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
Status of Application
1. Applicants’ arguments/remarks filed 14 July 2026 are acknowledged. Claims 14-15, 21, 23 and 34-37 are currently pending. Claims 1-13, 16-20, 22, and 24-33 are cancelled. Claims 34-37 are newly added. Claims 14-15 are amended. Claims 14-15, 21, 23 and 34-37 are examined on the merits within.
Withdrawn Rejections
2. Applicants’ arguments, filed 14 July 2026, with respect to the 35 U.S.C. 102(a)(1) Rejections have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) Rejections of claims 14-15, 21, and 23 have been withdrawn.
New Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 14-15, 21, 23, and 34-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (Frontiers in Chemistry, 2019) in view of Jeong et al. (WO2018/131890).
Tran et al. teach encapsulation of FITC catalase in PDA hollow capsules wherein the FITC-catalase loaded MSN were subjected to PDA coating and core removal process, i.e., a hollow polydopamine capsule and a TC coated to an internal surface. See page 2-3. Cancer treatment is an intended use of the composition. The PDA coating thickness was strongly affected by the coating conditions such as polymerization time and temperature. The MSN increased from 158 to 178 and 226 nm after coating with PDA. This equates to a PDA coating thickness of 20 nm and 68 nm. See pages 4-5. Tran et al. do not mention cationic components and is thus interpreted to be non-cationic.
Tran et al. do not teach siRNA.
Jeong et al. teach poly(lactic-co-glycolic acid) microspheres coated with polydopamine. See abstract. A drug or bioactive is in the microspheres, selected from chemicals, proteins, peptides, antibodies, genes, siRNAs and microRNAs. See claim 4. Referring to FIG. 4C, it was possible to identify a flexible polydopamine capsule composed of a very thin sealing film and two parts of small particles bonded to the surface thereof. See paragraph [76].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one known biologic agent for another to yield predictable results because Jeong et al. teach the effective delivery of siRNA encapsulated by polydopamine. It would have been well within the purview of the skilled artisan to modify the thickness of the coating by changing the duration and temperature of the coating process, wherein thin coatings result in flexible (deformable) capsules. Since the prior art makes obvious the combination of ingredients, i.e., a hollow PDA capsule loaded with siRNA, the properties should be the same, i.e., charge. In addition, it would have been well within the purview of the skilled artisan to modify the conditions to generate the hollow polydopamine nanocapsules with the desired thickness and charges to optimize the formulation.
Response to Arguments
Applicants’ arguments filed 14 July 2026 have been fully considered but they are not persuasive.
5. Applicants argued, “siRNA is mentioned among a lengthy list of alternative materials and does not rise to the level of teaching effective delivery. Given the size and rigidity, the particles of Jeong would be understood as intended for local or ex vivo use. The prior art does not teach deformable polydopamine capsules.”
In response to applicants’ arguments, the prior art does not need to exemplify each and every embodiment. The prior art is analyzed as a whole, and in such, teaches that proteins, peptides, antibodies, genes, siRNAs and microRNAs can be encapsulated. See claim 4. Thus substitution of one bioactive for another should yield predictable results, because both Tran and Jeong et al. are directed to polydopamine capsules comprising bioactive components. With regards to the size and rigidity of the capsules of Jeong et al., it is noted that the prior art of Jeong et al. is provided to show that siRNA is known to be encapsulated by polydopamine. However, the hollow capsules that meet the claim limitations are those taught by Tran. Thus Tran teaches hollow polydopamine capsules with active ingredients and Jeong et al. make obvious the substitution of one active agent for another. In addition, the prior art of Tran teaches how to modify the thickness of the coating and the prior art of Jeong et al. teach that thin coating layers allow for flexibility. Thus it would have been obvious to modify the reaction conditions, i.e., duration and temperature, to control the polydopamine coating thickness to create a flexible capsule.
Thus this rejection is maintained.
Conclusion
6. Applicants’ 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.
Correspondence
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
