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. Claims 1-15 are pending upon entry of amendment filed on 4/10/26.
Claims 1-15 are under consideration in the instant application.
3. Applicant’s IDS filed on 4/10/26 has been acknowledged.
4. New title filed on 4/10/26 has been entered.
5. In light of Applicant’s amendment to the claims filed on 4/10/26 and the response filed on 4/10/26, the rejections under 35 U.S.C. 112(b), 103 and double patenting rejections (see section 6-7, 10-14 of the office action mailed on 10/27/25) have been withdrawn.
6. The following rejection remains.
7. 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.
8. Claims 1-15 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating an atypical hemolytic syndrome (aHUS) and renel condition of lupus nephritis comprising administering MASP antibody set forth in SEQ ID NO:2-5, 10-50mM of citrate or histidine, 200-300mM of arginine and surfactant of 0.01-0.1% polysorbate at pH 5-7 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 MASP antibody formulation that treats all or any of MASP dependent complement associated disease or disorder set forth in claims 11-15 other than aHUS and lupus nephritis.
Although Examples 1-4 exhibit stability studies of MASP antibody comprising various excipients, other than aHUS and/or renal disorder, no treatment method or regimen comprising antibody are disclosed.
U.S. Pub. 2015/0166676 (IDS reference) discloses or suggests treatment of aHUS comprising MASP2 antibody or OMS646 antibody. As such, given that the stabilizing effect for the excipient cannot be extrapolated any of MASP dependent complement associated disease or disorder set forth in claims 11-15 other than aHUS and lupus nephritis 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. It is unpredictable to develop antibody formulation and one exemplary formulation disclosed in the example cannot be extrapolated to various formulations 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 4/10/26 has been fully considered but they were not persuasive.
Applicant has asserted that it is not reasonable to state stable formulations would be unpredictable to treat disorders associated with MASP-2 dependent complement associated disorders.
However, the specification of the instant application discloses treatment method for aHUS, TMA or Lupus Nephritis comprising OMS646 antibody but no other treatment encompassed by MASP-2 dependent complement associated disorders is disclosed. Applicant is advised to limit MASP-2 dependent complement associated disorders to be aHUS, TMA or Lupus Nephritis.
9. No claims are allowable.
10. THIS ACTION IS MADE FINAL. 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.
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.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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 Examiner
Technology Center 1600
June 16, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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