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
This Office Action is a response to Applicant’s Amendment and Remarks filed December 16, 2025.
Claim 7 has been amended. New claims 26-29 are acknowledged.
Claims 7, 9-11, 13-18, 20-23 and 25-29 are pending in the present application.
This application contains claims 13, 20 and 25 drawn to an invention nonelected without traverse in the reply filed August 15, 2024. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Accordingly, claims 7, 9-11, 14-18, 21-23 and 26-29 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed June 16, 2025, claims 7, 9-11, 14-18 and 21-23 were 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. This rejection is maintained for the reasons of record set forth in the previous Office Action mailed June 16, 2025. NOTE: New claims 26-29 are drawn to subject matter within the scope of the rejected claims and, if present, would have been rejected in the prior Office Action. Therefore, the instant rejection applies to new claims 26-29 as well.
Response to Arguments
In response to this rejection, Applicants traverse and argue that a person having ordinary skill in the art would have readily recognized that Applicant had possession of the full scope of the claims in view of the general knowledge in the art and the Specification disclosure. In support of their argument and traversal, Applicants provide a Rule 1.132 Declaration filed December 16, 2025 arguing that the technical significance of the claimed method for treating arthritis lies in achieving treatment through the inhibition of FoxM1 activity or suppression of the expression of FoxM1. The Declaration submits that in the present specification, the therapeutic effects of the claims are elucidated based on a two-step demonstration: first at the genetic level, and second through validation using a specific FoxM1 inhibitor. Applicants point the Examiner to Test Examples 4 and 5 of the Specification. Based on these Examples, Applicants submit that the test results would be sufficient for a person having ordinary skill in the art to easily and fully understand that the method for treating arthritis through inhibiting or suppressing the function of FoxM1 has been validated by the test results provided in the Specification. For these reasons, Applicants argue that the method for treating arthritis of the present claims is fully supported by the original disclosure of the present specification.
Applicant’s arguments have been fully considered, but are not found to be persuasive. Also, the Rule 1.132 Declaration has been fully considered by the Examiner, however it is not found persuasive because as noted and discussed in the previous Office Actions mailed February 27, 2025, August 29, 2024 and June 16, 2025, not a single structure of a FoxM1 inhibitor (other than thiostrepton) that treats arthritis in a patient needing treatment has been disclosed; experimentally shown; or reduced to practice in the present invention.
Applicant is reminded of the following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the disclosure must provide written support for the entire scope of the genus. Support for a genus is generally found where the Applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed and that Applicant was in possession of the claimed genus.
As noted and discussed in the previous Office Actions mailed February 27, 2025, August 29, 2024 and June 16, 2025, and maintained therein, there is insufficient written description of the therapeutic agents encompassed by the claims.
The above position is further supported by In re Clarke, 148 USPQ 665, (CCPA 1966), which held that:
“It appears to be well settled that a single species can rarely, if ever, afford support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.21 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of a small genus such as halogens, consisting of four species, a reduction to practice of three, or perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably large number of reductions to practice would probably be necessary.”
The entire genus of therapeutic agent inhibitors of FoxM1 as an active ingredient that treats arthritis in a patient needing treatment does not exist in the instant application. Applicant has failed to show a sufficient number of representative species of FoxM1 inhibitor that treats arthritis in a patient needing treatment. The specification nor the art disclose a representative number of species that would enable one of skill to immediately envision the genus of inhibitors of FoxM1 as an active ingredient that treats arthritis in a patient needing treatment required to practice the full scope of the invention. Only thiostrepton was experimentally shown in the instant application and the art (Hasegawa et al. (Nature Immunology, 2019 Vol. 20:1631-1643)) (of record) to inhibit arthritis in a collagen-induced arthritic mouse model.
The Examiner appreciates the 1.132 Declaration and the discussion regarding the therapeutic effects of the claims are based on a two-step demonstration, however, the evidence is not sufficient to satisfy the written description requirement since the Inventors have failed to identify those inhibitors of FoxM1 that carry out the functionality of the claimed invention. Only the small molecule, thiostrepton satisfies the written description requirement.
New claims 26-29 also fail to provide adequate description and evidence of possession of a claimed genus of FoxM1 inhibitor that treats arthritis in a patient needing treatment.
Claim 28 is broad and recites, “wherein the inhibitor of FoxM1 is selected from the group consisting of thiostrepton, RCM-1, a splicing modifier of the FoxM1 gene and a siRNA of the FoxM1 gene.” Looking to the specification for guidance, it appears that the Specification only discloses that thiostrepton has the required functionality of the claims.
To satisfy the written description requirement an Applicant must describe the invention is such a way as to convey to one skilled in the art that Applicant had the invention in his possession when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In cases such as the instant application where a genus is claimed, the specification must contain “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350. However, the unbounded claim recitation of a “therapeutic agent”, wherein the therapeutic agent inhibits FoxM1 activity or expression encompasses any therapeutic agent which has the required function, whether described in the prior art or not. Accordingly, this claim recitation reasonably encompasses agents not described in any way in the specification. See Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) (“[N]aming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.”).
Therefore, the disclosure does not provide sufficient written description of therapeutic agents encompassed by the claims and rejection under 35 USC 112(a) is appropriate.
The claims encompass using a genus of therapeutic agents which are not adequately described. The claims are rejected because there is insufficient description of the genus of therapeutic agents encompassed by the claims. It is therefore maintained that neither the Specification nor the art provide sufficient descriptive support for the myriad of agent inhibitors of FoxM1 as an active ingredient that treats arthritis in a patient needing treatment embraced by the claims. The 35 USC § 112 rejection for written description is appropriately maintained.
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In the previous Office Action mailed June 16, 2025, claims 7, 9-11, 14-18 and 21-23 were 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. This rejection is withdrawn in view of Applicant’s Amendment to claim 7 filed December 16, 2025.
Applicant’s Amendment filed December 16, 2025 necessitated a new grounds of rejection as presented below:
Claims Rejection - Improper Markush
Claim 28 is rejected on the judicially-created basis that it encompasses an improper grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The claims include different FoxM1 inhibitors which do not share a common substantial feature (i.e. there is no common “core” structure shared by all members of the group).
The claim encompasses different FoxM1 inhibitors. For example, thiostrepton (small molecule encompassing a cyclic oligopeptide antibiotic), RCM-1 (low molecular weight small molecule), a splicing modifier of the FoxM1 gene (e.g. Foxm1 peptide) and a siRNA (short interfering RNA, nucleic acid) of the FoxM1 gene.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1).
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.
Claim Rejections - 35 USC § 102
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.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 7, 9-11, 14-18, 21-23 and 26-29 rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lai et al. (Journal of Immunology, 2015 Vol. 195:3912-3921) (submitted on the Information Disclosure Statement filed July 27, 2021) as evidenced by Kwok et al. (Mol. Cancer Ther., 2008 Vol. 7:2022-2032) (of record) or Hedge et al. (Nature Chemistry Volume 3, pages 725-731 (2011) or Gartel, A.L. (Cell Cycle 10: 4341-4342, (2011)).
The claims are drawn to a method for treating arthritis, comprising administering a therapeutically effective amount of a therapeutic agent to a patient needing treatment, wherein the therapeutic agent comprises an inhibitor of Forkhead box M1 (FoxM1) as an active ingredient, and wherein the treatment is achieved by inhibition of FoxM1 activity or suppression of expression of FoxM1. NOTE: The present Specification discloses that thiostrepton is a known FoxM1 inhibitor. See section titled, “Advantageous Effects of Invention”. Further, Kwok et al. teach that thiostrepton inhibits FoxM1 protein and gene expression. Also, see Hedge et al. and Gartel, A.L. for similar teachings.
Lai et al. teach that TLR7-9 is associated with the pathogenesis of autoimmune diseases such as rheumatoid arthritis; thiostrepton effectively inhibits TLR7-9 activity, and thus, thiostrepton can be applied to the treatment of immune diseases caused by inappropriate activation of TLR7-9.
Also, like by Kwok et al., Hedge et al. and Gartel, A.L., Lai et al. taught that thiostrepton was known to control the transcriptional activity of FoxM1.
Lai et al. conclude with the beneficial use of thiostrepton in the treatment of autoimmune diseases. In particular, arthritis and rheumatoid arthritis are mentioned.
Before the effective filing date of the claimed invention, a method for treating arthritis comprising administering a therapeutically effective amount of thiostrepton as a therapeutic agent to a patient needing arthritis treatment was taught and suggested in the prior art of Lai et al.
Before the effective filing date of the claimed invention, thiostrepton was a known inhibitor of FoxM1 activity as evidenced by Kwok et al., Hedge et al. and Gartel, A.L. A person of ordinary skill in the art would have been motivated and expected reasonable success to devise the method of the claimed invention for the purpose of treating arthritis in a patient as demonstrated, taught and suggested by the prior art of Lai et al.
For the reasons above, 7, 9-11, 14-18, 21-23 and 26-29 are anticipated by or obvious over Lai et al.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635