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 § 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.
Claims 5 and 20 are 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.
The term “configured” in claims 5 and 20 is a relative term which renders the claim indefinite. The term “configured” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how the nanoparticle is “configured”, which implies modification of some sort, such that it is capable of securing the lipid bilayer.
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) 1-9, 16-24, 26, 56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaparro et al., (Applied Materials & Interfaces, 2018, cited in IDS).
Chaparro et al. teaches “lipid bilayers composed of mixtures of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC) and 1,2-dioleoyl-sn-glycer-3-phospho-(1’-rac-glycerol) (DOPG) stabilize the folded state of nitroreductase (NfsB), increasing the rate of refolding relative to unfolding of enzyme molecules on the bilayer surface” (Abstract). Note: NfsB is a protein-based enzyme.
“The impact of lipid composition on NfsB stability on SLBs [supported lipid bilayers] was determined by preparing SLBs composed of DOPC, DOPG, and DOPC/DOPG mixtures (with 15, 25, 35, 50, 75% DOPG) on fused silica surfaces via vesicle fusion” (p. 19506, left column, 2nd paragraph) (clm. 7 and 8). DOPC is zwitterionic and DOPG is anionic, as per claims 1-3. The fused silica suffices as the “nanoparticle configured to secure said lipid bilayer” as per claims 5 and 20.
The prior art is anticipatory insofar as it teaches a composition comprising a lipid bilayer composed of zwitterionic and/or anionic phospholipids. Here, the prior art is capable of performing the intended use insofar as it fully and intrinsically sets forth all of the limitations of the claimed invention.
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.
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.
Claim(s) 5 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaparro et al., (Applied Materials & Interfaces, 2018, cited in IDS) as applied to claim1 above, and further in view of Gao et al., (J Mater Chem B Mater Biol Med. 2013).
Chaparro et al., which is taught above, differs from claims 5 and 20 assuming for the sake of argument that it does not teach a nanoparticle configured to secure the lipid bilayer.
Gao et al. teaches, “the applications of conventional liposomes face challenges due to their inherit instability. Liposomes, particularly with sub-100 nm size, are prone to fuse with each other to reduce their surface tension, leading to payload loss or undesired mixing” (p. 2, 1st paragraph).
Gao et al. further teaches, “an emerging strategy to stabilize liposomes is to bind tiny nanoparticles to liposome surfaces (Figure 7). Particularly, the non-specific adsorption of charged nanoparticles onto phospholipid bilayers provides steric and electro static repulsions. In a density-dependent manner, these adsorbed nanoparticles prevent liposomes from fusing with each other to from larger vesicles” (p. 7, 2nd paragraph).
Gao et al. also teaches use of nanoscale vesicles, such as “exosomes”, which are “vesicles approximately 40~100 nm in size” that can cross the “blood brain barrier” enabling delivery to the brain (p. 10, last paragraph).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use a nanoparticle as a means for securing the lipid bilayer of Chaparro et al., since lipid bilayers are recognized in the art as inherently unstable, as taught by Gao et al. Nanoparticles and nano-sized vesicles are known means for securing lipid bilayers to prevent fusing, leading to payload loss or undesired mixing. Accordingly, it would have been obvious to use the nanoparticles of Gao et al. to secure the lipid bilayers of Chaparro et al.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612