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 .
DETAILED ACTION
1. Claims 16-34 are currently pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 16-31 in the reply filed on September 2, 2026 is acknowledged.
Claims 32-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 2, 2026.
Claims 16-31 are currently under examination.
Priority
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/058,277, filed on November 24, 2020.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on March 5 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy attached hereto.
Claim Objections
5. Claim 16 is objected to because of the following informalities: in the third line of the claim there is the recitation “lipids are adsorbed, and the coefficient…”. There is an extra comma after and which needs to be removed. Appropriate correction is required.
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.
6. Claims 16-31 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.
Claim 16 is rendered vague and indefinite by the use of the phrase “the coefficient of variation in the quantity of lipids adsorbed at the surface of a subpopulation of particles, of diameter characterized by a coefficient of variation less than or equal to 15%, is less than or equal to 20%.” It is unclear what is meant by said phrase, particularly as it pertains to those sections that have been underlined. As written, it is impossible to determine the metes and bounds of the claimed invention. Is this a grammatical error? If so, perhaps Applicant intends to require that the subpopulation of particles has a diameter characterized by a coefficient of variation less than or equal to 15% or is less than or equal to 20%. Clarification is required.
Additionally, Claim 16 is rendered vague and indefinite by the use of the phrase “functionalized liquid colloidal particles in suspension in a liquid”. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. The particles in suspension in a liquid, is the suspension in a liquid the same or different from the stated functionalized liquid? As written, it is impossible to determine the metes and bounds of the claimed invention.
7. Claim 21 recites the limitation "wherein the one or more active agents is hydrophilic or hydrophobic" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. Claims 16-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,269,000 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a colloid comprising functionalized liquid colloidal particles in suspension in a liquid wherein the functionalized liquid colloidal particles consist of oil droplets on the surface of which lipids are adsorbed, and the coefficient of variation in the quantity of lipids adsorbed at the surface of a subpopulation of particles, of diameter characterized by a coefficient of variation less than or equal to 15%, is less than or equal to 20%.
The patented claims are drawn to
15. A colloid comprising functionalized liquid colloidal particles obtainable by the method according to claim 1.
1. A method for obtaining a colloid comprising functionalized liquid colloidal particles comprising the following steps:
a) dispersing an oil in an aqueous solution comprising a fragmentation surfactant, leading to obtaining an emulsion comprising oil droplets suspended in an aqueous phase;
b) dissolving lipids aimed at functionalizing the oil droplets in a polar aprotic solvent, leading to obtaining a functionalization solution;
c) preparing a functionalization mixture comprising the emulsion and the functionalization solution, the volume fraction of the polar aprotic solvent in the functionalization mixture being comprised between 1 and 15%;
d) incubating the functionalization mixture, during which at least a part of the lipids initially present in the functionalization solution are adsorbed on the surface of the oil droplets initially present in the emulsion; and
e) eliminating non-adsorbed lipids during step d);
thus allowing to obtain a colloid comprising functionalized liquid colloidal particles consisting of the oil droplets obtained after step a) on the surface of which the lipids are adsorbed during step d).
The patented claims anticipate or make obvious the co-pending claims.
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.
9. Claim(s) 16-19, 21, 25 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hadorn et al., PNAS, 2012; 109(50):20320-20325.
Independent claim 16 is drawn to a colloid comprising functionalized liquid colloidal particles in suspension in a liquid wherein the functionalized liquid colloidal particles consist of oil droplets on the surface of which lipids are adsorbed, and the coefficient of variation in the quantity of lipids adsorbed at the surface of a subpopulation of particles, of diameter characterized by a coefficient of variation less than or equal to 15%, is less than or equal to 20%.
Hadorn discloses functionalized biotinylated soft colloid oil-in-water emulsion droplets with biotinylated single-stranded DNA oligonucleotides using streptavidin as an intermediary linker. Hadorn shows the components of this modular linking system to be stable and to induce sequence specific aggregation of binary mixtures of emulsion droplet (see abstract; meets claims 25, 27). EDs offer figurable and recyclable soft-colloid system with interesting properties for the fabrication of new delivery systems and advanced synthetic materials with adaptable properties. By exploiting the well-characterized ligand–receptor pair biotin–streptavidin, EDs were immobilized on glass surfaces and actively transported along microtubules. In the context of self-assembly, both polymer-mediated and biotin–streptavidin-mediated aggregation of EDs was shown. Despite the advantages a combination of EDs as building blocks and DNA oligonucleotides as linking agent offers, a protocol for DNA-directed self-assembly of EDs is currently missing. To close this gap, Hadorn prepared an o/w emulsion composed of heavier-than-water diethyl phthalate (DEP) dispersed in an aqueous medium, stabilized by phospholipids, and functionalized with single-stranded DNA (ssDNA) oligonucleotides (meets claim 21). Palmitoyl oleoyl phosphatidylcholine (POPC) and distearoylphosphatidyl ethanolamine (DSPE) in a 9:1 molar ratio were used to stabilize the EDs. The DSPE was grafted with flexible poly(ethylene glycol) (PEG) tethers with a molecular weight of 2,000 (DSPEPEG). The PEG tethers are known to prevent nonspecific aggregation of lipid surfaces driven by attractive van der Waals and other less pronounced aggregating potentials such as polymer bridging and the hydrophobic effect (see page 20320).
Figure 1 demonstrates that ED1 (Left) and ED2 (Right) were both stabilized by a ternary mixture of phospholipids POPC (PL1), DSPE-PEG (PL2), and DSPE-PEG-btn (PL3) in a molar ratio of 90:9:1. The surface of the EDs was functionalized with btn-ssDNA oligonucleotides (btn-ssDNA1-AF488 and btn-ssDNA2) using streptavidin (Strept.) as a connecting element. Both Strept. populations and one btn-ssDNA population were fluorescently modified by Alexa Fluor (AF), resulting in ED1 labeled green (AF488) and red (AF532) and ED2 labeled blue (AF350) (see page 20321; meets claim 19). After chloroform was removed (under vacuum, 60 min), DEP (1 mL, Sigma-Aldrich) was added, resulting in a 2-mM final concentration of phospholipids in a solution. For the emulsification, PS (20 μL) was placed in an aqueous medium (450 μL). The mixture was emulsified (see page 20324; materials and methods; all of the above correlates to claim 16). For the surface functionalization of ED1, equal volumes of ED solution and a 1.35:0.5:98.15 (volume ratio) (meets claim 16)) mixture of. This procedure was repeated for combinations of Strept.-AF350: btn-ssDNA2 (ED2), Strept.-AF488: btn-ssDNA1 (ED3), Strept.-AF532: btn-ssDNA1′ (ED3′), Strept.-AF532: btn-ssDNA2 (ED4), Strept.: btn-ssDNA3 (ED5), Strept.: btn-ssDNA3′ (ED5′), and Strept.: btn-ssDNA4 (ED6). A schematic representation of the surface functionalization of all ED populations is shown in Fig. S3A. The functionalized EDs were frozen in liquid nitrogen and stored at −20 °C until use. (see page 20324; Functionalization of Eds; meetings claim 16).
Moreover, for btn-DNA coupled via streptavidin to a biotin-doped supported phospholipid bilayer showed that the intuitive assumption of a 2:1 molar ratio of btn-ssDNA oligonucleotides may be too simplistic and that the combination of electrostatic repulsion and steric hindrance may prevent efficient coupling of two btn-DNA oligonucleotides per streptavidin. In this case, only one btn-DNA oligonucleotide would be coupled per streptavidin; consequently, the DNA surface coverage would be halved. In the next step, we estimate the force acting on the linkers composed of the anchoring DSPE-PEG-btn, streptavidin, and dsDNA (see page20323; meets claim 19). For colloid systems at the microscale, mechanical disturbance, for example, shaking and induced flow, was applied to reverse the streptavidin-induced aggregation process of cholesterol-PEG-biotin–modified lymphoblastoid cells of an average diameter of 10 μm (see page 20324)
As it pertains to claim 17, absent evidence to the contrary, the oil disclosed in Hadorn is a commonly used vegetable oil.
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
10. No claim is allowed.
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xu et al., Chem. Eur. J., 2015; 21: 15516-15519.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 September 30, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
