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 .
Election/Restrictions
Claims 1-6, 13, and 15-17 are allowable. Claims 18-20 and 22-24, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions I-IV, as set forth in the Office action mailed on 03/26/2025, is hereby withdrawn and claims 18-20 and 22-24 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendment
Applicant’s remarks and claim amendments filed 06/16/2026 have been acknowledged. The amendments to the claims overcome the 35 USC 112(a) and 35 USC 112(b) rejections previously set forth in the Non-Final Rejection of 03/16/2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because “use” claims do not purport to claim a process, machine, manufacture, or composition of matter and thus fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering an anti-C7 antibody or antibody fragment thereof (or pharmaceutical composition comprising such) to treat or prevent a disease associated with complement dysregulation, does not reasonably provide enablement for treating or preventing said disease comprising administering a nucleic acid sequence encoding the antibody. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The nature of the invention relates to anti-C7 antibodies and fragments thereof and their use in inhibiting complement activation in order to treat or prevent a disease associated with the dysregulation of complement in a subject (see Technical Field, Page 1 of Specification).
Claim 22 encompasses methods of treating or preventing a disease associated with complement dysregulation comprising administering a nucleic acid encoding the anti-C7 antibody or fragment thereof recited in the claims.
The specification teaches that several anti-C7 monoclonal antibody clones were generated including 17E7, 59E7, 3B11, 2H2, and 73D1 and tested for the ability to bind to C7 as well as inhibit complement activation. All antibodies bind to human and cynomolgus C7 as determined by ELISA (Page 57, Ln. 30-35 and Table 1). Further, it was found that the anti-C7 antibodies efficiently inhibited complement activation (Table 1). Clones 17E7 and 73D1, in particular, inhibited in vivo complement activation as measured by a classical pathway hemolysis assay (Page 55, Ln. 3-21; Page 61, Ln. 15-16 to Page 62, Ln. 1-21). However, the specification does not provide evidence that administration of nucleic acids encoding the claimed antibodies predictably treats or prevents complement-mediated disorders in a subject. Further, the specification lacks sufficient guidance on an effective nucleic acid delivery system (e.g. a viral vector such as an lentiviral vector; nonviral delivery such as a lipid nanoparticle; administration of naked DNA/RNA; or an ex vivo cell-based approach in which cells are genetically modified to express the inhibitory antibody, etc.) (see, e.g. Mali et al); route of administration, dosage, regimen, and other parameters for achieving therapeutically effective systemic levels of the claimed anti-C7 antibodies.
While the prior art teaches the use of aptamers—single-stranded DNA or RNA molecules that can bind specifically to a target and neutralize the function of a protein—to inhibit complement activation as reviewed by Garred et al (see “Aptamers” in Section V, Part B-3 on Page 817); it does not establish that administration of a nucleic acid encoding an antibody targeting complement (e.g. an anti-C7 antibody) can predictably treat or prevent complement-mediated disorders in a subject.
A person of ordinary skill in the art at the time of filing would have had experience diagnosing and treating complement-mediated disorders. Even at this high level of skill, however, it would require undue trial and error experimentation to determine appropriate nucleic acid delivery vehicle or system (e.g. a viral vector such as an lentiviral vector; nonviral delivery such as a lipid nanoparticle; administration of naked DNA/RNA; or an ex vivo cell-based approach in which cells are genetically modified to express the inhibitory antibody, etc.), route of administration, dosage, and regimen to achieve therapeutically effective levels of the encoded anti-C7 antibody, particularly absent of sufficient guidance provided either in the specification or prior art.
Therefore, the specification is not enabling over the full scope of the claims.
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 20 and 23 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 claims 20 and 23, the phrase "for example" 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).
Claim 23 appears to claim a process without setting forth any steps involved in the process. In particular, the claims recite 1) a non-therapeutic use of the claimed anti-C7 antibody for detecting C7 in a method of diagnosing or monitoring a disease. However, as presently written, the claims do not set forth any positive, active steps to carry out any process. Thus, the claims are indefinite as it is unclear whether the claims are directed to process since no positive, active steps are recited (see MPEP 2173.05(q)).
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 19, 20, 22, and 24 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 19 recites “[a] cell expressing the nucleic acid sequence of claim 15”; however, claim 15 is directed to an antibody or antibody fragment thereof, not to a nucleic acid. Thus, claim 19 fails to limit the subject matter of claim 15.
Claim 20 recites that the cell of claim 16 is a hybridoma; however, claim 16-as presently written—is directed to an antibody or antibody fragment, not a cell. Thus, claim 20 fails to limit the subject matter of claim 16.
Similarly, claim 24 refers to “[t]he method of claim 20”; however, claim 20 is directed to a hybridoma cell—a product—not a method. Thus, claim 24 fails to limit the subject matter of claim 20.
Claim 20 (which depends indirectly from claim 1) also recites the following hybridomas: ECACC Accession No. 19041601, corresponding to clone 17E7 (HCDRs of SEQ ID NOs: 2-4 and LCDRs of SEQ ID NOs: 6-8); ECACC Accession No. 19080601, corresponding to clone 7D31 (HCDRs of SEQ ID NOs: 20-22 and LCDRs of SEQ ID NOs: 24-26); ECACC Accession No. 19080602, corresponding to clone 59E7; and ECACC Accession No. 19080603, corresponding to clone 2H2. Claim 1 does not recite the CDRs of clone 2H2 nor makes references to the hybridoma from which it is obtained. Thus, claim 20 improperly broadens (rather than further limits) the scope of claim 1.
Claim 22 recites a method of treating or preventing a disease associated with complement dysregulation comprising administering “the antibody or antibody fragment or pharmaceutical composition or nucleic acid sequence of any preceding claim to the subject”, and thus depends from claims 1-6, 13, and 15-20. However, claims 19 and 20 are each directed to a cell, not an antibody, pharmaceutical composition, or nucleic acid. Thus, claim 22 does not incorporate all of the limitation from which it depends from and does not further limit the subject matter of claims 19 and 20.
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.
Conclusion
Claims 1-6, 13, and 15-18 are allowable. Claims 19, 20, 22, 23, and 24 are not allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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