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 .
Claims 1-10 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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN109381448 (‘448) in view of Arya et al., International Journal of ChemTech Research, 2010, V ol.2, No.1, pp 576-583, Reddy et al., Indo American Journal of Pharmaceutical Research, 2018, vol. 8, issue 6. Page 1315-1326, Kushwah et al., Pharmaceutics, 2021, Feb, 13, 238, 1-22, and WO2019/186386 (‘386).
‘448 teaches a oral film composition comprising razaxaban, a Xa inhibitor with BCS class II, formulated in an oral film composition (see the abstract, [0003], and claim 1).’448 teaches suitable excipients for making the oral film include plasticizers such as glycerol and triethyl citrate; polymers such as polyvinyl pyrrolidone and HPMC (see example 1-3)
‘448 does not expressly teach the use of maltodextrin, microcrystalline cellulose and the herein claimed surfactants, in the amount recited.
Arya et al. teaches a general review of oral film delivery systems. Arya et al. teaches typical amounts and excipients for formulating an oral film composition (see the abstract, also page 577, col. 1, Composition of the system Section). Arya et al. teaches sodium lauryl sulfate as one of the commonly used surfactants for solubilizing the drugs (see page 577, col. 2). Ayra et al. teaches glycerol as one of plasticizers (0-20% of the total composition) (see page 577, col. 2). Ayra et al. teaches maltodextrin, PVP, HPMC as commonly used polymers (40-50% of the total composition) (see page 577, col. 2). Ayra et al. also teaches the use of flavouring and coloring agents (see page 577, col. 2 bridging page 578, col. 1).
Reddy et al. teaches a detailed review of oral film with similar content for the components (see 1319, Table). Reddy et al. teaches the various advantages of oral film delivery systems (see page 1318, Figure). Reddy et al. teaches plasticizers used can be glycerol and triethyl citrate (see page 1320, first paragraph).
Kushwah et al. teaches rivaroxaban as classified in BSC class II (see the abstract).
‘386 teaches an oral film composition with melatonin as the active agent, comprising Cremophor (aka polyoxyl 40 hydrogenated castor oil), as the solubilizing agent (see page 9, line 2; and claim 4) and microcrystalline cellulose as the anti-absorbent agents (see page 12, line 6). ‘386 also teaches HPMC, maltodextrin, Povidone as the components of the oral film composition (see examples 1-3).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate a rivaroxaban oral film composition with the herein claimed components, in the herein claimed amount.
One of ordinary skill in the art would have been motivated to formulate a rivaroxaban oral film composition with the herein claimed components, in the herein claimed amount. Razaxaban and rivaroxaban are both factor Xa inhibitor and classified in BCS class II. Formulating rivaroxaban into oral film composition would be obvious substitution between Razaxaban and rivaroxaban. The herein claimed components are taught in the secondary references to be conventional and commonly used for formulating oral film composition. Employing the well-known conventional excipients for oral film composition into the herein claimed composition would be seen as obvious.
The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the cited prior art teaches the approximate amount for each of the components, adjusting the amount of the components would give rise to the maximum benefits of the oral film composition.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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