DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Applicant’s election without traverse of Group I (drawn to a method of inhibiting the activity of CD154) in the Response filed on May 4, 2026 is acknowledged.
Claims 1-26 have been canceled.
Claims 38 and 38 have been added.
Claims 27-39 are pending.
Claims 28-37 have been withdrawn under 37 CFR 1.142(b) as being drawn to nonelected invention.
Claims 27, 38, and 39 are currently under consideration.
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code, e.g. page 3 of the instant specification as-filed; 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.
4. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
The sequences disclosed in page 10 and Figures 21A-C in the specification as-filed do not have SEQ ID NOs.
Applicant is reminded of the Sequence Rules which require a submission for all sequences of 10 or more nucleotides or 4 or more amino acids (see 37 CFR 1.1821-1.1825) and is also requested to carefully review the submitted specification for any and all sequences which require compliance with the rules.
5. 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.
6. Claims 27, 38, and 39 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.
Claims 27, 38, and 39 are indefinite in that they only describe the number of amino acid residue positions without reciting the numbering system. There are several numbering systems used when referring to the amino acid positions in the Fc region. For example, Presta (US 6,737,056) teaches that EU and Kabat are two different systems. In Table 6, Presta teaches that S239 in EU numbering is also referred as position 252 in Kabat. It is suggested that the claims be amended to recite the particular numbering system used (e.g. EU numbering system if there is support in the instant specification).
Further, claims 27, 38, and 39 are indefinite in the recitation of “optionally comprises one additional Fc modification….” because the list of potential alternatives with respect to the additional Fc modification raises ambiguity. For the purpose of examination and application, the one additional Fc modification is read as optional.
7. 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.
8. Claims 27, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-13 of U.S. Patent No. 9,028,826 (the ‘826 Patent, reference on IDS, claims are drawn to a method of immune therapy comprising administering a humanized anti-CD154 antibody of IgG1 isotype comprising E269R and K322A substitution in the Fc region);
Claims 1-14 of US 9,321,833 (the ‘833 Patent, reference on IDS, claims are drawn to a method of therapy comprising administering a humanized anti-CD154 antibody comprising the amino acid sequences of the VL CDRs and VH CDRa, and mutations including E269R and K322A);
Claims 1-14 of US 9,758,587 (the ‘587 Patent, reference on IDS, claims are drawn to a metho of immune therapy comprising administering a human or humanized anti-CD154 antibody of an IgG1 isotype comprising amino acid substitutions in E269R and K322A in the Fc region); and
Claims 1-8 of US 10,822,423 (the ‘423 Patent, claims are drawn to a method of inhibiting the activity of CD154 by administering a humanized anti-CD154 of a human IgG1 isotype having the recited amino acid sequences for the VL CDRs and VH CDRs, and comprising amino acid substitutions including E269R and K322A in the Fc region).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims in the US Patents listed above are drawn to the same or nearly the same methods encompassing administering the same or nearly the same anti-CD154 antibody comprising identical amino acid substitutions E269R and K322A in the Fc region. Therefore, the claims in the US Patents listed above would anticipate the instant invention.
These rejections are necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that prohibition under 35 U.S.C. 121 does not apply to claims in a pending case which are directed to a non-elected invention of an application and the case is not a divisional of the application.
9. Claims 27, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 8,852,597 (the ‘597 Patent, reference on IDS) in view of Van Vlijmen et al. (US 2008/0305116).
The instant claims are drawn to a method of inhibiting the activity of CD154 in a subject in need thereof by administering a therapeutic effective amount of an anti-CD154 antibody of the human IgG1 isotype comprising amino acid substitutions E269R and K322A in the Fc region. Dependent claims 38 further recite the amino acid sequences of the VH CDRs and VL CDRs.
The claims in the ‘597 Patent are drawn to a human or humanized anti-CD154 antibody comprising amino acid substitutions E269R and K322A in the Fc region, and a pharmaceutical composition thereof comprising a pharmaceutically effective amount of the antibody.
The claims in the ‘597 Patent differ from the instant claims by not reciting a method of inhibiting the activity of CD154 in a subject by administering the anti-CD154 antibody.
Van Vlijmen et al. teach that CD154 is a critical costimulatory molecule (and a ligand for CD40) expressed in an activation-dependent temporally-restricted manner on the surface of CD4+ T cells. Signaling through CD40 by CD154 initiates a cascade of events that result in the activation of CD40 receptor bearing cells and promotes the differentiation of B cells into antibody secreting cells and memory B cells (e.g. see [0004]-[0005]). CD40-CD154 interaction has been shown to be important in inducing autoimmune diseases (e.g. see [0006]). Anti-CD154 antibodies were shown to be beneficial in a wide variety of autoimmunity and transplantation (e.g. see [0010]). Van Vlijmen et al. further teach a method of treating a CD154-related human disease by administering a therapeutically effective amount of an anti-CD154 antibody (e.g. see claims 80 and 81).
It would thus be obvious to one of ordinary skill in the art to administering the anti-CD154 antibody recited in the claims in the ‘597 Patent to treat a CD154 related disease. An ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, because it was known that CD40-CD154 interaction is important in inducing autoimmune disease and anti-CD154 antibody blocking the interaction was shown to be beneficial in treating CD154 related human disease. As such, administering the anti-CD154 antibody recited in the ‘597 Patent already formulated in a pharmaceutical composition to CD154 related conditions would be well within the skill of an ordinary artisan.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641
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