DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 11/26/25 has been entered in full. Claims 1 and 4-6 are amended. Claims 2-3 and 7-12 canceled. Claims 1 and 4-6 are pending.
Applicants' election without traverse of Group II, currently all pending claims, claims, was previously acknowledged. The election without traverse of “no additional therapeutic method steps” as the species of “additional therapeutic method step” was also previously acknowledged.
Claims 1 and 4-6 are under consideration, as they read upon the elected species.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (7/28/25).
The objection to the specification at page 3 is withdrawn in view of the amendments to the title.
All objections and/or rejections of canceled claims 3 and 7 are moot.
The objections to claims 1 and 4-6 at page 3 are withdrawn in view of the amendments to the claims.
The rejection of claims 5 and 6 at page 3 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
The rejection of claims 1 and 4-6 at pages 4-6 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement is withdrawn in view of Applicants’ amendment to the claims and further in view of Applicants’ persuasive arguments at pages 5-6 of the 11/26/25 Office action.
The rejection of claims 4-6 at pages 7-12 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of Applicants’ amendment to the claims.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(a), written description
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.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection was set forth previously at pages 6-12 of the 7/28/25 Office action.
Applicants’ arguments (7/28/25; pages 3-4) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
In the response, Applicants argue that “the application describes anti-IL-1β antibodies in the section entitled “IL-1β inhibitors” at pages 7-8 of the international PCT application PCT/US2020/052811 as filed” (page 4). Applicants further argue that “at the time of filing anti-IL-1β antibodies and methods of making them were well known in the art” and that “[a]s of the priority date, a skilled person was in possession of a wealth of information concerning anti-IL-1β antibodies” (page 4). Applicants further argue that “one of skill in the art, when viewing the specification and claims as a whole, would have recognized that what was discovered by the inventors was the inhibition of the IL-1β signaling pathway reverses the ACM phenotype” and that the disclosure is “not about new or untested anti-IL-1β antibodies (or any inhibitor of IL-1β)” (page 4).
Applicants’ arguments have been fully considered but are not found persuasive. The instant application represents the national stage (35 U.S.C. 371) of the ‘811 PCT application. As such, the disclosure referred to by Applicants as the ‘811 application is the same as the specification of the instant application. The entirety of the instant specification, including the section titled “IL-1β inhibitors” that begins on page 7, was fully considered as part of the rejection of record. The rejection of record at pages 7-8 discusses the anti-IL-1β antibodies referenced in this section, including APX002 and XOMA052, which were held to meet the written description requirement, and immunereszumab and LY2189102, which were not. Applicants do not point to any other examples of anti-IL-1β antibodies described in this section or elsewhere in the specification. With respect to the argument that anti-IL-1β antibodies were well known in the prior art, this is not found persuasive because Applicants do not provide any evidence that the genus of structures encompassed by the term “anti-IL-1β antibody” was described by the prior art.
With respect to the argument methods of making anti-IL-1β antibodies were well known in the art, while it is acknowledged that methods of making antibodies to particular target antigens, e.g., IL-1β, were well known in the art, such is not sufficient to provide written description for the products produced by such methods. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). The Federal Circuit in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Circ. 2017) held that a claim directed to an antibody requires written description of the antibody itself rather than being satisfied solely by a written description of the antigen to which it binds (the so-called "newly characterized antigen" test). Thus, a description of a target protein (e.g., IL-1β) is not in and of itself sufficient to provide a written description of the genus of antibodies that bind to said target.
With respect to the argument that the invention is a method of using the anti-IL-1β antibodies to treat ACM, rather than the antibodies themselves, it is acknowledged that Applicants are claiming a method, and not a product, but the CAFC has held that method claims directed to use of a composition that is not described are also subject to the written description requirement. Per MPEP 2163:
“See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69
SPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").”
Conclusion
Claims 4-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674