FINAL 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 .
Status of the Claims
This action is in response to papers filed 06/10/2026 in which claims 2-3, 7, and 18 were canceled; claims 13-17 were withdrawn; claims 1 and 12 were amended; and claim 19 was newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1, 4-6, 8-12, and 19 are under examination.
Withdrawn Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Modified Rejections
Necessitated by Applicant’s Claim Amendments
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.
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.
Claim(s) 1, 4-6, 10, 12, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Traynor et al (US 2012/0104639 A1) in view of Karkkainen (US 2010/0016488 A1), Xia et al (J. Porous Mater., 2010, 17: 225-252), Jones et al (Chem. Mater., 2008, 20: 3385-3397), Chen et al (Langmuir, 2018, 34: 10397-10406) and Gehin-Delval et al (US 2016/0316806 A1), and as evidenced by Thierauf (US 2010/0174045 A1).
Regarding claim 1, Traynor teaches a method of forming spherical silica particles comprising (i) providing at least one pre-hydrolyzed silica precursors; (ii) removing the alcohol byproduct from the prehydrolyzed silica precursors to provide a dispersed phase containing pre-condensed silica precursors; iii) mixing the dispersed phase containing pre-condensed silica precursors with an aqueous continuous phase to form an oil-in-water emulsion; and iii) adding ammonia (a condensation catalyst) to the emulsion to obtain spherical silica particle suspension (Abstract; [0008]-[0039], [0046]-[0056], [0061]-[0064] and [0081]; claims 1-7). Traynor teaches the silica particles are made porous and the use of prehydrolyzed functionalized silanes can speed up reaction time while functional groups such as phenyls can align at interface and form pores, i.e., porosity is controlled by modified silanes ([0081]). Traynor teaches the silica precursors used in the method are selected from a silicate (silicon acetate, silicic acid or salts thereof), a silsequioxanes or poly-silsequioxanes, silicon alkoxides (e.g., from silicon methoxide to silicon octadecyloxide), and functionalized alkoxides (such as ethyltrimethoxysilane, aminopropyltriethoxysilane, vinyltrimethoxysilane, diethyldiethoxysilane, diphenyldiethoxysilane, etc). Further specific examples of silica precursors include tetramethoxysilane (TMOS), tetraethoxysilane (TEOS), tetrabutoxysilane (TBOS), tetrapropoxysilane (TPOS), polydiethoxysilane, methyltrimethoxysilane, methyltriethoxysilane, ethyltriethoxysilane, phenyltriethoxysilane, octylpolysilsesquioxane and hexylpolysilsesquioxane ([0056]).
While Traynor does not expressly mentioned the technique used for removing the alcohol byproduct from the prehydrolyzed silica precursors to provide a dispersed phase containing pre-condensed silica precursors, it would have been obvious to use known and conventional distillation technique to remove the alcohol byproduct from the prehydrolyzed silica precursors of Traynor, as it is well established in the prior art in view of Karkkainen, the alcohol byproduct from the prehydrolyzed silica precursors is normally removed by conventional distillation technique to obtain pre-condensed organosiloxane precursors (Karkkainen: Abstract; [0020]-[0035], [0039]; Examples 3-6). Thus, it would have been obvious and with reasonable expectation of success to apply known distillation technique per guidance from Karkkainen to remove the alcohol byproduct from the prehydrolyzed silica precursors of Traynor so as to yield predictable results of pre-condensed organosiloxane precursors.
While Traynor does not expressly teach separately hydrolyzing in separate containers two or more silica precursors, it would have been obvious to one of ordinary skill in the art to modify the method of forming spherical silica particles of Traynor such that two or more pre-hydrolyzed silica precursors are used in the preparation producing spherical silica particles in view of the guidance from Xia and Jones.
Xia teaches processes of preparing mesoporous organosilicas with varieties of silica precursors (Abstract; pages 225-229, 234-235 and 245-247). Xia further describes the preparation of mesoporous nano/microparticles comprising co-condensation of mixed precursors tetraalkoxysilane and bridged organosiloxane with terminal organosiloxane, or the co-condensation of multiple bridged organosiloxane (Abstract; pages 225-229, 234-235 and 245-247). Xia further teaches the distribution of organic groups in the mesoporous organosilicas can be controlled using prehydrolysis of organosilicas precursors, and multifunctional mesoporous organosilicas are produced by first separately hydrolyzing the silica precursors and structural symmetry of the porous network are synthesized by co-condensation of the pre-hydrolyzed silica precursors (Abstract; pages 234-235). Xia cited reference [102] on the left column of page 234, which is Jones et al, therein teaches the process and technique of producing the mesoporous organosilicas by first separately hydrolyzing the silica precursors (page 234, left column, middle paragraph). Jones teaches the silica precursors were separately hydrolyzed before mixing or combining together (Jones: page 3386, right column under “Experimental Section” to page 3397), thereby each of the silica precursor would be separately hydrolyzed in a separate container, as Jones indicated that “after the prehydrolysis the silica solutions were added to the acid/surfactant mixture and stirred vigorously for 24 h at 40 °C” (Jones: page 3386, right column under “Experimental Section”). Thus, Xia in view of Jones teaches the known technique/concept of first separately hydrolyzing the silica precursors to form separate prehydrolyzed silica solutions in the production of silica particles.
It would have been obvious to one of ordinary skill in the art to modify the method Traynor such that two or more silica precursors are hydrolyzed separately and then combined to be used in the preparation producing spherical silica particles. One of ordinary skill in the art would have been motivated to do so because Xie in view of Jones provided the guidance to do so by teaching that multifunctional mesoporous organosilicas can be produced by separately hydrolyzing two or more silica precursors in separate containers to produce separate prehydrolyzed silica solutions, and followed by co-condensation of the pre-hydrolyzed silica precursors. One of ordinary skill in the art would have reasonable expectation of modifying the method Traynor such that two or more hydrolyzed silica precursors are used in the preparation because as discussed above, Traynor indicated that at least one or in other words, more than one prehydrolyzed silica precursors with multiple functionality can be used and such use of said prehydrolyzed silica precursors can be tailored to provide silica particles with desired porosity, thereby indicating modification of the method of Traynor can be made by using the guidance from Xia and Jones so as to produce mesoporous organosilica particles.
While Traynor teaches that the emulsification step uses a surfactant, it would have been obvious to modify the method of Traynor such that the emulsification step is absent of a surfactant in view of the guidance from Chen.
Chen teaches a process for forming spherical submicron silica capsules using a surfactant-free emulsion approach, in which a liquid silica precursor polymer, hyperbranched polyethoxysiloxane (PEOS) (Abstract; pages 10398-10399; pages 10404-10405). Chen teaches PEOS can be used as both silica source and stabilizer of an oil-in-water emulsion because of its hydrolysis-induced interfacial activity (Abstract; page 10398, left column). Chen teaches the submicron size silica capsules are formed by performing ultrasonication or high-shear homogenization during the emulsification step (Abstract; pages 10404-10405). As evidenced by Thierauf, the polyethoxysiloxane of Chen is a prehydrolyzed silica precursor which is made by performing hydrolysis-condensation reactions of tetraethoxysilane (TEOS) (Abstract; [0008]-[0064]; Example 1).
It would have been obvious to one of ordinary skill in the art to modify the method Traynor in view of Xia such that one of the prehydrolyzed silica precursors is a polyethoxysiloxane of Chen and arrived at the claimed process in which the method of Traynor does not need to use a surfactant in the emulsification step yet be capable of arriving at spherical silica particles, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Chen provided the guidance to do by teaching that the emulsification step of Traynor can be free of surfactant when a polyethoxysiloxane is used as the silica precursor, as polyethoxysiloxane functions as both the silica source and the stabilizer of an oil-in-water emulsion because of its hydrolysis-induced interfacial activity (Chen: Abstract; page 10398, left column). Furthermore, Chen teaches that using the surfactant-free emulsion approach provides a process of producing silica capsules/particles that is environmentally friendly (Chen: Abstract; pages 10404-10405). Thus, an ordinary artisan seeking to produce silica particles that are environmentally friendly, would have looked to the surfactant-free emulsion approach of Chen such that polyethoxysiloxane is used as one of the silica precursors in the method of Traynor, thereby eliminating the use of a surfactant in the emulsification step.
While Traynor does not teach the silica particles obtained were submicron/nanoparticles size, it would also have been obvious to one of ordinary skill art to perform known technique of ultrasonication or high-shear homogenization during the emulsifying step of Traynor so as to reduce to the size of the particles to submicron/nanoparticles size, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Chen provided the guidance to do so by teaching that the size of the capsules can be controlled by emulsification energy and rate of subsequent stirring using the technique of ultrasonication or high-shear homogenization, and decreasing the capsule sizes to submicron size can be performed by increasing of the emulsification energy, and strong stirring of the resulting emulsion (Chen: Abstract; pages 10404-10405). Thus, an ordinary artisan seeking to produce silica particles of Traynor in submicron/nanoparticles size would have looked to using ultrasonication or high-shear homogenization during the emulsifying step so as increase the emulsification energy and stirring speed so as to obtain silica particles in submicron/nanoparticles size.
While Traynor in view of Xia, Jones and Chen do not teach the disperse phase further comprises a carboxylic acid containing compound comprising at least 8 carbon atoms as recited in claim 1, it would have been obvious to include a carboxylic acid containing compound comprising at least 8 carbon atoms with the pre-hydrolyzed organosiloxane precursors before the emulsification step in the method of Traynor in view of Xia, Jones and Chen, in view of Gehin-Delval.
Gehin-Delval teaches emulsions stabilized by silica coated or absorbed onto their surface, a fatty acid such as octanoic acid (caprylic acid) (Abstract; [0001], [0010]-[0013], [0029]; Example 1). Gehin-Delval teaches the use of caprylic acid with silica produce oil-in-water emulsions with good stability against shear, having droplets with a narrow size distribution and spherical shape ([0011]).
It would have been obvious to one of ordinary skill in the art to include octanoic acid with the pre-hydrolyzed organosiloxane precursors before the emulsification step in the method of Traynor in view of Xia, Jones and Chen, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gehin-Delval provided the guidance to do so by teaching that the use of caprylic acid with silica produce oil-in-water emulsions with good stability against shear, having droplets with a narrow size distribution and spherical shape. Thus, an ordinary artisan seeking to maximize the stability of the emulsion against shear during the emulsification step, as well as, obtain droplets with a narrow size distribution, would have looked to including octanoic acid with the pre-hydrolyzed organosiloxane precursors before the emulsification step in the method of Traynor in view of Xia, Jones and Chen, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 4, Traynor teaches the prehydrolyzed silica precursor is combined with another organosiloxane precursor in the dispersed phase ([0008]-[0016, [0031], [0037], claims 1-4).
Regarding claim 5, Traynor teaches the prehydrolyzed silica precursor can be combined with another prehydrolyzed silica precursor in the dispersed phase ([0008]-[0016, [0031], [0037], claims 1-5).
Regarding claim 6, Traynor teaches a nonpolar active ingredient in a continuous phase is mixed with the dispersed phase containing the silica precursors (Abstract; [0009]-[0010], [0014], [0024]-[0028]).
Regarding claim 10, Traynor teaches the nonpolar active ingredient is cosmetic or pharmaceutical compound ([0027]).
Regarding claim 12, as discussed above, Gehin-Delval provided the guidance for including octanoic acid with the pre-hydrolyzed organosiloxane precursors before the emulsification step in the method of Traynor in view of Xia, Jones and Chen.
Regarding claim 19, Karkkainen teaches the distillation is performed at a temperature of 50°C (Examples 3-6), which reads on the claimed range of the distillation is conducted at a temperature of 40 to 101°C.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Traynor et al (US 2012/0104639 A1) in view of Karkkainen (US 2010/0016488 A1), Xia et al (J. Porous Mater., 2010, 17: 225-252), Jones et al (Chem. Mater., 2008, 20: 3385-3397), Chen et al (Langmuir, 2018, 34: 10397-10406) and Gehin-Delval et al (US 2016/0316806 A1), and as evidenced by Thierauf (US 2010/0174045 A1), as applied to claims 1 and 6 above, and further view of Zhao et al (US 2018/0200689 A1).
The process of claims 1 and 6 are discussed above, said discussion being incorporated herein in its entirety.
However, Traynor, Karkkainen, Xia, Jones, Chen, and Gehin-Delval do not teach the active/payload molecule is a hydrophobic/liposoluble molecule in a liquid state of claim 8 and the active/payload molecule is a hydrophobic molecule in a solid state of claim 9.
Regarding claims 8-9, Zhao teaches silica nanocapsules encapsulating hydrophobic compound produce via emulsion technique (Abstract; [0001]-[0002], [0007]-[0056]). Zhao teaches the encapsulated substances can be a wide range of hydrophobic substance that include any hydrophobic liquids and any solids that melt into hydrophobic liquid at high temperature ([0055]-[0056]).
It would have been obvious to one of ordinary skill in the art incorporate hydrophobic compound in a liquid state or a solid state as the nonpolar active ingredient in the method of Traynor in view of Karkkainen, Xia, Chen and Gehin-Delval, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Zhao provided the guidance to do so by teaching that any hydrophobic substance whether in liquid state or solid state can be used as the hydrophobic substance that is encapsulated in the silica particles produced by emulsion technique of Traynor in view of Xia, Chen and Gehin-Delval. Thus, an ordinary artisan would have reasonable expectation that any hydrophobic substance whether in liquid state or solid state would be suitable as the hydrophobic substance encapsulated in the silica particles produced by emulsion technique of Traynor in view of Karkkainen, Xia, Chen and Gehin-Delval, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Traynor et al (US 2012/0104639 A1) in view of Karkkainen (US 2010/0016488 A1), Xia et al (J. Porous Mater., 2010, 17: 225-252), Jones et al (Chem. Mater., 2008, 20: 3385-3397), Chen et al (Langmuir, 2018, 34: 10397-10406) and Gehin-Delval et al (US 2016/0316806 A1), and as evidenced by Thierauf (US 2010/0174045 A1), as applied to claims 1 and 6 above, and further in view of Lin et al (WO 2017/201528 A1).
The process of claims 1 and 6 are discussed above, said discussion being incorporated herein in its entirety.
However, Traynor, Karkkainen, Xia, Jones, Chen, and Gehin-Delval do not teach the active/payload is a taxane of claim 11.
Regarding claim 11, Lin teaches silica nanoparticles encapsulating hydrophobic drugs including paclitaxel and docetaxel (pages 4-11, 38-39 and 43-44). Lin teaches silica nanoparticles formulation provides improve delivery of the anticancer agents to tumors (page 4).
It would have been obvious to one of ordinary skill in the art to incorporate paclitaxel or docetaxel as the nonpolar active ingredient in the method of Traynor in view of Karkkainen, Xia, Chen and Gehin-Delval, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Lin provided the guidance to do so by teaching that hydrophobic drugs such as paclitaxel and docetaxel are suitable for encapsulation in silica nanoparticles and such encapsulation of paclitaxel or docetaxel in silica nanoparticles provides a delivery platform for chemotherapeutics to improve their delivery. Thus, an ordinary artisan seeking to provide a delivery platform for chemotherapeutics that provides improve delivery of the hydrophobic chemotherapeutics such as paclitaxel and docetaxel to the target site, would have looked to incorporating paclitaxel or docetaxel as the nonpolar active ingredient in the method of producing silica submicron/nanoparticles of Traynor in view of Karkkainen, Xia, Chen and Gehin-Delval, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant argues:
“Traynor does not teach or suggest the following process steps as presently claimed: i1) Separate hydrolysis of the silica precursors; i2) Formation of "pre-condensed silica precursors" to which a "carboxylic acid" is added for forming the dispersed phase and i3) Generation of an emulsion using a dispersed phase that already contains pre- hydrolyzed and pre-condensed silica precursors at the emulsification step, which is mixing this dispersed phase into an aqueous continuous phase. In view of present step i2), Traynor does not teach obtaining and using a dispersed phase composed of pre-condensed silica precursors, carboxylic acid compound and optionally an active (present claim 6), and using this dispersed phase for the emulsification step.” (Remarks, pages 8-9).
In response, the Examiner disagrees. Applicant’s arguments directed to Traynor is improperly providing a piecemeal analysis of the cited references. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The 103 rejection is based on the combined teachings of Traynor, Karkkainen, Xia, Jones, Chen, and Gehin-Delval. As discussed above in the pending 103 rejection, the process of independent claim 1 comprising steps i1), i2), i3), i4), and i5) have been taught and render obvious by the combined teachings of Traynor, Karkkainen, Xia, Jones, Chen, and Gehin-Delval. See 103 rejection, pages 3-10 of this office action.
Applicant argues that paragraph [0010] of Traynor only mentioned that the dispersed phase may contain silica precursors. Applicant alleges that paragraph [0010] of Traynor does not provide any teachings regarding the order of steps and when the silica precursors are introduced. Applicant goes on to further alleges that the Examiner is neglecting that claim 1 includes subsequent steps, for example Step (i2), where the organosiloxane precursors are combined into one container prior to emulsification, and Step (i3), where the organosiloxane precursors are concentrated by distillation of the volatile solvents and combined with a carboxylic acid.” Applicant goes on to allege that “while alternative embodiments might be used as evidence in a rejection, this does not remove the burden that any alternative embodiments must still be relevant to the rejected claim. Paragraph [0010] of Traynor, an alternative embodiment relied on in this rejection, teaches and describes in detail a "water-in-oil" emulsion. However, the presently claimed process produces an "oil-in-water" emulsion, and in particular an "oil-in- water" nanoemulsion. Therefore, whether paragraph [0010] is an alternative embodiment or not, any reference to it is not relevant to the presently claimed process, which produces an "oil-in-water emulsion". (Remarks, pages 9-10).
In response, the Examiner disagrees. Aside from paragraph [0010] of Traynor, the earlier paragraph [0009] of Traynor teaches the same yet for an “oil-in-water emulsion,” in which said paragraph [0009] like paragraph [0010], also teach the dispersed phase contains prehydrolyzed silica precursor. Thus, Traynor does teach and provide guidance for the dispersed phase to contain pre-hydrolyzed silica precursor.
Applicant argues “"removing a part or totality of the volatile solvents from
said combined pre-hydrolyzed organosiloxane precursors" is herein amended to "removing a part or totality of the volatile solvents from said combined pre-hydrolyzed organosiloxane precursors by distillation". This amendment distinguishes the presently claimed process from Traynor, because Traynor is silent on using distillation for this step. Instead, Traynor teaches washing reaction solutions with water using a centrifuge in Traynor Examples 1-7.” (Remarks, pages 11-12).
In response, the Examiner disagrees. As previously discussed, Paragraph [0026] of Traynor teaches “[t]he alcohol byproduct can be removed before emulsion templating using the prehydrolyzed silica precursor.” As to using distillation as the technique for removing the volatile solvents, as discussed in the pending 103 rejection, it would have been obvious to use known and conventional distillation technique to remove the alcohol byproduct from the prehydrolyzed silica precursors of Traynor, as it is well established in the prior art in view of Karkkainen, the alcohol byproduct from the prehydrolyzed silica precursors is normally removed by conventional distillation technique to obtain pre-condensed organosiloxane precursors (Karkkainen: Abstract; [0020]-[0035], [0039]; Examples 3-6). Thus, it would have been obvious and with reasonable expectation of success to apply known distillation technique per guidance from Karkkainen to remove the alcohol byproduct from the prehydrolyzed silica precursors of Traynor so as to yield predictable results of pre-condensed organosiloxane precursors.
Applicant argues:
“The present process is further distinguished from Traynor, because the distillation in step (i3) provides partial condensation (formation of prepolymer) of the pre-hydrolyzed organosiloxane precursors to pre-condensed (i.e. oligomerized) organosiloxane precursors (prepolymers). See present PCT Specification, p. 8, paragraph [0036]. Therefore, Traynor does not teach the formation of a prepolymer (i.e. pre-condensed silica precursors) as a component of the dispersed phase at this stage. Moreover, Traynor does not teach the controlled formation of pre-condensed polysiloxane precursors that can be used as the dispersed phase for creating the
emulsion. Instead, Traynor teaches that the pre-hydrolyzed organosiloxane precursor is
condensed all in one step after oil-in-water emulsion formation. See Traynor Examples 1-7. There is no mention of pre-condensation in the water removal step of Traynor. Moreover, pre- condensation is not inherent in Traynor, as the water removal is done at room temperature with no added condensation catalyst.” (Remarks, page 11, middle paragraph).
In response, the Examiner disagrees. As discussed above and in the pending 103 rejection, it would have been obvious to use known and conventional distillation technique to remove the alcohol byproduct from the prehydrolyzed silica precursors of Traynor, as it is well established in the prior art in view of Karkkainen, the alcohol byproduct from the prehydrolyzed silica precursors is normally removed by conventional distillation technique to obtain pre-condensed organosiloxane precursors (Karkkainen: Abstract; [0020]-[0035], [0039]; Examples 3-6). Thus, it would have been obvious and with reasonable expectation of success to apply known distillation technique per guidance from Karkkainen to remove the alcohol byproduct from the prehydrolyzed silica precursors of Traynor so as to yield predictable results of pre-condensed organosiloxane precursors.
Applicant argues “[a]s amended, the dispersed phase comprises a carboxylic acid, not a "carboxylic acid-containing compound" as previously claimed. Gehin-Deval does not teach or suggest "fatty acid coated silica" as alleged. Instead, Gehin-Deval teaches "particles of an edible inorganic salt" with "fatty acids coated or adsorbed onto their surface". (Gehin-Deval, paragraph [0001]) Thus, Gehin-Deval teaches fatty acid/edible inorganic salt composite particles, not "carboxylic acids" per se, as required by the present claims. Gehin-Deval provides no reason to think that carboxylic acids by themselves would be effective stabilizers in the absence of the edible inorganic salt. Moreover, Gehin-Deval provides no motivation to remove the edible inorganic salt from the carboxylic acid/edible inorganic salt composites taught therein as
stabilizers.” (Remarks, bottom of page 12 to page 13).
In response, the Examiner disagrees. “carboxylic acid” as amended claim 1 is still as broad and generic as the previously recited “carboxylic acid containing compound,” as the instantly claimed “carboxylic acid” is followed by the transitional phrase “comprising” and thus, is open-ended to include carboxylic acid derivatives containing at least 8 carbon atoms. Thus, it is maintained that octanoic acid coated silica as taught in Gehin-Deval meets the broadly claimed “a carboxylic acid comprising at least 8 carbon atoms” as recited in claim 1. Nevertheless, it is noted that the 103 rejection is using Gehin-Deval for teaching octanoic acid (caprylic acid) as a known carboxylic acid used for stabilizing emulsion. Gehin-Deval established it is the octanoic acid (caprylic acid) from the “octanoic acid coated silica” that is the component which stabilizes oil-in-water emulsion, as the silica particles alone did not stabilize the emulsion under shear force (Gehin-Deval: [0011]). Thus, octanoic acid is an emulsion stabilizer. This is supported by Applicant’s specification which defines octanoic acid as an emulsion stabilizer (Specification: [0031] and [0068]-[0069]). This is preponderance of evidence to support the Examiner’s obviousness rejection.
As a result, for at least the reasons discussed above and of record, claims 1, 4-6, 8-12, and 19 remain rejected as being obvious and unpatentable over the combined teachings of the cited priors in the pending 103 rejections as set forth in this office action.
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.
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Claims 1, 4-6, 8-12, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-14 of copending Application No. 17290052 (reference application) in view of Chen et al (Langmuir, 2018, 34: 10397-10406).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the instant application significantly overlap with the subject matter of the copending application ‘052, e.g., processes of preparation of organosiloxane nano-/microspheres comprising: i0) separately hydrolyzing two or more silica precursor in a hydrolytic media to provide two or more pre-hydrolyzed silica precursor; i1) combining the pre-hydrolyzed silica precursors of step i0) to provide a dispersed phase comprising combined pre-hydrolyzed silica precursors; i2) removing a part or totality of volatile solvents from said combined pre-hydrolyzed silica precursors to provide a dispersed phase comprising pre-condensed silica precursors; i3) emulsifying, in absence of a surfactant, the dispersed phase of the step i2) in a continuous phase to provide a water in oil emulsion; i4) adding a condensation catalyst to the emulsion of step i3) to provide said organosiloxane nano-/microspheres (nano-/microparticles), and wherein the organosiloxane nano-/microspheres (nano-/microparticles) are porous.
While the claims in the copending application ‘052 does not recite that the emulsifying step was performed with shear force or sonication as in the claims of the instant application, it would have been obvious to perform the emulsifying step in the copending application ‘052 with shear force or sonication to obtain a desired nanoparticle/nanosphere size per guidance from Chen et al, which teaches the size of the capsules can be controlled by emulsification energy and rate of subsequent stirring using the technique of ultrasonication or high-shear homogenization, and decreasing the capsule sizes to submicron size can be performed by increasing of the emulsification energy, and strong stirring of the resulting emulsion (Chen: Abstract; pages 10398-10399; pages 10404-10405).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 17290052 in view of Chen.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-6, 8-12, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12201956 in view of in view of Chen et al (Langmuir, 2018, 34: 10397-10406).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the instant application significantly overlap with the subject matter of the Patent ‘956, e.g., processes of preparation of spheroidal organosiloxane particle containing 1) separately hydrolyzing two or more silica precursors in a hydrolytic media to provide two or more pre-hydrolyzed silica precursors; 2) pre-condensing said pre-hydrolyzed silica precursors of step 1) to provide a pre-condensed silica precursor mixture; 3) adding a liposoluble active/payload to the mixture of step 2) to provide a dispersed phase; 4) emulsifying, in absence of a surfactant, the dispersed phase of the step 3) in an aqueous continuous phase to provide an oil in water emulsion; 5) adding a condensation catalyst to the emulsion of step 4) to obtain said spheroidal organosiloxane particle.
While the claims in the Patent ‘956 does not recite that the emulsifying step was performed with shear force or sonication as in the claims of the instant application, it would have been obvious to perform the emulsifying step in the Patent ‘956 with shear force or sonication to obtain a desired submicron/nanoparticle size per guidance from Chen et al, which teaches the size of the capsules can be controlled by emulsification energy and rate of subsequent stirring using the technique of ultrasonication or high-shear homogenization, and decreasing the capsule sizes to submicron size can be performed by increasing of the emulsification energy, and strong stirring of the resulting emulsion (Chen: Abstract; pages 10398-10399; pages 10404-10405).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the claims of U.S. Patent No. 12201956 in view of Chen.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant argues by requesting to defer further comment until claims in the '052 application [or ‘956 Patent] and the claims in the present application are otherwise allowable, and it is determined whether this provisional rejection becomes an actual rejection. (Remarks, pages 14-15).
In response, the claims in the instant application are not allowable and thus, the provisional double patent rejection over copending Application No(s). 17290052, and the double patenting rejection over U.S. Patent No. 12201956, are maintained for the reason of record, and pending filing of a terminal disclaimer.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/DOAN T PHAN/Primary Examiner, Art Unit 1613
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