sections. Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims are drawn to nucleotides encoding the same fusion protein in the instant claims, which comprises a PD-1 extracellular domain, a spacer and an interferon (IFN)-α2 protein, specified as IFN-α2a in reference claims 3-4.
Regarding claim 11, the fusion protein comprising a PD-1 extracellular domain of a protein encoded by the nucleotide sequence of any one of SEQ ID NOs 14, 16 or 17; a second polynucleotide encoding a spacer; and a third polynucleotide encoding an interferon (IFN)-α2 protein, specified as IFN-α2a in claim 3 of US ‘950 B2 is a species of the genus of the fusion proteins in instant claim 11. Therefore reference claim 3 anticipates instant claim 11.
Regarding claim 12, the extracellular domain of a mutant PD-1 protein encoded by any one of SEQ ID NOs: 14, 16 or 17 as recited in patented claims 1-3 is a species of the genus of PD-1 extracellular domains having at least 95% sequence identity to any of SEQ ID NOs: 14, 16 or 17. Therefore, instant claim 12 is anticipated by claim 3 of US ‘950 B2.
Regarding claims 13, 14 and 15, claim 1 of US ‘950 B2 recites the extracellular domain of the mutant PD-1 protein is encoded by any one of SEQ ID NOs: 14, 16 or 17, thus anticipating claims 13, 14 and 15, respectively.
Regarding claim 16, the extracellular domain of a mutant PD-1 protein comprising the amino acid sequence of SEQ ID NO: 05 or SEQ ID NO: 06, as recited in patented claim 2 is a species in the genus of PD-1 extracellular domains with at least 95% sequence identity to SEQ ID NO: 05 or SEQ ID NO: 06 recited in instant claim 16. Therefore, instant claim 16 is anticipated by claims 2-3 of US ‘950 B2.
Regarding claims 17 and 18, US ‘950 B2 recites identical extracellular domains for the mutant PD-1 protein comprising SEQ ID NO: 05 or SEQ ID NO: 06, thus anticipating instant claims 17 and 18, respectively.
Regarding claim 20, the interferon-α2a protein encoded by the nucleotide sequence SEQ ID NO: 01 recited by patented claim 4 of US ‘950 B2 is identical to the limitation recited in instant claim 20. Therefore, instant claim 20 is anticipated by claim 4 of US ‘950 B2.
Regarding claim 21, the spacer comprising at least 3 consecutive glycine residues recited by patented claim 5 of US ‘950 B2 is identical to the limitation recited in instant claim 21. Therefore, instant claim 21 is anticipated by claim 5 of US ‘950 B2.
Regarding claims 22-24, the spacer comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 07, 08 or 09 as recited by claim 6 of US ‘950 B2 are identical to the sequence identity limitations recited by instant claims 22-24. Therefore, instant claims 22-24 are anticipated by claim 6 of US ‘950 B2.
10. Claims 25-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11-15 of U.S. Patent No. 10,919,950 B2 (listed in the IDS filed 5/27/2021; referred to as US ‘950 B2 in subsequent sections) in view of JUNE et al (US 8906682 B2; published 12/9/2014; referred to as JUNE in subsequent sections).
Instant claim 25 recites “a method of preparing a cell comprising a chimeric polypeptide, comprising: introducing into the cell a nucleic acid encoding the polypeptide of claim 11”. US ‘950 B2 recites a cell comprising the nucleic acid encoding the fusion protein (see reference application claim 11). As discussed above, the nucleic acid sequence of taught in instant application claim 11 and reference application claim 1 are the same invention. US ‘950 B2 also teaches a vector comprising the nucleic acid encoding the fusion protein (see reference application claim 9), wherein said vector is a lentiviral vector (reference application claim 10). US ‘950 B2 does not specifically recite a method of preparing this cell by introducing into the cell a nucleic acid encoding the fusion protein in in the claims. However, it is a point of fact that for a cell to comprise a non-naturally occurring, recombinant nucleotide sequence encoding a fusion protein, said nucleic acid is required to be “introduced” into the cell. Methods for introducing non-native nucleotide sequences to living cells are well-known, commonly practiced in the art and can be classified in two distinct genera - transfection or transduction. In general, transfection relies on physical stimuli such as ion concentration, temperature and/or electroporation to introduce foreign DNA into living cells. On the other hand transduction methods use viral vectors to deliver foreign DNA into recipient cells. JUNE teaches a method for transduction of human T cell subsets with lentivirus (see entire document). JUNE and US ‘950 B2 are both directed to engineering T-cells for cancer immunotherapies. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, to modify the lentiviral vector and cell comprising nucleic acid encoding the fusion protein taught by US ‘ 950 B2 with the lentiviral transduction methods taught by JUNE to achieve the predictable result of obtaining a cell composition suitable for transgenic expression of chimeric proteins. One of ordinary skill in the art would have been motivated to do so because JUNE et al. teach that lentiviruses are unique among the retroviruses in being able to infect non-dividing cells; they can deliver a significant amount of genetic information into the DNA of the host cell, so they are one of the most efficient methods of a gene delivery vector (JUNE column 15, second paragraph).
Regarding claim 26, US ’950 B2 in view of JUNE teach the method of claim 25. Additionally, US ’950 B2 recites that the cell is selected from a lymphocyte, NK cell, precursor T cell, stem cell, hematopoietic stem cell, NK cell, neuronal stem cell or a B cell in claim 14. This limitation is identical to the limitation recited in instant claim 26. Therefore, claim 14 of patent US ‘950 B2 is obvious over claim instant claim 26, in view of JUNE.
Regarding claim 27, US ’950 B2 in view of JUNE teach the method of claim 25. Additionally, US ’950 B2 recites that the cell is a CD8+ T cell or CD4+ T cell in claim 15. This limitation is identical to the limitation recited in instant claim 27. Therefore, claim 15 of patent US ‘950 B2 is obvious over claim instant claim 27, in view of JUNE.
Regarding claim 28, US ’950 B2 in view of JUNE teach the method of claim 25. Additionally, US ’950 B2 recites that the cell comprises a chimeric antigen receptor in claim 12, as taught by instant claim 28. Therefore, claim 12 of patent US ‘950 B2 is obvious over claim instant claim 28, in view of JUNE.
Regarding claim 29, US ’950 B2 in view of JUNE teach the method of claim 28. Additionally, US ’950 B2 recites that the chimeric antigen receptor (CAR) comprises an anti-CD19 CAR in claim 13. This limitation is identical to the limitation recited in instant claim 29. Therefore, claim 13 of patent US ‘950 B2 is obvious over claim instant claim 29, in view of JUNE.
Addressing applicant arguments
11. Applicant's arguments filed 06/18/2025 have been fully considered but they are not persuasive. In the remarks filed 06/18/2025, applicant argues against the nonstatutory double patenting rejections because none of the claims of the reference patent recite the features of the newly amended claims. Of the amended claims filed 06/18/2025, only instant claim 11 recites a new feature or limitation that was previously not recited; this is the limitation reciting that the IFNα2 protein is IFNα2a. Reference claim 3 recites this exact same limitation and reference claims 4 and 19 recite that this IFNα2a protein is encoded by the nucleotide sequence of SEQ ID NO: 01, which is identical to the nucleotide sequence encoding IFNα2a in the present claim set. See sequence alignment below comparing reference claim sequence (Db) to the instant application sequence (Qy).
Further, given the CON relationships between the instant application and the parent US 10,919,950 B2, Amgen, Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009) which indicated that the prohibition under 35 U.S.C. 121 does not apply to claims in a pending case which are directed to a non-elected invention of an application and the case is not a divisional of the application, the above obviousness-type double patenting rejections are set forth.
Conclusion
12. No claim is allowed.
13. THIS ACTION IS MADE FINAL. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES L MCLELLAN whose telephone number is (703)756-1906. The examiner can normally be reached Monday - Thursday 7:30 am - 5:30 pm. *Compressed day off on first Friday of each Bi-week.
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/JAMES LYLE MCLELLAN/Examiner, Art Unit 1641
/CHUN W DAHLE/Primary Examiner, Art Unit 1641