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
Claims 64-93 are pending in the present application.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed November 14, 2023 have 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.
Claims 64-93 are 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.
The term “improving activity” in claim 64 is a relative term which renders the claim indefinite. The term “improving activity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As the agents as well as the overall method of present claim 64 are not directed to a particular disease, disorder or condition, one of skill in the art would not be clear as to the activity that needs to be improved and further, which degree of improvement of that activity is required.
Present claims 65-93, which are dependent upon claim 64, do not clarify the indefinite subject matter and are similarly rejected.
Regarding claim 68, the term “clinically established” in claim 68 is a relative term which renders the claim indefinite. The term “clinically established” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The half maximal inhibitory concentration present claim 68.
Regarding claim 86, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Applicant may delete the phrase “e.g., -C(O)(C1-C7 alkyl)” from claim 86 to overcome this rejection.
Regarding present claim 91, claim 91 recites the limitation where the compound is selected from Table 1 in line 2 of present claim 91.
From MPEP 2173.05(s):
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim.
Applicant may amend the claim to include specific compounds from Table 1 to overcome this rejection.
Claim Rejections - 35 USC § 103
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 64-93 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (WO 2018/190511 A1, date filed: 02/28/2018; with all citations from EP 3603641 B1 as an English translation), in view of Shen (Shen, Jiliang, et al. "Role of DUSP1/MKP1 in tumorigenesis, tumor progression and therapy." Cancer medicine 5.8 (2016): 2061-2068) and Vogt et al. (WO 2018/144597 A1, Published: August 9, 2018; International Filing Date: January 31, 2018).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Ryu discloses a pharmaceutical composition for preventing or treating cancer comprising compounds of formula (I) as Dual specificity protein phosphatase 1) DUSP1 inhibitors as an active ingredient (see claims 13-14 of Ryu).
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Ryu discloses specific DUSP1 inhibitor example compound 7 which corresponds to compound of claim 90 (see claim 16 of Ryu). Compound 7 of Ryu is encompassed also by present claims 72-91 (see compound RE01 in Table 1 of the present specification).
Ryu discloses where the composition further comprises a pharmaceutically acceptable carrier (see paragraphs [80]-[82] of Ryu). See present claim 92.
Ryu discloses where the pharmaceutical composition comprising the DUSP1 inhibitors of formula (I) may further be administered as a separate therapeutic agent or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be single or multiple doses (see paragraph [84] of Ryu).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Ryu does not disclose improving activity of one or more secondary therapeutic agents.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Shen discloses the following regarding the ability of DUSP1 inhibitors to increase sensitivity of various cancer cells to secondary therapeutic agents, including cisplatin:
An increase in DUSP1 levels was first found in the treatment of ovarian carcinoma cells with cisplatin. This suggests that DUSP1 may play a role in the cellular response to chemotherapy. Knocking down DUSP1 resulted in a more efficient activation of JNK and p38 under cisplatin treatment and correlated with an increase in sensitivity to cisplatin. DUSP1 was proved to be essential for cisplatin resistance as cells from Dusp 1 knockout mice could not form resistance compared to normal cells. Besides, overexpressing DUSP1 also reduced sensitivity to cisplatin in NSCLC cells through the PI3K/Akt/NF-kappaB pathway. Targeting DUSP1 also promoted dexamethasone sensitivity in lung cancer and gemcitabine sensitivity in pancreatic cancer. DUSP1 promotes the chemoresistance of many chemo-agents in various cancers (Fig. 1A).
See page 2063, lc, last paragraph to rc, first paragraph of Shen.
Vogt discloses a method of treating cancer in a subject comprising administering, to the subject, (i) an amount of a dual specificity mitogen-activated protein kinase phosphatase (DUSP-MKP) inhibitor that sensitizes cancer cells to immune cell killing, and (ii) an agent that promotes a cell-mediated anti-cancer immune response in the subject.
Vogt discloses the following in page 21, lines 18-30
Anti-cancer agents include, but are not limited to, chemotherapeutic agents, radiotherapeutic agents, cytokines, anti-angiogenic agents, apoptosis-inducing agents or anti-cancer immunotoxins. In certain non-limiting embodiments, an inhibitor can be administered in combination with one or more anticancer agents.
In certain embodiments, the cancer therapy comprises cryotherapy, radiation therapy, chemotherapy, hormone therapy, biologic therapy, bisphosphonate therapy, high- intensity focused ultrasound, frequent monitoring, frequent prostate-specific antigen (PSA) checks and radical prostatectomy.
See present claim 65.
It would have been obvious for one of ordinary skill in the art to administer the compound 7 of Ryu, which Ryu discloses as a DUSP1 inhibitor, along with a secondary therapeutic agent as described by Ryu and Vogt for the purpose of preventing and treating cancer. Ryu discloses compound 7 as a DUSP inhibitor, Vogt discloses methods of sensitizing cancer cells comprising administration of DUSP inhibitors and Shen discloses where DUSP inhibition led to increased sensitivity to chemotherapeutic agents such as cisplatin and dexamethasone. There would be a reasonable expectation of success towards improving the activity of one of more secondary therapeutic agents, where cancer cells are more sensitive to the one or more secondary agents, following the administration of DUSP inhibitors of formula (I) of present claim 64.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05, Section II, subsection A.
As the present claims do not require a particular dosage or amount for either the compound of formula (I) or the one or more secondary agents, one of skill in the art would reasonably arrive at the claimed invention by adjusting dosage during routine optimization.
The present claims are prima facie obvious.
Conclusion
Claims 64-93 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/ Primary Examiner, Art Unit 1626