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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1, 3-15, and 19, and the species of pesticides and agrochemical use, in the reply filed on 02/06/2026 is acknowledged. The traversal is on the ground(s) that Haynes is not relevant to the instant claims as the reference does not disclose formulations containing antibacterial active ingredients. Without agreeing to Applicants’ arguments, in view of Applicants’ elected invention and species, Haynes is no longer relied upon in the office action and the arguments with respect to the teaches of Haynes are moot. Applicants assert the Office fails to indicate whether Groups I-IV are classified in different classes or subclasses, and asserts no evidence of a serous search burden has been established, however, the examiner notes that different classifications and proof of a serious search burden is not a requirement under 371 practice.
Groups I-IV lack unity of intention because even though the inventions of these groups require the technical feature of the liquid formulation comprising microparticles of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kinzell et al (WO 2000042990 A1), for the same reasons discussed below. Therefore, the common technical feature is not a special technical feature, and unity is broken.
Applicants assert claims 1, 3-13, 15, and 19, are readable on the elected invention and species.
Claims 16-18, 20, and 21, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/06/2026.
Claim Status
Claims 1, 3-13, and 15-21, are pending.
Claims 16-18, 20, and 21, are withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites “said” throughout. Further, the abstract appears to be a machine translation, and the examiner requests review of the text. For example, the abstract beings with “Microparticle” and should read “A microparticle containing”, “A microparticle comprising”, “Microparticle comprising”, etc. Further, the language “one or more active substance being water immiscible, and being liquid (at 21 deg C) pesticide or dissolved in a non-aqueous solvent…” should be reviewed. An example of suitable language could be “wherein the one or more active substances are water-immiscible pesticides and are liquid at 21 deg C, or are dissolved in a non-aqueous solvent…”, etc., but are not limited thereto.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In the present instance, embedded hyperlinks and/or other forms of browser-executable code are found on pp. 20 and 30 of the instant specification.
Claim Objections
Claim 1 is objected to because of the following informalities: “one or more active substance” should read “one or more active substances”. Further, where one or more active substances are followed by “is”, “are” should be used in place of “is.”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: in ln 1, following “according to claim 1”, the extra space between 1 and wherein should be removed. Appropriate correction is required.
Claim 3 is also objected to because of the following informalities: in ln 3, “wherein phospholipid PL and sterol ST,” should read “wherein the at least one phospholipid PL and the at least one sterol ST,” in order to be consistent with the language used in claim 1.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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, 3-13, 15, and 19, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein said one or more active substance is a liquid (at 21 deg C),” and it is unclear if the 21 deg C limitation is a required limitation or is optional, in view of the parenthesis. For purposes of examination, the examiner is interpreting the temperature as required and the claim as “wherein said one or more active substance is a liquid at 21 deg C.”
Claim 3 recites “wherein a microparticle,” and it is unclear if “a microparticle” is intended to refer to the microparticles of claim 1, or an additional microparticle. For purposes of examination, the claim is interpreted as “wherein the microparticles” to make clear that the microparticles of claim 1 are being further defined. Additionally, where the microparticles of claim 1 are plural, the remainder of claim 3 should reflect the plurality of the microparticles. For example, “is a microcapsule” and “is a microsphere” should read “are microcapsules” and “are microspheres,” etc.
Claims 3-13, 15, and 19, are also rejected for the same reasons for depending upon rejected claim 1.
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, 3, 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 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). 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 claim 3, 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.
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, 3, 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 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, 3, 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, 3, 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, 3-13, 15, and 19, 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 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 0.1-20 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, 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612