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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/25/26 has been entered.
3. Claims 32-52 are pending upon entry of amendment filed on 2/25/26.
Claim 32-52 readable upon aHUS are under consideration in the instant application.
4. Applicant’s IDS filed on 2/25/26 has been acknowledged.
5. The following rejections remain.
6. 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.
7. Claims 32-52 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating aHUS, PNH or gMG comprising administering anti-C5a antibody formulation comprising SEQ ID NO 3-6, 8, 11-14, 18, 19 in phosphate buffer, sucrose, arginine and polysorbate; does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use anti-C5a antibody composition in treatment of any complement -associated conditions as set forth in claims 32-51 other than aHUS, PNH and gMG. The currently amended claims are readable upon treatment of any complement associated diseases.
Examples 2-3 describe administrations of ALXN1210 and compare intravenous or subcutaneous administrations in safety, tolerability, pharmacokinetics or pharmacodynamics. No examples show treatment of representative studies of complement-associated diseases encompassed by the antibody formulation.
The claims of the instant application recite treatment of any complement associated disease comprising administrating of C5a antibody set forth in SEQ ID NO:3-6, 8, 11-14, 18, 19 in the presence of phosphate buffer, arginine, sucrose and polysorbate.
The Ultomiris insert (2018, Alexion, p. 1-63, IDS reference) suggests treatment of PNH, aHUS and gMG comprising administering the composition comprising the ravulizumab in the presence of phosphate buffer, sucrose, polysorbate and arginine (p. 51-52). This treatment programs cannot be extrapolated any treatment methods encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. The specification safety, PK or PD data bur does not disclose any other treatment methods encompassed by the claimed invention. The specification does not discloses treatment of diseases or conditions recited in claim 49 such as Alzheimer’s diseases or diabetes that is encompassed by the treatment method of the claimed invention. It is unpredictable to develop studies in the example cannot be extrapolated to treatment methods that are encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s response filed on 2/25/26 has been fully considered but they were not persuasive.
Applicant has asserted that ULTOMIS has established additional treatment of NMOSD and IgAN supported by the references in p.8 of the response filed on 2/25/26.
Although treatment plan may be extended to additional disorders NMOSD, IgAN, IgA nephropathy and delayed graft function, this cannot be extrapolated to all the disorders encompassed by the disorders recited in claim 49. As in p. 19 of the ULTOMIS, some adverse reactions include vascular disorders and nervous system disorders (note Tables 15-16). As such, the skilled artisan would have reasonably doubted that all the disorders listed in claim 49 is enabled, especially Alzheimer’s disease, vascular disorders, septic shock or renovascular disorders. Applicant is required to amend the claims to reflect what is encompassed by the complement associated conditions by reciting disorders in claim 52 into claim 32.
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 32-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21, 25-26, 29-30, 37-39 of U.S. application number 17/773,941.
The claims of the ‘941 application recite method of treating PNH, gMG and aHUS comprising administering C5a antibody formulation comprising phosphate buffer, polysorbate, arginine and sucrose.
Applicant’s response filed on 2/25/26 have been fully considered but they were not persuasive.
Applicant has asserted that the ‘941 application has a later filing date and the rejection should be withdrawn without a terminal disclaimer when the provisional rejection is the only remaining rejection.
This rejection is not the only remaining rejection and the rejection is maintained until the further prosecution.
10. No claims are allowable.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent ExaminerTechnology Center 1600
March 12, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641