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 .
Application Status
Claims 1-11 are pending and examined on the merits herein.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 24. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; 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.
Claim Objections
Claims 4-11 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim (claim 3 is a multiple dependent claim in proper form). See MPEP § 608.01(n). Accordingly, claims 4-11 have not been further treated on the merits.
Claim Interpretation
Claim 1, line 3 recites “said antibody or fragment being capable of binding to CD38 and/or CD138”; any fragment that can bind to CD38 and/ or CD138 reads on a peptide/ protein of 2 amino acids or longer that is capable of binding one or both of CD38 and/ or CD138.
Claim Rejections - 35 USC § 112(b)
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 and 3 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.
Regarding claim 1, recites “an antibody or antibody fragment” in lines 2-3 but in lines 3 and 4 refers to “said antibody or fragment”; is this “fragment” distinct from the “antibody fragment” previously recited? This renders the claim indefinite as it is unclear whether the later recited “fragment” is to be considered a distinct invention. This rejection can be rendered moot by correcting the language to said “antibody fragment’ throughout.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Examiner’s note: Claims 4 and 9 also recite the terminology “preferably” and would therefore have the same rejection. Claims 6 and 9 also recite the language “more particularly” in the claim which also renders these claims indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu (EP 2176298 B1; IDS entered 09/18/2023).
Regarding claim 1, Chu teaches an immunoglobulin Fc fusion that is covalently linked to an autoantigen selected from citrullinated fibrinogen (para 0009), wherein the target antigen of the immunoglobulin include CD38 and/ or CD138 (para 0086).
Regarding claim 2, Chu teaches that conjugate partners may be linked to any region of an immunoglobulin disclosed herein, including at the N- or C- termini, or at some residue in-between the termini and further that a variety of linkers may find use to covalently link conjugate partners to an immunoglobulin including PEG (para 0141).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (EP 2176298 B1; IDS entered 09/18/2023) as applied to claims 1-2 above and further in view of Lelieveldt (Sl: sn, 2019; PTO-892).
The teachings of Chu regarding claims 1-2 are detailed above.
Chu does not teach wherein said peptide is derived from all or part of the sequence of the alpha or beta chain of a vertebrae fibrin by substitution of at least one arginyl residue by a citrullyl residue.
Lelieveldt teaches affinity matrix (AM) technology comprising anti-CD138 F(ab)2 fragments conjugated to an autoantigen (Fig 10. Page 29). Lelieveldt further teaches that all plasma cells will be coated with the AM, however, the matrix will only capture any antigen-selective antibodies if those are secreted by the cell, wherein the cells will subsequently undergo complement mediated lysis (page 29). Lelieveldt further teaches that rheumatoid arthritis (RA) is hallmarked by the presence of anti-citrullinated protein antibodies (ACPA) that sustain destructive inflammation (page 30, paras 4-5) and that citrullinated fibrinogen is an autoantigen in RA that has been targeted with β60-74Cit peptide which is the major epitope of citrullinated fibrinogen (page 31, last para; Fig 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the β60-74Cit peptide as taught by Lelieveldt as the autoantigen in the anti- CD138 (or CD38)-spacer-autoantigen fusion as taught by Chu. The ordinary artisan would have been motivated to do so because Lelieveldt teaches that citrullinated fibrinogen is an autoantigen in RA that has been targeted with β60-74Cit peptide which is the major epitope of citrullinated fibrinogen and Chu is also targeting citrullinated fibrinogen. The ordinary artisan has a reasonable expectation of success to use the β60-74Cit peptide to generate an anti-CD138 (or CD38)-spacer- β60-74Cit peptide (autoantigen) fusion
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/551,129 (reference application) in view of Lelieveldt (Sl: sn, 2019; PTO-892).
Regarding claim 1, the copending claims teach a hybrid molecule comprising at least one antibody Fc fragment covalently linked to at least one fibrin-derived peptide having at least one citrullyl residue, at least one spacer being optionally present between said Fc fragment and said peptide (claim 1).
Regarding claim 2, the copending claims teach wherein said spacer is a polymer containing one or more repeating units containing the ether group, said spacer preferably being polyethylene glycol of formula PEGn, wherein n represents an integer between 1 and 100, preferably between 1 and 10 and in particular 1, 2, 3, 4 or 8 (claim 3).
Regarding claim 3, copending claim 2 is identical.
The copending claims do not teach that the antibody fragment targets CD38 or CD138.
Lelieveldt teaches affinity matrix (AM) technology comprising anti-CD138 F(ab)2 fragments conjugated to an autoantigen used to deplete autoreactive memory plasma cells (Fig 10. Page 29). Lelieveldt further teaches that all plasma cells will be coated with the AM, however, the matrix will only capture any antigen-selective antibodies if those are secreted by the cell, wherein the cells will subsequently undergo complement mediated lysis (page 29). Lelieveldt further teaches that rheumatoid arthritis (RA) is hallmarked by the presence of anti-citrullinated protein antibodies (ACPA) that sustain destructive inflammation (page 30, paras 4-5) and that citrullinated fibrinogen is an autoantigen in RA that has been targeted with β60-74Cit peptide which is the major epitope of citrullinated fibrinogen (page 31, last para; Fig 11-12).
It would have been obvious to one of ordinary skill in the art to target CD138 as taught by Lelieveldt in the Fc fragment antibody-citrullinated fibrin hybrid molecule as taught by the copending claims. The ordinary artisan would have been motivated to do so because Lelieveldt teaches that anti-CD138 fragments conjugated to an autoantigen can be used to deplete autoreactive memory plasma cells. The ordinary artisan has a reasonable expectation of success to use an anti-CD138 Fc fragment to generate an anti-CD138 -spacer-citrullinated fibrin peptide fusion
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER K FAUST/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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