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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Status of the Claims
This action is in response to papers filed 11/20/2025 in which claims 2-3 and 7 were canceled; claims 13-17 were withdrawn; and claim 1 was amended. All the amendments have been thoroughly reviewed and entered.
Claims 1, 4-6, 8-12, and 18 are under examination.
Withdrawn Rejection
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 Any rejection and/or objection not specifically addressed below is hereby withdrawn.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.
New Rejection
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 1, 4-6, 8-12, and 18 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.
Regarding claim 1, the formula of R4-xSi(L)x renders the claim indefinite because R4 is not defined in claim 1. Claim 1 recites the description of “R,” yet there is no “R” group in any of the formula(s) recited in claim 1. Thus, it is unclear the metes and bounds of R4 in the formula of R4-xSi(L)x, as well as, the metes and bounds of the description of the “R” group in claim 1 is also unclear. Claims 4-6, 8-12, and 18 are also rejected as they depends directly or indirectly from indefinite claim 1.
As a result, claims 1, 4-6, 8-12, and 18 do not clearly set forth the metes and bounds of patent protection desired.
Maintained-Modified Rejections
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 introduces new matter as the claim recites the limitation: the two or more pre-hydrolyzed organosiloxane precursors are each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor. There is no support in the specification for this broadly generic limitation.
Applicant asserted that support for claim 18 is found in page 7, paragraph 31, and in Examples 1 and 2, on page 60, paragraph 132 to page 64, paragraph 137, of the PCT application.
However, after thorough review of said pages and paragraphs as cited by Applicant in the PCT application, as well as, throughout the specification, there remained to be no support for the generic claimed limitation of “the two or more pre-hydrolyzed organosiloxane precursors are each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor.”
It is noted that page 7, paragraph 31 of the specification is drawn to nanoemulsion stabilizer and thus, is not pertinent to limitation of claim 18 drawn to each hydrolyzed organosiloxane precursors being hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor.
With respect to Examples 1 and 2, on page 60, paragraph 132 to page 64, paragraph 137 of the specification, the Examples 1-2 are drawn to specific molar compositions as set forth below:
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60
666
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192
652
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248
652
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250
658
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As shown above, Examples 1 and 2 are limited to particular silica precursors (i.e. TEO, C1-TES and C8-TES), particular inorganic acid (hydrochloric acid), and in their different respective concentrations, as well as, different molar ratios (i.e., molar ratio of water to TEOS 1.1:1, molar ratio of water to C1-TES was 3.3:1, and molar ratio of water to C8-TES was 3.3:1). However, claim 18 is drawn to generically to “each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor,” which encompassed broadly any organosiloxane precursors, any inorganic acid, and an indefinite range of molar ratios of water to organosiloxane precursors and inorganic acid to organosiloxane precursor. For example, the limitation of claim 18 is very broad to the extent that it encompasses silica precursors, tetrabutoxysilane, methyltrimethoxysilane, and phenyltriethoxysilane, wherein a set of molar ratios of water to tetrabutoxysilane is 5:1, water to methyltrimethoxysilane 2:1, and water to phenyltriethoxysilane 8:1, and the inorganic acid is sulfuric acid at molar concentration of 1M. This example is not supported by the specification, yet reads on the generically claimed “the two or more pre-hydrolyzed organosiloxane precursors are each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor.”
Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
Applicant argues:
“The Examiner has correctly identified specific pre-hydrolyzed organosiloxane precursors, different ratios of water to organosiloxane precursors, and a specific inorganic acid, indicating that the scope of the claim is well understood. Moreover, support for this claim is not limited to Examples 1 and 2. In fact, all of inventive Examples 1 to 30 provide support for the broad scope of claim 18. Applicant respectfully submits that the breadth of scope of Examples 1 to 30 provides sufficient support for the general concept behind the broad scope of claim 18.” (Remarks, page 15, last paragraph to page 16).
In response, the Examiner disagrees. Examples 3-30 are similar to Examples 1 and 2 and uses the same procedures as Example 2, thereby are limited to the same particular silica precursors (i.e. TEO, C1-TES and C8-TES), particular inorganic acid (hydrochloric acid), and in their different respective concentrations, as well as, different molar ratios (i.e., molar ratio of water to TEOS 1.1:1, molar ratio of water to C1-TES was 3.3:1, and molar ratio of water to C8-TES was 3.3:1).
Thus, as discussed in the standing New Matter rejection, it is maintained that claim 18 is drawn to generically to “each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor,” which encompassed broadly any organosiloxane precursors, any inorganic acid, and an indefinite range of molar ratios of water to organosiloxane precursors and inorganic acid to organosiloxane precursor. For example, the limitation of claim 18 is very broad to the extent that it encompasses silica precursors, tetrabutoxysilane, methyltrimethoxysilane, and phenyltriethoxysilane, wherein a set of molar ratios of water to tetrabutoxysilane is 5:1, water to methyltrimethoxysilane 2:1, and water to phenyltriethoxysilane 8:1, and the inorganic acid is sulfuric acid at molar concentration of 1M. This example is not supported by the specification, yet reads on the generically claimed “the two or more pre-hydrolyzed organosiloxane precursors are each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor.”
As such, it is maintained that, Applicant does not have possession of the generic claimed limitation of “the two or more pre-hydrolyzed organosiloxane precursors are each hydrolyzed with different molar ratios of water to organosiloxane precursor, different molar ratios of inorganic acid to organosiloxane precursors, or both different molar ratios of water to organosiloxane precursors and different molar ratios of inorganic acid to organosiloxane precursor.”
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 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Traynor et al (US 2012/0104639 A1) in view of 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 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 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 18, Jones provides the guidance for conducting the separate hydrolyzation of the two silica precursors where the silica precursors were separately hydrolyzed with different molar ratios of inorganic acid (HCl) to silica precursors so as the resultant mesoporous organosilica particles exhibited increased pore dimensions and the ability to control the molecular recognition properties of the porous network by altering organic functionalities (Abstract; Introduction; pages 3386-3388 and 3397) Thus, an ordinary artisan seeking to increase pore dimensions and control the molecular recognition properties of the resultant porous network of the mesoporous organosilica particles, would have looked optimizing the method of Traynor such that the silica precursors were separately hydrolyzed with different molar ratios of inorganic acid (HCl) to silica precursors, 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) 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 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, 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 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 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 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, 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 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 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 11/20/2025 have been fully considered but they are not persuasive.
Applicant argues that the dispersed phase of Traynor does not contain the silica precursors (Remarks, pages 6-9).
In response, the Examiner disagrees. Paragraph [0010] Traynor does teach and provide guidance for the disperse phase to contain prehydrolyzed silica precursor. While paragraph [0010] of Traynor is an alternative embodiment, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art and thus, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant argues the precursors mentioned in Xia are only of formulation (L)3Si-R’-Si(L)3, which is contrast to claim 1 reciting that “at least one of the at least two silica precursors has the formula R4-xSi(L)x” (Remarks, page 7, last paragraph to page 8).
In response, the Examiner disagrees. Xia was only used for teaching the technique of separately hydrolyzing silica precursors in the method producing mesoporous organosilica particles. As discussed above in the pending 103 rejection, the two silica precursors wherein at least one of the two or more silica precursors has the formula R4-xSi(L)x was taught by Traynor. As discussed in the 103 rejection, 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), and specific examples of silica precursors include tetramethoxysilane (TMOS), tetraethoxysilane (TEOS), tetrabutoxysilane (TBOS), tetrapropoxysilane (TPOS), polydiethoxysilane, methyltrimethoxysilane, methyltriethoxysilane, ethyltriethoxysilane, phenyltriethoxysilane, octylpolysilsesquioxane and hexylpolysilsesquioxane ([0056]), thereby meeting the claimed “wherein at least one of the two or more silica precursors has the formula R4-xSi(L)x.”
Applicant argues that paragraph [0026] of Traynor only teaches a simple solvent removal step and not to a pre-condensation step by solvent removal, and thus, Traynor does not teach the formation of a prepolymer (i.e., precondensed silica precursors) as the main component of the dispersed phase. Applicant further alleges that “Traynor does not teach the controlled formation of an oligomer of silica precursors that can be used as the dispersed aqueous phase for creating the emulsion” (Remarks, page 9, 1st paragraph).
In response, the Examiner disagrees. Step i3) of claim 1 recites “removing a part or totality of the volatile solvents from said combined pre-hydrolyzed organosiloxane precursors to provide a dispersed phase comprising pre-condensed organosiloxane precursor.” Paragraph [0026] of Traynor teaches “[t]he alcohol byproduct can be removed before emulsion templating using the prehydrolyzed silica precursor,” which reads on the claimed step of “removing a part or totality of the volatile solvents from said combined pre-hydrolyzed organosiloxane precursors.” Thus, the removal of the alcohol byproduct before emulsion templating of Traynor would provide a dispersed phase comprising pre-condensed organosiloxane precursor, as the active step of “removing a part or totality of the volatile solvents from said combined pre-hydrolyzed organosiloxane precursors” has been taught by Traynor.
Applicant argues Ghehin-Delval does not “teach or suggest that it is the fatty acids themselves, not the edible inorganic salts or the edible inorganic salts coated with fatty acids, that is responsible for stabilization of the emulsion.” Thus, Applicant alleges that “Gelhin-Deval provides no motivation to add fatty acids alone, as there is no expectation of emulsion stabilization from fatty acids alone.” Applicant further alleges that Ghehin-Delval is a pickering emulsion and thus, is different from the claimed nanoemulsion. Applicant further alleges that “there is nothing in Gehin-Delval to suggest that the fatty acid used therein would be effective in promoting emulsion stability if it were not confined to the interface(s) between the immiscible phases instead of dissolved in the dispersed phase in the absence of the edible inorganic particles.” (Remarks, page 9, last paragraph to page 11),
In response, the Examiner disagrees. While the preferred embodiment of Gehin-Deval is to producing a double emulsion, the main objective of Gehin-Deval relates to emulsion and the use of fatty acid (octanoic acid) coated silica to stabilize the emulsion (Gehin-Deval: [0001]). Octanoic acid coated silica as taught in Gehin-Deval meets the broadly claimed “a carboxylic acid-containing compound comprising at least 8 carbon atoms” as recited in claim 1. Gehin-Deval established it is octanoic acid (caprylic acid) that is coated on the particles which stabilizes oil-in-water emulsion, as the particles alone did not stabilize the emulsion under shear force (Gehin-Deval: [0011]). Thus, octanoic acid is an emulsion stabilizer, irrespective of the type of emulsion. As discussed above, Gehin-Deval established it is octanoic acid (caprylic acid) that is coated on the particles which stabilizes oil-in-water emulsion, as the particles alone did not stabilize the emulsion under shear force. 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.
Applicant argues that “Xia does not teach combining the pre-hydrolyzed organosiloxane precursors together into one container before continuing with other steps.” Applicant the alleges that Jones only teaches precursors of formulation (L)3Si-R’-Si(L)3 and thus, does not teach “at least one of the at least two silica precursors has the formula R4-xSi(L)x.” Applicant further alleges “Jones does not teach or suggest the formation of a precondensed silica precursor or the use of such a precursor as the dispersed phase of an oil in water nanoemulsion” and “Traynor is also silent regarding a separate hydrolysis step.” (Remarks, pages 11-13).
In response, the Examiner disagrees. As discussed above, Xia and Jones were only used for teaching the technique/concept of separately hydrolyzing silica precursors in the method producing mesoporous organosilica particles. As discussed above in the pending 103 rejection, the two silica precursors wherein at least one of the two or more silica precursors has the formula R4-xSi(L)x was taught by Traynor. As discussed in the 103 rejection, 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), and specific examples of silica precursors include tetramethoxysilane (TMOS), tetraethoxysilane (TEOS), tetrabutoxysilane (TBOS), tetrapropoxysilane (TPOS), polydiethoxysilane, methyltrimethoxysilane, methyltriethoxysilane, ethyltriethoxysilane, phenyltriethoxysilane, octylpolysilsesquioxane and hexylpolysilsesquioxane ([0056]), thereby meeting the claimed “wherein at least one of the two or more silica precursors has the formula R4-xSi(L)x.”
With respect to the claimed step “i1) separately hydrolyzing in a separate containers at least two organosiloxane precursors in a hydrolytic media,” as discussed above in the standing 103 rejection, this step was render obvious by the teachings from Xia in view of Jones. As discussed in the 103 rejection, 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). Accordingly, 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. As such, Applicant’s claimed step i1) separately hydrolyzing at least two organosiloxane precursors in a hydrolytic media to provide pre-hydrolyzed organosiloxane precursors” in the process of preparing spheroidal organosiloxane submicron/nanoparticles is an obvious step in producing a desired porous spheroidal organosiloxane submicron/nanoparticles because as discussed above, Xia in view of Jones established the claimed step of i1) is an obvious and feasible modification in the method Traynor to produce porous spherical silica particles.
As a result, for at least the reasons discussed above, claims 1, 4-6, 8-12, and 18 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts 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.
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.
Claims 1, 4-6, 8-12, and 18 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 18 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 11/20/2025 have been fully considered but they are not persuasive.
Applicant argues by requesting to defer further comment until claims in the '052 and the claims in the present application are otherwise allowable, and it is determined whether this provisional rejection becomes an actual rejection. (Remarks, page 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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613