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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Invention Group I (claims 1-18, 44-52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148, 180-182, 185, 187, 189, 191, 193, 195, 197, 199, 201-202, 210-262, and 277) in the reply filed on 03/11/2026 is acknowledged. In response to species election requirement, Applicant elected the following species:
(i). Complement-activating serine protease effector domains as recited in claim 2: C1r or a fragment thereof.
(ii). Antigens bound by a target-binding domain: (b) an antigen present on a microbial pathogen as recited in claim 7.
(iii). Antibodies recited in claims 15-16, 18, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, and 148: anti-fHbP antibody or an antigen-binding fragment thereof.
(iv). Antibodies represented by SEQ ID NOS recited in claims 180-182, 185, 187, 189, 191, 193, 195, 197, 199, and 201: the heavy chain set forth as SEQ ID NO: 104 and the light chain set forth as SEQ ID NO:103.
(v). Serine protease effector domains represented by SEQ ID NOS as recited in claim 202: the serine protease effector domain comprising an amino acid sequence set forth in SEQ ID NO: 76.
(vi). Fusion proteins represented by SEQ ID NO as recited in claims 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, and 254: the fusion protein comprising an amino acid sequence set forth in SEQ ID NO: 108.
(vii). Infections as recited in claim 287: bacterial infection.
Applicant further elected the following subspecies: an antigen present on a bacterial pathogen from claim 8.
2. Claims 1-18, 44-52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148, 180-182, 185, 187, 189, 191, 193, 195, 197, 199, 201-202, 210-269, 277-288, 292, 295, 297, and 301 are pending. Claims 1-4, 7-10, 14, 17-18, 44-51, 76, 185, 202, 238-239, 256-262, and 277 are currently under consideration. Claims 5-6, 11-13, 15-16, 52, 60, 68, 84, 92, 100, 108, 116, 124, 132, 140, 148, 180-182, 187, 189, 191, 193, 195, 197, 199, 201, 210-237, 240-255, 263-269, 278-288, 292, 295, 297, and 301 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species.
Information Disclosure Statement
3. The information disclosure statement filed on 03/11/2026, 09/24/2025, 06/03/2025, 03/03/2023, and 02/21/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 10/06/2022 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. The following is a quotation of the first paragraph of 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.
6. Claims 1-4, 7-10, 14, 17-18, 44-51, 76, 185, 202, 238-239, 256-262, and 277 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 1 is drawn to a targeted complement-activating molecule comprising a target-binding domain and a complement-activating serine protease effector domain. The claim does not require that the target-binding domain and the complement-activating serine protease effector domain possess any particular conserved structure nor other disclosed distinguishing feature. Thus, the claim encompasses a genus of targeted complement-activating molecules without particular structural features. Claims 3-4, 44-47, 51, 256-262, and 277 depend from claim 1.
Claim 2 limits the complement-activating serine protease effector domain comprises C1r or a fragment thereof, among others. The claim does not require that the fragment of C1r domain possess any particular conserved structure.
Claim 7 recites “wherein the target-binding domain binds to an antigen present on a microbial pathogen”. However, the claim does not define the microbial pathogen and does not require that the target-binding domain possess any particular conserved structure. While limiting microbial pathogen, claims 8-10 do not require that the target-binding domain possess any particular conserved structure.
Claim 14 recites “wherein the target-binding domain comprises an antibody or an antigen-binding fragment thereof”. There is no structural limitation for the antibody or an antigen-binding fragment thereof. While reciting an antigen, claims 17-18 and 48-50 do not require that the antibody possesses any particular conserved structure nor other disclosed distinguishing feature. Claim 76 recites “anti-fHbP antibody clone 19 or an antigen-binding fragment thereof” and “C1r or a fragment thereof”. The claim does not recite the amino acid sequences of anti-fHbP antibody clone 19 and does not require that the fragment of C1r possess a structural feature.
Claim 185 does not require that the complement-activating serine protease effector domain possess any particular conserved structure nor other disclosed distinguishing feature, whereas claim 202 The claim does not require that the target-binding domain possess any particular conserved structure nor other disclosed distinguishing feature.
Claim 238 appears to recite a partial structure (amino acid sequence) for the fusion protein by reciting a serine protease effector domain derived from C1r, whereas claim 239 only recites a light chain for the target-binding domain (see specification at page 64).
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses a number of targeted complement-activating molecules, comprising a target-binding domain, including anti-fHbP antibody clone 19 or an antigen-binding fragment thereof and a complement-activating serine protease effector domain, including C1r or a fragment thereof (see, e.g., specification, page 4). However, such a disclosure is insufficient to support the broad genus of targeted complement-activating molecules.
Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other targeted complement-activating molecules might be. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of targeted complement-activating molecules.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
7. 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.
8. Claims 1-4 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by US 2019/0016824 A1 (Pub. Date: Jan. 17, 2019).
US 2019/0016824 A1 teaches a complex protein comprising human mannan-binding lectin (MBL) that forms a specific and high affinity interaction through its collagen-like domain with unique C1r/C1s-like serine protease (page 2, paragraph [0011]). US 2019/0016824 A1 also teaches a complex protein with separate functional domains, which comprise a binding site for mannan-binding lectin (MBL) and ficolins, a serine protease catalytic site, a binding site for proteolytic substrate C2, a binding site for proteolytic substrate C4, a MASP-2 cleavage site for autoactivation of MASP-2 zymogen (page 54, paragraph [0592]). Thus, the teachings of US 2019/0016824 A1 meet the limitations of claims 1-4.
Claim Objections
9. Claim 238 is objected to because it recites SEQ ID NO: 119 twice.
Conclusion
10. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
May 1, 2026
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