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 1-21 are pending.
Claim Objections
Claims 4-5, 7-12, 17, 20, 21 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend on another multiple dependent claims. See MPEP § 608.01(n).
For further prosecution, these claims are treated as if they are depending on the broadest independent claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the use of the composition does not recite any active steps is not a complete method.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is indefinite because the claim does not recite any active method steps for the use of the herein claimed pharmaceutical composition.
At the outset, the herein claimed phospholipid composition are known to be Phosal 53 MCT or Phosal 50 PG (see pages 8-9 of the instant specification).
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) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/123011 (‘011) in view of WO2007/050574 (‘574) and US 10,940,205 (‘205). ‘011 and ‘574 are references of record in IDS filed 4/5/2023.
‘011 teaches the herein claimed compounds and the method of synthesizing the same (see claim 1). ‘011 also teaches the detailed synthesis method and purification steps (see page 17-20, [068] – [077]). Most of the solvents are in non-polar solvents and the rinsing solution being acetic acid and water, indicating that the compounds are being fairly hydrophobic. ‘011 teaches the compounds as useful for being sedative and anxiolytic to treat sleeping disorders and anxiety disorders (see page 21, [089]).
‘011 does not teach the phospholipid solvent systems and the surfactant as claimed in the composition.
‘574 teaches the use of Phosal 53 MCT and Phosal 50 PG (see page 17, lines 7-16). ‘574 teaches the use of Labrasol and Phosal 53 MCT together in a formulation for poorly soluble drug (ABT-102) (see page 38, lines 15-16, Formulation #23). The examiner notes that Labrasol is known as caprylocaproyl polyoxyl-8-glycerides. ‘574 observed the use of such systems increased the bioavailability of the drugs being administered. (see for example, page 20, lines 20-25; page 23, last paragraph bridging page 24, line 6; page 53, lines 27 bridging page 54, line 4).
‘205 teaches other surfactants such as diethylene glycol monoethyl ether and other alkyl ether derivatives as useful solvent systems for poorly soluble drugs to increase the stability and bioavailability of the same (see the abstract; col. 12, line 61 for example).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the solvent system including Phosal 53 MCT or Phosal 50 PG, with Labrasol and/or diethylene glycol monoethyl ether, to increase the bioavailability of the herein claimed compound.
One of ordinary skill in the art would have been motivated to employ the solvent system including Phosal 53 MCT or Phosal 50 PG, with Labrasol and/or diethylene glycol monoethyl ether, to increase the bioavailability of the herein claimed compound. It is well-known in the art that the phospholipid solvent systems that would enhance the bioavailability for poorly soluble drugs, therefore, formulating the composition containing poorly soluble drugs, including the herein claimed compounds, with the Phosal 53 MCT or Phosal 50 PG, with Labrasol and/or diethylene glycol monoethyl ether, would be reasonably expected to be successful.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627