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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated February 25, 2026, has been received. By way of this reply, Applicant has elected, without traverse, Group I: claims 1-32, and the species of D domain, TSP1 domain, C domain, and S domain (DTCS), and SEQ ID NO: 4.
Claims 1-41 are pending in the application. Claims 33-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inveniton, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 25, 2026.
Claims 1-32 are therefore under examination before the Office.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-32 are rejected under 35 U.S.C. 103 as being unpatentable over Payne (US20170051035A1) in view of Zheng (Haematologica. 2010 Sep;95(9):1555-62).
Payne teaches a chimeric autoantibody receptor specific for an autoantibody (para. 0007).
Payne further teaches an isolated nucleic acid sequence encoding a chimeric autoantibody receptor (CAAR), wherein the isolated nucleic acid sequence comprises a nucleic acid sequence of an autoantigen or fragment thereof, a nucleic acid sequence of a transmembrane domain, a nucleic acid sequence of an intracellular domain of a costimulatory molecule, and a nucleic acid sequence of a signaling domain (para. 0008).
Payne further teaches that the intracellular domain of a costimulatory molecule may be 4-1BB (para. 0165), which is pertinent to claims 7-8 and 22-23.
Payne further teaches that the intracellular signaling domain may be CD3-zeta (para. 0166), which is pertinent to claims 9 and 24.
Payne further teaches that the transmembrane domain may be CD28 (para. 0154), which is pertinent to claims 10 and 25.
Payne further teaches that the CAAR may further comprise KIR transmembrane and cytoplasmic domains (Figure 8 and para. 0322), which is pertinent to claims 11 and 26.
Payne further teaches vectors comprising the above CAAR (para. 0009), which is pertinent to claim 12.
Payne further teaches that the vector may be a lentiviral vector (para. 0122), which is pertinent to claim 13.
Payne further teaches that the vector may be mRNA (para. 0177), which is pertinent to claim 14.
Payne further teaches that the vector may further comprise an inducible promoter operably linked to the desired sequence (para. 0104, 0112, 0186), which is pertinent to claim 15.
Payne further teaches compositions comprising at least one chimeric autoantibody receptor (CAAR) specific for an autoantibody, vectors comprising the same, compositions comprising CAAR vectors packaged in viral particles, and recombinant T cells or other effector cells comprising the CAAR (para. 0128), which is pertinent to claims 16-31.
Payne further teaches the use of human T cells (para. 0204), which is pertinent to claim 30.
Payne further teaches pharmaceutical compositions of the above, in combination with one or more pharmaceutically or physiologically acceptable carriers, diluents or excipients, (para. 0241), which is pertinent to claim 32.
Payne also teaches that a CAAR expressed on a cell has high affinity to autoantibodies expressed on B cells and induces killing of B cells expressing autoantibodies (para. 0019), and is useful for treating an autoimmune disease (para. 0020 and 0129).
However, Payne does not teach ADAMTS13 autoantigen.
Zheng teaches that patients with the autoimmune disease thrombotic thrombocytopenic purpura (TTP) have detectable autoantibodies against ADAMTS13 (page 1556, left column, second paragraph).
Zheng further teaches that patients with TTP possess autoantibodies that are able to bind full-length ADAMTS13 or the N-terminal half, MDTCS (i.e., the M domain, the D domain, TSP1 domain, C domain, and S domain) (page 1560, left column, second paragraph and Table 2, also see Figure 1A), which is pertinent to claims 2-5.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Payne and Zheng to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Payne and Zheng are concerned with autoimmune diseases. The use of CAARs for the treatment of autoimmune disease is taught by Payne; specifically, a CAAR that binds an autoantibody through its autoantigen. Zheng teaches that autoantibodies against ADAMTS13 are highly prevalent in patients with TPP, and said autoantibodies bind to the N terminal domain of ADAMTS13, which comprises the D domain, TSP1 domain, C domain, and S domain. One of ordinary skill could apply the ADAMTS13 autoantigen of Zheng to the CAAR of Payne by simple substitution, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
While Payne and Zheng do not explicitly teach Applicant's SEQ ID NO: 4, Applicant's specification at page 59 states that SEQ ID NO: 4 is the D domain, TSP1 domain, C domain, and S domain of ADAMTS13. As Zheng teaches a molecule that comprises these domains of ADAMTS13, Zheng inherently teaches the sequence of SEQ ID NO: 4 recited in claims 4 and 6.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
The transitional term "comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). MPEP 2111.03(I).
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 1-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over the listed claims of the U.S. patents and patent applications listed below in view of Zheng:
Conflicting patent Conflicting
Or application claims
10,301,370 1, 3, 5, 9, 15
11,407,802 1-2, 5, 8-9, 13
11,407,803 1-2, 5, 8-9, 13-14, 17, 20-21
11,407,804 1-2, 5, 8-9, 13
18/156,442 1, 6, 8, 14, 16, 19, 34
By means of example, the '803 patent claims an isolated nucleic acid encoding a chimeric receptor comprising an extracellular domain that binds an autoantibody expressed on a B-cell, and a transmembrane domain (claim 1).
The '803 patent further claims that the chimeric receptor further comprises a CD8 alpha chain signal peptide (claim 5).
The '803 patent further claims that the transmembrane domain comprises a KIR transmembrane domain (claim 8).
The '803 patent further claims that the transmembrane domain comprises a CD8 alpha chain hinge and transmembrane domain (claim 9).
The '803 patent further claims that the chimeric receptor further comprises a KIR cytoplasmic domain (claim 13).
The '803 patent further claims that the chimeric receptor further comprises an intracellular signaling domain (claim 14), and that the intracellular signaling domain comprises a CD3 zeta signaling domain (claim 17).
The '803 patent further claims vector comprising the above isolated nucleic acid sequence (claim 20), and that the vector may be a lentiviral vector or an RNA vector (claim 21).
However, the '803 patent does not claim ADAMTS13 autoantigen.
Zheng teaches that patients with the autoimmune disease thrombotic thrombocytopenic purpura (TTP) have detectable autoantibodies against ADAMTS13 (page 1556, left column, second paragraph).
Zheng further teaches that patients with TTP possess autoantibodies that are able to bind full-length ADAMTS13 or the N-terminal half, MDTCS (i.e., the M domain, the D domain, TSP1 domain, C domain, and S domain) (page 1560, left column, second paragraph and Table 2, also see Figure 1A).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '803 patent with the teachings of Zheng to arrive at the claimed invention. As taught by Zheng, ADAMTS13 autoantibodies were known to be present in patients with TPP, and that the N-terminal sequence of ADAMTS13 was a known binding partner for such autoantibodies. Starting from the chimeric autoantibody receptor of the '803 patent, one of ordinary skill could apply the ADAMTS13 autoantigen of Zheng to the chimeric autoantibody receptor by simple substitution, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ludwig (Front Immunol. 2017 May 31:8:603, cited in IDS) teaches that CAAR T cells are useful in treating autoimmune disease (page 16, right column, last paragraph through page 17, left column, first paragraph). Ludwig also teaches that patients with TTP have autoantibodies against ADAMTS13, particularly the N-terminal of the protein (pages 17-18 and Figure 9A).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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