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 .
Status of the Claims
Claims 21-30, 32, and 33 previously were withdrawn. Claim 31 has been canceled. Claims 1-20 remain pending and under current examination.
Withdrawn Objections and Rejections and Response to Arguments
Applicant’s arguments filed 7/22/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows.
The objection to claims 1 and 16 is withdrawn in view of Applicant’s amendments to the claims. Applicant’s argument to this effect is persuasive.
The rejection of claims 1-20 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims. Applicant’s argument to this effect is persuasive.
In view of the narrowed scope of claim 1, the following rejections are withdrawn: the rejection of claims 1-4, 6-13, 18, and 20 under 35 U.S.C. 102(a)(1) as being anticipated by CN105287380A (“Cui”); the rejection of claims 1-4, 6-14, 18, and 20 under 35 U.S.C. 103 as being unpatentable over CN105287380A (“Cui”); the rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over CN105287380A (“Cui”) as applied to claims 1-4, 6-14, 18, and 20 above, and further in view of US 5,716,637 (Anselem et al., “Anselem”); and the rejection of claims 15-17 under 35 U.S.C. 103 as being unpatentable over CN105287380A (“Cui”) as applied to claims 1-4, 6-14, 18, and 20 above, and further in view of Xu et al. (“Xu”, Biomaterials, 2007, pages 2687-2694). Applicant’s argument to this effect is persuasive.
New grounds of rejection necessitated by amendments filed 7/22/2026 are presented below. It is noted that the range recited in claim 1 is narrower than the range previously examined in former claim 18.
New Grounds of Rejection Necessitated by Amendments of 7/22/2026
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 1-4, 6-14, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CN105287380A (“Cui”) in view of WO2019/070885A1 (Rodriguez et al., hereafter “Rodriguez”, newly cited).
The elected claims are drawn to a microparticle [product] containing (i) at least one phospholipid, (ii) at least one sterol, (iii) at least one polypeptide, (iv) optionally at least one polysaccharide that is overall positively charged, and (v) optionally an inorganic salt as further specified in the claims, wherein said microparticle contains one or more active substance and wherein said microparticle is a microsphere or a microcapsule with the phospholipid, sterol, polypeptide, and polysaccharide comprised in the shell of said microcapsule, as further specified in the claims. Claim 1 newly requires microparticeles to have an average diameter d50 of 0.5 to 20 micrometers.
Cui teaches an antimicrobial agent product containing cinnamon essential oil nanoliposomes. The liposomes comprise cinnamon essential oil (one or more active substance and limitation of claim 20), soybean lecithin (at least one phospholipid and limitation of claim 3), and cholesterol (at least one sterol, limitation of claim 4) as well as chitosan (limitation of claims 9 and 10) and gelatin (peptide, oligopeptide, polypeptide, gelatin, limitations of claims 6-7, 11) (see abstract,in particular). The ratio of lecithin to cholesterol is 5:1 (see Cui claim 8)(limitation of claim 13). Cui’s liposome structure is understood to constitute a microparticle as in the instant claims wherein the liposome lipid bilayer constitutes a shell surrounding its core on a scale which may be considered a microcapsule or a microsphere. Cui’s cinnamon essential oil may be considered an active agent on account of its antibacterial efficacy that Cui discloses. Regarding claim 2, Cui does not teach microplastic to be included. Further regarding claim 8, Cui teaches the structure addressed above and accordingly renders obvious the claimed product. There is no showing that the process of making and/or use otherwise mentioned in claim 8 distinguishes over the product of Cui. Further regarding claim 12, Cui also teaches the inclusion of polyvinylpyrrolidone as a surfactant, which is noted to be nonionic.
Regarding claim 1 and further regarding claim 18, Cui does not teach that the microparticles’ average diameter is within the claimed range of 0.5 to 20 micrometers or 1 to 10 micrometers, respectively.
Rodriguez cures this deficiency. Rodriguez teaches encapsulated plant-based compositions (see title, in particular). Rodriguez’s formulations include sterols microencapsulated (see [0006], may include phospholipids (see [0096], lipid soluble components (see [0096]) and polypeptides (see [0051]). Rodriguez demonstrates an encapsulated extract material having a size of about 1 to 5 micrometers or 5 to 10 micrometers, among other acceptable sizes (see [0130] referencing FIG. 5).
Both Cui and Rodriguez are directed to structurally and functionally similar microparticle products. It would have been prima facie obvious to use one of Rodriguez’s explicitly suggested microparticles’ sizes for the formulation and delivery of Cui’s components, with a reasonable expectation of success. One would have been motivated to do so to facilitate good stability and storage/protection of the encapsulated and/or interior components as suggested by Rodriguez (see [0130] in particular).
Regarding claims 1-4, 6-13, 18, and 20, limitations therein are addressed above in regard to claim 1.
Regarding claim 14 and the overlapping range recited therein, according to Cui the concentration of the soybean lecithin is 1 g plus 150 mg of cholesterol sterol per 0.2 g cinnamon essential oil (see experimental techniques, section 1, step 1), whereas for the liposome the cinnamon essential oil to gelatin in solution is 1:10. Accordingly, it would have been obvious to perform routine optimization procedures with regard to these ratios in order to achieve the desired functional efficacy of the antibacterial agent and further as taught by Cui to achieve the desired envelop rate and therefore microparticle physical stability character desired, as such optimization is customary in the art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over CN105287380A (“Cui”) in view of WO2019/070885A1 (Rodriguez et al., hereafter “Rodriguez”, newly cited) as applied to claims 1-4, 6-14, 18, and 20 above, and further in view of US 5,716,637 (Anselem et al., “Anselem”).
The teachings of Cui and Rodriguez have been delineated above. These do not teach an oligopeptide as in claim 5.
Anselem cures this deficiency. Anselem teaches nanoemulsions of particles having a lipid core surrounding by at least one phospholipid bilayer for parenteral, oral, intranasal, rectal, vaginal, or topical delivery of hydrophilic and lipophilic active agents; the particles have a mean diameter in the range of 10 to 250 nm (see abstract, in particular). Anselem teaches the state of the art with regard to peptides which are included, where the term “peptide” is explicitly defined to include both oligopeptides and proteins wherein a gelatin (see paragraph [0027]).
Both Cui and Anselem are directed to nanoscale liposomes in emulsion formulations for storage and/or delivery of an active agent. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to substitute or include oligopeptides as in Anselem in place of the more generally defined peptides of Cui, with a reasonable expectation of success. One would have been motivated to do so since Anselem teaches the state of the art wherein the term “peptide” is considered to include oligopeptides.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over CN105287380A (“Cui”) in view of WO2019/070885A1 (Rodriguez et al., hereafter “Rodriguez”, newly cited) as applied to claims 1-4, 6-14, 18, and 20 above, and further in view of Xu et al. (“Xu”, Biomaterials, 2007, pages 2687-2694).
The teachings of Cui and Rodriguez have been delineated above. These do not teach the inorganic salt as in claims 15-17.
Xu teaches that hydroxyapatite present on the shell type structure of a liposome comprising water insoluble active agents provides influence of the release rate of the active agent from the liposomes (see abstract, in particular).
Both Cui and Xu are directed to liposome structures comprising a water insoluble active agent. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add hydroxyapatite as in the microparticle structure of Xu to the analogous microparticle structure of Cui, with a reasonable expectation of success. One would have been motivated to do so to allow tunability of release rate of the hydrophobic active agent as taught by Xu.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617
