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 .
Applicant’s preliminary amendment filed 7/31/2023, is acknowledged. Claims 1-9, 11, 13-16 and 21-27 are pending. Claims 24-27 are new.
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 3 and 9 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation of radioisotopes, and the claim also recites “specific” isotopes which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites “DFO*.” The specification suggests that it is a DFO derivative or has a specific structure. If it is a specific structure there is no reason why that structure cannot be in the claim. In any event, the claim is rendered indefinite.
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 1-9, 11, 13-16 and 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 4, 5, 13, 18-23 and 25 of copending Application No. 18/029,893 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims rectie the same recombinant anti-oxMIF antibody or antigen binding fragment thereof that has reduced aggregation potential and reduced hydrophobicity; nucleic acids encoding such; and a method of treating cancer by administering such antibody.
Claim 1 of the reference application recites a recombinant anti-oxMIF antibody or an antigen binding fragment thereof having reduced aggregation potential and reduced hydrophobicity, comprising the following variable domains:
(a) a light chain variable domain, wherein the light chain variable domain comprises:
(i) SEQ ID NO: 9 with 1, 2, 3, 4, or 5 amino acid substitutions selected from M30L, F49Y, A51G, P80S and W93F, or
(ii) SEQ ID NO: 9 with 1, 2, 3, 4, or 5 amino acid substitutions selected from M30L, F49Y, A51G, P80S and W93F, and with 1, 2, 3, 4, or 5 further amino acid substitutions, with the proviso that the tyrosine at position 36 is preserved; and
(b) a heavy chain variable domain, wherein the heavy chain variable domain comprises:
(i) SEQ ID NO: 6,
(ii) SEQ ID NO: 6 with 1 or 2 amino acid substitutions selected from L5Q and W97Y, or
(iii) SEQ ID NO: 6 with 1 or 2 amino acid substitutions selected from L5Q and W97Y, and with 1, 2, 3, 4 or 5 further amino acid substitutions,
wherein amino acid positions are numbered according to Kabat, and wherein aggregation potential and hydrophobicity are reduced compared to an antibody or an antigen binding fragment thereof comprising SEQ ID NO: 6 and SEQ ID NO: 9 lacking the amino acid substitutions.
Meanwhile, claim 1 of the instant application recites a radioimmunoconjugate comprising a recombinant anti-oxMIF antibody or an antigen binding fragment thereof, comprising:
(a) a light chain variable domain, wherein the light chain variable domain comprises:
(i) SEQ ID NO: 32 with 1, 2, 3, 4, or 5 amino acid substitutions selected from M30L, F49Y, A51G, P80S and W93F, or
(ii) SEQ ID NO: 32 with 1, 2, 3, 4, or 5 amino acid substitutions, further comprising a conserved tyrosine at position 36 and at least one of amino acid substitutions M30L, F49Y, A51G, P80S, or W93F; and
(b) a heavy chain variable domain, wherein the heavy chain variable domain comprises:
(i) SEQ ID NO: 29,
(ii) SEQ ID NO: 29 and amino acid substitutions L5Q and/or W97Y, or
(iii) SEQ ID NO: 29 having at least one of amino acid substitutions L5Q and W97Y, and 1, 2, 3, 4 or 5 further amino acid substitutions,
wherein amino acid positions are numbered according to Kabat, and wherein said antibody or antigen binding fragment thereof has reduced aggregation potential and reduced hydrophobicity compared to an antibody or an antigen binding fragment thereof comprising SEQ ID NO: 6 and SEQ ID NO: 9 lacking the amino acid substitutions.
It is noted that the light chain amino acid sequence of SEQ ID NO: 32 of the instant application is 100% identical to SEQ ID NO: 9 of the referebce application. Additionally, the heavy chain amino acid sequence of SEQ ID NO: 29 of the instant application is 100% identical to the amino acid sequence of SEQ ID NO: 6 of the reference application.
The amino acid sequence of SEQ ID NO: 31 of the instant application is 100% identical to the refence amino acid sequence of SEQ ID NO: 8 (see claim 4 of the reference application). The amino acid sequences of SEQ ID NO: 33, 34, 35, and 36 of the instant application are 100% identical to the instant amino acid sequences of SEQ ID NOs: 10, 11, 12, and 13 (see claims of reference application). The amino acid sequence of SEQ ID NO: 37 of the instant application is 100% identical to the amino acid sequence of SEQ ID NO: 1 of the reference application.
Claim 8 of the instant application and claim 13 of the reference application recite that the antibody is selected from the group consisting of scFv, Fab, Fab', F(ab')2, Fab'-SH, fusions of two single chain antibodies, and minobodies.
Claim 11 of the instant application and claim 15 of the reference application recite pharmaceutical compositions.
Claims 13-16 of the instant application and claims 20-23 of the reference application recite nucleic acids encoding the anti-oxMIF antibody, vectors, host cell, and methods of producing such.
Claims 23-27 of the instant application and claims 19 and 25 of the reference application recite methods of treatment comprising administration of the anti-oxMIF antibody.
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 ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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