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 .
Claims 1-19, 21-28, 30, 32, 33, 37-40, 73, and 76 are pending and currently under consideration.
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 2, 3, 6-9, 10-19, 21-28, 30, 32, 33, 37-40, 73, and 76 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 2, 3, 7-9, 15-19, 21-28, 30, 32, 33, 38, 39, 73, and 76 are rejected because claims 2, 7-9, 15-18, 21, 30, 33, 38, 39, 73, and 76 all recite “the antibody”. There is insufficient antecedent basis for “the antibody” in the claims.
Claim 6 is rejected for reciting “wherein the…antibody administration dose”. There is insufficient antecedent basis for “wherein the…antibody administration dose” in the claim.
Claim 9 is rejected for reciting “the maintenance dose of the antibody”. There is insufficient antecedent basis for “the maintenance dose of the antibody” in the claim.
Claims 10-17, 37-40, and 76 are rejected because it is unclear how, or if, “(CASI Pharma)” after “CID-103” at claims 10 and 37 limits the claims. It is noted that a source of a product does not identify, or describe, a product.
Claims 10-17, 37-40, and 76 are rejected because claims 10 and 37 contain the trademark/trade name “Morphosys”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an anti-CD38 antibody and, accordingly, the identification/description is indefinite.
Claims 13-14 are rejected for reciting “…further comprising administering a maintenance dose of the daratumumab to the subject thereafter.” The metes-and-bounds of the claims are unclear because it is unclear what would, or would not, be considered “thereafter”.
Claim 39 is rejected for reciting “the antibody dose”. There is insufficient antecedent basis for “the antibody dose” in the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 5, and 40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites that a weekly administration of some type of antibody comprises a recited amount; however, claim 4 does not require one to administer a weekly dose and does not further the limit the subject matter of the claim upon which it depends.
Claims 5 and 40 recite that administering amount a recited mg/m2 of some type of antibody comprises administering about a recited amount of antibody; however, the claims do not require one to administer a recited mg/m2 of any antibody and do not further the limit the subject matter of the claims upon which claims 5 and 40 depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 5, 10-14, 37, and 40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wall et al (WO 2021/097360 A1; 5/20/21; 3/12/24 IDS) in view of Milani et al (Blood, 2019, 134(Supp_1): 1860).
Wall et al teaches a modified anti-amyloid antibody with a VH comprising SEQ ID NO:15 and a VL comprising SEQ ID NO:16 ([[0172], in particular). It is noted that SEQ ID NO:15 is identical to instant SEQ ID NO:1 and SEQ ID NO:16 is identical to instant SEQ ID NO:2. Wall et al further teaches the modified anti-amyloid antibody comprises an amyloid reactive protein comprising a sequence selected from SEQ ID NOs: 1-14 ([0175] and Table 1, in particular). Wall et al further teaches the modified anti-amyloid antibody unexpectedly shows higher affinity to human amyloid fibrils by virtue of binding of the antibody and the amyloid reactive peptide to human amyloid fibrils and, in some embodiments, the peptide provides enhanced activity of the antibody to clear amyloid deposits and the antibody Fc recruits macrophages that phagocytose and clear amyloid fibrils and deposits ([0012], in particular). Wall et al further teaches a method of treating a subject suffering from multiple myeloma comprising administering the modified anti-amyloid antibody to the subject (see Embodiments 20, 23, and 26, in particular). Wall et al further teaches the parental antibody of the modified anti-amyloid antibody, m11-1F4, binds an epitope present on N-terminal denatured kappa 4 light chain proteins ([0106] and [0402], in particular).
Wall et al does not specifically teach administering an anti-CD38 antibody, such as Daratumumab, to the subject in addition to the modified anti-amyloid antibody of Wall et al. However, these deficiencies are made up in the teachings of Milani et al.
Milani et al teaches subjects with multiple myeloma with associated amyloidosis therapeutically respond to a regimen comprising administering 16 mg/Kg once a week (“first cycle”) to the subjects for two months followed by every other week for the next four months (“second cycle”), and subsequently a maintenance dose every 28 days (METHODS and CONCLUSION, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating subjects with multiple myeloma with associated amyloidosis comprising administering the modified anti-amyloid antibody of Wall et al to the subjects in combination with the regimen of Milani et al to the subjects because Wall et al teaches a method of treating a subject suffering from multiple myeloma comprising administering the modified anti-amyloid antibody to the subject, Wall et al teaches the anti-amyloid antibody shows high affinity to human amyloid fibrils and clears amyloid fibrils and deposits, and Miani et al teaches subjects with multiple myeloma with associated amyloidosis therapeutically respond to the regiment of Milani et al. Noting Wall et al teaches the parental antibody of the modified anti-amyloid antibody, m11-1F4, binds an epitope present on N-terminal denatured kappa 4 light chain proteins, said method is a method of “inhibiting amyloid formation by binding to precursor misfolded proteins in the circulation of a subject” because the antibodies would bind any precursor misfolded proteins in the circulation of a subject for which the antibodies are specific. This is an example of combining prior art elements according to known methods to yield predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent 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, 4, 5, 10-14, 37, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 19-21, 23, 25, 27, 29, 43, 51, 59, 68, 74, 75, 82, 84, 98, 107, 108, and 111 of copending Application No. 18/026185 in view of Wall et al (WO 2021/097360 A1; 5/20/21; 3/12/24 IDS) in view of Milani et al (Blood, 2019, 134(Supp_1): 1860).
The instant claims are drawn to methods of treating multiple myeloma comprising administering a combination of (a) antibodies with VH and VL comprising instant SEQ ID NOs:1-2 and (b) anti-CD38 antibodies. The copending claims are drawn to compositions comprising antibodies with VH and VL comprising instant SEQ ID NOs:1-2 and methods of treating subject, including subjects with multiple myeloma, comprising administering said antibodies. The instant claims differ from the copending claims in that the instant claims also comprise administering anti-CD38 antibodies such as daratumumab. However, these differences are made-up by the teachings of Wall et al and Milani et al. One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating subjects with multiple myeloma of the copending claims wherein the multiple myeloma is with associated amyloidosis comprising administering the modified anti-amyloid antibody of Wall et al (comprising SEQ ID NOs:1-2 of the instant & copending claims) to the subjects in combination with the regimen of Milani et al to the subjects because Wall et al teaches a method of treating a subject suffering from multiple myeloma comprising administering the modified anti-amyloid antibody to the subject, Wall et al teaches the anti-amyloid antibody shows high affinity to human amyloid fibrils and clears amyloid fibrils and deposits, and Miani et al teaches subjects with multiple myeloma with associated amyloidosis therapeutically respond to the regiment of Milani et al. Noting Wall et al teaches the parental antibody of the modified anti-amyloid antibody, m11-1F4, binds an epitope present on N-terminal denatured kappa 4 light chain proteins, said method is a method of “inhibiting amyloid formation by binding to precursor misfolded proteins in the circulation of a subject” because the antibodies would bind any precursor misfolded proteins in the circulation of a subject for which the antibodies are specific.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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