DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 12/28/2023, is acknowledged.
3. Claims 22-42 are pending and under examination.
4. Applicant’s IDS, filed 06/07/2023, 06/07/2023, 12/28/203, 04/29/202025 and 10/06/2025, is acknowledged.
5. 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.
6. Claims 22-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11591386 B2 (IDS #2). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `386 patent are directed to methods of inhibiting classical pathway of complement activation in a subject, comprising administering to a subject in need thereof an effective amount of a monoclonal antibody or antigen-binding fragment thereof that specifically binds to human complement factor C2, wherein said monoclonal antibody or fragment thereof comprises: a VH domain comprising the amino acid sequence set forth in SEQ ID NO: 3; and a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, wherein the autoimmune disease is selected from the group consisting of allergic neuritis; type II collagen-induced arthritis; myasthenia gravis; hemolytic anemia; glomerulonephritis; idiopathic membranous nephropathy; rheumatoid arthritis; systemic lupus erythematosus; immune complex-induced vasculitis; adult respiratory distress syndrome; stroke; xenotransplantation; allotransplantation; multiple sclerosis; burn injuries; extracorporeal dialysis and blood oxygenation; inflammatory disorders, including sepsis and septic shock; toxicity induced by in vivo administration of cytokines or monoclonal antibodies; antibody-mediated rejection of allografts such as kidney allografts; multiple trauma; ischemia-reperfusion injuries; and myocardial infarction.
The claims of the `386 patent anticipate the claimed invention.
7. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
8. Claims 22-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims 22, 26, and 42 and dependent claims thereof encompass a broad genus of monoclonal antibodies and antigen-binding fragments thereof that compete for binding to human complement factor C2 with monoclonal antibody comprising VH of SEQ ID NO: 2 and VL of SEQ ID NO: 3 in the inhibition classical pathway of complement activation, inhibition lectin pathway of complement activation and inhibiting binding of human complement factor C2 to C4b in a cell.
However, there does not appear to be an adequate written description in the specification as-filed of the essential structural feature that provides the recited function of the inhibition classical pathway of complement activation, inhibition lectin pathway of complement activation and inhibiting binding of human complement factor C2 to C4b in a cell. The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus.
Claims 22, 26, and 42 require "competes for binding to human complement factor C2 with a monoclonal antibody or fragment thereof comprising: a VH domain comprising the amino acid sequence set forth in SEQ ID NO: 3; and a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2”. While the amino acid sequence of complement factor C2 was known, immunizing an animal with complement factor C2 will generate antibodies directed to a number of different epitopes within the amino acid sequence of complement factor C2 and not necessarily to the same epitope which is bound by the claimed antibody 5F2.4. The knowledge of the amino acid sequence of complement factor C2, by itself, did not put Applicants in possession of antibodies that compete for binding with claimed 5F2.4 mAb.
In determining that the Specification did not support the claimed anti-complement factor C2 antibodies, the Specification disclosure is considered. The specification fails to disclose a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The specification fails to provide any anti-human C2 antibodies that compete with the claimed 5F2.4 mAb and inhibit classical pathway of complement activation, inhibit lectin pathway of complement activation and inhibit binding of human complement factor C2 to C4b in a cell. Thus, the skilled artisan could not envision the detailed chemical structure of the encompassed genus of antibodies ... until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Absent a recitation of distinguishing identifying characteristics, the Specification does not provide adequate written description support of the claimed genus.
there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed competing anti-C2 antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). The Court reiterated that adequate written description must “contain enough information about the actual makeup of the claimed products . . . .” The Court simultaneously suggested that the “newly characterized antigen” test “flouts” section 112 because it “allows patentees to claim antibodies by describing something that is not the invention, i.e. the antigen.” The Court concluded that for written description of an antibody to be adequate when presented with “functional” terminology, there must be an established correlation in the art between structure and function.
For instance, citing to Centocor, the Court analogized an antigen and antibody to a lock and a key. For an antigen where there is only a finite number of binding antibodies, discovering those antibodies may be routine and conventional, and description of the antigen alone may be sufficient. By contrast, for antigens with millions of keys, or millions of potentially binding antibodies, description of the antigen and even a couple of examples may be far from sufficient.
This case is thus similar to Centocor Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341 (Fed. Cir. 2011). In Centocor, patentee claimed an antibody or antibody fragment that competitively inhibits binding of A2 (a mouse antibody) and that binds an epitope of TNF-α with a specified affinity. 636 F.3d at 1346. Both TNF-α protein and antibodies to that protein were known in the literature. Id. at 1352. Patentee argued that the patent at issue satisfied the written description for the claimed antibodies because it "not only describes the antibodies by their binding affinity for TNF-α, but further describes the antibodies by specifying that they competitively inhibit binding of the A2 mouse antibody to TNF-α." Id. At 1349. The Federal Circuit rejected this argument, finding that "[a]t bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-α antibody should have: high affinity, neutralizing activity, and the ability to bind in the same place as the mouse A2 antibody." Id. At 1351. The court explained that "[t]he specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations."
In finding that the specification at issue did not provide written description support for the claimed antibodies, the Centocor court recognized that the written description does not require examples or an actual reduction to practice, but clarified that "it does demand ... that one of skill in the art can 'visualize or recognize' the claimed antibodies based on the specification's disclosure." Id. at 1353. "In other words the specification must demonstrate constructive possession." Id; see also, AbbVie Deutschland GmbH & Co., KG., v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014) (reiterating requirement for structure-function correlation in functionally defined claims and finding that the patents at issue do not meet the written description requirement because they "do not describe any common structural features of the claimed antibodies.").
Here, as in Centocor, Applicant seeks to ground written description support for a claimed antibody in its competitive inhibition of another antibody (here, the monoclonal antibody 5F2.4, in Centocor, mouse A2 antibody) and in the description of a known antigen (here human complement factor C2, in Centocor, TNF-α). While the state of the art has progressed since the Federal Circuit's decision in Centocor, the basic problem remains that the description at issue must allow one of skill in the art to "visualize or recognize" the claimed antibodies. Here, the evidence of record does not support that the skilled artisan would have visualized or recognized the claimed antibodies based on the description provided. As in Centocor, the Specification provides only a plan for identifying the claimed antibodies.
Possession is not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Sufficient description to show possession of such a genus may be achieved by means of a recitation of anti-human complement factor C2 competing antibodies falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. See Eli Lilly, 119F.3d at 1568, 43 USPQ2d at 1406.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
9. 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.
10. Claims 22-33, 35 and 39-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2014189378-A1 (IDS # B9).
The `878 publication teaches antibody binding molecule that bind to human complement factor C2 and uses thereof in the treatment or prevention complement activation mediated diseases or disorders, such as antibody-mediated inflammatory diseases and ischemia-reperfusion (I/R) injury in ischemic conditions (abstract) and autoimmune diseases (see page 25, 1st ¶).
The `378 publication teaches humanized anti-complement C2 antibody no. 5F2.4-VL3 of SEQ 101 and VH4, SEQ 106 that are 100% and 99% identical to claimed SEQ ID NO: 2 and 3, respectively, for treating an inflammatory disease, a neurological disease, or from antibody-mediated inflammation or ischemia-reperfusion injury, such as acute myocardial infarction, stroke, sepsis, immune complex diseases, rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple trauma, multifocal motor neuropathy, antibody-mediated rejection of a renal allograft, (auto)immune hemolytic anemia, cardiopulmonary bypass and other vascular surgery, idiopathic membranous nephropathy, Goodpasture's syndrome. The present sequence is a humanized anti-complement C2 monoclonal antibody no. 5F2.4 heavy chain variable region (VH) 5F2.4-VH4, useful for preparing the binding molecule or antibody for treating an individual suffering from excessive or overactive complement activity (see claims 12-14), wherein the diseases are human disease (abstract). The `878 publication teaches full-length monoclonal antibody comprising humanized IgG4 chain 5F2.4 (see page 7, lines 18+) or IgG1 antibody (page 13, lines 7+).
The published antibody would compete with the claimed antibody because both antibodies are derive from the mAb 5F2.4 and bind C2b and share the same CDRs.
Claim 35 is included because under Example 11 at page 54 of the `378 teaches the generation of chimeric human IgG1̝κ and/or human IgG4κ anti-C2-5F2.4 antibody.
Alignment of claimed SEQ ID NO: 2 with referenced SEQ ID NO: 101, 117.
Qy 1 DNVLTQSPDSLAVSLGERATISCRASKSVRTSGYNYMHWYQQKPGQPPKLLIYLASNLKS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DNVLTQSPDSLAVSLGERATISCRASKSVRTSGYNYMHWYQQKPGQPPKLLIYLASNLKS 60
Qy 61 GVPDRFSGSGSGTDFTLTISSLQAEDAATYYCQHSRELPYTFGQGTKLEIK 111
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GVPDRFSGSGSGTDFTLTISSLQAEDAATYYCQHSRELPYTFGQGTKLEIK 111
Alignment of claimed SEQ ID NO: 3 with published SEQ ID NO: 106.
Qy 1 EVQLVQSGAEVKKPGASVKVSCKASGYTFTDYNMDWVRQATGQGLEWIGDINPNYESTGY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVQSGAEVKKPGASVKVSCKASGYTFTDYNMDWVRQATGQGLEWIGDINPNYESTGY 60
Qy 61 NQKFKGRATMTVDKSISTAYMELSSLRSEDTAVYYCAREDDHDAFAYWGQGTLVTVSS 118
||||||||||||:|||||||||||||||||||||||||||||||||||||||||||||
Db 61 NQKFKGRATMTVNKSISTAYMELSSLRSEDTAVYYCAREDDHDAFAYWGQGTLVTVSS 118
The reference teachings anticipate the claimed invention.
11. No claim is allowed.
12. SEQ ID NOs: 3-4, 6 and 8 are free from prior art.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
December 20, 2025
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644