DETAILED ACTION
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 amendment and remarks, filed 2/27/26, are acknowledged.
Claims 1-2, 10, 17, 33, 49, 68, 73 have been amended.
Claims 1-2, 5, 10, 17, 24-26, 30, 32-37, 42, 45-47, 49-51, 54, 56, 60, 62-63, 65-68, 71-73, 75-76 are pending.
Claims 32, 49-50, 51, 54, 60, and 62 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
Claims 1-2, 5, 10, 17, 24-26, 30, 33-37, 42, 45-47, 56, 63, 65-68, 71-73, 75-76 read on the elected invention and are being acted upon.
The double patenting rejection over 12,209,135 is withdrawn in view of Applicant’s terminal disclaimer. The prior art rejections over the ‘135 patent are also withdrawn in view of Applicant’s response invoking the 102(b)(2)(C) exception. Regarding the other rejections, in view of Applicant’s claim amendments filed on 2/27/26, only the following rejections remain.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5, 10, 17, 24-26, 30, 33-37, 42, 45-47, 56, 63, 65-68, 71-73, 75-76 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
B) Claim 1-2 and 73 are indefinite because it is unclear whether the administered antibody comprises SEQ ID NO: 107, of whether the claim encompass antibodies having VH CDR1-3 found within SEQ ID NO: 107. The same issue exists in the recitation for the VL.
To the extent that the claim intends to encompass antibodies having CDRs from the VH/VL of SEQ ID NO: 107 and 111, the claim is further indefinite in that it is unclear which specific residues from SEQ ID NO: 107 and 111 would be required as CDRs. The specification on page 11 discloses that in certain embodiments, numbering of immunoglobulin amino acids residues is according to Kabat, but that any numbering scheme can be utilized. The specification on page 11 also discloses that the term “complimentary determining region” refers to a hypervariable region, and that the amino acid positions that delineate a hypervariable region of an antibody can vary depending on the context and various definitions known in the art. Therefore, the scope of the claims is unclear and indefinite since the specification does not provide a limiting definition clearly delineating which CDR residues would be encompassed by the present claims.
D) Regarding claims 2, the scope of the limitation is unclear, because it is still unclear whether the claim intends to exclude administration of an immunosuppressive agent or not. For example, do the claims merely require administration of an amount of CD45-ADC that can deplete on its own without administration of an immunosuppressive agent, or do the claims actually exclude administration of the immunosuppressive agents. Furthermore, it is not clear what the recitation of “for at least seven days prior to administration of a transplant” is intending to limit. Does this limit the anti-CD45 antibody administration step, i.e. administering a CD45 antibody for at least 7 days prior to transplant? Or does it intending to limit the time period wherein immunosuppressive agents are not administered (as in claim 1). Does it limit both conditions? The scope of the claims is unclear and indefinite.
Applicant’s arguments filed 10/3/25 have been fully considered, but they are not persuasive.
Regarding B), Applicant argues that the amendment overcomes the rejection since the claims now recite that the anti-CD45 antibody, or antigen-binding portion thereof comprises a variable region that comprises CDRs within the variable region defined by the SEQ ID NO.
The claims have not been amended to recite that the antibody comprises CDRs within the variable region defined by the SEQ ID NO. Rather, claim 1 recites that the antibody or antigen binding portion hereof, comprises a heavy chain variable region (VH) that comprise three CDR regions within the heavy chain variable region, wherein “the VH” comprise SEQ ID NO: 107. In the claim VH, stands for heavy chain variable region, and it is not clear which recitation of heavy chain variable region the limitation of “the VH comprises SEQ ID NO: 107” is intended to modify (the first or second one). If it modifies the first recitation of a heavy chain variable region, the claims would be limited to an antibody comprising a heavy chain variable region that comprises the amino acid sequence of SEQ ID NO: 107 that comprises three CDRs within the VH, i.e. it would require SEQ ID NO: 107 and CDRs therein. If, on the other hand, the limitation modifies the second recitation of heavy chain variable region, the claims would encompass CDRs within the heavy chain variable region of SEQ ID NO: 107. It is noted that even if the latter interpretation is given, the claims are still indefinite for the reasons set forth above, i.e. the scope of the CDRs is unclear and indefinite because it is not clear which specific residues from SEQ ID NO; 107 and 111 would be encompassed as CDRs.
Regarding D), Applicant argues that the amendment corrects the lack of antecedent basis for “the absence”. That part of the rejection is sufficient, but the scope of claim 2 is still unclear and indefinite for the reasons set forth above. For example, does the limitation only limit the amount of the CD45 antibody administered, i.e. it must be administered in an amount sufficient to deplete without cyclophosphamide, or does the claimed method actually exclude administration of cyclophosphamide. Does the claim require administration of anti-CD45 for at least 7 days prior to administration of a transplant, or does the 7 day limitation intend to limit only the immunosuppressive agents?
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 1-2, 5, 10, 17, 24-26, 30, 33-37, 42, 45-47, 56, 63, 65-68, 71-73, 75-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69, 73, 75, 77-78, 86, 90-92, 94-98, 100-106 of copending Application No. 17/452,028, now issued as claims 1-21 in patent ,12,570,756, in view of US 20180264039 and Sussman, 2017.
The ‘756 patent claims a method of depleting CD45+ cells in a human patient in need thereof, comprising administering an anti-CD45 antibody drug conjugate (ADC) comprising an antibody comprising a VH and VL of SEQ ID NO: 41 and 45 which are identical to SEQ ID NO: 111 and 107 of the instant application, wherein antibody is conjugated to a cytotoxin via a linker, and wherein the cytotoxin is a DNA alkylating agent such an indolinobenzodiazepine. The ‘756 patent claims that the patient is a cancer patient in need of HSC. The ‘756 patent claims that the CD45+ cells are depleted from the bone marrow and further comprising administering an HSC transplant, and wherein the transplant is allogeneic. Although the ‘756 patent does not explicitly claim an HLA mismatched HSC transplant, or administration without immunosuppressive agents, these would be obvious based on the teachings of the ‘039 publication, for the same reasons set forth above. Additionally selecting a dosing regimen and optimizing engraftment and chimerism when using the anti-CD45 would be routine and well within the purview of the ordinary artisan. Furthermore, the VH/VL of the ‘756 patent are inherently human and it would be obvious to use a human IgG1 and conjugation via an Fc engineered cysteine based on Sussman, which teaches that ADCs can be conjugated with IgG1 Fc cysteines to provide ADCs with improved properties.
Applicant’s statement that the rejection be held in abeyance until the time of allowance is acknowledged.
Claims 1-2, 5, 10, 17, 24-26, 30, 33-37, 42, 45-47, 56, 63, 65-68, 71-73, 75-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of copending Application No. 19/085,767 in view of US 20180264039.
The ‘767 application claims a method of depleting CD45+ cells in a human subject in need of HSC transplant, comprising administering an anti-CD45 antibody ADC comprising an anti-CD45 antibody linked to a cytotoxin via a linker, and wherein the antibody has a VH of SEQ ID NO: 41 and a VL of SEQ ID NO: 45, which are identical to SEQ ID NO: 107 and 111 of the instant application. The ‘767 application claims administration of a single dose of the antibody, wherein the subject has cancer and administering an HSC transplant to the subject. The ‘767 application claims that the antibody is an IgG1, and that the cytotoxin is conjugated via a cysteine residue in the Fc region. The ‘767 application claims that the cytotoxin is an indolinobenzodiazpeine and that the ADC is a monotherapy conditioning agent (i.e. administered in the absence of other immunosuppressive agents). It would be obvious to use a haploidentical or mismatched HSC transplant as taught by the ‘039 publication for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Applicant’s statement that the rejection be held in abeyance until the time of allowance is acknowledged.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
Prosecution Insights