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 .
Applicant’s amendments filed 6/5/2024 have been entered.
Claims 10-19 have been added and are pending.
Claims 1-9 have been cancelled.
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) 10, 12, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2013/082253 (‘253) in view of Martini et al., Annals of the Rheumatic Diseases, 2010;69:1260-1263.
‘253 teaches the herein claimed compound as a NF-kB modulator useful for treating inflammatory diseases such as rheumatoid arthritis and rheumatic diseases by blocking the NF-kB pathway (see claim 1; page 55, compound of Example 9; pages 76-77 on experiment on mouse model for arthritis and asthma; also page 3, [011])). ‘253 teaches the use of 10, 20mg/kg of the herein clamed compounds in the animal studies for 14 days(see page 76-77). ‘253 teaches oral administration as one of the suitable routes of administration (see [0158] and [0159]).
‘253 does not expressly teach the method of treating juvenile rheumatoid arthritis. ‘253 does not expressly teach the duration of the treatment.
Martini et al. teaches juvenile idiopathic arthritis (aka juvenile rheumatoid arthritis) (herein after referred as JIA) as an exclusion diagnosis that applies to any arthritis of unknown origin, persisting for more than 6 weeks and with onset before age of 16 years. JIA is now being understood to have many subset of arthritic diseases (see page 1260, col. 1, first paragraph bridging page 1261, col. 1, third paragraph). Some of the arthritic diseases are well-defined and some are not. Martini et al. teaches RF-positive polyarthritis is the same disease as adult RF-positive rheumatoid arthritis. (see page 1260, col. 2, third paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed compound, in the herein claimed dosing regimen, in a method of treating JIA.
One of ordinary skill in the art would have been motivated to employ the herein claimed compound, in the herein claimed dosing regimen, in a method of treating JIA since JIA encompasses RF-positive polyarthritis, which is the same as adult-onset rheumatoid arthritis. Since the instant claimed compound is known to be effective in treating rheumatoid arthritis and rheumatic diseases, it would be reasonably expected the use of the compound to be effective. As for the duration of the treatment, JIA is a chronic disease, therefore administering the instant compound in a long-term manner, such as 2-3 months, would be reasonably expected to be effective. Optimizing the therapeutic effects while minimizing the side effect would be considered as routine performance by one of ordinary skill in the art.
Claim(s) 10, 13-14, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2013/082253 (‘253) in view of Chirico et al., IUBMB Life, 2012; 64: 72-80.
‘253 teaches the herein claimed compound as a NF-kB modulator useful for treating inflammatory diseases such as rheumatoid arthritis and rheumatic diseases by blocking the NF-kB pathway (see claim 1; page 55, compound of Example 9; pages 76-77 on experiment on mouse model for arthritis and asthma; also page 3, [011])). ‘253 teaches the use of 10, 20mg/kg of the herein clamed compounds in the animal studies for 14 days (see page 76-77). ‘253 teaches oral administration as one of the suitable routes of administration (see [0158] and [0159]).
‘253 does not expressly teach the method of treating sickle cell anemia. ‘253 does not expressly teach the duration of the treatment.
Chirico et al. teaches the involvement of NF-kB activation increasing sickled cells adhesion to the endothelium and other blood cells, as well as precapillary obstruction by rigid, sickled blood cells can initiate vaso-occulsion in the microvasculature (see page 75, col. 2, first paragraph). Chirico et al. teaches the inhibition of NF-kB decreases the expression of VCAM-1, ICAM-1, and R-selectin in human microvasculature (see page 75, col. 2, first paragraph). Chirico et al. teaches “Hypoxia causes an increased proportion in the amount of sickled cells, possibly due to the sickle-inducing extended deoxygenation period brought about by the decreased oxygen. Conditions of hypoxia can also further increase the adhesive interactions within the vessel walls, exacerbating vaso occlusion. Setty and Stuart demonstrated that sickled RBC, contrary to normal cells, exposed to hypoxia have a 66% greater risk of adhering to both the macrovasculature (as seen in the aorta) and the microvasculature (as seen in the retina). It was shown that hypoxia regulates the production of VCAM-1 and ICAM-1, although VCAM-1 is solely responsible for the adherence of sickled cells to the endothelium. This regulation could be due to NF-kB, which is abundantly observed after hypoxia, and can alter the expression of these adhesion molecules” (see pages 76, col. 2, first paragraph; also Figure 4 and 5). Chirico et al. teaches NF-kB inhibitor was shown to attenuate oxidative stress, adhesion, and inflammation in murine models of sickle cell disease (herein after referred as SCD) (see page 78, col. 1, third paragraph from the bottom).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed compound, in the herein claimed dosing regimen, in a method of treating SCD and sickle cell anemia.
One of ordinary skill in the art would have been motivated to employ the herein claimed compound, in the herein claimed dosing regimen, in a method of treating sickle cell anemia since the inhibition of NF-kB would reduce the adhesion of the sickled cells and thereby reasonably expected to reduce the vaso-obstruction and/or inflammatory process of SCD and improving hypoxia would be reasonably expected to improve the anemia associated with SCD. As for the duration of the treatment, SCD is a chronic disease, therefore administering the instant compound in a long-term manner, such as 2-3 months, would be reasonably expected to be effective. Optimizing the therapeutic effects while minimizing the side effect would be considered as routine performance by one of ordinary skill in the art.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627