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 05/03/2024, has been entered.
Claims 3, 20, 27, 31-42 have been canceled.
Claims 1-2, 4-19, 21-26, 28-30 and 43-45 are pending and currently under examination as they read on a method of treating myasthenia gravis (MG) comprising administering antibody inebilizumab.
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.
Claims 1-2, 4-19, 21-26, 28-30 and 43-45 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 do not recite an antigen specificity for the antibody. Thus, one of skill in the art would not know how to make or use the antibody.
Antibodies are glycoproteins that possess the ability to react in vitro and in vivo specifically and selectively with the antigenic determinants or epitopes eliciting their production or with an antigenic determinant closely related to the homologous antigen.
Antibodies are immunoglobulins that are formed in response to immunogens or that are screened for specificity an antigen / immunogen.
It has been well established in the art that the antigen binding specificity is critical to how the skilled artisan would employ antibodies in various modalities (e.g., affinity purification, detection or diagnostic assays, bioassays, treatment), including those consistent with the instant disclosure (see specification, including the Summary of the Invention).
However, the instant claims do not recite an antigen specificity for CD19.
The specification provides insufficient direction or guidance regarding how to make and/or use antibody comprising the claimed sequences in the absence of an antigen specificity for CD19 and yet retain substantially the same binding specificity of the anti-CD19 antibodies and antigen-binding fragments thereof, which are enabling consistent with the disclosed utilities of the instant disclosure.
Given the well-known polymorphism of antibodies, it would have been undue experimentation to make and use the vast repertoire of antibodies encompassed by the claimed invention in the absence of binding specificity for CD19 to enable the scope of the claimed antibodies encompassed by the claimed invention.
Without sufficient guidance and given the well-known complexity and unpredictability of using antibodies with no particular antigen specificity as well the well-known polymorphism of antibodies; it would be unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue to make and use the vast repertoire of antibodies broadly encompassed by the claimed invention in order to make and/or use the anti-CD19 antibodies consistent with the instant disclosure.
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-19, 21-26, 28-30 and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04524273 (“MINT”; Aug 2020) in view of UPLIZNA (inebilizumab-cdon) Prescribing Information (June 2020).
MINT teaches methods of treating MG patients using inebilizumab (the anti-CD19 monoclonal antibody as recited in the present claims, see, e.g., claim 19). MINT further teaches administration of inebilizumab to patients who are AChR-Ab+ and MuSK-Ab+ (see Detailed Description). MINT teaches administration on Day 1, Day 15 and Day183, with continued administration during the extension phase of the study (see Arms and Interventions).
MINT does not expressly disclose administering inebilizumab at a dose of about 250 mg to about 350 mg every six months, nor does MINT expressly disclose administering an initial 300 mg dose followed by a second 300 mg dose two weeks later and subsequence 300 mg doses every six month.
The UPLIZNA prescribing information teaches administering of the identical antibody, inebilizumab, at a dose of 300 mg by intravenous infusion followed by a second 300 mg intravenous infusion two weeks later and subsequence single 300 mg by intravenous infusion every six months beginning six months from the first infusion (see DOSAGE AND ADMINSTRATION on page 1). The prescribing information further teaches that this dosing regimen produces sustained depletion of CD19-positive B cells (see Animal Data on page 10).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to administer inebilizumab in the treatment of MINT using the dosing regiment disclosed in the UPLIZNA prescribing information because the dosing regimen was already established for the identical therapeutic antibody and was known to safely provide sustained CD19-positive B cell depletion. Employing a known dosing schedule for the same therapeutic antibody in another antibody-mediated autoimmune disease would have represented the predictable use of prior art elements according to their established functions and would have provided a reasonable expectation of success.
Regarding claim 14-18, Furthermore, MINT teaches enrollment of patients receiving standard-of-care therapy including corticosteroids and immunosuppressive therapies (Inclusion Criteria). The recited concomitant administration of prednisone, azathioprine, tacrolimus, mycophenolate mofetil and mycophenolic acid constitute routine treatment of MG and would have been obvious to continue in patients receiving inebilizumab because such therapies were conventionally used in the management of MG.
Regarding claim 21-26, MINT teaches treatment of MG patients, including patients exhibiting active disease despite existing therapy (Inclusion Criteria). Therefore, optimization of treatment for patients having inadequately controlled disease or refractory disease would have been an obvious patient selection criterion because such patients represent the population most likely to benefit from receiving additional biological therapy.
Regarding claims 4-8, 21 and 29-30, MINT teaches administration of inebilizumab, an anti-CD19 monoclonal antibody, to subjects having MD. The UPLIZNA prescribing information likewise teaches administration of inebilizumab and explains that the drug binds CD19 expressed on pre-B cells and mature B cells, thereby resulting in the depletion of CD19-postive B cells (Mechanism of Action, page 11). Because the claimed biological effects are the direct consequence of administering the prior art antibody according to the prior art methods, the recited effects are inherent properties of the obvious combination and do not impart patentability. In re Best, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
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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/SHARON X WEN/Primary Examiner, Art Unit 1641
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