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 .
Priority
The following continuity data is acknowledged in the present application file:
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Claims 9-16 and 20-22 have been canceled. Claims 1-8 and 17-19 are pending and before the Examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/31/2024 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “optionally in combination with chemotherapy”, which is indefinite because it contains both a narrow and broad limitation in the same claim. Therefore, it is unclear whether the method of treating a carcinoma in a subject requires the chemotherapy embodiment in some circumstances, whether it is merely an optional component of the treatment, or whether the limitation imposes a particular manner or timing of the administration of the chemotherapy. Applicant may amend claim 1 to remove “optionally” in the instant claim to overcome the rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-8, and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Publication No. 20230087078 (Lim et al; Filing Date: 02 March 2020; IDS).
Regarding claims 1-3, 5, and 17-19 Lim et al. discloses a method for treating pancreatic ductal adenocarcinoma (PDAC) by targeting the canonical MAPK cascade, which is a heavily pursued therapeutic strategy in PDAC [par. 0008]. The method includes administering an effective amount of an MK2 inhibiting agent or administering an effective amount of a chemotherapy composition in combination with an effective amount of the MK2 inhibiting agent [par. 008-0011]. It further investigates the mechanism by which DNA damage activates MK2, wherein PDAC cells were treated with SN38 (the active metabolite of irinotecan) alone or in combination with inhibitors of TAK1 (e.g., 5z-7-oxozeanol (Oxo)) [par. 0149]. Of the inhibitors tested, Oxo completely blocked SN38-induced p-p38, p-MK2, and p-Hsp27 (FIG. 3A) and potentiated the apoptotic effect of SN38 (FIG. 3B), strongly suggesting TAK1 as an upstream activating kinase of MK2 and Hsp27 [par. 0150]. Notably, SN38-induced induction of TNFa is abrogated by the TAK1 inhibitor 5z-7-oxozeanol, suggesting NF-kB and TAK1 activation as the triggering event for TNFa [par. 0151].
Regarding claim 4, Lim et al. discloses non-limiting examples of suitable chemotherapy compounds to be co-administered with the MK2 inhibitor including Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) [par. 0099], and other administration can include
nanospheres or other suitable delivery vehicles that provide the desired release profile in varying proportions [par. 0102]. The use of nanoparticles for drug delivery is well known to the skilled artisan and is therefore encompassed within the scope of this reference.
Regarding claims 7 and 8, Lim et al. discloses that the chemotherapy composition may include one, two, three, five, or more chemotherapy compounds, wherein the compounds are not limited to leucovorin calcium (folinic acid), fluorouracil, irinotecan, oxaliplatin, gemcitabine, nab-paclitaxel, and any combination thereof. It further discloses a method wherein the chemotherapy composition comprises administering a regiment not limited to FOLFIRINOX (a cocktail of folinic acid, 5-FU, irinotecan, and oxaliplatin), FOLFOX (a cocktail of folinic acid, fluorouracil, and oxaliplatin), FOLFOX/CD40 agonist/anti-PD1 cocktail, FOLFOX/anti-CTLA4/anti-PD1 cocktail, and gemcitabine/nab-paclitaxel [par. 0063].
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 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20230087078 (Lim et al; Filing Date: 02 March 2020; IDS), in view of Ellestad et al., Chirality, 2019; IDS.
Lim et al. discloses a method wherein PDAC cells are treated with SN38 in combination with 5z-7-oxozeanol (Oxo) as described above, but it does not disclose wherein the method comprises administering E6201 (1H-2-Benzoxacyclotetradecin-1,7(8H)-dione, 14-(ethylamino)-,4,9,10-tetrahydro-8,9,16-trihydroxy-3,4-dimethy1-, (3S,4R,5Z,88,9S,11E)-); L-783,277; hypothemycin; ER-803064; or an exo-enone analogue of (5Z)-7-oxozeaenol. Ellestad et al. discloses these analogues compounds and their inhibitory activity against kinases including TAK1 and MEK. Therefore, due to the structural similarity of these compounds to Oxo and their inhibitory kinase activity, it would have been obvious to one of the ordinary skills in the art to use the analogues compounds disclosed by Ellestad and apply it to the method taught by Lim and have reasonable expectation of success due to the retained kinase inhibitory activity. Additionally, determining whether the known analogues compounds retain this inhibitory activity would have involved routine experimentation. Accordingly, the claimed use of Oxo and its analogues compounds disclosed by Ellestad as kinase inhibitors would have been obvious to one of ordinary skill in the art.
Conclusion
Claims 1-8 and 17-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARINE P SEUDIEU SEUDIEU whose telephone number is (571)272-0459. The examiner can normally be reached Mon-Fri 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.S./Examiner, Art Unit 1626
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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