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 .
Election/Restrictions
Applicant’s election without traverse of Compound B and Carboplatin in the reply filed on 8/15/2025 is acknowledged.
Priority
This application is a continuation in part of PCT/US2021/038571, which claims priority to US provisional applications 63/163,118 and 63/164,308. There is also a family member US application 18/469,467.
The instant claims find support from the provisional application ‘118. Therefore the effective filing date is 03/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 08/15/2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings of 1/25/2022 are low resolution and are poor quality. All figures need to be replaced with higher resolution versions (where the text is not blurry). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10, 11, 12, 14, and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 10-12, 14, and 17 depends on claim 1 (which only recites ovarian cancer). Claim 10 recites a different scope of cancer is ovarian, endometrial, primary peritoneal, fallopian tube, and breast cancer. Claim 10 does not further limit the scope of claim 1, in fact it recites a boarder scope. The dependent claims are similarly rejected for not resolving the rationale underpinning this rejection. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-2,5,8-12,14-23,25 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over AACR (“AACR 2015: Olaparib-carboplatin combination showed Early signs of clinical activity against ovarian and triple-negative breast cancers”, Ecancer, April 21, 2015), in view of LU (Lu et al., “Abstract 5210: Novel SIK2 inhibtiors sensitive ovarian and breast cancer to PARP inhibitors”, Cancer Research, August 15, 2020; provided by applicants in the IDS), and as evidenced by PROBECHEM (“ARN3261”, ProbeChem, published after 2016 since it cites Patent US20140256704) and ALGAHTANI (Alqahtani et al., “Advances in Oral Drug Delivery”, Front Pharmacol, 2021 Feb 19) and ZYL (ZYL et al,. “Biomarkers of platinum resistance in ovarian cancer: what can we use to improve treatment:, BioScientifica, May 2018).
AACR teaches that Olaparib–carboplatin combination treating ovarian cancer and tripe-negative breast cancer; the combination treatment did not alter the side effects experienced by patients (title and page 1). AACR teaches that among women with ovarian cancer on the trial with germline BRCA mutations there was a 60 percent overall response rate with the combination, which is higher than the approximately 30 percent reported response rate for olaparib treatment of heavily pretreated ovarian cancer patients who have a germline BRCA mutation (title and page 1). This also teaches carboplatin and a method of treating ovarian cancer and increasing apoptosis of ovarian cancer cells in a patient.
AACR also teaches an additional chemotherapeutic drug (Olaparib) of claim 9 (page 1).
AACR teaches ovarian cancer of claim 10. AACR is silent to if the cancer is recurrent. Given there are only two physical ways the cancer can manifest (for the first time or a recurrent time), the AACR ovarian cancer is either primary or recurrent. This teaches claim 11.
AACR teaches that the dosing schedule can maximize/enhance carboplatin-induced DNA damage (of claim 5), which likely correlates with anti-tumor effects of claim 8, and minimize clinical tonicities (page 1). This helps teach claims 5 and 8.
AACR’s cancer is responsive to carboplatin, therefore it is carboplatin-sensitive of claim 12.
AACR teaches triple-negative breast cancer of claim 17 (title).
AACR does not teach a SIK2 inhibitor or the elected SIK2 inhibitor.
LU teaches that SIK2 inhibitors sensitive ovarian and breast cancer to PARP inhibitors (such as Olaparib) for ovarian cancers with or without BRCA gene mutation (title and page 1).
LU teaches that SIK2 inhibitors (ARN3236 and ARN3261) induce double strand breaks in DNA in HR-competent cells and produce synthetic lethality with multiple PARP inhibitors (page 1).
PROBECHEM is relied upon for the beneficial teaching that ARN3261 is the elected species of SIK2 inhibitor (the structure of ARN3261 matches the instant “compound B” from the instant specification paragraph [0069]).
LU teaches that olaparib-induced-growth inhibition was significantly enhanced/made more sensitive by concurrent treatment with either ARN3236 or ARN3261 in each of 12 ovarian cell lines tested (page 1). This teaches Compound B and a method of treating ovarian cancer and increasing apoptosis of ovarian cancer cells in a patient. This also helps teach claim 5.
Compound B teaches claim 18 (page 1).
LU teaches that SIK2 is overexpressed and correlates with poor prognosis in patients with high-grade serous ovarian carcinoma. This helps teach that the combination treatment would be expected to be effective in treating high-grade serous ovarian carcinoma of claim 14.
The artisan would have found it obvious to combine Olaparib, carboplatin, and ARN3261, which are all known to be treatments for ovarian cancer. It is prima facie obvious to combine one ovarian cancer treatment with another in order to form a composition to be used for the very same purpose (treating ovarian cancer). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claim 1. In treating ovarian cancer, the artisan would further expect that in treating ovarian cancer that there would be an increase apoptosis of ovarian cancer cells in the patient. This teaches claim 2.
LU teaches that olaparib-induced-growth inhibition was significantly enhanced/made more sensitive by concurrent treatment with ARN3261 in each of 12 ovarian cell lines tested (page 1). AACR teaches that the dosing schedule can maximize/enhance carboplatin-induced DNA damage (of claim 5), which likely correlates with anti-tumor effects of claim 8, and minimize clinical tonicities (page 1). The artisan would be motivated to optimize the dosing schedule to find the amounts and timing of the combination therapy in order to increase the carboplatin-induced DNA damage, which in turn correlates with anti-tumor effects. This teaches claims 5 and 8.
ALGAHTANI discloses that The oral route is the most common route for drug administration and it is the most preferred route, due to its advantages, such as non-invasiveness, patient compliance and convenience of drug administration (abstract).
The advantages of oral administration are known, non-invasiveness, patient compliance and convenience of drug administration (ALGAHTANI abstract). The artisan would have been motivated by the advantages of oral administration and found it obvious to administer the combination therapy orally. This teaches claim 19.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, containing ARN3261, Olaparib, and carboplatin, and its properties are inseparable. See MPEP 2112.01 (II). This teaches claims 15-16, 20-23, 25, 29-31.
ZYL teaches that Ovarian cancer has poor survival rates due to a combination of diagnosis at advanced disease stages and disease recurrence as a result of platinum chemotherapy resistance (abstract). ZYL also teaches that Platinum-resistant ovarian cancer has a median survival of 9–12 months and less than 15% respond to subsequent chemotherapy (Platinum chemotherapy resistance).
The artisan would be motivated by the fact that Platinum-resistant ovarian cancer has a poorer survival rate to find more effective and responsive treatments. The artisan would be motivated and expected to give a more responsive treatment (AACR page 1 says its combination had a more responsive (60%) rate; LU’s combination also was significantly enhanced with ARN3261 page 1). Additionally (and alternatively) it is obvious to administer the combination treatment to any ovarian cancer patient, including a sub-population of platinum-resistant ovarian cancer patients, because nothing precludes them from the treatment. This teaches claim 32.
Conclusion
No claims are allowed.
The family member co-pending application 18/469,467, requires a PARP inhibitor, which the instant application’s claims do not require. Therefore, this is not a double patent reference.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625