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 .
Applicant's response to the previous Office action, dated August 14, 2026, has been received. By way of this submission, Applicant has amended claims 1, 4-5, 11, 16, 19, 26, and 37, and cancelled claims 2-3, and 17-18.
Claims 1, 4-16, and 19-41 are pending in the application. Claims 33-41 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed October 27, 2025.
Claims 1, 4-16, and 19-32 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated May 14, 2026.
Claim Interpretation
Claims 1 and 16 as amended are interpreted to require the extracellular domain to possess at least one ADAMTS13 domain from among those recited in the first wherein clause of the claims, one of the combinations of domains recited in the second wherein clause of the claims, and not the metalloprotease domain of ADAMTS13.
Response to Amendment
Applicant argues that the references to Payne and Zheng do not teach every aspect of the claims as amended; specifically, Payne and Zheng do not teach constructs of combinations of ADAMTS13 domains as specified in claims 1 and 16.
Applicant's amendments to the claims have addressed this issue, and the rejection under to claims 1-32 under 35 U.S.C 103 over Payne in view of Zheng is hereby withdrawn, and the nonstatutory double patenting rejections over claims 1-32 over U.S. patents 10,301,370, 11,407,802, 11,407,803, 11,407,804, and U.S. patent application 18/156,442 are hereby withdrawn.
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, 4-16, and 19-32 are rejected under 35 U.S.C. 103 as being unpatentable over Payne (US20170051035A1) in view of Shang (Haematologica. 2010 Sep;95(9):1555-62). This is a new grounds of rejection, necessitated by Applicant's amendments to the claims.
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.
Shang teaches that patients with idiopathic thrombotic thrombocytopenic purpura (TTP) are caused by acquired autoantibodies that bind and inhibit proteolytic activity of ADAMTS13 (page 1).
Shang further teaches that patient autoantibodies may interact with a fragment consisting of a disintegrin domain, the first TSP1 repeat, the Cys-rich and spacer domains (construct DTCS) (page 2).
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 Shang 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 Shang 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. Shang teaches that autoantibodies against ADAMTS13 are highly prevalent in patients with TPP, and said autoantibodies may bind to the D domain, TSP domain, C domain and S domain. One of ordinary skill could apply the ADAMTS13 autoantigen of Shang 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 Shang 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 Shang teaches a molecule that comprises these domains of ADAMTS13, Shang inherently teaches the sequence of SEQ ID NO: 4 recited in claims 4 and 6.
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, 4-16, and 19-32 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 Shang. This is a new grounds of rejection, necessitated by Applicant's amendment to the claims.
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.
Shang teaches that patients with idiopathic thrombotic thrombocytopenic purpura (TTP) are caused by acquired autoantibodies that bind and inhibit proteolytic activity of ADAMTS13 (page 1).
Shang further teaches that patient autoantibodies may interact with a fragment consisting of a disintegrin domain, the first TSP1 repeat, the Cys-rich and spacer domains (construct DTCS) (page 2).
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 Shang to arrive at the claimed invention. As taught by Shang, autoantibodies against ADAMTS13 are highly prevalent in patients with TPP, and said autoantibodies bind to the D domain, TSP domain, C domain and S domain. Starting from the chimeric autoantibody receptor of the '803 patent, one of ordinary skill could apply the ADAMTS13 autoantigen of Shang 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.
While Shang does 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 Shang teaches a molecule that comprises these domains of ADAMTS13, Shang inherently teaches the sequence of SEQ ID NO: 4 recited in claims 4 and 6.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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, 6:00 to 2:00.
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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/Primary Examiner, Art Unit 1644
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