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 preliminary amendments filed 4/12/2024 have been entered.
Claims 1-153 have been cancelled.
Claims 154-171 have been added and are pending.
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) 154-171 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pohl et al., Br J Clin Pharmacol 2019;85(7):1516-1527 and WO2017/106814 (‘814) in view of US2019/000812 (‘812) and Iam et al., (Obstet Gynecol 2003;101:402–12. Pohl et al., ‘812, and ‘814 are references of record in IDS filed 4/12/2024.
Pohl et al. teaches the use of OBE022 (the compound of formula (2)) and atosiban in delaying preterm labour. Pohl et al. teaches “Tocolytics including atosiban (approved in Europe 4,5) and nifedipine are used as treatments to delay preterm labour by reducing uterine contractions” (see page 1517, col. 1, second paragraph). Pohl et al. teaches “OBE022 is a potent, small molecule PGF2α receptor antagonist being developed to inhibit preterm labour.21 Ongoing clinical investigations are testing twice daily administrations of OBE022 during up to 7 days in preterm labour patients.” See page 1517, col. 1, last paragraph). Pohl et al. teaches” CombiningOBE022 with other treatments may generate additive or synergistic effects on uterine contractions thereby, extending gestation periods.” (see page 1517, col. 2, second paragraph). Pohl et al. teaches the administration of OBE022 as 1100mg over 3 days or 1000mg over days 4-9 and then OBE022 and atosiban together (see page 1518-1519, Section 2.3). Pohl et al. teaches “Atosiban was administered as aninfusion using the high‐dose part of the standard clinical regimen. A6.75‐mg dose was administered as a 0.9‐ml intravenous bolus injec-tion given over 1 minute followed by a 54‐mg dose administered asa 3 hours intravenous loading infusion at 24 ml/h (300 μg/min).” (see page 1520, col. 1, section 2.4).
‘814 teaches a method of treating pregnant patient to slow or prevent preterm labor with tocolytic agents such as atosiban (see [0008] and [0009]) and/or prostaglandin F2a receptor inhibitor such as OBE-001, OBE-002 (see [0008]). ‘814 further teaches “In humans, ORA (Atosiban®) is delivered as an infusion in three steps: Initial loading dose of 6.75mg, followed by 300 µg/min for 3 hours (54mg) and up to 45 hours subsequent intravenous infusion at 100 µg/min. So the overall dose is in the range of 70-330 mg/person or (considering the average weight of 60 kg) 1.2-5.5 mg/kg. Thus, the given dose of ORA is below the physiologically relevant concentrations of the drug.” (see [0088]).
The references do not expressly teach the use of both ODE022 and atosiban together in delaying preterm onset of delivery. The references do not expressly teach the use of compound of formula (3). The references do not expressly teach the patient characteristics.
‘812 teaches the use of compounds of formula (3) or (2) together with atosiban in a method of treating or preventing preterm labour (see claims 1, 2, 12, 62, 63, 105).
Iam et al. teaches the “traditional criteria for preterm labor (persistent contractions accompanied by progressive cervical dilatation and effacement) are most accurate when contraction frequency is six or more per hour, cervical dilatation is 3 cm or more, effacement is 80% or more, membranes rupture, or bleeding occurs.” (see page 402, col. 2, last paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ both OBE022 and atosiban together for treating preterm labor. It would have been obvious to one of ordinary skill in the art at the time of filing to employ compound of formula (3) in the method of treating preterm labour.
One of ordinary skill in the art would have been motivated to employ both OBE022 and atosiban together for treating preterm labor. It is well-known in the art that they can be effectively used together to treat or prevent pre-term labour. Therefore, the reasonably expectation of being effective in treating or preventing preterm labour by the herein claimed combination exists.
One of ordinary skill in the art would have been motivated to employ compound of formula (3) in the method of treating preterm labour. It is well-known in the art that they can be effectively used together to treat or prevent pre-term labour. Therefore, the reasonably expectation of being effective in treating or preventing preterm labour by the herein claimed combination exists.
As for the patient population, those are having the signs of preterm labour (e.g., 4 or more uterine contractions per 30 min) the method of treating preterm labour are the ones who experiencing early onset of delivery. Accordingly, the method suggested by the prior art to employ the compound of formula (2) or (3) with atosiban would be reasonably expected to be useful and effective to treat or prevent preterm labour, thereby delay the onset of delivery.
No claims are allowed.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627