DETAILED ACTION
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
Claims 74-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/28/2024.
Claim Status
The amendment filed on 6/12/2026 has been entered. Claims 1-62, 66, 69 and 71-73 have been canceled. Claim(s) 63-65, 67-68, 70 and 74-87 is/are pending with claims 74-81 withdrawn from consideration. Claims 63-65, 67-68, 70 and 82-87 are under examination in this office action.
Response to Arguments
Applicant's argument, filed on 6/12/2026, with respect to 103 rejection has been fully considered but is moot in view of the new grounds of rejection presented below.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claim(s) 63-65, 67-68, 70 and 82-87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skov et al (WO 2016189117 A1) in view of Matsuda et al (“Cyclodextrins in transdermal and rectal delivery”, Advanced Drug Delivery Reviews 36 (1999) 81–99) and Ho et al (WO2016072939 A1).
Regarding claims 63-65 and 67-68, Skov teaches an elastomer composition [abstract], in which silicone was mixed with glycerol at high shear to form a glycerol-in-silicone emulsion and the emulsion can be cured to form an elastomer [P9L15-21, P13L6-15]. The silicone is preferably polydimethylsiloxane (PDMS) [P6L11-13]. Pt catalyst was used to crosslink the silicone [P9L2-4]. The composition can comprise excipients and additives [P3L23-24] including pharmaceutical substances [P8L7].
The examiner submits that the glycerol-in-silicone emulsion reads on the claimed glycerol-in-silicone-pre-elastomer emulsion because it forms the elastomer upon curing.
The Pt catalyst reads on the claimed platinum-based polymerization catalyst.
Skov does not teach the claimed cyclodextrin or octenidine. However, Skov’s silicone elastomer can be used as a skin adhesive [P3L3] and can be combined with pharmaceutical substances for controlled release [P8L5-11]. This suggests transdermal patch application. Skov further teaches that the composition can include excipients [abstract].
In the same field of endeavor, Matsuda teaches cyclodextrins (including β-cyclodextrin, α-cyclodextrin and γ-cyclodextrin) used in dermal drug delivery (both local and systemic use), and teaches that cyclodextrin can alleviate local irritation and can also modulate release of drugs [P82 last para. of “1. Introduction”; P82 under “2. Cyclodextrins in dermal drug delivery”].
It would have been obvious to one of ordinary skill in the art at the time of filing to add cyclodextrin in Skov’s composition in order to alleviate local irritation and modulate release of drugs.
In the same field of endeavor, Ho teaches an antimicrobial composition that can be administered transdermally [081] (a controlled release dosage form). Ho teaches that “the antimicrobial agent may be triclosan, octenidine dihydrochloride, mupirocin calcium or derivatives thereof” and “octenidine dihydrochloride has generally superior antimicrobial efficacy in vitro and bactericidal activity as compared to chlorhexidine and alexidine” [0047].
It would have been obvious to one of ordinary skill in the art at the time of filing to use Ho’s antimicrobial agent as the pharmaceutical substance additive in Skov’s composition, as it is expressly disclosed as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07. It would also be obvious to choose otenidine as the antimicrobial agent as Ho disclosed that otenidine has generally superior antimicrobial efficacy.
Regarding claim 70, Ho teaches that octenidine dihydrochloride as antimicrobial agent may be between about 0.1% w/v to about 10% w/v in the composition [052], which overlaps the claimed 0.1 wt% to 6 wt%.
Regarding claim 82, Matsuda teaches a composition comprising 1.8% w/v of cyclodextrin and a composition comprising 6.0% w/v of cyclodextrin [P88 section 2.3 right column].
It would have been obvious to one of ordinary skill in the art at the time of the invention to form a transdermal composition according to Skov including 1.8 % w/v or 6.0 % w/v, as Matsuda demonstrates this range to be suitable for similar transdermal composition. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416-21 (2007). See MPEP 2141. These concentrations meet the claimed 0.1-6 wt%.
Regarding claim 83, Ho teaches that octenidine dihydrochloride as antimicrobial agent may be between about 0.1% w/v to about 10% w/v in the composition [052], which is about 0.1-10 wt%. Matsuda teaches 1.8 % w/v or 6.0 % w/v of cyclodextrin as stated above. Therefore, the ratio of octenidine to cyclodextrin is about 5.6:1 to 1:60, overlapping the claimed range of 4:1 to 1:1.5. A prima facie case of obviousness exists where the claimed ranges overlap ranges disclosed by the prior art (MPEP 2144.05.I).
Regarding claim 84, the recited “the cyclodextrin and octenidine form a cyclodextrin-octenidine complex, and nitrogen from the octenidine is at least partially within a cavity of the cyclodextrin-octenidine complex” is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present. Besides, Ho teaches that cyclodextrins form complexes with octenidine [0047, 0053].
Regarding claim 85, the recited “an average diameter of a droplet of the emulsion is smaller relative to an emulsion without cyclodextrin and octenidine” is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present.
Regarding claim 86, the recited “the average diameter of the droplet is approximately 9.3 µm±2.4 µm” is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present.
Regarding claim 87, Skov teaches PDMS as state above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762
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