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 1-27 are pending.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2004/060401 (‘401).
‘401 teaches a composition comprising orlistat and behenic acid and fumed silica (see page 34, Example 2). Fumed silica is considered as a pharmaceutically acceptable carrier.
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) 5, 6, 10, 12-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘401 in view of Kim et al., Journal of Nanoscience and Nanotechnology Vol. 19, 634–639, 2019 and Chaudhuri et al., International Journal of Health & Allied Sciences • Vol. 2 • Issue 4 • Oct-Dec 2013.
‘401 teaches a method of ameliorating the undesirable side effects associated with lipase inhibitors by using a composition comprising a lipase inhibitor and a long-chain fatty acid with C14-24 (see page 3, fourth paragraph). ‘401 teaches a composition comprising orlistat and behenic acid and fumed silica (see page 34, Example 2). ‘401 teaches the composition can be formulated into liquid composition (see page 19, third paragraph). ‘401 teaches a method of treating obesity and Type II diabetes ( see the abstract for example). ‘401 teaches the composition can be formulated for animal administration (see claim 2). ‘401 teaches “the compositions may be administered in a variety of manners that will be well-known to those of ordinary skill in the art” (see page 31, last paragraph bridging page 32, first paragraph). ‘401 also teaches “method of administering compositions that are suitable for administration to an animal for the purpose of stiffening one or more lipophilic substances present in the gastrointestinal tract of the animal.” (see page 31, third paragraph).
‘401 does not teach the method of preventing or treating acute pancreatitis. ‘401 does not expressly teach the self-emulsifying system. ‘401 does not expressly teach enteral administration.
Chaudhuri et al. teaches “Orlistat is an anti-obesity drug that acts by inhibiting pancreatic and gastric lipase in the gastrointestinal tract. It has been linked to rare instances of acute pancreatitis, some of which have been severe” (see the abstract).
Kim et al. teaches the self-emulsifying system would enhance the solubility and dissolution of orlistat (see the abstract).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the orlistat/fatty acid composition to treat and/or prevent acute pancreatitis. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate self-emulsifying systems to the orlistat/fatty acid composition. It would have been obvious to one of ordinary skill in the art at the time of filing to employ enteral administration to treat the herein claimed diseases.
One of ordinary skill in the art would have been motivated to employ the orlistat/fatty acid composition to treat and/or prevent acute pancreatitis as the herein claimed composition is well-known in the art to be effective in treating the side effects of orlistat, which include acute pancreatitis. One of ordinary skill in the art would have been motivated to incorporate self-emulsifying systems to the orlistat/fatty acid composition because increasing the dissolution and solubility of orlistat would be reasonably expected.
One of ordinary skill in the art would have been motivated to employ enteral administration to treat the herein claimed diseases because it is well-known in the art the purpose of the method of ‘401 is to deliver the fatty acid to the GI tract along with orlistat. Therefore, employing any conventional routes of administration including enteral route, would be reasonably expected to be successfully deliver the composition to the GI tract.
No claims are allowed.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627