DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 10/06/2025, has been entered.
Claims 67-76 are pending.
Election/Restrictions
Applicant’s election of specific antibody with HC CDR1 SEQ ID NO: 84, HC CDR2 SEQ ID NO: 86, HC CDR 3 SEQ ID NO: 88, LC CDR1 SEQ ID NO: 258, LC CDR2 SEQ ID NO: 144 and LC CDR3 SEQ ID NO: 161 in the reply filed on 03/04/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claims 67-76 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The present claims are drawn to a method of inhibiting alternative pathway complement activation comprising administering a MASP-3 inhibitory antibody. Given that the only disclosed utility for administering the MASP-3 inhibitory antibody was to treat or prevent diseases, the claims would encompass treating/preventing diseases. However, the instant specification, as filed, does not provide sufficient enabling description for treating the full scope of the diseases encompassed by the claims because there does not appear to be sufficient in vitro or in vivo evidence to support administering a MASP-3 inhibitory antibody to prevent or ameliorate the symptoms of all the diseases encompassed by the claims.
The instant application discloses a plethora of diseases as stated in claim 73. One of skill in the art is well-aware that Alzheimer’s disease, a disclosed species for example, is difficult to treatment and does not have a cure (Safiri et al.). However, the instant disclosure does not provide sufficient in vitro or in vivo evidence showing the administration of a MASP-3 inhibitory antibody can counter-act the manifestation of Alzheimer’s disease in order to treat the disease.
Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992).
The specification does not adequately teach how to effectively prevent or treat the breadth of diseases or reach an appropriate beneficial therapeutic endpoint in by administering the antibody. The specification does not teach how to extrapolate data obtained from various in vitro or in vivo observations as well as clinical experience with the antibody to the development of effective methods of preventing or treating plethora of the diseases broadly encompassed by the claimed invention.
There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art (e.g., treating a Alzheimer’s disease) to which the invention pertains, undue experimentation would be required to practice the claimed method of treating any cancer with a reasonable expectation of success, absent a specific and detailed description in applicant's specification of how to effectively use the claimed agent and absent working examples providing evidence which is reasonably predictive that the claimed agent is effective for treating any disease commensurate in scope with the claimed invention.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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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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/SHARON X WEN/Primary Examiner, Art Unit 1641
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