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 .
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 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.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/18/2026 was filed after the mailing date of the non-final rejection on 05/18/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of claims
The amendment filed on 05/18/2026 is acknowledged. Claims 18, 20, 22, and 23 have been canceled. Claims 1-17, 19, and 21 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 05/18/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. The rejections are modified based on the amendments.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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.
Claims 1-6, 10-17, 19, and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hillman (US 2009/0048167 A1) in view of Misso (US 2012/0259011 A1).
Hillman teaches methods for the treatment of skin wrinkles in human (i.e., non-injured skin → the claimed healthy skin in step a) according to the instant specification paragraph 26, skin wrinkles are caused by decrease in skin elasticity and loss of tight junctions of epithelial cells → the claimed treatment of decrease in skin elasticity in step b) and the claimed improving tight junctions of epithelial cells in the instant claim 19, the claimed improving skin condition in the instant claim 1, the claimed visual appearance of age on skin in the instant claim 21), etc., (paragraph 51, 56, 182, and 220) comprising topically administrating (paragraph 50),
one or more antimicrobial peptide (AMP) or analog thereof including about 2 ng/mL to about 10 μg/mL of human defensins including β-defensins 1-6 (encompassing the claimed mixture of 1st defensin β-defensin 3 and 2nd defensin β-defensin 1 in the instant claims 1, 3, 4, 11-17, within the claimed concentration of instant claims 5 and 16 and thus meets the claimed concentration of instant claims 1, 2, and 13 and obvious to the claimed concentration of claims 6 and 17) and
excipients such as types of starch, gelatin (the instant claim 10), etc., (paragraph 234).
Hillman does not teach the types of starch including tapioca starch (one of the components ii) in the instant claim 1).
This deficiency is cured by Misso who teaches tapioca starch being a thickener in a topical composition (abstract and paragraph 39).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Hillman and Misso to specify the types of starch in a topical composition including tapioca starch. Tapioca starch being a thickener in a topical composition was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
Applicants argue that Hillman teaches treatment of skin wrinkles associated with inflammation (paragraph 3, 11, and 220) which does not treat the claimed skin conditions such as a decrease in skin elasticity, etc., since there are causes other than inflammation, such as aging.
However, this argument is not deemed persuasive. Wrinkles associated with inflammation is a species within the wrinkle genus. Wrinkles, whether associated with inflammation or not, are caused by a decrease in skin elasticity according to “What Causes Wrinkles?” (https://www.lockhartmatterdermatology.com/what-causes-wrinkles/). Skin inflammation causing a decrease in skin elasticity according to Uitto et al. (The complexity of elastic fiber biogenesis in the skin - a perspective to the clinical heterogeneity of cutis laxa, Exp Dermatol. 2013 February; 22(2): 88–92) who disclose elastic fibers, including elastin, being critical connective tissue components providing elasticity and resilience to skin while inflammation can lead to degradation of elastic fibers (abstract and the section under “Elastin turnover”). Thus, skin wrinkles associated with inflammation also has a decrease in skin elasticity as wrinkles with any other causes.
Claims 7-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hillman (US 2009/0048167 A1) and Misso (US 2012/0259011 A1), as applied to claims 1-6, 10-17, 19, and 21, further in view of Viladot Petit et al. (US 2013/0017239 A1).
The teachings of Hillman are discussed above and applied in the same manner.
Hillman does not specify the defensins being encapsulated in a nanoparticle and the defensin is associated with a protein albumin carrier.
This deficiency is cured by Viladot Petit et al. who teach topical pharmaceutical compositions comprising lipid nanoparticles containing at least one active ingredient and which are polymerically coated with a protein albumin (genus of the albumins in the instant claim 9) (claims 1, 5, 6, and 10).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Hillman and Viladot Petit et al. to specify the defensins in the topical pharmaceutical composition being encapsulated in nanoparticle coated (associated) with protein albumin. Active ingredients in topical pharmaceutical compositions being encapsulated in protein albumin coated nanoparticles was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Argument regarding the 103 rejection is basically the same as the above rejection, thus the response discussed above applies here as well and is not persuasive for reason discussed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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