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 .
Applicants’ arguments, filed 06/10/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1, 4-13, and 15-23, are pending.
Claims 16-18, 20, and 21, are withdrawn.
Claim Objections
Claims 1, 7, 8, and 22 are objected to because of the following informalities: the claims include nonstandard abbreviations including “PL”, “ST”, and “S” in a manner which is grammatically incorrect. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: “the active substance” should read “the one or more active substances” followed by “are” instead of “is” in order to be consistent with claim 1 as well as its use throughout the instant claims. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 7, 8, 12, 13, 15, 19, and 22, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Domb (US 5221535 A, cited on IDS dated 09/06/2023), as evidenced by Chojnacka et al (Biotechnol Lett, 2009, 31:705-709), Scholfield (JAOCS, 1981, pp. 889-892), and National Pesticide Information Center (DEET Technical Fact Sheet, 2008).
Domb teaches microsuspensions containing insect repellent that include lipospheres (abs). The lipospheres are coated with phospholipid on their surface (abs). The core of the liposphere may contain an insect repellent dispersed in a solid vehicle, such as a wax (abs). Steroids such as cholesterol may be incorporated into the phospholipid coating (col 5 ln 28-34). Insect repellants include DEET, plant oils to repel insects from plants including neem, citronella, eucalyptus, turpentine, etc. (col 5 ln 50 to col 6 ln 14). As evidenced by National Pesticide Information Center, DEET is a liquid and has a water solubility of less than 1.0 g/L at 25 °C (physical/chemical properties). The lipospheres are dispersed in an aqueous solution (col 2 ln 12-15 and 50-51, col 3 ln 18-21, claim 15). In particular embodiments, the formulations comprise water and lipospheres comprising DEET, core material, lecithin from soybean or egg yolk (ex. 4). The carriers were tripalmitin, beeswax, stearic acid, ethylstearate, and stearyl alcohol (ex. 4). The formulations comprised a ratio DEET:carrier:phosphatidylcholine of 1:2:1 (ex. 4). The lipospheres had an average particle size of 10-30 microns (ex. 4). In other embodiments, the formulation comprised 1 g of phosphatidylcholine, 1 g of tristearin, 0.5 g of DEET, and 10 ml of 0.9% saline, where the microparticles had an average size between 8 and 15 microns (ex. 3). In other embodiments, the formulations contained lipospheres comprising DEET, egg yolk lecithin, and tristearin, wherein DEET was included at 5 and 10 wt% based on the weight of the formulation (ex. 7, table 2). As evidenced by Chojnacka et al, egg yolk lecithin comprises cholesterol (intro 1st ¶). As evidenced by Scholfield, soy lecithin comprises campesterol, stigmasterol, and beta-sitosterol (pg 889 2nd col 1st ¶).
Regarding claim 1, where Domb discloses liquid formulations comprising lipospheres that are micron sized comprising egg yolk or soy lecithin phospholipid coating, and a core comprising DEET (liquid water immiscible pesticidal active agent) dispersed within the core, and are suspended in an aqueous medium, and wherein egg yolk or soy lecithin comprise at least one sterol, it appears the limitation of a microcapsule having a shell and a core, wherein the shell comprises at least one phospholipid and at least one sterol is met.
Regarding claim 6, there appears to be no microplastics in the embodiments disclosed above by Domb.
Regarding claims 7 and 8, while example 4 discloses that the phosphatidylcholine used were lecithin from egg yolk and from soybean, and partially hydrogenated phosphatidyl choline, the skilled artisan would at once envisage an embodiment comprising soy lecithin. A generic disclosure will anticipate a claimed species covered by that disclosure when the species can be at once envisaged from the disclosure. A reference disclosure can anticipate a claim when the reference describes the limitations but does not expressly spell out the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination. Where embodiments comprising soy lecithin are anticipated above, and soy lecithin comprises campesterol, stigmasterol, and beta-sitosterol, it appears the limitations are met.
Regarding claim 12, the embodiment of example 3 have average particle sizes ranging from 8 to 15 microns, thereby meeting the claimed limitation.
Regarding claim 13, where the embodiments disclosed above comprise a weight ratio of DEET:carrier:phosphatidylchole of 1:2:1, the percentage by weight of the active agent was 25 wt% of the microparticles, falling within the claimed range.
Regarding claim 15, where the embodiments disclosed by Domb comprise 1 g of phosphatidylcholine, 1 g of tristearin, 0.5 g of DEET, and 10 ml of 0.9% saline (about 10.05 g, calculated from the density of normal saline), the resulting percentage by weight of the active agent is 1 g/12.55 g, or about 8 wt%, thereby meeting the claimed limitation.
Regarding claim 19, the limitation is intended use, and where the formulation is anticipated above comprises pesticidal active agents, it appears the formulations would be capable of use in agrochemical applications.
Regarding claim 22, the active substance is taught to be distributed in the core of the microparticles, therefore the limitation appears to be met.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 6, 7, 8, 10, 12, 13, 15, 19, 22, and 23, are rejected under 35 U.S.C. 103 as being unpatentable over Domb (US 5221535 A), as evidenced by Wheatley et al (US 20120237450 A1), Chojnacka et al (Biotechnol Lett, 2009, 31:705-709), Scholfield (JAOCS, 1981, pp. 889-892), and National Pesticide Information Center (DEET Technical Fact Sheet, 2008), and Parchem (Citronella Oil, retrieved 2026)
Domb teaches microsuspensions containing insect repellent that include lipospheres (abs). The lipospheres that are water-insoluble microparticles are coated with phospholipid on their surface (abs). The core of the liposphere may contain an insect repellent dispersed in a solid vehicle, such as a wax (abs). Steroids such as cholesterol may be incorporated into the phospholipid coating (col 5 ln 28-34). Insect repellants include DEET, plant oils to repel insects from plants including neem, citronella, eucalyptus, turpentine, etc. (col 5 ln 50 to col 6 ln 14). As evidenced by National Pesticide Information Center, DEET is a liquid and has a water solubility of less than 1.0 g/L at 25 °C (physical/chemical properties). The lipospheres are dispersed in an aqueous solution (col 2 ln 12-15 and 50-51, col 3 ln 18-21, claim 15). In particular embodiments, the formulations comprise lipospheres comprising DEET, core material, lecithin from soybean or egg yolk, and water (ex. 4). The carriers used were tripalmitin, beeswax, stearic acid, ethylstearate, and stearyl alcohol (ex. 4). The formulations comprised a ratio DEET:carrier:phosphatidylcholine of 1:2:1 (ex. 4). The lipospheres had an average particle size of 10-30 microns (ex. 4). In other embodiments, the formulation comprised 1 g of phosphatidylcholine, 1 g of tristearin, 0.5 g of DEET, and 10 ml of 0.9% saline, where the microparticles had an average size between 8 and 15 microns (ex. 3). In other embodiments, the formulations contained lipospheres comprising DEET, egg yolk lecithin, and tristearin, wherein DEET was included at 5, 10, and 15 wt% based on the weight of the formulation (ex. 2, 7, tables 1, 2). As evidenced by Chojnacka et al, egg yolk lecithin comprises cholesterol (intro 1st ¶). As evidenced by Scholfield, soy lecithin comprises campesterol, stigmasterol, and beta-sitosterol (pg 889 2nd col 1st ¶). As evidenced by Parchem, citronella (i.e., citronella oil) is a water insoluble liquid. The effective concentration of the insect repellant is determined empirically by comparing effectiveness of formulations containing different quantities of active agents, and in particular embodiments, the active agent is included between 1 and 50% by weight (col 6 ln 33-38). The lipospheres have an average particle diameter between 0.35 and 250 microns (col 2 ln 10-12, ex. 4, claims 1, 9). The formulations can further include surfactants including Tween, Span, etc. (col 5 ln 44-49). As evidenced by Wheatley et al, Tween and Span are nonionic surfactants (¶ 86).
Domb is discussed above and purely arguendo, if DEET is somehow not capable of pesticidal agrochemical use as elected by applicants and if the skilled artisan would not have envisaged an embodiment comprising soy lecithin, the following applies.
Regarding claim 1, a formulation as instantly claimed comprising DEET is anticipated above, however, it would have been obvious to select from other suitable liquid pesticides for being dispersed in the core, including plant oils such as citronella oil, as taught by Domb.
Where Domb discloses liquid formulations comprising lipospheres that are micron sized comprising egg yolk or soy lecithin phospholipid coating, and a core comprising a liquid water immiscible pesticidal active agent dispersed within the core, and are suspended in an aqueous medium, and wherein egg yolk or soy lecithin comprise sterols, it appears the limitation of a microcapsule having a shell and a core, wherein the shell comprises at least one phospholipid and at least one sterol is met.
Regarding claim 6, it would have been obvious to formulate liquid formulations that are free of any microplastics, where the core and shell materials are taught to comprises components that appear to be free of microplastics.
Regarding claim 7, purely arguendo, if somehow the skilled artisan would not at once envisage an embodiment comprising soy lecithin, it would have been obvious to select from soy lecithin as the phospholipid, as taught by Domb.
Regarding claim 8, where the selection of soy lecithin as the phospholipid is made obvious above, and Scholfield evidences that soy lecithin comprises campesterol, stigmasterol, and beta-sitosterol, it appears the limitation of wherein the microparticles comprise a sterol selected from those of instant claim 8 is met.
Regarding claim 10, it would have been obvious to further include a nonionic surfactant, as taught by Domb, where the skilled artisan would recognize that surfactants can be used to aid in stability and dispersibility of dispersed formulations.
Regarding claim 12, it would have been obvious to formulate the microparticles with an average particle diameter between 0.35 and 250 microns, with particular examples with 8-15 microns, and 10-30 microns, as taught by Domb. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 13, it would have been obvious to include the pesticidal active agent made obvious above in the microparticles in amounts ranging from 1 and 50% by weight, as taught by Domb, depending on the active and desired use of the formulations.
Regarding claim 15, it would have been obvious to include the pesticidal active agent made obvious above from 1 to 50% by weight, including 5, 10, and 15% by weight from the working embodiments, which appear to be based on the entire weight of the liquid formulations. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 19, where the liquid formulation made obvious above comprises pesticidal active agents, including citronella oil that are taught to be capable of repelling pests from plants, it appears the formulations would be capable of being used in agrochemical applications.
Regarding claim 22, where the microparticle formulation made obvious above comprise the liquid pesticidal agent dispersed within the core, it appears the limitation is met.
Regarding claim 23, it would have been obvious to include the pesticidal active agent made obvious above from 1 to 50% by weight, as taught by Domb above and for the same reasons. Purely arguendo, if somehow the weight percentages are not based on the weight of the entire formulation, where the working embodiments comprise 15 wt% of active agent based on the total weight of the liquid formulation, it would have been well within the relative skills of the skilled artisan to have routinely adjusted the amount of active agent depending on the particular active, desired level of pest control, and intended use of the formulations. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Claims 4, 5, and 9, are rejected under 35 U.S.C. 103 as being unpatentable over Domb (US 5221535 A), in view of Kuriyama (JP 2006043689 A, cited on IDS dated 02/23/2026) and Xu et al (Biomat, 2007, pp. 2687-2694, hereinafter “Xu”), as evidenced by ACS (Hydroxyapatite, 2023).
Domb is discussed above but does not teach an inorganic salt or mineral as instantly claimed.
Kuriyama teaches stable particles having an average diameter of 5 microns or less, where it was known to adhere fine particles to the surface of the microparticles, in order to protect the nanoparticle from the effects of light, oxygen, heat, pressure, etc. (abs, ¶¶ 3, 22). The particles that can be adhered to the surface include poorly water-soluble inorganic calcium salt, including hydroxy apatite, etc. (¶ 37). As evidenced by ACS, hydroxyapatite has a water solubility of 44 μg/L at 37 deg C and comprises phosphate. The poorly water-soluble inorganic calcium salt adheres to anionic functional groups on the surface of the microparticles (¶ 16). The microparticles may comprise pesticides, etc. (¶ 38).
Xu teaches it was known to coat lipid particles comprising water insoluble active agents with hydroxyapatite, where the hydroxyapatite coatings altered the release rate of the active from the liposomes (abs).
It would have been obvious to modify the surface of the microparticles made obvious above, by including solid particles of a water-insoluble calcium salt, such as hydroxy apatite, to the surface of the phospholipid shell in order to protect the microparticle and water-insoluble pesticide from the effects of light, oxygen, heat, pressure, etc., where coating pesticidal microparticles with these inorganic salts and minerals were known by Kuriyama. Additional motivation is provided by Xu, where it would have been obvious to coat the microparticles with hydroxy apatite in order modulate the release properties of the water-insoluble active agent, as taught by Xu, for desired treatments, etc. The skilled artisan would have a reasonable expectation of success where coating microparticles comprising water insoluble pesticides were known from Kuriyama, and where Xu teaches coating phospholipid containing microparticles encapsulating water-insoluble actives with hydroxy apatite was known.
Regarding the water solubility, where hydroxyapatite is made obvious above and has a water solubility of 44 μg/L at 37 deg C (i.e., 44 μg/1000 g = 0.0000044 wt%), it would be expected that at a lower temperature of 21 deg C, the water solubility would be even less, falling within the claimed range.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Domb (US 5221535 A), in view of Domb (US 5188837 A, hereinafter “Domb ‘837”, cited on IDS dated 09/06/2023), and Schroeder et al (US 20190098895 A1, hereinafter “Schroeder”).
Domb is discussed above but does not teach the specific ratio of phospholipid to cholesterol of claim 11. Further, purely arguendo, if somehow the sterols comprised within the soy lecithin do not read on wherein the composition comprises the sterols of claim 8, the following applies.
Domb ‘837 teaches microsuspensions of lipospheres comprising a phospholipid coating and a core comprising an active agent, where steroids, such as cholesterol, were known to be included to the phospholipid component in order to increase the membrane’s stability and decrease its reactivity (col 5 ln 38-44).
Domb ‘837 does not specifically teach the sterols of claim 8, nor the ratio of claim 11.
Schroeder teaches known sterols used in phospholipid membranes include beta-sitosterol, beta-sitostanol, stigmasterol, stigmastanol, campesterol, campestanol, ergosterol, avanasterol, brassicasterol, etc. (¶¶ 81, 82). In embodiments, phosphatidylcholine and cholesterol were used in weight ratios of 79:19, 73:25, and 49:49 (table 1).
Regarding claim 8, while it appears the limitation is met for reasons discussed above, purely arguendo, if not, it would have been obvious to further include sterols in the phospholipid membrane, as taught by Domb, and where Domb ‘837 teaches sterols can be included in the phospholipid shell in order to increase the membrane’s stability and decrease its reactivity.
Regarding the particular sterol, it would have been obvious to include known sterols suitable for phospholipid membranes, including beta-sitosterol, beta-sitostanol, stigmasterol, stigmastanol, campesterol, campestanol, ergosterol, avanasterol, brassicasterol, etc., as taught by Schroeder, with a reasonable expectation of success where the particles of Domb, Domb ‘837, and Schroeder all comprise a phospholipid shell.
Regarding claim 11, where the combination of phospholipid and sterol is made obvious above and was known to increase membrane stability and decrease its reactivity, it would have been obvious to include known ratios of phosphatidylcholine:sterol suitable for phospholipid membranes, including ratios of 79:19, 73:25, and 49:49, falling within the claimed range.
Claims 1, 6-8, 11-13, 15, and 19, are rejected under 35 U.S.C. 103 as being unpatentable over Kinzell et al (WO 2000042990 A1, hereinafter “Kinzell”), as evidenced by Tsumoto et al (2011 Internation Symposium on Micro-NanomMechatronics and Human Science, 2011, pp. 439-444), and Parchem (Citronella Oil, retrieved 2026) and Scholfield (JAOCS, 1981, pp. 889-892).
Kinzell teaches liposomal formulations containing pest growth regulators, pest repellants, and pesticides, wherein the liposomes can have particle diameters up to 50 microns, including up to 10,000 A (0.1 micron), etc. (pg 6 ln 13-33). As evidenced by as evidenced by Tsumoto et al liposomes can be classified as microcapsules. Pesticides include ivermectin, etc. (insecticide, see ¶ 230 of the instant specification), pest repellants include citronella, etc. (pg 5 ln 5-23). As evidenced by the instant specification, pest repellants are pesticides (see ¶ 67 of the instant specification). As evidenced by Parchem, citronella (i.e., citronella oil) is a water insoluble liquid. In one embodiment, the liposome comprises about 0.001-10.0 wt% of the at least one active agent, a lipid phase, and an aqueous phase (pg. 9 ln 16-24). The lipid phase contains the active ingredient and phospholipids, suitable phospholipids include soy lecithin, etc. (pg 10 ln 7-21). As evidenced by Scholfield, soy lecithin comprises campesterol, stigmasterol, and beta-sitosterol (pg 889 2nd col 1st ¶). In addition, the lipid phase may contain one or more sterols, cholesterol, in an amount from about 0.01-12.0 wt% of the lipid phase (pg 11 ln 3-10). Liquid liposome formulations can be prepared, including liquid suspensions (pg 16 ln 11). The phospholipids can be about 2.0-75.0 wt% of the lipid phase (pg 10 ln 7-8). The amount of the active agent in the liposome formulation of the invention can vary within the full range employed by those skilled in the art, e.g., from about 0.001 weight percent (wt%) to about 99.99 wt% of the active agent based on the total formulation (pg 8 ln 20-30). The compositions have broad utility and can be used on agricultural plants, etc. (pg 4 ln 15-20).
Regarding claim 1, it would have been obvious to formulate a liquid microparticle formulation comprising citronella (water immiscible liquid), a phospholipid, and a sterol, wherein the microparticles are dispersed in an aqueous medium, as taught by Kinzell.
Regarding the limitation of microparticles of claim 1, it would have been obvious to formulate the liquid formulation comprising particles in known sizes, such as up to 10,000 A (i.e., 0.1 micron), up to 50 microns, etc., thereby reading on microparticles.
Regarding the pesticide of claim 1, where the instant specification defines pesticides to include pest repellants, it appears that the liquid citronella pest repellent reads on a pesticide as instantly claimed.
Regarding the microparticles of claim 1, where a liquid formulation comprising liposomes are made obvious above, and comprise phospholipid and sterol, it would be reasonably expected that the phospholipid and sterol would be present in the outer shell of the microsphere, defining a microparticle core.
Regarding claim 6, it would have been obvious to formulate the microparticles made obvious above free from microplastics, where there are no teachings or suggestions in Kinzell for the inclusion of microplastics.
Regarding claim 7, it would have been obvious to select from soy lecithin as the phospholipid, as taught by Kinzell.
Regarding claim 8, where the selection of soy lecithin as the phospholipid is made obvious above, and Scholfield evidences that soy lecithin comprises campesterol, stigmasterol, and beta-sitosterol, it appears the limitation of wherein the microparticles comprise a sterol selected from those of instant claim 8 is met.
Regarding claim 11, where the lipid phase can comprise from about 2.0-70.0 wt% of the phospholipid and 0.01-12.0 wt% of sterols, it would have been obvious for the skilled artisan to select from ratios within that range, such as 2:12 to 10:1, as instantly claimed. Note, since mass and weight are directly proportional under normal Earth gravity, the numerical values for mass% and wt% are the same.
Regarding claim 12, it would have been obvious to formulate the microparticles made obvious above with an average size falling within the particle sizes taught to be suitable by Kinzell, such as up to 10,000 angstroms (i.e., 0.1 microns), up to 50 microns, etc., overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 13 and 15, it would have been obvious to include the pesticidal active ingredient from 0.001-99.99 wt%, such as from about 0.001-10.0 wt%, as taught by Kinzell. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 19, the examiner notes that the limitation is the intended use of the formulations, and where the formulations made obvious above can be used on agricultural plants, it appears the compositions would be capable of being used in agrochemical applications, thereby meeting the claimed limitation.
Response to Arguments
Applicants assert Kinzell’s teachings of a liposome are distinct from microcapsules and microspheres as instantly claimed. Applicants assert liposomes are not microspheres as microspheres do not include a lipid bilayer and they are not microcapsules because liposomes do not have a core.
Respectfully, this argument is not persuasive. While the examiner recognizes that Kinzell teaches liposomes comprising a lipid bilayer, the broadest reasonable interpretation of a micro sized liposome is a particle that comprises a core (aqueous), and a shell (lipid bilayer) comprising phospholipid and cholesterol. The examiner notes that aside from new claim 22, the active agent is not required to be contained in the core. Applicants cite a reference where liposomes are included separately from the description of microspheres and microcapsules, however, the terms microcapsules and microspheres are not used consistently in the prior art. As evidenced by Tsumoto et al, liposomes can be classified as microcapsules. Accordingly, it appears that where the liposomes encapsulate a core, are micro-sized, and have a phospholipid membrane shell comprising a sterol, the limitation of microcapsules appears to be reasonably met.
Claims 4, 5, and 9, are rejected under 35 U.S.C. 103 as being unpatentable over Kinzell et al (WO 2000042990 A1, hereinafter “Kinzell”), as applied to claims 1, 6-8, 11-13, 15, and 19, above, and further in view of Kuriyama (JP 2006043689 A, cited on IDS dated 02/23/2026) and Xu et al (Biomat, 2007, pp. 2687-2694, hereinafter “Xu”), as evidenced by ACS (Hydroxyapatite, 2023).
Kinzell is discussed above but does not teach an inorganic salt or mineral as instantly claimed.
Kuriyama teaches stable particles having an average diameter of 5 microns or less, where it was known to adhere fine particles to the surface of the microparticles, in order to protect the nanoparticle from the effects of light, oxygen, heat, pressure, etc. (abs, ¶¶ 3, 22). The particles that can be adhered to the surface include poorly water-soluble inorganic calcium salt, including hydroxy apatite, etc. (¶ 37). As evidenced by ACS, hydroxyapatite has a water solubility of 44 μg/L at 37 deg C and comprises phosphate. The poorly water-soluble inorganic calcium salt adheres to anionic functional groups on the surface of the microparticles (¶ 16). The microparticles may comprise pesticides, etc. (¶ 38).
Xu teaches it was known to coat liposomes comprising water insoluble active agents with hydroxyapatite, where the hydroxyapatite coatings altered the release rate of the active from the liposomes (abs).
It would have been obvious to modify the surface of the microparticles made obvious above, by including solid particles of a water-insoluble calcium salt, such as hydroxy apatite, to the surface of the liposomes in order to protect the microparticle and water-insoluble pesticide from the effects of light, oxygen, heat, pressure, etc., where coating pesticidal microparticles with these inorganic salts and minerals were known by Kuriyama. Additional motivation is provided by Xu, where it would have been obvious to coat the liposomal microparticles with hydroxy apatite in order to modulate the release properties of the water-insoluble active agent, as taught by Xu, for desired treatments, etc. The skilled artisan would have a reasonable expectation of success where coating microparticles comprising water insoluble pesticides were known from Kuriyama, and where Xu teaches coating liposomes encapsulating water-insoluble actives with hydroxy apatite was known.
Regarding the water solubility, where hydroxyapatite is made obvious above and has a water solubility of 44 μg/L at 37 deg C (i.e., 44 μg/1000 g = 0.0000044 wt%), it would be expected that at a lower temperature of 21 deg C, the water solubility would be even less, falling within the claimed range.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kinzell et al (WO 2000042990 A1, hereinafter “Kinzell”), as applied to claims 1, 6-8, 11-13, 15, and 19, above, and further in view of Schroeder et al (US 20190098895 A1, hereinafter “Schroeder”).
Kinzell is discussed above, and purely arguendo, if somehow the sterols comprised within the soy lecithin do not read on wherein the composition comprises these sterols, the following applies.
Schroeder teaches liposomal formulations for use in agriculture, wherein the liposomes comprise phospholipids and a sterol (abs, claim 37). Known sterols include beta-sitosterol, beta-sitostanol, stigmasterol, stigmastanol, campesterol, campestanol, ergosterol, avanasterol, brassicasterol, etc. (¶¶ 81, 82).
Regarding claim 8, where the inclusion of a sterol is made obvious above, it would have been obvious to select from known sterols suitable for liposomal formulations that can be used in agricultural applications, such as beta-sitosterol, beta-sitostanol, stigmasterol, stigmastanol, campesterol, campestanol, ergosterol, avanasterol, brassicasterol, etc., as taught by Schroeder.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kinzell et al (WO 2000042990 A1, hereinafter “Kinzell”), as applied to claims 1, 6-8, 11-13, 15, and 19, above, and further in view of Parikh et al (US 5922355 A, hereinafter “Parikh”).
Kinzell is discussed above but does not specifically teach formulations further comprising a non-ionic surfactant.
Parikh teaches compositions comprising particles comprising water-insoluble or poorly soluble drugs or other compounds, wherein the particles comprise phospholipids, and one or more surfactants, including non-ionic surfactants, where the combination of phospholipids and surfactants allow for the formation and stabilization of micron sized compound particles and prevents these particles from aggregation or flocculation (col 1 1st ¶).
Regarding claim 10, it would have been obvious to further include a non-ionic surfactant to the liquid formulations made obvious above, where non-ionic surfactants in combination with phospholipids, were known to prevent microparticles comprising water-insoluble actives from aggregation and flocculation, as taught by Parikh.
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, 4-13, 15, 19, 22, and 23, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/689,107 (reference application), hereinafter ‘107. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘107 disclose a microparticle comprising a water immiscible active substance, wherein the active substance is a liquid at 21 deg C or dissolved in a non-aqueous solvent that is immiscible with water, wherein the microparticle contains at least one phospholipid, at least one sterol, and optionally an inorganic salt. The microparticle is free from a microplastic. The microparticles are dispersed in an aqueous medium. The sterol is selected from those of instant claim 8. The microparticle further comprises a non-ionic surfactant. The water inorganic salt or mineral has a water solubility of less than 0.01 wt% at 21 deg C and is selected from those of instant claim 9. The microparticles have an average diameter of 1-10 microns, and contains from 1-95 wt% active substance selected from pesticides, etc.
It would have been obvious to formulate a liquid formulation as instantly claimed comprising a liquid pesticidal active agent and in the claimed amounts, at least one phospholipid, and at least one sterol, as disclosed by the claims of ‘107, thereby arriving at the instantly claimed formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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