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 preliminary amendments received May 9, 2024 are acknowledged.
Claims 1-310 have been canceled.
Claims 311-329 are newly presented.
Claims 311-329 are pending in the instant application.
Information Disclosure Statement
The IDS forms received 5/9/2024 are acknowledged and the references cited therein have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
The filing date of the instant application necessitates compliance with ST.26, yet the instant application claims priority to earlier filed applications which were under ST.25. Under ST.25, applicants were dissuaded, but not forbidden, from assigning SEQ ID numbers to polypeptide sequences shorter than 4 defined residues, whereas under ST.26 such short peptides are explicitly forbidden from being identified via SEQ ID numbers. In the claims, VL CDR2 is SEQ ID NO:33, which per the electronic sequence listing is nothing (i.e. it is skipped/blank) while Table 36 identifies it as the tripeptide “LVS”. Thus, while the sequence listing is proper under ST.26, neither the specification nor the claims are proper. Specifically, the claims cannot recite “SEQ ID NO:33” and must instead recite the tripeptide sequence LVS. Similarly, the specification cannot use “SEQ ID NO:33” as a shorthand notation for “LVS” and all instances of SEQ ID NO:33 must be changed to recite “LVS” in the text of the specification. Note that Table 36 should be amended to remove the SEQ ID number let leave the description and the sequence itself in the table. Note also that this issue concerning the inappropriate assignment of SEQ ID numbers to small sequences may be present for other SEQ ID numbers, that no attempt to identify all such instances has been made by the examiner, and that applicant’s assistance in finding and correcting all sequence compliance issues is earnestly solicited
Claim Objections
Claims 311, 316, 324, and 327 are objected to for the impermissible recitation of a SEQ ID number for a biological sequence which per DT.26 can never be identified in such a manner. See above. Removal of “SEQ ID NO:33” and its replacement with “LVS” in all claims is very strongly suggested.
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 311-329 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,879,008 in view of Holers et al. (WO 2011/163412).
The issued claims recite methods of treating complement mediated diseases by administering fusion proteins comprising an antibody or antigen binding fragment thereof that binds complement protein 3d (C3d) and complement modulatory peptide chosen from the group consisting of CR1, DAF, MCP, Crry, Map44, Map19, and CD59. Notably such antibodies are defined by SEQ ID number at the level of CDR sequences (see issued claim 1 for example) as well as complete variable domains (see for example issued claims 4 and 6) and complete heavy and light chains (see for example issued claims 5 and 7-9). The SEQ ID numbers for both antibody as well as complement modulatory peptides are identical when comparing the instant and issued claims, a fact which is hardly surprising as the application which became the ‘008 patent is the parent of the instant application related as a continuation. The issued claims teach specific clinical conditions to be treated by their administration methods, including lupus nephritis, hemolytic uremic syndrome, and diabetic retinopathy (compare issued claims 3 and 31 to instant claim 312). The issued claims differ from that which is presently claimed in that the issued administration methods never recite that the fusion proteins are present in a pharmaceutical compositions (even though artisans would know it is not reasonably possible to actually administer the recited fusion proteins in the absence of a pharmaceutical composition comprising the recited fusion proteins) and in that the specific disease ANCA-associated vasculitis is not recited as being treated by the issued methods.
Holers et al. disclose antibodies that bind C3d, fusion proteins comprising such antibodies, the inclusion of such antibodies and fusion proteins in pharmaceutical compositions, and the administration of such compositions to treat complement mediated disorders including ANCA-associated vasculitis (see entire document, particularly the title, abstract, claims, and paragraphs [0007], [0027-0029], [0031-0038], [0053], [0074], [0104] and [0286-0300]).
Therefore, it would have been obvious to ordinary artisans that the products administered by the issued claim would need to actually be present in a pharmaceutical composition in order to actually be administered to a subject as this fact is so exceedingly well known in the prior art even if it were not explicitly taught by Holers et al. It further would have been obvious to artisans to practice the issued methods on ANCA-associated vasculitis subjects as the fusion constructs disclosed by Holers et al are exceedingly similar to those recited in the issued claims and Holers et al. disclose their constructs are to be administered to treat ANCA-associated vasculitis.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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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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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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