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
Applicants elected diosmetin (as a species of formula II).
This reads on claims 5-7, 12-18, 20-22, 24-26, and 30.
Claims 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/27/2025.
Current Status of 17/920,731
This Office Action used the claims of 05/21/2026.
Claims 5-7, 12-18, 20-22, 24-26, and 30 are examined on the merits.
Priority
This Application is a national stage entry of PCT/CN2021/089105 and also claims foreign priority to CN202001334025.0.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
A review of the file wrapper indicates a foreign language priority document. However, since it is not in English, a judgement cannot be made as to whether it supports the instant claims, which is required to perfect foreign priority. The conditions of 35 U.S.C. § 119(a)-(d) or (f) are not met.
Therefore, the effective filing date for the instant claims is the international filing date of 04/23/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/21/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicants’ claim amendments and Remarks of 05/21/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the claim objection, these objections and withdrawn. Applicants have amended claims 5 and 6.
In regard to the 112(b) rejection, this rejection is withdrawn. Applicants have added an active step of “administering”.
In regard to the 102 rejection, this rejection is withdrawn.
Due to Applicants amendments, an obviousness rejection is written below.
Response to Amendment
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.
Claim(s) 5-7, 12-18, 20-22, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over INAMI (WO2013146913A1) in view of Stromberg (Joseph Stromberg, “These mites live on your face and come out to have sex at night”, Vox, June 13, 2014) and Salamon (Salamon et al., “Eyelash Mites: Symptoms, Causes, and Treatment”, WebMD, July 18, 2020) and LEE (Lee at al., “Anti-inflammatory effects of natural flavonoid diosmetin in IL-4 and LPS-induced macrophage activation and atopic dermatitis model”, Int Immunopharmacology, October 9, 2020).
INAMI teaches a method of administering diosmetin (ref. claims 1, 3) to humans (Bottom of page 3 of the machine translation). INAMI teaches diosmetin is part of a skin external preparation composition (ref claims 3 and 8). Examiner understands this phrasing as a topical preparation of claim 15.
Diosmetin is a compound of claims 5-7, 30.
INAMI teaches a pharmaceutical composition or cosmetic product (“third invention… can be used as a pharmaceutical product, a quasi-drug or a cosmetic product” on page 4) of claim 13.
INAMI teaches diosmetin is part of a skin external preparation composition (ref claims 3 and 8). Examiner understands this phrasing as a topical preparation of claim 15. INAMI teaches administering this to human and nonhuman mammals (i.e. veterinary composition) (page 3). This teaches claims 15-16.
INAMI teaches using the composition as part of a body or hand soap (page 5) of claim 17 and lotion (page 7) of claims 18 and 26.
INAMI does not (explicitly) teach treating the mites on or in the eye of a subject.
Stromberg teaches that 99.9% of humans carry mites (page 2). Stromberg teaches these mites as either Demodex Folliculorum and/or Demodex Brevis (page 3). These are mites of claims 12, 20 and 21 (and helps teach claim 30’s mites).
Stromberg teaches these mites are densest on the face near your eyebrows, and eyelashes (page 3). This helps teach claim 5’s treating the mites on the eye of a subject.
Stromberg does not teach that Diosmetin would be expected to control or kill mites.
LEE teaches that Atoptic dermatitis (itching) is caused by many things including house dust mites and that treatment with diosmetin was found to suppress these symptoms (4. Discussion). LEE also teaches that Diosmetin is antibacterial, anti-inflammatory and has antioxidant effects (abstract).
The artisan would have been motivated to administer INAMI’s topical composition in view of Stromberg’s teaching (where mites are densest). The artisan would expect that INAMI’s method (achieved by administering an external skin composition containing diosmetin) to be effective in controlling mites, especially when administered to the place where the mites are present/densest. The artisan would also be motivated to by Lee’s teachings and would expect that diosmetin would be helpful in controlling/killing the mites. This teaches claims 5-7, 12-13, 20-21.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, containing diosmetin, and its properties, controlling or killing mites, are inseparable. See MPEP 2112.01 (II).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
INAMI and Stromberg do not teach ophthalmic preparations.
Salamon teaches that treatment include an eye drop (an ophthalmic preparation of claims 25-26) called lotilaner (page 1).
The artisan would have found it obvious to try a known route of administration (eye drop) with Inami’s active ingredient. The artisan would expect that diosmetin would retain its chemical properties when used in a different route of administration. This teaches claims 25 and 26.
Regarding claim 14, 22, 24’s “wherein” clauses, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In this case, the wherein clause expresses the desired result of the positive step of treating the mites with a product comprising diosmetin. Since the prior art reference teaches the instantly claimed method, this limitation is met. See also MPEP 2112.02. This teaches claims 14, and 22, 24.
Claim(s) 5-7, 12-18, 20-22, 24-26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over INAMI (WO2013146913A1) in view of Stromberg (Joseph Stromberg, “These mites live on your face and come out to have sex at night”, Vox, June 13, 2014) and Salamon (Salamon et al., “Eyelash Mites: Symptoms, Causes, and Treatment”, WebMD, July 18, 2020), LEE (Lee at al., “Anti-inflammatory effects of natural flavonoid diosmetin in IL-4 and LPS-induced macrophage activation and atopic dermatitis model”, Int Immunopharmacology, October 9, 2020) and Tarkowski (Tarkowski et al., “Demodex sp. as a Potential Cause of the Abandonment of Soft Contact Lenses by Their Existing Users”, Biomed Res. Int., July 21, 2015).
Claims 5-7, 12-18, 20-22, and 24-26 are taught above.
Tarkowski teaches that Demodex mites is factor in the development of various eye and skin disorders (abstract and introduction).
Tarkowski teaches that xerophthalmia (an ocular disease of claims 25 and 30) is the primary reason given for dissatisfaction with wearing soft contact lenses and accounts for about 50% of abandonments (Introduction). Tarkowski also teaches that there is a positive coloration between the presence of Demodex mites and inflammation of the eyelid margins (introduction). Tarkowski teaches 92% of people with an intolerance to contact lenses were positive for the presence of Demodex (Figure 9).
The artisan would be motivated and expect that in treating mites in a subject around the eye (using diosmetin, see the rejection above) that the subject (who is suffering from an ocular disease such as xerophthalmia) would also benefit from controlling/killing mites (Tarkowski, Introduction and figure 9). This teaches claim 30.
Conclusion
No claims are allowed as currently written.
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 GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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