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 provisions of the AIA .
Claims 1, 3, 11, 43-44, 68-69, and 104-107 are pending.
Claims 2, 4-10, 12-42, 45-67, and 70-103 are cancelled.
Claims 104-107 are new.
Applicant’s election of Group I in the reply filed on 07/23/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement as it relates to the election of Groups, the election of Group I, claims 1, 3, and 11, has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 43-44, 68-69, and 107 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups/inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/23/2024.
Upon further consideration the restriction requirement as between species of antibodies having a CDR2 of SEQ ID NO: 8 or SEQ ID NO: 120 has been withdrawn.
Claims 1, 3, 11, and 104-106 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/24/2025 has been considered by the examiner.
Withdrawn Objections and Rejections
The objection to the specification has been withdrawn as addressed by the 07/24/2025 amendments. The objection to claims 1, 3, and 11 are withdrawn as addressed by the 07/24/2025 amendments. The rejection of claim 11 under 35 USC §112(b) is withdrawn as addressed by the 07/24/2025 amendments. The rejections of the claims under 35 USC §103 as presented in the 01/27/2025 IDS are withdrawn. The rejections for double patenting are withdrawn.
Newly Necessitated Claim Rejections
35 U.S.C. §112(a)
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 1, 3, 11, and 104-106 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 specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The specification does not reasonably provide enablement for preventing, stabilizing or reducing antibody mediated rejection (ABMR) (as recited in claim 1) let alone practicing said method in a subject suffering from chronic ABMR (CABMR).
The specification does not provide sufficient evidence that the claimed method of using the antibody is effective for preventing, stabilizing or reducing ABMR and/or CABMR. The evidence provided merely shows a reduction in c4d deposition and all mentions of actual in vivo or in vitro data appear to be prospective (see for example the description of the figures). Therefore, 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 use the invention.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S.261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied.
In re Wands, 858F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In regard to Wands factors (A) and (B), the breadth of the claims needed to enable the invention is determined by whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought in the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The nature of the invention is a biological/chemical case, where there is natural unpredictability in performance of certain species other than those specifically enumerated; see MPEP § 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the claimed method(s), with a reasonable expectation of success, because it would not have been predictable from the disclosure that the claimed antibody would function as claimed with respect to ABMR or CABMR (see MPEP § 2164.03).
In regard to Wands factors (C), (D) and (E), the state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains and provides evidence for the degree of predictability in the art; see MPEP § 2164.05(a).
Accordingly, Kanbay et al (Targeting IL-6 in antibody-mediated kidney transplant rejection, Clinical Kidney Journal, Volume 18, Issue 5, May 2025, sfaf108, https://doi.org/10.1093/ckj/sfaf108) teach that a notable gap remains regarding the effectiveness of IL-6 pathway inhibition in treating chronic forms of AMR (cAMR) and that, despite promising phase 2 trial results, clazakizumab is no longer in clinical development for cAMR after early termination of the phase III Imagine trial due to clinical futility (see for example the abstract at page 1 and pages 4 and 6; see also NCT03744910). The pathology underlying ABMR and CABMR as well as the diagnostic criteria (as taught by Djamali et al (Diagnosis and management of antibody-mediated rejection: current status and novel approaches. Am J Transplant. 2014 Feb;14(2):255-71. doi: 10.1111/ajt.12589. Epub 2014 Jan 8.; see for example pages 255-258) demonstrate that futility with respect to prevention, reduction, or stabilization of CABMR casts significant doubt onto enablement of the claims for prevention, reduction, or stabilization of ABMR.
Given the cited teachings of the prior art that clazakizumab was futile in a phase III trial and is no longer being considered for treating ABMR , the cited references demonstrate that the use of clazakizumab for prevention, reduction, or stabilization of ABMR and/or CABMR is unpredictable.
While the level of skill in the art is high, the amount of guidance provided regarding how to use the claimed antibody in the claimed methods is scant. Accordingly, the amount of experimentation required to determine how to use the recited antibody to prevent/stabilize/treat AMBR/cABMR is quite extensive.
Due to the large quantity of experimentation necessary to determine how to use the recited antibody to prevent, reduce, or stabilize ABMR/CABMR, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to the same, the complex nature of the invention, the limited state of the prior art, the unpredictability of the effects of complex biological molecules on diseased physiological systems, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. §112 first paragraph.
Conclusion
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678