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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Joabsson et al (WO 2005/046642), Chung et al (“Diabetologia, 2002, 45, pp 448-451), Zhai et al (ACS Nano, vol 13, no 6, 2019, pp6178-6206), and Tran et al (RSC Advances, vol 5, no 34, 2015, pp 26785-26895), and.
Joabsson et al discloses bioactive peptides (proteases, hormones or insulin) encapsulated in LLC nanoparticle dispersions comprising glycerol monooleate, Pluronic F127, oleic acid and water. While oleic acid is preferred, capric acid or caprylic acid, or salts thereof, may represent suitable alternatives to oleic acid or salts thereof. (see Discussion)
Chung et al discloses nanoparticulate LLC dispersions comprising glycerol monooleate, Pluronic F127 and insulin in ethanol/water are disclosed, which spontaneously form nanoparticles without need for microfluidization at high temperature; hence, peptide destabilisation is avoided. Chung et al further teaches high insulin encapsulation efficiency and in vivo data in animal model shows efficient intestinal absorption and therapeutic insulin levels suitable for peroral delivery of insulin.
Tran et al discloses LLC dispersion systems are disclosed comprising glycerol monooleate /Poloxamer/oleic acid nanoparticles as carrier for encapsulation of peptides, such as insulin. Tran et al teaches that C10 fatty acid (capric acid) may be an alternative to oleic acid, and that matrix morphology is influenced by the choice of the fatty acid additive.
Joabsson et al discloses LLC nanoparticle dispersions based on GMO/Pluronic F127/capric acid and water, and discusses the influence of capric acid in self-assembly morphology and stabilization of the LLC nanoparticles.
The instant claims differ in that the LLC nanoparticle dispersion system comprise, as the fatty acid component, a salt of a C6-C12 fatty acid, instead of oleic acid.
It would have been obvious to one of ordinary skill in the art to read the references for teaching the general concept of forming lyotropic liquid crystalline nanoparticles comprising glycerol, a fatty acid, an amphiphilic block copolymer, and a bioactive macromolecule having peptide bonds where such teaching is clearly laid out above. Further, it would have been obvious to include salts of capric acid to form the particles where they are taught as optional fatty acids and that the morphology and stabilization will vary based on the fatty acid.
Further, where the fatty acid and other components are known to vary the self-assembly morphology and stabilization of the LLC nanoparticles, it would have been a matter of routine optimization to vary the amounts of each to produce stable nanoparticles carrying the desired bioactive agents. MPEP 2144.05(II).
Claims 120 are rejected under 35 U.S.C. 103 as being unpatentable Chung et al (“Diabetologia, 2002, 45, pp 448-451), Zhai et al (ACS Nano, vol 13, no 6, 2019, pp6178-6206), Tran et al (RSC Advances, vol 5, no 34, 2015, pp 26785-26895), and Joabsson et al (WO 2005/046642), in view of Tamarkin et al (US 8,795,693).
Chung et al, Zhai et al, Tran et al, and Joabsson et al are discussed above but do no teach the use of octanoic acid.
Tamarkin et al teaches fatty acid salts for lyotropic liquid crystals can vary and include various carboxylic acids such as octanoic acid (col 16 lines 31-50).
It would have been obvious to use known fatty acid salts suitable for lyotropic liquid crystal nanoparticles in the method made obvious by the primary references. MPEP 2144.06.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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