DETAILED ACTION
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 .
Claim Rejections - 35 USC § 112
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, 3-30 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.
The variable “p” is not defined.
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.
Claims 1-30 remain rejected under 35 U.S.C. 103 as being unpatentable over:
WO 2016083468 (WO 468); or
Tiberghien et al., TETRAHEDRON LETTERS, vol. 58, no. 46, 2017, pages 4363-4366 (Tiberghien); or
WO 2014140862 (WO 862);
in view of
WO 2020146432 (WO 432); and
WO 2020092654 (WO 654); and
WO 9513093 (WO 093).
The recited linker-PBD’s were known:
WO 468 discloses conjugates having the structures:
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530
552
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Tiberghien discloses the PBD-linker compound SG3376:
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160
424
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WO 862 also discloses antibody-drug conjugates, wherein the PBD-linker compound is encompassed under the structure of DLb according to present claim 1 (see claims 1-96, see in particular compound 27 on page 118; page 134, line 29 to page 135, line 19):
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153
442
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The above references may fail to explicitly teach ADC’s with antibodies that bind to CD45. However, it is for that proposition that the examiner joins the secondary references, which demonstrate that anti-CD45-PBD conjugates were known at the time of the invention for treating cancer or a conditioning agent for transplantation.
For example, WO 432 discloses anti-CD45-PBD conjugates (see page 97, line 1 to page 100, line 1). WO 432 discloses also the anti-CD45 antibodies YTH24.5 and YTH54.12 (page 53, line 29; page 54, line 10).
WO 654 relates to anti-CD45 antibodies, and antibody drug conjugates thereof that are useful as therapeutic agents, e.g., in treating leukemia or acting as a conditioning agent for transplantation. WO 654 discloses also anti-CD45-PBD conjugates (see claims 23, 30, 37-47; p. 12, I. 15-33).
YTH24.5 and YTH54.12 antibodies covered in the examples and claims of the present application are taught by WO 093.
In this way, those of ordinary skill could have applied the anti-CD45 antibodies in the manner required and in a predictable fashion for purposes of obtaining an anti-CD45-PBD ADC for cancer treatment or transplantation. As outlined above, the primary references demonstrate that the recited PBD-linker drug conjugates were known. The secondary references are added for the proposition that anti-CD45 antibodies were applicable to these conjugates. Specifically, the secondary references teach that particular known technique using the recited anti-CD45 antibodies in anti-CD45-PBD ADC’s for cancer/transplantation was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to other PBD ADC’s, such as those taught by the primary references, would have yielded predictable results. Accordingly, using an anti-CD45 provide an anti-CD45-PBD ADC for cancer treatment or transplantation would have been prima facie obvious.
The reason to combine the elements in the references is provided by the references, themselves. Namely, the prior art demonstrates that the claimed pyrrolobenzodiazepine-linker combination was known to be effective. A POSA would have combined this pyrrolobenzodiazepine-linker with a CD45 antibody since the prior art exemplifies CD45 as a known tumor antigen. Therefore, since the recited linker-drug was known to be effective, and since CD44 was a known tumor antigen, a POSA would have reasonable expectation that the recited anti-CD45 ADC would successfully treat cancer/tumors.
The examiner acknowledges the unexpected results provided in the specification. However, the results set forth in the specification, describing the B4 linker- payload bound to a particular anti-CD45 antibody, are not commensurate with the
claims, which covers any anti-CD45 antibody bound to B4. In particular, the results set forth in the specification are probative only because they illustrate potency and toxicity of the B4 linker-payload as compared to other linker-payloads when bound to the same anti-CD45 antibody. Therefore, the showing of unexpected results supports ADC’s with the exemplified anti-CD45 antibody bound to B4, not across all anti-CD45 antibodies bound to B4, as covered by the rejected claims. In this manner, the rejection is maintained over those B4 embodiments not requiring the particular anti-CD45 antibody as described by the showing of unexpected results. In this connection, the record does not clarify that the recited SEQ ID NOS correspond to the antibody described in the alleged unexpected results.
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 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9649390 in view of WO 2020146432 (WO 432); and WO 2020092654 (WO 654); and WO 9513093 (WO 093).
Although the claims at issue are not identical, they are not patentably distinct from each other. Namely, the conjugates, compositions and methods covered in the rejected claims are anticipated by those covered in the conflicting claims.
Alternatively, the difference between rejected claims and the conflicting claims is that the conflicting claims may not recite the instant conjugates with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
The conflicting claims may fail to explicitly teach ADC’s with antibodies that bind to CD45. However, it is for that proposition that the examiner joins the secondary references, which demonstrate that anti-CD45-PBD conjugates were known at the time of the invention for treating cancer or a conditioning agent for transplantation, as outlined above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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