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 .
Claims (filed 03-09-2026) 1-18, and 20-28 are pending and under consideration.
Information Disclosure Statement
The IDS filed 02/07/2025 had some references not considered/lined through for the following reasons:
Reference 10 (Altschul et al.) was not legible.
Reference 29 (Hellstrom et al.) was not legible.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 19, line 13 and page 73, line 5. 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.
Page 53, line 25+ contains a vertical line in the margin. This may cause a printer query should the application pass to the issues branch. Applicants are requested to delete the line.
Claim Objections
The following claims contain minor informalities:
Claim 6 recites the phrase “which is a fully human” which is grammatically unclear. Applicants may wish to rephrase this as “which is fully human”.
Claim 10 recites “wherein the antigen antigen-binding fragment” which is unclear because “antigen” is stated twice.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 24 does not further limit the subject matter of Claim 22 because all of the tumors listed in claim 22 are cancers. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-18, and 20-28 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-36 of copending Application No. 18534969 (reference application, ‘969) in further view of Dotti et al. Human Gene Therapy, Vol. 20, November 2009. Although the claims at issue are not identical, they are not patentably distinct because the antibodies and antigen binding proteins of the current application encompass different structures. For example, the specification teaches [0097] that the definition of an “antigen-binding protein” encompass chimeric antigen receptors (CARs). The current specification also teaches that the structure of the heavy (Vh) and light chains (Vl) are joined by a peptide-encoding linker [0111-0117] which encompasses the linkers claimed in ‘969. (The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.) The ‘969 application is claiming CARs with the antigen binding proteins claimed in the current application. Further, the transition from therapeutic antibodies to CARs is well-known and advantageous as taught by Dotti et al.
Dotti et al. teach (abstract) that ‘‘T-body’’ or chimeric antigen receptor (CAR) technology, which combines the specificity of an antibody with the homing, tissue penetration, and target cell destruction of T cells, was first described in 1993. Many of the target antigens for these CARs have been validated in preclinical and clinical studies of the native monoclonal antibody or other ligand used, which facilitates early adoption of CARs in human subjects. Dotti et al. further teach (pages 1229-1230) that CARS are advantageous over the native antibodies because of their physical association with effector T cells. CAR-modified T cells have an active biodistribution, with migration through multiple tissue planes along chemokine gradients and can recruit multiple cytotoxic effector mechanisms available to a T cell, rather than the more restricted cytotoxic machinery associated with the Fc component of an antibody. Dotti et al. further teach (Figure 1, and below) the common structures of first, second, and third generation CARs including the CD3ζ chain and at least two costimulatory molecules such as the endodomain of 4-1BB or CD28. Page 7.
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Claims of the ‘969 application comprise all of the same heavy and light chain CDRs (Claim 1), and all of the same VH and VL chains (Claims 3-5) as currently claimed. The difference between the two claim sets is that the current application is drawn to the antibody itself, while the claims of the ‘969 application use the antibody’s structure (referred to in Claim 1 as the “extracellular antigen-binding domain”) as part of a chimeric antigen receptor. While the structures (e.g., transmembrane domains, intracellular signaling domain, co-stimulatory signaling regions, and linkers) are not claimed in the current application, all of these structures are well known to those of ordinary skill in the art and as taught by Dotti et al. and would have been obvious. The methods of treatment claimed in both applications are also the same patient populations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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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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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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