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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/28/2026 has been entered.
Status of claims
The amendment filed on 08/28/2026 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Rejections withdrawn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 08/26/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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 maintained 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 atopic dermatitis in human (i.e., non-injured skin → the claimed healthy skin in step a) according to the instant specification paragraph 26, atopic dermatitis causing inflammation and inflammation causing a decrease in skin barrier function → the claimed treatment of decrease in a barrier property of skin in step b) and the claimed improving skin condition in the instant claim 1 and the claimed redness in the instant claim 21) (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).
Although Hillman is silent about the claimed improving tight junctions of epithelial cells in the instant claim 19, Hillman teaches treating the same skin condition with the same active agent and the same concentration by the same mode of administration as claimed, it does not appear that the claim limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. Thus, the method of treatment taught by Hillman would necessarily result in the claimed improving tight junctions of epithelial cells whether Hillman recognize it or not.
“It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 16 U.S.P.Q.2d 1934 (Fed. Cir. 1990)
“[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc.,246 F.3d 1368, 1376 (Fed. Cir. 2001).
Please refer to MPEP 2112.I, MPEP 2112 II, and MPEP 2112.02.II:
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
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.
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.). See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation of polypropylene by mixing it with one of a genus of compounds, including nickel dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate to lower heat degradation. The court held that the claims read on the obvious process of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the claim was merely directed to the result of mixing the two materials. “While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition.” 363 F.2d at 934, 150 USPQ at 628.
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).
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.
Correspondence
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.
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/HONG YU/
Primary Examiner, Art Unit 1614
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