DETAILED ACTION
This office action is in response to applicant’s filing dated June 29, 2026.
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 Claims
Claims 1-20 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed June 29, 2026. Acknowledgement is made of Applicant's amendment of claim 5.
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to a preparation method of the cyclodextrin-based LAE clathrate comprising mixing the cyclodextrin compound, the LAE compound, and water, and conducting clathration to obtain the cyclodextrin-based LAE clathrate in the reply filed on June 29, 2026 is acknowledged.
Claims 1-4, 13, 14, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 29, 2026.
Applicant’s election without traverse of LAE hydrochloride and hydroxypropyl-β-cyclodextrin as the elected formulation species in the reply filed on June 29, 2026 is acknowledged.
Claims 5-12 and 15-18 are presently under examination as they relate to the elected species: LAE hydrochloride and hydroxypropyl-β-cyclodextrin or cyclodextrin.
Priority
The present application is a 371 of PCT/CN2022/097863 filed on June 9, 2022, which claims benefit of foreign priority to CHINA 202210335067.5 03/31/2022 filed on March 31, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 6, 2023 and October 16, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on May 16, 2023. These drawings are accepted.
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.
Claims 5, 7-11, 15, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al (CN105054220 (A), cited in the IDS filed November 6, 2023).
He teaches a lauroyl arginine ethyl ester hydrochloride microcapsule, characterized in that: the lauroyl arginine ethyl ester hydrochloride uses lauroyl arginine ethyl ester hydrochloride as the core material and wall materials [0012]; the wall material includes cyclodextrin. A clathrate by broadest reasonable interpretation is where a substance is physically enclosed within the structure of another. The microcapsule of He reads on a lauroyl arginine ethyl ester hydrochloride enclosed by cyclodextrin, a cyclodextrin ethyl lauroyl arginate clathrate.
Regarding claims 5, 7, 15, and 16, He teaches a method of making a cyclodextrin ethyl lauroyl arginate microcapsule/clathrate comprising adding 1.1 kg lauroyl arginine ethyl ester hydrochloride into a water phase comprising 10 kg cyclodextrin and mixed (Example 1, [0026-0027]). He teaches 10 kg cyclodextrin is added to 50-90% water and str to dissolve and water solution.
Regarding claim 11, He teaches the method further comprises spray drying the microemulsion [0028].
Regarding claim 8, the cyclodextrin ethyl lauroyl arginate microcapsule/clathrate taught by He comprises 10 kg cyclodextrin in about 100 kg total weight of the components, which is equivalent a mass concentration of cyclodextrin compound of 10%.
Regarding claims 9, 10, and 18, He teaches the method is conducted at 60-80° and lauroyl arginine ethyl ester hydrochloride is mixed online with a pipeline shear, 10,000 to 16,000 rpm for 5 to 10 minutes. This reads on high-speed dispersion is conducted at 10,000 rpm to 18,000 rpm for 5 to 20 min.
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)).
Thus, the teachings of He anticipate the method of claims 5, 7-11, 15, 16, and 18.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over He et al (CN105054220 (A), cited in the IDS filed November 6, 2023) as applied to claims 5, 7-11, 15, 16, and 18 above.
He teaches all the limitations of claim 6, except wherein the cyclodextrin compound and the LAE compound are at a molar ration of (0.5-6): 1. However, as set forth above, He teaches a method of making a cyclodextrin ethyl lauroyl arginate microcapsule/clathrate comprising adding 1.1 kg lauroyl arginine ethyl ester hydrochloride into a water phase comprising 10 kg cyclodextrin and mixed (Example 1, [0026-0027]). The composition formed by the method of He would result in a molar ratio of cyclodextrin compound and LAE compound of about 9.1: 1.
MPEP 2144.05 states: A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").
Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed frequency and dosing cycles, the determination of the optimum or workable frequency of administration given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the method of claim 6 with a reasonable expectation of success.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over He et al (CN105054220 (A), cited in the IDS filed November 6, 2023) as applied to claims 5, 7-11, 15, 16, and 18 above, and further in view of Gao et al (Journal of Molecular Liquids, 2020; 305:112858 pp 1-8).
He teaches all the limitations of claim 6, except wherein the cyclodextrin compound is β-cyclodextrin or the elected cyclodextrin, hydroxypropyl-β-cyclodextrin.
However, Gao teaches beta-cyclodextrin (β-CD) has an external outer edge and hydrophobic lume, and the inner cavity can provide a hydrophobic binding site, which can be used as a host molecule to selectively encapsulate other suitable size guest molecules other than water, thereby forming a unique host-guest inclusion; the function of β-CD is almost conformity with hydroxypropyl-beta-cyclodextrin (HP-β-CD), and can be used as a novel molecular encapsulating material to produce clathrates with various substances; cyclodextrin was non-toxic, and β-CD was the most widely used variety on the market; the unique cavity structure of cyclodextrin was really important in optimizing the application effect of the guest molecule; it had been proved that the clathrate formed by cyclodextrin and herbicide has better thermal stability, sustained-release effect, oxidation resistance and stronger water solubility (page 1, right, 2nd paragraph). The poor aqueous solubility, thermostability and bactericidal effect of chlorothalonil could be effectively improved after complexing with β-CD or HP-β-CD clathrate. Thus, Gao establishes that it was known in the art that both β-CD or HP-β-CD were known cyclodextrin compounds utilized for making clathrate encapsulated compositions.
Since He teaches a method of making a cyclodextrin LAE chloride microcapsule, and since Gao teaches that β-CD or HP-β-CD are cyclodextrins useful for forming clathrate encapsulated compositions, at the time of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any cyclodextrin) for another (β-CD or HP-β-CD) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claim 17, with a reasonable expectation of success.
Claim Objections
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 5-11 and 15-18 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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