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 .
DETAILED ACTION
The Amendment filed 7/31/2026 in response to Office Action of 5/6/2026, is acknowledged and has been entered. Claims 17-18 and 21 are now pending. Claims 17 is amended. Claims 21 is new.
Withdrawn Claim Rejections
The 102 and 103 rejections recited in Office Action dated 5/6/2026 is hereby withdrawn in view of claim amendments.
Status of the claims
Claims 17, 18 and 21 are currently being examined.
Maintained Rejections
(Arguments Addressed)
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 17-18 and 21 remain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection.
The claims are drawn to a method for treating fulminant myocarditis in a subject, comprising: administering an effective amount of an antibody to the subject; wherein the antibody is one of anti-sST2 neutralizing antibody and anti-CD163 neutralizing antibody. Thus, the claims disclose the antibodies by function only, to treat fulminant myocarditis. No structure of the antibodies is disclosed in the claims.
With regards to the claimed antibody, the instant specification discloses one experimental example of an anti-sST2 neutralizing antibody and an anti-CD163 neutralizing antibody that treats fulminant myocarditis as claimed. This is disclosed in experimental example 6 (Anti-sST2 neutralizing antibody can inhibit myocardial injury induced by CVB3 in A/J fulminant myocarditis mice) and experimental example 7 (Anti-CD163 neutralizing antibody can improve cardiac dysfunction in A/J fulminant myocarditis mice induced by CVB3). The specification fails to disclose any structural sequence required of a drug to possess the function of treating fulminant myocarditis.
By the time of the filing of the instant application, it was well established in the art that the formation of an intact antigen-binding site in an antibody usually required the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three “complementarity determining regions” (“CDRs”) which provide the majority of the contact residues for the binding of the antibody to its target epitope. E.g., Almagro & Fransson, Frontiers in Bioscience 2008; 13:1619-33; (see Section 3 “Antibody Structure and the Antigen Binding Site” and Figure 1). Humanized antibodies comprise only the CDRs, or in some cases an abbreviated subset of residues within the CDRs, of a parental rodent antibody in the context of human framework sequences. Id. at Section 4. All of the CDRs of the heavy and light chain, in their proper order of CDR1, then 2, then 3, and in the context of framework sequences which maintain their required conformation are generally required to produce a humanized antibody in which the heavy and light chains associate to form an antigen-binding region that binds the same antigen as the parental rodent antibody. Id. at Section 4.
Antibody binding to the same antigen, or even the same epitope on that antigen, can be accomplished with an impressively wide variety of antibody structures, even when the antibodies are limited to those from a particular source (Gershoni et al., Epitope Mapping, Biodrugs 2007; 21 (3): 145-156 page 146 section 1.1). The skilled artisan therefore understood that antibodies from a variety of different sources may bind the same antigen and even mediate the same functional effects, but differ widely in the details of the structure of their antigen-binding sites, particularly in the amino acid sequence and length of VH-CDR3.
Further, it is not possible to predict the amino acid sequence when an epitope is recited, because there are many different epitope arrangements, such as linear and discontinuous epitopes that is dictated by the unique interaction between an antibody and its cognate epitope (Blythe et al., Benchmarking B cell epitope prediction: Underperformance of existing methods, Protein Science (2005), 14:246–248 pg. 246) . 3D structural analyses of antibody-epitope binding highlighting that the deficiency in the ability to predict the structural features of an antibody when the epitope is disclosed (Schreiber et al.,3D-Epitope-Explorer (3DEX): Localization of Conformational Epitopes within Three-Dimensional Structures of Proteins, Wiley Interscience, 2005 42–44, 60596, page 879).
The structure activity relationship of the CDR antigen binding region that neutralizes sST2 or CD163 are not known and the binding epitopes cannot be predicted based on the antibody sequences. Kania G. (Soluble ST2 beyond a biomarker: a pathogenic driver and therapeutic target in fulminant myocarditis. Eur Heart J. 2026 Mar) teaches soluble growth stimulation-expressed gene 2 (Sst2) is a central pathogenic factor in FM and teaches that targeting sST2 with antibodies can be a promising therapeutic, however, there are long-term consequences of sST2 that need to be evaluated. [whole document] With regards to anti-CD163 antibodies, Etzerodt et al (CD163 and inflammation: biological, diagnostic, and therapeutic aspects. Antioxid Redox Signal. 2013 Jun 10;18(17):2352-63) teaches the role of CD163, and teaches the use of only one CD163-targeting therapy. [whole document] CD163 antibody are not known in the art.
To provide adequate written description and evidence of possession of the claimed antibody genus, the instant specification can structurally describe representative drugs that function as listed above or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.). A disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product.
Although Applicants may argue that it is possible to screen for targets that function as claimed and listed above, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future drugs yet to be discovered that may function as claimed. The biomarker antigens provide no information about the structure of an antibody functions to treat fulminant myocarditis as recited above.
The instant specification fails to describe structural features common to the members of the genus, which features constitute a substantial portion of the genus because the instant specification does not disclose any structures/sequences that function as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the antibody does, rather than what it is. The specification fails to provide any structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of sequences for the genus of drugs that function as claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to perform the claimed method.
Given the lack of representative examples to support the full scope of the claimed antibody used in the claimed method, and lack of reasonable structure-function correlation for the antibody to function as listed above, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of antibodies that treat fulminant myocarditis that is required to practice the claimed invention. Since the specification fails to adequately describe the product to which the claimed method uses, it also fails to adequately describe the method.
Response to Arguments
Applicant submits Federal Circuit’s recent decision in Teva Pharmaceuticals International GmbH v. Eli Lily & Co and argues that it is directly controlling and compels the withdrawal of this rejection as applied to currently amended claim 17. Applicant argues that In Teva, the Federal Circuit addressed precisely the issue presented here: whether a method-of- treatment claim using a known genus of antibodies satisfies the written description requirement when the specification does not disclose a representative number of species or structural features of that genus. Applicant argues that the court explicitly ruled that when the claimed invention is the use of a known genus for a particular therapeutic purpose, rather than a claim to the genus itself, the written description inquiry must account for that distinction. Applicant argues that the court further held that a specification need not disclose what is already known in the art, and that when a skilled artisan would understand from the specification that all members of the genus would work for the claimed purpose, the written description requirement is satisfied. Applicant argues that the framework of the recent court decision applies directly to currently amended claim 17. Applicant argues that this is a method-of-treatment claim using a known class of antibodies for a particular therapeutic purpose. Applicant argues that the anti-sST2 neutralizing antibody genus is not the invention; the invention is the use of that known genus to treat a precisely defined, threshold-selected patient population. Applicant argues that a skilled artisan reading the specification would understand that the invention is not the antibody itself but the targeted therapeutic approach of treating biomarker-defined fulminant myocarditis patients with a known class of antibodies, and that the method works for its intended purpose.
Applicant’s arguments have been considered but are not persuasive.
With regards to Teva, the case notes the following:
“Although there was just one humanized anti-CGRFP antagonist antibody, it is also disclosed several murine version and prior art CGFR antagonist antibodies” [pg 13, 2nd paragraph]
“As already discussed, a reasonable jury could have found that, by priority date, (1) anti-CGFRP antagonist antibodies and methods of making them were already known, and (2) humanization was a routine procedure. The specification disclosed several examples of murine anti-CGRP antagonist antibodies and prior-art methods of humanization.” [pg 14-15]
The Teva case is directed to humanized versions of murine antibodies. Anti-CGRP antibodies are well known in the art and the process of humanizing antibodies are also well known. This is unrelated case the claimed antibodies are not well known in the art, regardless if they are humanized/human, or even chimeric. Additionally, the anti-CGRP antagonist antibodies were well described in the specification. In this instant case, the instant specification discloses one experimental example of an anti-sST2 neutralizing antibody and an anti-CD163 neutralizing antibody that treats fulminant myocarditis as claimed. This is disclosed in experimental example 6 (Anti-sST2 neutralizing antibody can inhibit myocardial injury induced by CVB3 in A/J fulminant myocarditis mice) and experimental example 7 (Anti-CD163 neutralizing antibody can improve cardiac dysfunction in A/J fulminant myocarditis mice induced by CVB3). Two examples does not provide full written description support of the broad genus of anti-sST2 antibodies and anti-CD163 antibodies. Thus, the Teva vs. Lily case is not applicable to this instant situation. There is a limited number of these antibodies, and they do not provide full scope of the genus of an anti-sST2 neutralizing antibodies or an anti-CD163 neutralizing antibodies. Thus, to provide support for the claimed method, there needs to be support for the products used therein. Examiner points to MPEP 2163 II.A.3(a):
3. Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 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
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600
