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Claims 74-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Response to Amendment
The amendment filed on 1/26/2026 has been entered. Claims 1-62, 66, 69 and 71-73 have been canceled. Claim 87 is new. Claim(s) 63-65, 67-68, 70 and 74-87 is/are pending with claims 74-81 withdrawn from consideration.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 1/26/2026, with respect to 103 rejection has been fully considered but is not persuasive.
Applicant argued that octenidine is a nitrogen- containing compound and nitrogen is a known contributor to poison Pt catalysts. If the Pt catalyst becomes poisoned, the reaction of the polymer is impacted. However, the instant application discloses surprising effects of an emulsion with both octenidine and Pt catalysts present. It was observed that the complexation of poisons of the platinum catalyst by cyclodextrins significantly decreased the inhibition of the addition cured systems. As such, the present application discloses the surprising conclusion that systems containing octenidine can still be reacted using Pt catalysts. The combination of Skov and Ho fails to render such findings obvious.
In response, as the applicant acknowledged [P5L1], CN102716104A reported that β-cyclodextrin can protect a platinum catalyst from catalyst poisoning of silicone gels in the presence of plant oils comprising elements selected from N, S and P. CN102716104A teaches that β-cyclodextrin is used to encapsulate the nitrogen containing compounds, forming a stable complex [CN102716104A machine translation, P3L25-31]. Therefore, using β-cyclodextrin in combination with nitrogen containing compound to protect Pt catalyst from poisoning is not surprising. In addition, Ho teaches that antimicrobial agents, especially octenidine, form complex with cyclodextrins [0047, 0053]. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use β-cyclodextrin in combination with octenidine in order to prevent poisoning Pt catalyst.
Applicant argued that Ho merely discloses in Para. [0045] that cyclodextrin "...enhances the solubility [of hydrophobic moieties or hydrophobic antimicrobial agents] in aqueous solution." (Emphasis added.) The system of Skov is not an aqueous solution (e.g., water based solution), but is instead a polymer composition.
In response, Skov’s composition is used as skin adhesives [P3L3] and can be combined with pharmaceutical substances for controlled release [P8L5-11], suggesting transdermal patch application. In a transdermal patch, even though the adhesive itself is not an aqueous solution, the active pharmaceutical ingredient (API), e.g., octenidine, needs certain degree of water solubility in order to be released in the bloodstream. Enhancing octenidine’s water solubility with cyclodextrin certainly gives the transdermal patch advantage.
Applicant argued that Skov already addresses adding additives to either the glycerol or silicone rubber based on the hydrophobic/hydrophilic properties of the additive. As such, it is not clear why one of skill in the art would find it obvious to add the cyclodextrin and octenidine of Ho to Skov.
In response, Skov’s additive does not teach away or prevent adding cyclodextrin and octenidine to the composition. The motivation of adding cyclodextrin and octenidine is addressed in the 103 rejection.
Applicant argued that the motivation to include the two references appears to only be gleaned by the Application's own disclosure and suffers from hindsight reasoning and there lacks a motivation to combine the compositions of Skov and Ho.
In response, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The office only takes Skov’s teaching and Ho’s teaching to construct the obviousness rejection, without citing any of the applicant’s teaching. Therefore, the hindsight reasoning is appropriate.
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 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].
In the same field of endeavor, Ho teaches a 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]. Combination of octenidine and cyclodextrin enhances the solubility [0045]. The cyclodextrin can be β-cyclodextrin [0053].
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.
It would also have been obvious to one of ordinary skill in the art at the time of filing to add β-cyclodextrin in order to enhance its solubility.
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, Ho teaches that the cyclodextrin is β-cyclodextrin [0053] (MW=1135); the concentration of the cyclodextrin may vary depending on the physic-chemical characteristics of the antimicrobial agent, such as chemical polarity, hydrophobicity, solubility, temperature, pressure, the solvent and the presence of other solutes in the solvent, and may be about 20mM to about 200 mM [0055].
The concentration of about 20-200 mM is equivalent to about 2.27-22.7 % w/v, as calculated by the examiner. The about 2.27-22.7 % w/v is about 2.27-22.7 wt%, overlapping the claimed 0.1-6 wt%. A prima facie case of obviousness exists where the claimed ranges overlap ranges disclosed by the prior art (MPEP 2144.05.I).
In addition, Ho recognizes the claimed cyclodextrin concentration being affected by factors such as chemical polarity, hydrophobicity, solubility, temperature, pressure, the solvent and the presence of other solutes in the solvent. It would have been obvious to one of ordinary skill in the art at the time of filing to optimize the concentration of cyclodextrin based on the aforementioned factors by routine experimentation, thereby arriving at the claimed 0.1-6 wt%. "[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.
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%. Ho also teaches about 2.27-22.7 wt% of cyclodextrin as stated above. Therefore, the ratio of octenidine to cyclodextrin is about 10:2.27 to 0.1:22.7, 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
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 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 date of this final action.
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