DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/20/2036 has been entered.
Claims 1-35, 37-45, 53, 54, 62, and 63 have been cancelled. Claims 36 and 66-71 have been amended. Claims 81-84 are new.
Claims 36, 46-52, 55-61, and 64-84 are pending and under examination.
2. The objections to claims 36 and 66-71 are withdrawn in response to the amendment filed on 02/20/2026.
Double Patenting
3. 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.
4. Claims 36, 46-52, 55-61, and 64-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 15, and 16 of U.S. Patent No. 10,865,242, in view of both Jensen et al. (Biol Blood Marrow Transplant, 2010. 16: 1245-1256) and Kochenderfer et al. (J. Immunother., 2009, 32: 1-25). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to (1) a nucleic acid encoding a CAR comprising the same hinge set forth by SEQ ID NO: 21, same TM, same intracellular signaling domain comprising the CD3 zeta signaling domain and the 4-1BB costimulatory domain, and the same marker; and (2) an engineered T-cell expressing the CAR. The patent specification defines that SEQ ID NO: 21 recited in the patent claim 16 is ESKYGPPCPPCP (i.e., identical to SEQ ID NO: 21 recited in the instant claim 36).
While the patent claim 1 recites a spacer comprising SEQ ID NO: 1 (i.e., XPPXP), the patent specification discloses that this spacer could be set forth by SEQ ID NO: 21 (see column 8, lines 45-47; Fig. 10). Thus, the spacer set forth by SEQ ID NO: 21 is an embodiment of the patent claim 1. MPEP 804 B 2(a) states:
In analyzing the disclosure of the reference patent or application, a determination is made as to whether a portion of the disclosure is directed to subject matter that is encompassed by the scope of a reference claim. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent includes a disclosure of several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to determine whether the reference patent claim, as properly construed in light of that disclosure, anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining obvious variations of the reference patent claim.
The specific species of T-cells recited in the patent claims 7-10 anticipate the genus of T-cells recited in the instant claims 57, 58, 79, and 80 and recite the same T-cell species as the instant claims 71, 83, and 84.
The patent specification discloses that the CAR nucleic acid is encoded by a lentiviral vector (as recited in the instant claims 64 and 65); the marker is the EGFTt set forth by the instant SEQ ID NO: 81 (as recited in the instant claim 66); EGFTt is operably linked to an upstream T2A which is set forth by the instant SEQ ID NO: 82 (as recited in the instant claims 67 and 82); the TM domain is the CD28 TM set forth by the instant SEQ ID NO: 75 (as recited in the instant claims 68, 72, 75, and 76); the intracellular domain is set forth by the instant SEQ ID NO: 83 (as recited in the instant claims 69, 70, 73, 74, and 77-80). See column 38, lines 61-65; column 66, lines 28-56; Table 1 on columns 92-93; Fig. 10 and 13A.
The difference is that the patent claims recite an extracellular domain targeting CD171, not CD19 as recited in the instant claims. However, Jensen et al. teach that CAR specificity could be changed by simply swapping one extracellular domain for another one (see p. 1246, column 1, last paragraph and Fig. S1). Thus, one of skill in the art would have reasonably concluded that the CAR backbone could be used in conjunction with different scFvs. Furthermore, Kochenderfer et al. teach a CD19 CAR T-cells having the scFv based on FMC63 as the extracellular domain, which could be used for treating human B cell cancers (see Abstract; p. 2, first and last two paragraphs; p. 3). Modifying the nucleic acid recited in the patent claims by using the FMC63 scFv taught by Kochenderfer et al. as the extracellular domain would have been obvious to one of skill in the art to achieve the predictable result of obtaining a CD19 CAR suitable to treat B-cell malignancies, when treating B-cell malignancies was needed. As evidenced by the attached Sequence Alignment and GenBank: ADM64594.1, the FMC63 scFv taught by Kochenderfer et al. is set forth by SEQ ID NO: 80, as required by the instant claim 36.
Furthermore, one of skill in the art would have reasonably concluded that possession of the CD19 CAR-encoding nucleic acid also entails possession of the encoded CD19 CAR polypeptide. One of skill in the art would have considered further claiming the CD19 CAR polypeptide an obvious variant of the patent claims.
Thus, the patent claims and the instant claims are obvious variants.
Response to Arguments
5. The arguments have been considered but not found persuasive.
While the applicant argues that the patent claims do not disclose or render obvious a CD19-binding extracellular domain, there is no requirement for the patent claims to do so. The double patenting rejection is based on the obviousness, not the anticipation rationale. The obviousness rationale uses an analysis similar to the one undertaken under 35 USC § 103 and can use references supporting the obviousness analysis for the double patenting rejection (see MPEP 804 II B 3). The patent claims recite a CAR and Jensen teaches that the specificity of a CAR can be easily tailored as needed by simply changing the extracellular domain. Kochenderfer provides the motivation to modify the patent claims by using the CD19 scFv set forth by the claimed SEQ ID NO: 80 as the extracellular domain.
With respect to the argument that the issuance of the pending claims would not prolong protection for the invention recited in the ‘242 patent claims, double patenting rejections are also made to prevent possible harassment by multiple assignees. MPEP 804 states: “The doctrine of nonstatutory double patenting also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982) (citing Chisum, Patents, § 9.04(2)(b) (1981) )”.
The applicant refers to the PTAB decision in application 17/135,529 (Appeal No. 2024-002920). However, the facts in the application ‘529 are different from the facts in this application.
The claims of application ‘529 were rejected as being unpatentable over the claims of five patents. The Board noted that application ‘529 and the patents do not share a priority and do not stem from the same application family. Application ‘529 was the earlier filed, was published well before the earliest filing dates of the patents, and thus, it could have been used as prior art against the patents. The Board noted that, since the claims of the patents were allowed, the examiner determined that the patented claims were not obvious from the disclosure of the published ‘259 application. The Board also noted the examiner acknowledged that “the claims of the later-filed, now issued patents were non-obvious over the instant disclosure and could not have been presented in the instant application”. For these reasons only, the Board concluded that the pattern claims could not serve as reference claims against application ‘529 claims.
However, the instant application was published after the earliest effective filing date of the patent and it could not have been used as prior art against the patent. Thus, there was no determination that the patent claims were not obvious from the disclosure of the instant application. Furthermore, the examiner did not indicate non-obviousness of the patent claims over the instant claims, nor did the examiner indicate that the patent claims could not have been presented in the instant application.
In this case, the later-filed and later-expiring patent claims can serve as reference against the instant claims. See also p. 7-8 of the PTAB decision in application ‘529.
5. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
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, Christopher Babic can be reached at 571-272-8507. 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.
/ILEANA POPA/Primary Examiner, Art Unit 1633