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
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) 29, 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Abo et al. (WO 2016/016893) in view of Corne et al. (US 2018/0207096).
Regarding claims 29, 33, 36 Abo discloses stable amorphous calcium carbonate (ACC) compositions, and food articles comprising said compositions (abstract). Abo discloses encapsulated amorphous calcium carbonate (ACC) composition, comprising a plurality of ACC particles comprising an ACC core, comprising ACC and at least one agent stabilizing the ACC in amorphous form, and an encapsulation matrix comprising at least one coating layer, wherein the at least one coating layer comprises an encapsulating agent selected from the group consisting of a film forming polymer and a lipid, and wherein the at least one coating layer at least partly coats the ACC core (page 4, lines 19-25). The lipid is selected from the group consisting of an edible wax, a fatty acid, a fatty acid ester, an oil, and any combination thereof. The coating layer which comprises a lipid further comprises at least one agent selected from a natural resin, a biocompatible polymer, a prolamine protein, an agent stabilizing the ACC, a surfactant, a color and a pigment. Each possibility represents a separate embodiment of the invention (page 5, line 11-30). The term "encapsulation" as used herein refers to a process to entrap one substance within another substance, thereby producing particles with particle size of a few nanometers (urn) to a few millimeters (mm) (page 13, line 18-26).
However, Abo fails to disclose that lipids are one or more amphiphilic compounds having hydrophilic head and hydrophobic tail such as phosphatidyl serine, phosphatidyl glycerol and mixture thereof.
Whereas, Corne discloses manufacturing a negatively charged supported lipid bilayer. The method comprises the steps of preparing a formulation comprising at least three lipids (1,2-dioleoyl-sn-glycero-3-phospho-L-serine (DOPS), cholesterol and at least one lipid different from DOPS and cholesterol) dissolved in a first solvent, of evaporating the first solvent, of adding an aqueous formulation of mesoporous silica nanoparticles, of performing an ultra-sonication and of performing a centrifugation (abstract). Corne discloses a supported lipid bilayer (SLB), it is interesting to be able to functionalize the MSNPs with a reactive moiety which is on the external surface of the MSNPs, allowing subsequently further functionalization (para 0005). The at least one lipid different from DOPS and cholesterol is 1,2-dipalmitoyl-sn-glycero-3-phosphocholine alias DPPC (para 0068). The thickness of the bilayer coating is 5.3 nm (para 0095). Corne discloses manufacturing a negatively charged supported lipid bilayer. The method comprises the steps of preparing a formulation comprising at least three lipids (1,2-dioleoyl-sn-glycero-3-phospho-L-serine (DOPS), although Corne does not disclose 2-dioleoyl-sn-glycero-3-phospho-L-serine, it would be obvious to one of ordinary skill in the art to chose 2-dioleoyl-sn-glycero-3-phospho-L-serine as the compound is equivalent and interchangeable and would yield the same properties.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to attach negatively charged bilayer 1,2-dioleoyl-sn-glycero-3-phospho-L-serine (PEG free) as taught by Corne on to the core of calcium carbonate of Abo motivated by the desire to control the drug release as well improving the biocompatibility of the core.
As Abo in view of Corne discloses DOPS coated on to the calcium carbonate particles as presently claimed, it therefore would be obvious that nanoparticles would intrinsically have a surface charge having potential below 0 mV as determined by micro-electrophoretic light scattering technology and lipids would intrinsically be infiltrated into the core of the calcium carbonate nanoparticles.
Regarding claim 32, Abo in view of Corne does not explicitly disclose the plurality of bilayers infiltrated in to the core of the calcium carbonate nanoparticles, the extent of the infiltration ranging between 5-40% of the core diameter.
It would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges between 5-40% through process optimization motivated by the desire to control the drug release as well improving the biocompatibility as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05).
Regarding claim 34, As Abo in view of Corne discloses DOPS coated on to the calcium carbonate particles as presently claimed, it therefore would be obvious that when dispersed in water or aqueous media, nanoparticles would intrinsically be monodispersed.
Regarding claim 35, As Abo in view of Corne discloses DOPS coated on to the calcium carbonate particles as presently claimed, it therefore would be obvious that when dispersed in water or aqueous media, nanoparticles would intrinsically have a polydispersity index inferior to 0.2.
Claim(s) 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Abo et al. (WO 2016/016893) in view of Corne et al. (US 2018/0207096) as applied to claim 29, further in view of Nel et al. (WO 2014/138278).
Regarding claims 38-39, 41 Abo in view of Corne fails to disclose nanoparticles further comprises one or more additional amphiphilic compounds where each amphiphilic compound has one hydrophilic head and at least one hydrophilic tail and are positively charged and where said positively charged heads being inserted between negatively charged heads.
Whereas, Nel discloses submicron structure comprising a silica body defining a plurality of pores that are suitable to receive molecules therein, and having a surface, and a phospholipid bilayer coating the surface, wherein said submicron structure has a maximum dimension of less than one micron (abstract). Forming the phospholipid bilayer can include contacting a suspension of silica bodies (e.g., pre-loaded silica bodies) with a solution of phospholipids in a suitable solvent. The combined mixture can be supplied with energy (e.g., via sonication) to facilitate coating of the silica body surface with a phospholipid bilayer. Numerous phospholipids suitable for forming bilayers are known, including, but not limited to, l,2-dioleoyl-3-trimethylammonium-propane (DOTAP), l,2-dioleoyl-sn-glycero-3- phospho-L-serine (DOPS) and l,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC). The composition of the lipid bilayer can be adjusted as desired (page 12, lines 6-12).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include positively charged l,2-dioleoyl-3-trimethylammonium-propane (DOTAP) as taught by Nel on to the surface of amorphous calcium carbonate of Abo motivated by the desire to have high loading capacity and thus forming the layer or bilayer of ,2-dioleoyl-3-trimethylammonium-propane (DOTAP) being inserted between negatively charged heads.
Regarding claim 40, Nel discloses the thickness of the lipid bilayer is 9 nm (page 6, lines 24-25).
The only deficiency of Nel is that Nel disclose the use of thickness of bilayer is 9 nm, while the present claims require thickness of 10 nm or greater.
It is apparent, however, that the instantly claimed thickness of bilayer and that taught by Nel are so close to each other that the fact pattern is similar to the one in In re Woodruff , 919 F.2d 1575, USPQ2d 1934 (Fed. Cir. 1990) or Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed.Cir. 1985) where despite a “slight” difference in the ranges the court held that such a difference did not “render the claims patentable” or, alternatively, that “a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough so that one skilled in the art would have expected them to have the same properties”.
In light of the case law cited above and given that there is only a “slight” difference between the thickness of bilayer disclosed by Nel and the thickness disclosed in the present claims and further given the fact that no criticality is disclosed in the present invention with respect to the thickness of bilayer, it therefore would have been obvious to one of ordinary skill in the art that the thickness of bilayer disclosed in the present claims is but an obvious variant of the amounts disclosed in Nel, and thereby one of ordinary skill in the art would have arrived at the claimed invention.
Regarding claim 42, Corne discloses at least one lipid different from DOPS and cholesterol is 1,2-dipalmitoyl-sn-glycero-3-phosphocholine alias DPPC (para 0068), where DPPC corresponds to additional compound which would intrinsically have claimed potential ranging between -25 mV up to +50 mV or Nel discloses Numerous phospholipids suitable for forming bilayers are known, including, but not limited to, l,2-dioleoyl-3-trimethylammonium-propane (DOTAP), l,2-dioleoyl-sn-glycero-3- phospho-L-serine (DOPS) and l,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC). The composition of the lipid bilayer can be adjusted as desired (page 12, lines 6-12), where DOPC corresponds to additional compound which would intrinsically have claimed potential ranging between -25 mV up to +50 mV.
Response to Arguments
Applicant’s arguments filed on 03/05/2026 have been fully considered, but they are not persuasive.
Applicant respectfully suggests that even if a person of ordinary skill in the art were motivated to combine the disclosure of Corne and the teachings of Abo as suggested by the Examiner, they would not arrive at the subject matter of Claim 29. Specifically, nothing in the combined teachings of Corne and Abo teaches or suggests lipid-coated calcium carbonate nanoparticles presenting a bilayer of amphiphilic compounds infiltrated into the core of the nanoparticles. In contradistinction, Corne expressly teaches nanoparticles wherein the bilayer of amphiphilic compounds are not at all infiltrated nor adsorbed into the core of the nanoparticles. Thus, the proposed combination of Abo and Corne does not arrive at the claimed subject matter.
However, it should be noted that As Abo in view of Corne discloses DOPS coated on to the calcium carbonate particles as presently claimed, it therefore would be obvious, absent evidence to the contrary that lipids would intrinsically be infiltrated into the core of the calcium carbonate nanoparticles. However, if Applicant does not agree, then a Declaration/Affidavit needs to be filed to support this position.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RONAK C PATEL/Primary Examiner, Art Unit 1788
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