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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 7, 2026 has been entered.
Claims 1, 3, 5, 8-10 and 12-14 are pending.
Claims 2, 4, 6, 7 and 11 are cancelled.
Claims 1 and 3 are currently amended.
Claims 13 and 14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 3, 5, 8-10 and 12 as filed on May 7, 2026 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim objections are withdrawn, and all previous claim rejections under 35 USC 112(b) are withdrawn.
Applicant’s arguments 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 30, 2026 was considered.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5, 8, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (US 2020/0140703, published May 7, 2020, of record) in view of Chung et al. (KR 2014-0051091 A, published April 30, 2014, IDS reference filed May 4, 2023, as evidenced by the Google translation, of record).
Bao teaches encapsulated particles and a method for preparing the encapsulated particles comprising the steps of contacting an anti-UV agent (active ingredient) with a polymer solution to form a mixture, releasing the mixture from an encapsulator (Model B-390 BUCHI (electro-coextrusion as evidenced by paragraph [0049] of the instant specification)) into a collection solution, and collecting the encapsulated particles from collection solution (drying) (title; abstract; claims, in particular 1, 7, 10; Figures, in particular 2, 5, 6; paragraphs [0081]-[0085]; Example 1). The encapsulator can be fitted with a concentric nozzle (coextrusion) (paragraph [0081]). The particles are spherical (Figures 2, 7; paragraphs [0046], [0059]). The encapsulated particles may further comprise a second shell comprising a second polymer (claim 7; Figure 2; Example 1).
Bao teaches encapsulated anti-UV agents inclusive of C7-9-branched and linear alkyl esters (claim 2; paragraph [0049]).
Bao teaches the (first, encapsulation) polymer comprises inter alia a polysaccharide, a gelatin, a metal alginate such as sodium alginate, or poly(methyl methacrylate) (claims 4, 5; paragraph [0056]; Example 1). Bao exemplifies an embodiment comprising 1.2% sodium alginate (Example 1), as required by instant claim 5.
Bao teaches the second polymer comprises inter alia a polysaccharide or a chitosan (claim 8; Example 1).
Bao exemplifies an embodiment comprising an aqueous solution of calcium chloride as the collection solution (Example 1), as required by instant claim 9.
Bao further teaches the 2-shell encapsulated particle has a size between 20 microns and 2 mm (2000 microns) (paragraph [0061]), as required by instant claim 12. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 I.
Bao further teaches flow rates can be adjusted to control the size of the droplets (paragraph [0082]).
Bao does not teach a core solution flow rate of 0.1 to 10 mL/min and a shell solution flow rate of 0.5 to 20 mL/min as required by claim 1.
Bao does not teach electro-coextrusion at 1 to 5 kV as required by claim 8.
These deficiencies are made up for in the teachings of Chung.
Chung teaches a method for producing a microcapsule comprising a core containing a liquid active substance and a shell which is solid at room temperature (title; abstract; claims). The shell solution and core solution are passed through 1 to 10 co-axial nozzles at a shell flow rate of 100 to 900 mL/min (0.1 to 0.9 mL/min) and a core flow rate of 50 to 300 mL/min (0.05 to 0.3 mL/min) at a voltage of 1 to 15 kV (claim 1; page 2, description of drawings), as required by instant claim 8. The resultant microcapsules are dried after hardening at a temperature of 15 to 35 ºC (claims 2, 3; page 2, description of drawings; page 3, 1st full paragraph). Chung further teaches coextrusion and electro-coextrusion wherein coextrusion efficiency is improved by an electric field (page 3, 3rd & 4th full paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the encapsulation process of Bao to employ the flow rates and voltage taught by Chung because these parameters are suitable for producing microcapsules. There would be a reasonable expectation of success because Bao does not delimit these parameters. Additionally, it would have been obvious to optimize the flow rate(s) because Bao teaches the flow rates control the size of the droplets and it would have been obvious to optimize the voltage because Chung teaches improvements in extrusion efficiency are expected due to the electric field. It is prima facie obvious to optimize such result-effective variables within prior art conditions or through routine experimentation. See MPEP 2144.05.
Regarding the new wherein clause of claim 1 drawn to delivery into skin in stable form, because Bao is in possession of multilayered spherical particles comprising the same core comprising the same active as instantly claimed, the same shell comprising the same first polymer as instantly claimed and the same capsule comprising the same second polymer as instantly claimed and because the combined teachings of Bao in view of Chung render obvious the production of these particles by the same process as instantly claimed, it necessarily follows that the particles of Bao in view of Chung are also capable of delivering the active in stable form to skin because a chemical composition and its properties are inseparable.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (US 2020/0140703, published May 7, 2020, of record) in view of in view of Chung et al. (KR 2014-0051091 A, published April 30, 2014, IDS reference filed May 4, 2023, as evidenced by the Google translation, of record) as applied to claims 1, 5, 8, 9 and 12 above, and further in view of Fang et al. “3D porous crystalline polyimide covalent organic frameworks for drug delivery,” Journal of the American Chemical Society 137:8352-8355, 2015, of record.
The teachings of Bao and Chung have been described supra.
Bao further teaches the shell allows for controlled / extended release of the anti-UV agent (e.g., abstract; paragraph [0045]). The core can comprise particles (paragraph [0045]).
They do not teach the active ingredient forms a complex with a covalent organic framework as required by claim 3.
This deficiency is made up for in the teachings of Fang.
Fang teaches porous covalent organic frameworks that show high loading and good release control for drug delivery applications (title; abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the core of the encapsulated particles of Bao in view of Chung to further comprise the anti-UV agent loaded within porous covalent organic frameworks as taught by Fang in order to further control the release of the anti-UV agent. There would be a reasonable expectation of success because the core of the encapsulated particles of Bao may comprise particles and because the encapsulated particles are intended to control / extend the release of the anti-UV agent.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (US 2020/0140703, published May 7, 2020, of record) in view of in view of Chung et al. (KR 2014-0051091 A, published April 30, 2014, IDS reference filed May 4, 2023, as evidenced by the Google translation, of record) as applied to claims 1, 5, 8, 9 and 12 above, and further in view of Meyer-Boehm et al. (US 2019/0090529, published March 28, 2019, of record).
The teachings of Bao and Chung have been described supra.
They do not teach drying at 60 to 90 ºC as required by claim 10.
This deficiency is made up for in the teachings of Meyer.
Meyer teaches spherical particles and a method for the production thereof (title; abstract; claims). The particles are subsequently dried at temperatures between 40 and 120 ºC (claim 33; paragraph [0028]), as required by instant claim 10.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the encapsulation process of Bao to comprise the step of drying the collected (dried) encapsulated particles at temperatures between 40 and 120 ºC as taught by Meyer in order to ensure the encapsulated particles are sufficiently dry for subsequent use or processing.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s rehashed arguments have been fully considered but they remain unpersuasive.
Applicant’s argument at pages 6-7 that there is no motivation to combine remains unpersuasive for reasons of record. The allegation that Chung is directed to a highly specific technology is acknowledged but not found persuasive because Chung is merely relied upon in the rejection to evidence coextrusion operating parameters. Bao already evidences one skilled in the art would adjust flow rates (e.g., paragraph [0082]) in order to adjust / optimize size. Optimizing within art-recognized operating parameters is routine. The allegation that Chung contradicts Bao is unpersuasive because Bao and Chung are both drawn to processes of preparing microcapsules via coextrusion. Notably, the instant claims are drawn to a process.
Applicant’s argument at page 7 drawn to divergent physical properties of exemplary capsules of Chung and of Bao is unpersuasive because the physical compositions of these exemplary capsules also differ. That the product made depends not only on the process but also the material inputs is expected. Applicant’s rehashed conclusion that Chung and Bao are incompatible remains unpersuasive because Chung and Bao evidence coextrusion to be a known method of preparing microcapsules.
Applicant’s argument at pages 7-8 that there is no reasonable expectation of success remains unpersuasive for reasons of record. The allegation that the physical properties of the exemplary capsules of Bao and of Chung differ does not imply that one skilled in the art would not expect success of modifying the encapsulation process of Bao to employ art-recognized operating parameters. See also Jin et al. (copy provided).
Applicant’s arguments at page 9 that the additional references fail to remedy the deficiencies of Bao is acknowledged but not found persuasive because the combined teachings of Bao and Chung render obvious processes as instantly claimed.
Therefore, the rejections over Bao are properly maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hartmann et al. (WO 2007/012981 A2) teaches a process for manufacturing seamless breakable capsules comprising co-extruding an external and hydrophilic liquid phase and an internal and lipophilic (oil) liquid phase (title; abstract; claims; page 12, lines 11-24).
Lin et al. (CN 111449960 A, as evidenced by the Google translation) teaches nested capsules prepared from an O/W emulsion comprising a sub-capsule and a gel layer outside the sub-capsule (title; abstract; claims).
Jin et al. “Fabrication of double-layered alginate capsules using coaxial nozzle,” Journal of Micro- and Nano-Manufacturing 5:041007, 2017 teaches flow rates of 0.8 mL/min and 1.6 mL/min and further investigates the effects of flow rates on capsule geometry (page 5, paragraph bridging columns; page 6, lhc, 2nd paragraph of section 3.3; Figure 6; item (2) bridging pages 7 and 8).
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. 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.
/ALISSA PROSSER/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
Prosecution Insights