DETAILED ACTION
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 .
Status of Claims
The first preliminary amendment filed 03/16/2023 is acknowledged. Claims 6-9, 20, 21, 23, 28, 34, 35, 40-42, 47, 53, and 54 are amended. Claims 10-19, 22, 24-27, 29-33, 36-39, 43-46, 48-52 and 55-57 are cancelled. No restriction is being imposed in this case. Claims 1-9, 20, 21, 23, 28, 34, 35, 40-42, 47, 53, and 54 are pending and under examination.
Claim Objections
Claim 41 is objected to because of the following informalities: The claim recites “Extrarenal SLE Flare” without having made clear the full meaning of the term “SLE” in its first use. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 53 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrien et al.
Claims 53 and 54 are drawn to a kit comprising a structurally defined anti-C5 antibody.
Andrien et al. discloses an antibody that binds complement component human C5 comprising heavy and light chains depicted in SEQ ID NOs 14 and 11 [see claim 14] (instant claims 1, 3, 4, 7, 8, and 9), and further comprise the recited Fc modifications [see claim 11] (instant claim 6). These heavy and light chains necessarily comprise the heavy and light chain CDRs disclosed in instant claim 1, and thus Andrien et al. disclose the specific antibody composition of the instant application. Andrien et al. teach that the antibody may be included in a kit [see claim 26] (instant claims 53 and 54).
Therefore, claims 53 and 54 are rejected under 35 U.S.C. 102(a)(1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, 20, 21, 23, 34, 35, 40-42, 53, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Andrien et al. in view of Bachman et al., and in further view of Bai et al.
Claims 1-9, 20, 21, 23, 28, 34, 35, 40-42, 47, 53, and 54 are drawn to methods of treating specific complement-mediated kidney diseases using a structurally defined anti-C5 antibody, further limitations include patient subpopulations and a kit comprising said antibody.
Andrien et al. discloses an antibody that binds complement component human C5 comprising heavy and light chains depicted in SEQ ID NOs 14 and 11 [see claim 14] (instant claims 1, 3, 4, 7, 8, and 9), and further comprise the recited Fc modifications [see claim 11] (instant claim 6). These heavy and light chains necessarily comprise the heavy and light chain CDRs disclosed in instant claim 1, and thus Andrien et al. disclose the specific antibody composition of the instant application (instant claim 1). Further, Andrien et al. teach that the antibody may be administered intravenously [see p. 56, paragraph 2] (instant claim 20), to treat C5-mediated disorders such as lupus nephritis (LN) or glomerulonephritis [see specification, p. 14, paragraph 5] (instant claims 1 and 3), and may be included in a kit [see claim 26] (instant claims 53 and 54). Although Andrien et al. does not specifically disclose use for immunoglobulin A nephropathy (IgAN), IgAN was known in the art to be a complement mediated disorder, thereby falling within the scope of the C5-mediated diseases stated above (instant claim 4).
Furthermore, although Andrien et al. fails to disclose treatment for LN during an active flare, it was well understood in the art of management of relapsing diseases, like LN, that interventions are initiated or escalated during periods of active flares, and thus it would have been obvious to person having ordinary skill in the art to administer the claimed antibody during an active flare given that such patients represent those in need of intervention (instant claim 35).
However, Andrien et al. do not disclose dosing regimens, weight-based stratification of dosing, or pre-treatment with an additional immunosuppressive agent.
Bachman et al. disclose various administration protocols, including administration of loading doses on Day 1 followed by subsequent doses at about two weeks [see claim 1] and maintenance dosing at eight-week intervals [see claim 27], as well as dose concentrations including 400mg, 600mg, 900mg, 2400mg, 3000mg, and 5400mg, which are similar in value to the doses of instant claims 1-5 [see claims 5 and 6]. Bachman et al. notes that this dosing achieves sustained terminal complement inhibition [see specification, p. 76, paragraph 4]. Furthermore, the antibody can be administered following background therapy comprising an immunosuppressant [see specification, pg. 102, bullet 1] (instant claim 21). Although Bachman et al. do not recite the specific treatment protocols outlined in the instant application, refinement of dosing timeline and concentration would have been a matter of routine optimization for a person having ordinary skill in the art at the time (instant claims 1-5). Additionally, although the antibody sequence disclosed by Bachman et al. differs from the antibody of Andrien et al., it would have been obvious to one of ordinary skill in the art to combine these teachings to develop an administration timeline for the disclosed antibody as both references are directed to anti-C5 antibodies that inhibit terminal complement activity, are used to treat the same diseases, and use the same mechanism of action. Furthermore, one would have an expectation that the antibodies would follow a similar dosing schedule given that monoclonal antibody dosing is generally exposure driven and, again, both antibodies share the same biological target and mechanism of action.
However, Bachman et al. do not disclose the use of weight-based dosing tiers.
Bai et al. teaches that monoclonal antibody clearance and volume of distribution are influenced by patient weight and that dose adjustments based on weight are routinely used to achieve target systemic exposure [see abstract]. In view of the well-established relationship between body weight and monoclonal antibody pharmacokinetics, it would have been obvious and a matter of routine optimization for a person having ordinary skill in the art to utilize the antibody and dosing methods discussed above, and further stratify fixed dose amounts into weight categories to reliably achieve exposure targets.
In regards to instant claims 23, 34, and 40-42, these claims recite functional outcomes that are inherent results of effective C5 inhibition in complement-mediated renal disease and would be expected in light of the combination of the disclosed antibody and methods of use described in the prior art above.
Therefore, claims 1-9, 20, 21, 23, 34, 35, 40-42, 53, and 54 are rejected under 35 U.S.C. 103.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Andrien et al. in view of Bachman et al., and in further view of Bai et al. as applied to claims 1-9, 20, 21, 23, 34, 35, 40-42, 53, and 54 above, and further in view of Hanset et al.
Claim 28 is drawn to patient inclusion criteria comprising specific estimated glomerular filtration rate and proteinuria status.
The disclosure of Andrien et al., Bachman et al., and Bai et al. are discussed above.
The combination of these references fails to disclose a treatment population based on estimated glomerular filtration rates (eGFR).
Hanset et al. notes that patients with estimated glomerular filtration rates (eGFR) less than 30 ml/min per 1.73 m2 have been known in the art to be a distinct higher-risk subgroup for whom systemic treatment may be less appropriate due to a potential reversal of the risk benefit balance resulting from lower therapeutic efficiency and higher toxicity [see graphical abstract, paragraph 3]. In view of this, it would have been obvious for a person having ordinary skill in the art to select patients having eGFR greater than or equal to 30 ml/min per 1.73 m2 when administering the C5 antibody discussed above, as doing so reflects routine judgement to treat patients in whom the expected benefits outweigh the known risks, and constitutes a predictable application of routine clinical procedures.
Therefore, claims 1-9, 20, 21, 23, 28, 34, 35, 40-42, 53, and 54 are rejected under 35 U.S.C. 103.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Andrien et al. in view of Bachman et al., and in further view of Bai et al. as applied to claims 1-9, 20, 21, 23, 34, 35, 40-42, 53, and 54 above, and further in view of Nitta et al.
Claim 47 is drawn to additional therapeutic agents for the method of claim 3.
The disclosure of Andrien et al., Bachman et al., and Bai et al. are discussed above.
The combination of these references fails to disclose wherein the treatment further comprises one or more additional agents disclosed in claim 47.
Nitta et al. disclose that individuals with chronic kidney disease (CKD) are at increased risk of osteoporosis and that cotreatment with various agents was common in the art. Further, Nitta et al. specifically state that, generally, treatment for osteoporosis in patients with G1-G3 CKD (i.e., greater than 30 ml/min per 1.73 m2) is the same as that in patients without CKD [see Points to Consider]. It would have been obvious to administer a treatment for osteoporosis in addition to the claimed antibody as this would be consistent with standard care at the time.
Therefore, claims 1-9, 20, 21, 23, 34, 35, 40-42, 47, 53, and 54 are rejected under 35 U.S.C. 103.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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/TIRONE D. JOHNSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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