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 the Claims
Claims 1, 4, 5, 8 and 9 are currently pending. Claim 8 is withdrawn. Therefore, Claims 1, 4, 5 and 9 are presented for examination.
Response to Amendment/Arguments
The Amendment filed on 10/20/2025 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
Withdrawn rejection
Claims 1, 5 and 9 were rejected under 35 U.S.C. 103 as being unpatentable over Notterpek, Lucia (WO 2016/145219A1) in view of Agatsuma at al. (WO 2004/024141A1 – cited on 02/16/2023 PTO-892 form). Applicant’s amendment and corresponding reply pertaining to the newly added limitation have overcome the rejection made of record in the previous Office Action, specifically, the removal of the degenerative neuropathy limitation to claim 1.
Claim Rejections - 35 USC § 103
New rejection, necessitated by amendment
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro (US PG-PUB 2011/0201587) in view of Agatsuma at al. (WO 2004/024141A1 – cited on 02/16/2023 PTO-892 form). NOTE: The new machine translation (attached hereto) will be referenced for the teachings of the WO- application.
Claimed invention
A method of treating an LPS-induced inflammatory disease in a subject in need thereof, comprising administering to the subject a composition comprising a curvularin-type metabolite selected from the group consisting of compounds of Formula 2a to 2c and 4 below as an active ingredient,
[Formula 2]
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,
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wherein the inflammatory disease is selected from the group consisting of keratitis, gastritis, bronchitis, pleurisy, spondylitis, pancreatitis, urethritis, cystitis, burn inflammation, periodontitis, gingivitis, and degenerative neuropathy, and
wherein the composition is a food stuff or a dietary supplement.
Prior art
Shapiro teaches treatment of inflammatory diseases including pancreatitis (i.e., an LPS inflammatory disease) can be effectively treated by administering an Hsp90 inhibitor to a patient with. See Title; abstract; 0060; see also Claims 17. Shapiro teaches the composition can be formulated as a food stuff and other oral formulations. See 0064.
While Shapiro teaches treatment of degenerative neuropathies such as pancreatitis with an Hsp90 inhibitor, Shapiro does not expressly teach a compound of instant Formulae 2a/2b or Formula 4.
However, the compounds of the instant formulae were already known to possess inhibitory activity against Hsp90. For example, Agatsuma teaches compounds of general formula I that are Hsp90 family protein inhibitors. See title, abstract. Agatsuma also reported known compounds (e.g., geldanamycin) that “bind to the Hsp90 family protein and exhibit pharmacological activities such as antitumor activity by inhibiting the function of the Hsp90 family protein. Therefore, compounds that bind to the Hsp90 family protein are useful as therapeutic agents for diseases involving the Hsp90 family protein or the protein to which the Hsp90 family protein binds (Hsp90 client protein).” See p. 4. The compounds of formula (I) bind Hsp90 family protein and examples included Compounds 2a, 2b and 4:
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.
Reference Compound 2 (above) corresponds to instant Formula 4;
Reference Compound 4 (above) corresponds to instant Formula 2b or Formula 2a.
See p. 7; see also Table 1 at p. 7.
The Hsp90 inhibitors of Agatsuma are useful for treating diseases involving the Hsp90 family protein or the protein to which the Hsp90 family protein binds, the diseases include inflammatory diseases such as asthma, Bechet’s disease, Periarteritis, and ulcerative colitis. See p. 8.
A person of ordinary skill in the art (POSA) would have found it obvious to treat a inflammatory disease such as pancreatitis (i.e., an LPS inflammatory disease) in a subject in need thereof by administering to the subject a composition comprising Reference compounds 2 or 4 (i.e., Formulae 2a, 2b or 4). The POSA would have found it obvious because Shapiro teaches that an Hsp90 inhibitor can be used to treat pancreatitis, while Agatsuma teaches that compounds of instant Formulae 2a, 2b and 4 were already known Hsp90 inhibitors. The POSA would have had a reasonable expectation of success that compounds of instant Formulae 2a, 2b and 4 would be useful for treating pancreatitis given that they are Hsp90 inhibitors and the use of inhibitors of Hsp90 was disclosed as an effective strategy for treating pancreatitis.
Therefore, the claimed invention as a whole would have been prima facie obvious at the time the invention application was filed.
Claim 5, wherein the composition is a pharmaceutical composition further comprising a pharmaceutically acceptable carrier, excipient or diluent. Shapiro teaches formulations include food and further disclose the addition of excipients or carriers. See 0060.
Claim 9 is drawn to the limitation “wherein the curvularin-type metabolite is isolated from marine fungus Penicillium sp. SF-5859 Accession No. KCTC 13354BP.” This is a product-by-process limitation that is analyzed according to MPEP 2113. The product of the isolation process is the curvularin-type metabolite. The source of the metabolite (i.e., the marine fungus) does not impart any additional structural limitations to the metabolite. Therefore, the structure of curvularin metabolites is unchanged by the marine fungus from which it was isolated. Consequently, this limitation is not given patentable weight because the fungus does not carry any structural implications for the metabolite product. Since the reference compounds have the same structure as instant Formulae 2a, 2b and 4, the limitations of claim 9 are met in the same way as claim 1.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shapiro in view of Agatsuma at al. (WO 2004/024141A1 – cited on 02/16/2023 PTO-892 form) as applied to Claims 1, 5 and 9 above, taken further in view of Tianjin Medical University General Hospital (CN103417529A, “TMU”).
Claimed invention
Claim 4 limits claim 1, wherein the composition inherently inhibits expression of iNOS and COX-2.
Prior art
Shapiro and Agatsuma suggest the limitations claimed in Claim 1 as outlined above. Specifically, the references suggest treating pancreatitis by administering a composition containing compounds of Formulae 2a, 2b and 4. However, the references do not expressly teach the composition possessing the feature of inhibiting expression of iNOS and COX-2. However, TMU teaches that effective treatment includes inhibiting expression of inducible nitric oxide synthase (iNOS) and cyclooxygenase (COX-2). See abstract.
A POSA would have found it obvious to adapt the composition such that it also provides inhibitory activity against the expression of iNOS and COX-2 because TMU teaches that effective treatment includes inhibiting the expression of iNOS and COX-2. The POSA would have had a reasonable expectation of success that imparting inhibitory efficacy against COX-2 and iNOS as a function of the composition would benefit the treatment.
Therefore, the claimed invention as a whole would have been prima facie obvious at the time the invention application was filed.
Conclusion
No claims are allowed.
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 CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622