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 .
Claim Status
Claims 1-6, 8-9, 13-14, 20-21, 24, 28, 34-36, 73-77, 79-81, 90, 93, 97 and 103–105 are pending. Claims 8, 14, 20-21, 24, 28, 34-36, 73-77, 79-81, 90, 93, 97 and 103–105 are withdrawn. Claims 1-6, 9 and 13 are rejected.
Election/Restrictions
Applicant's election without traverse to prosecute Group I, claims 1-9, 13-14, 20-21, 24, 28, and 34-36, and the combination of Panobinostat as a downregulating agent and As26 as the CAPE-related compound in the reply filed on 09/08/2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species combination is not allowable. Therefore, examination has been limited to claims embracing the elected species which are claims 1-6, 9 and 13. Claims 1-6, 9 and 13 have been examined to the extent that they are readable on the elected embodiment. Subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Claims 8, 14, 20-21, 24, 28, 34-36, 73-77, 79-81, 90, 93, 97 and 103–105 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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.
Claim(s) 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/147718 A1 by Touaibia et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art discloses (title) “modulators of lipoxygenase and cyclooxygenase enzyme activity” including compound 152 which is identical to As26 of instant claim 9 (page 33, Table 9). Compound 152 is represented by the structure below:
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Regarding instant claims 1 and 9, Touaibia et al. teach a method of treating a lipoxygenase and/or a cyclooxygenase-mediated disease, including cancers such as breast cancer, by administering the prior art compound (paragraphs [0019]-[0020]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses methods of treating cancer by administering the compound 152 but is silent to the downregulation of cancer genes and the effect of CAPE analog wherein the compound reduces the number of cancer cells, tumor burden or tumor growth in the patient.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Although the prior art does not explicitly recite the intended use and effects of the instant claims a compound and its properties are inseparable so the properties of the instant compound would be inherent in the prior art given that the compounds are identical. Accordingly, the instant method of treating cancer by administering a CAPE analog to downregulate a cancer gene or protein target expression is obvious in view of the method of Touaibia et al. which involves administering the instant compound to treat cancer. A person of ordinary skill performing the method of Touiabia et al. could expect to achieve the same reduction in cancer cells, tumor burden, etc. recited by administering compound 152 as taught in the prior art.
Claim(s) 2-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/147718 A1 by Touaibia et al. as applied to claims 1 and 9 above, and further in view of Qin, et al. (2019). Panobinostat (LBH589) inhibits Wnt/β-catenin signaling pathway via upregulating APCL expression in breast cancer. Cellular signalling, 59, 62-75.
Touaibia et al. disclose a method of treating lipoxygenase and/or cyclooxygenase-mediated diseases, including cancers such as breast cancer, by administering the prior art compound in combination with an additional therapeutic agent that is useful for treating the same condition (paragraph [00261]); however, the prior art but does not suggest HDAC inhibitors such as Panobinostat.
Qin et al. discuss the effects of administering Panobinostat to treat breast cancer and teach (abstract):
Breast cancer is the most common malignant disease among women worldwide and the novel therapeutic agents are urgently needed. Panobinostat (LBH589), a pan-HDACs inhibitor, has shown promising anti-tumor effect in recent years. However, the targets of this compound are largely unclear because of its low selectivity. In consideration of the transcription promoting activity of panobinostat, we speculated that specific tumor suppressor genes might be upregulated after panobinostat treatment. In this study, we verified the inhibition effect of panobinostat in different subtypes of breast cancer cells in vivo and in vitro. We found that panobinostat suppressed proliferation, migration as well as invasion, and induced apoptosis in both TNBC and non-TNBC cells. Consistently, panobinostat inhibited breast cancer growth and metastasis in mouse models…
Accordingly, a person of ordinary skill seeking to treat breast cancer in the method of Touaibia et al. would have been motivated to administer prior art compound 152 in combination with the HDAC inhibitor panobinostat in order to improve therapeutic outcomes.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/147718 A1 by Touaibia et al. as applied to claims 1 and 9 above, and further in view of Bernard, et al. (2008). Targeting cyclooxygenase-2 in hematological malignancies: rationale and promise. Current pharmaceutical design, 14(21), 2051–2060.
Touaibia et al. disclose a method of treating lipoxygenase and/or cyclooxygenase-mediated diseases including some cancers by administering the prior art compound but do not teach that the compound is useful for treating the blood cancers of the instant claims.
Bernard et al. discuss (title) “Targeting cyclooxygenase-2 in hematological malignancies: rationale and promise” and teach (abstract):
Malignancies of hematopoietic and non-hematopoietic origin often have increased expression of cyclooxygenase-2 (Cox-2), a key modulator of inflammation. For example, hematological malignancies such as chronic lymphocytic leukemia, chronic myeloid leukemia, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and multiple myeloma often highly express Cox-2, which correlates with poor patient prognosis. Expression of Cox-2 enhances survival and proliferation of malignant cells, while negatively influencing anti-tumor immunity. Hematological malignancies expressing elevated levels of Cox-2 potentially avoid immune responses by producing factors that enhance angiogenesis and metastases. Cellular immune responses regulated by natural killer cells, cytotoxic T lymphocytes, and T regulatory cells are also influenced by Cox-2 expression. Therefore, Cox-2 selective inhibitors have promising therapeutic potential in patients suffering from certain hematological malignancies.
Accordingly, a person of ordinary skill seeking to treat additional cyclooxygenase mediated cancers in the method of Touaibia et al. would have been motivated to administer cyclooxygenase inhibitor compound 152 to improve therapeutic outcomes in subjects with blood cancers such as certain leukemias lymphomas or multiple myeloma.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 9 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 and 48-51 of copending Application No. 17604508 in view of Lemoine, Manuela et al. “The pan-deacetylase inhibitor panobinostat induces cell death and synergizes with everolimus in Hodgkin lymphoma cell lines.” Blood vol. 119,17 (2012): 4017-25.
Copending claim 1 discloses a method of inhibiting the growth of blood cancer cells by contacting the cells with As26 which identical to As26 of instant claim 9; this method embraces the instant method of treating blood cancers by administering CAPE analog As26. Copending claims 2, 5, and 9 further teach that the blood cancer cells are multiple myeloma cells, lymphoma cells, or leukemia cells which corresponds to instant claims 1 and 5-6.
Regarding instant claims 2-4 and 13, the copending claims are silent to contacting the blood cancer cells with a downregulating agent such as an HDAC inhibitor however MPEP 2144.06 suggests:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Lemoine et al. teach the following regarding Panobinostat for treating lymphoma (abstract):
The pan-deacetylase inhibitor panobinostat (LBH589) recently has been shown to have significant clinical activity in patients with relapsed Hodgkin lymphoma, but its mechanism of action in Hodgkin lymphoma remains unknown. In this study, we demonstrate that panobinostat has potent antiproliferative activity against Hodgkin lymphoma-derived cell lines…
Accordingly, a person of ordinary skill seeking to inhibit the growth of lymphoma cells in the copending method would have been motivated to administer As26 in combination with the HDAC inhibitor panobinostat in order to improve therapeutic outcomes.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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/A.A.C./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626