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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 21 July 2026 has been entered.
Status of Claims
Receipt is acknowledged of claim amendments filed on 21 July 2026.
Claims 1, 6-7, 9-11 and 13 have been amended.
Claims 5, 16-22, 27, 29 and 31 are cancelled.
Claims 1-4, 6-15, 23-26, 28 and 30 are pending and presented for examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) filed 07/21/2026 has been considered by the Examiner. A signed and initialed copy of the IDS is included with the instant Office Action.
Rejections Modified and Maintained
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 of this title, 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 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 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.
Claims 1-4, 6-9, 11-12, 14-15, 23-26, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over ZAKREWSKY (WO 2015/066647 A2) in view of DUFT (US 2010/0279921 A1, publication date of 04 November 2010), KELLAR (US 2018/0093011 A1) and AUNG-DIN (US 2018/0049994 A1) as evidenced by CLEVELAND CLINIC (“Dermis”, electronic article, at URL: https://my.clevelandclinic.org/health/body/22357-dermis, Last reviewed 02/07/2022, obtained on 22 February 2025).
Zakrewsky is primarily directed towards compositions containing a complex that contains a cation with alkyl chains and a macromolecule anion, wherein the macromolecule anions include nucleic acids, and wherein the compositions have enhanced penetration across the skin barrier and into the skin cells (abstract).
Regarding claims 1-4, 6-8 and 23, Zakrewsky discloses compositions topically applied to the skin (page 2, lines 23-24). Zakrewsky discloses that the compositions contain ILs (e.g., ionic liquids) that are able to direct delivery within the skin (paragraph bridging pages 2 and 3). Zakrewsky discloses that ionic liquids contain at least one cationic component and at least one anionic component (page 4, lines14-15). Zakrewsky discloses that the compositions preferably contain a drug to be delivered (page 4, lines 17-18). Zakrewsky discloses that the composition increases the transdermal drug delivery (page 4, lines 20-21). Zakrewsky discloses that exemplary molar ratios of cation:anion include 1:2 (page 5, lines 17-19). Zakrewsky discloses that in some embodiments, the IL (e.g., ionic liquid) is a deep eutectic solvent (DES) and exemplary DES include choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., choline cation and a fatty acid anion) (page 6, lines 20-24). Zakrewsky discloses that suitable drugs include siRNA (e.g., RNAi agent) (paragraph bridging pages 10 and 11; page 15, lines 3-4). Zakrewsky discloses use of the composition for including treating a wound (page 15, last paragraph). Zakrewsky discloses preparation of choline geranate by using 0.059 mol of geranic acid and 0.029 mol of choline bicarbonate (e.g., 2:1 molar ratio fatty anion to choline cation) (page 21, lines 8-11).
Regarding claims 1, 24-26, 28 and 30, Zakrewsky discloses that the composition may be selected to deliver a drug to a particular site, such as within the stratum corneum, epidermis and dermis, or through and beyond all of the layers of the skin (e.g., penetrate skin surface and reach a target depth within or beyond the skin) (page 10, lines3-5). As evidenced by Cleveland Clinic, the thickness of the dermis can be as thin as 0.6 mm and as thick as 4 mm (see the fifth page of the copy of the electronic literature).
Regarding claim 9, Zakrewsky discloses that the ionic liquid contains an additional hydrogen bond donor (i.e. any molecule that can provide an -OH or an -NH group) (page 5, lines 13-14).
Zakrewsky does not specifically teach from 1 µM to 500 µM of the siRNA as a drug. Zakrewsky does not specifically teach that the ionic liquid is present in the pharmaceutical composition at a concentration of from about 10% to about 90%. Zakrewsky does not specifically teach that the composition further comprises RNase-free water. Zakrewsky does not specifically teach that the composition further comprises a pharmaceutically acceptable carrier (e.g., claim 12) and that the carrier comprises an ointment base (e.g., claim 14). The deficiency is made up for by the teachings of Duft, Kellar and Aung-Din.
Duft is primarily directed towards methods and composition comprising anti-connexin agent including anti-connexin polynucleotides for promotion and/or improvement of wounds and wound healing and/or tissue repair (abstract).
Regarding claim 1, Duft teaches use of including anti-connexin polynucleotides the treatment of wounds (paragraph [0009]). Duft teaches effective amounts of the anti-connexin polynucleotide to promote healing or tissue repair in a subject (paragraph [0011]). Duft teaches that anti-connexin polynucleotide includes siRNA (paragraph [0017]). Duft teaches that anti-connexin agent is applied at concentration of including about 10-200 µM, 200-300 µM, 300-400 µM and 400-500 µM (paragraph [0175]).
Kellar is primarily directed towards compositions for enhancing wound healing (abstract).
Regarding claims 1 and 15, Kellar teaches that the composition includes an ionic liquid. Kellar teaches that the ionic liquid is antimicrobial and that the ionic liquid includes choline geranate. Kellar teaches that the ionic liquid is present in an amount of about 0.1% w/w to about 99% w/w (paragraph [0012]). Kellar teaches an embodiment where the ionic liquid is present in an amount of about 40% w/v (paragraph [0012]). The amount of about 40% w/v lies inside the amount of “from about 10% to about 90%” and “from about 20% to about 80%”, recited in claims 1 and 15, respectively. Thus, the limitations in claims 1 and 15 are rendered prima facie obvious. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also MPEP 2144.05.
Aung-Din is primarily directed towards a topical composition that contains a drug and a pharmaceutically acceptable topical carrier, such as including a cream and lotion (abstract).
Regarding claims 1, 11-12 and 14, Aung-Din teaches a topical formulations comprising a drug in including an ointment, gel and cream. Aung-Din teaches that the composition contains a carrier (paragraph [0168]). Aung-Din teaches that the amount of the drug is preferably 0.01 wt. % to 50 wt. %, the permeation enhancer is preferably from about 1 wt. % to about 30 wt. %, and the remainder of the composition comprising a carrier or vehicle (e.g., 20 wt. % to 98.99 wt. % of carrier) (paragraph [0168]). Aung-Din teaches that carrier materials suitable for the topical composition well-known for use in the cosmetic and medical arts as bases for including ointments. Aung-Din teaches that suitable carriers include water (e.g., ointment base/gel base) (paragraph [0188]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a topical composition comprising DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) as an ionic liquid; a drug including siRNA for promoting wound healing; and a carrier including water (e.g., RNase-free water/gel base/ointment base); wherein the concentration of the siRNA for promoting wound healing is 10-200 µM, 200-300 µM, 300-400 µM or 400-500 µM; and wherein the concentration of the DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) is present in an amount of including about 40% w/v. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) obtain a topical composition that provides wound healing by including siRNA promotes wound healing at a concentration of including 10-200 µM, 200-300 µM, 300-400 µM or 400-500 µM, which is taught by Duft; 2) obtain a topical composition with optimal amount of ionic liquid to provide antimicrobial and increase in transdermal transport of the drug to be delivered (e.g., siRNA) by using the amount of ionic liquid that is taught by Kellar including of about 40% w/v; and 3) obtain desired compositions for topical application by including carriers including water (e.g., RNase-free water/gel base/ointment base) to form including an ointment or a gel. The person of ordinary skill in the art would have reasonably would have expected success because Zakrewsky discloses compositions topically applied to the skin (page 2, lines 23-24). Zakrewsky discloses that the compositions contain ILs (e.g., ionic liquids) that are able to direct delivery within the skin (paragraph bridging pages 2 and 3). Zakrewsky discloses that ionic liquids contain at least one cationic component and at least one anionic component (page 4, lines14-15). Zakrewsky discloses that the compositions preferably contain a drug to be delivered (page 4, lines 17-18). Zakrewsky discloses that the composition increases the transdermal drug delivery (page 4, lines 20-21). Zakrewsky discloses that in some embodiments, the IL (e.g., ionic liquid) is a deep eutectic solvent (DES) and exemplary DES include choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., choline cation and a fatty acid anion) (page 6, lines 20-24). Zakrewsky discloses that suitable drugs include siRNA (e.g., RNAi agent) (paragraph bridging pages 10 and 11; page 15, lines 3-4). Zakrewsky discloses use of the composition for including treating a wound (page 15, last paragraph). Duft teaches use of including anti-connexin polynucleotides the treatment of wounds (paragraph [0009]). Duft teaches effective amounts of the anti-connexin polynucleotide to promote healing or tissue repair in a subject (paragraph [0011]). Duft teaches that anti-connexin polynucleotide includes siRNA (paragraph [0017]). Duft teaches that anti-connexin agent is applied at concentration of including about 10-200 µM, 200-300 µM, 300-400 µM and 400-500 µM (paragraph [0175]). Kellar teaches that a composition includes an ionic liquid. Kellar teaches that the ionic liquid is antimicrobial and that ionic liquid includes choline geranate. Kellar teaches that the ionic liquid is present in an amount of about 0.1% w/w to about 99% w/w (paragraph [0012]). Aung-Din teaches a topical formulations comprising a drug in including an ointment, gel and cream. Aung-Din teaches that the composition contains a carrier (paragraph [0168]). Aung-Din teaches that the amount of the drug is preferably 0.01 wt. % to 50 wt. %, the permeation enhancer is preferably from about 1 wt. % to about 30 wt. %, and the remainder of the composition comprising a carrier or vehicle (e.g., 20 wt. % to 98.99 wt. % of carrier) (paragraph [0168]). Aung-Din teaches that carrier materials suitable for the topical composition well-known for use in the cosmetic and medical arts as bases for including ointments. Aung-Din teaches that suitable carriers include water (e.g., ointment base/gel base) (paragraph [0188]).
Regarding the recitation “to penetrate a healthy skin surface”, is directed towards the intended use of the claimed composition (e.g., used on healthy skin surface). Intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 [R-3]. In the instant case, Zakrewsky discloses that in some embodiments, the IL (e.g., ionic liquid) is a deep eutectic solvent (DES) and exemplary DES include choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., choline cation and a fatty acid anion) (page 6, lines 20-24). Zakrewsky discloses that the composition may be selected to deliver a drug to a particular site, such as within the stratum corneum, epidermis and dermis, or through and beyond all of the layers of the skin (page 10, lines 3-5). Zakrewsky discloses that the ionic liquid provides transdermal penetration through all layers of the skin (page 10, lines 5-9). Kellar teaches that the ionic liquid is antimicrobial and that ionic liquid includes choline geranate. Kellar teaches that the ionic liquid is present in an amount of about 0.1% w/w to about 99% w/w (paragraph [0012]). Kellar teaches an embodiment where the ionic liquid is present in an amount of about 40% w/v (paragraph [0012]). Aung-Din teaches a topical formulations comprising a drug in including an ointment, gel and cream. Aung-Din teaches that the composition contains a carrier (paragraph [0168]). Aung-Din teaches that suitable carriers include water (e.g., ointment base/gel base) (paragraph [0188]). It is obvious for one of ordinary skill in the art to determine the optimum amount of ionic liquid including an amount of about 40% w/v in order to provide a desired skin penetration and antimicrobial effect, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). In light of disclosure of Zakrewsky and the teachings of Duft, Kellar and Aung-Din, it would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a topical composition comprising DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) as an ionic liquid; and a drug including siRNA for promoting wound healing; wherein the concentration of the siRNA for promoting wound healing is 10-200 µM, 200-300 µM, 300-400 µM or 400-500 µM; and wherein the concentration of the DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) is present in an amount of including about 40% w/v. The composition that is prima facie obvious is light of the disclosure of Zakrewsky and the teachings of Duft, Kellar and Aung-Din contains the same ionic liquid (e.g., choline geranate) as the instantly claimed composition and in an amount that lies inside the instantly claimed amount (e.g., about 40% w/v). Thus, the composition that is prima facie obvious is light of the disclosure of Zakrewsky and the teachings of Duft, Kellar and Aung-Din is capable of application to healthy skin surface and would penetrate the healthy skin surface.
New Grounds of Rejections
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zakrewsky in view of Duft, Kellar and Aung-Din as evidenced by Cleveland Clinic as applied to claims 1-4, 6-8, 11-12, 14-15, 23-26, 28 and 30 above, and further in view of DAI (US 2016/0199498 A1, publication date of 14 July 2016).
Regarding claims 6-7, the composition of claim 1 is described above in section 8.
Zakrewsky, Duft, Kellar and Aung-Din do not specifically teach that the composition further comprises a penetration enhancer and that the penetration enhancer comprises oleyl alcohol. The deficiency is made up for by the teachings of Dai.
Dai is primarily directed towards composition for transdermal delivery that comprises skin penetration enhancers (abstract).
Regarding claims 6-7, Dai teaches additional penetration enhancers or permeation enhancers are included and that the penetration enhancers include oleyl alcohol and 2-(2-ethoxyethoxy)ethanol (paragraph [0048]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a topical composition comprising DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) as an ionic liquid; a drug including siRNA for promoting wound healing; additional penetration enhancers including oleyl alcohol and 2-(2-ethoxyethoxy)ethanol; and a carrier including water (e.g., RNase-free water/gel base/ointment base); wherein the concentration of the siRNA for promoting wound healing is 10-200 µM, 200-300 µM, 300-400 µM or 400-500 µM; and wherein the concentration of the DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) is present in an amount of including about 40% w/v. The person of ordinary skill in the art would have been motivated to make those modifications to further provide skin penetration by including additional skin penetration enhancers. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Exparte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). The person of ordinary skill in the art would have reasonably would have expected success because Zakrewsky discloses that the composition increases the transdermal drug delivery (page 4, lines 20-21). Dai teaches additional penetration enhancers or permeation enhancers are included and that the penetration enhancers include oleyl alcohol and 2-(2-ethoxyethoxy)ethanol (paragraph [0048]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zakrewsky in view of Duft, Kellar and Aung-Din as evidenced by Cleveland Clinic as applied to claims 1-4, 6-8, 11-12, 14-15, 23-26, 28 and 30 above, and further in view of KEY (WO 2009/085574 A2, publication date of 09 July 2009).
Regarding claim 10, the composition of claim 9 is described above in section 8. Zakrewsky discloses that the ionic liquid contains an additional hydrogen bond donor (i.e. any molecule that can provide an -OH or an -NH group) (page 5, lines 13-14).
Zakrewsky, Duft, Kellar and Aung-Din do not specifically teach that that the hydrogen-bond donor comprises citric acid. The deficiency is made up for by the teachings of Key.
Key is primarily directed towards a composition that includes at least one polar solvent or ionic liquid (abstract).
Regarding claim 10, Key teaches that hydrogen bond donors for forming ionic liquid (e.g., deep eutectic solvent) includes citric acid (page 7, lines 5-13).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a topical composition comprising DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) as an ionic liquid; a drug including siRNA for promoting wound healing; an additional hydrogen bond donor including citric acid and a carrier including water (e.g., RNase-free water/gel base/ointment base); wherein the concentration of the siRNA for promoting wound healing is 10-200 µM, 200-300 µM, 300-400 µM or 400-500 µM; and wherein the concentration of the DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) is present in an amount of including about 40% w/v. The person of ordinary skill in the art would have been motivated to make those modifications because Zakrewsky discloses including additional hydrogen bond donor (i.e. any molecule that can provide an -OH or an -NH group) and Key teaches that suitable hydrogen bond donors for ionic liquid includes citric acid, which one of ordinary would select as a specific hydrogen bond donor for the composition. The person of ordinary skill in the art would have reasonably would have expected success because Zakrewsky discloses that the ionic liquid contains an additional hydrogen bond donor (i.e. any molecule that can provide an -OH or an -NH group) (page 5, lines 13-14). Key teaches that hydrogen bond donors for forming ionic liquid (e.g., deep eutectic solvent) includes citric acid (page 7, lines 5-13).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zakrewsky in view of Duft, Kellar and Aung-Din as evidenced by Cleveland Clinic as applied to claims 1-4, 6-8, 11-12, 14-15, 23-26, 28 and 30 above, and further in view of SHINOHARA (US 2011/0092438 A1, publication date of 21 April 2011).
Regarding claim 13, the composition of claim 12 is described above in section 8. Aung-Din teaches that carrier and vehicles include materials known in the art including solvent (paragraph [0187]).
Zakrewsky, Duft, Kellar and Aung-Din do not specifically teach that the composition comprises diisopropyl adipate as the carrier. The deficiency is made up for by the teachings of Shinohara.
Shinohara is primarily directed towards composition of good skin permeability (abstract).
Regarding claim 13, Shinohara teaches solvent that act on the skin surface to improve the transdermal absorbability and include diisopropyl adipate (paragraph [0125]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a topical composition comprising DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) as an ionic liquid; a drug including siRNA for promoting wound healing; and a carrier including water (e.g., RNase-free water) and diisopropyl adipate; wherein the concentration of the siRNA for promoting wound healing is 10-200 µM, 200-300 µM, 300-400 µM or 400-500 µM; and wherein the concentration of the DES including choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., ionic liquid comprising a choline cation and a fatty acid anion) is present in an amount of including about 40% w/v. The person of ordinary skill in the art would have been motivated to make those modifications to further enhance transdermal absorbability by including diisopropyl adipate as a carrier, which Shinohara teaches is included as a solvent that improve the transdermal absorbability. The person of ordinary skill in the art would have reasonably would have expected success because Aung-Din teaches that carrier and vehicles include materials known in the art including solvent (paragraph [0187]). Shinohara teaches solvent that act on the skin surface to improve the transdermal absorbability and include diisopropyl adipate (paragraph [0125]).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that Zakrewsky teaches numerous possible penetration enhancers may be selected and fails to direct a person having ordinary skill in the art to select Zakrewsky’s LAN-21 and modify it by adding an RNAi agent and RNase-free water. Applicant argues that undue experimentation would be required, therefore, a person having ordinary skill in the art would not have had the required reasonable expectation of success. Applicant argues that Duft and Kellar also fails to direct a person having ordinary skill in the art to successfully arrive at the instantly claimed topical composition without undue experimentation.
Applicant's arguments filed on 21 July 2026 have been fully considered but they are not persuasive. In response, Zakrewsky discloses compositions topically applied to the skin (page 2, lines 23-24). Zakrewsky discloses that the compositions contain ILs (e.g., ionic liquids) that are able to direct delivery within the skin (paragraph bridging pages 2 and 3). Zakrewsky discloses that in some embodiments, the IL (e.g., ionic liquid) is a deep eutectic solvent (DES) and exemplary DES include choline oleate, choline hexanoate, choline geranate and choline malonate (e.g., choline cation and a fatty acid anion) (page 6, lines 20-24). Zakrewsky discloses that suitable drugs include siRNA (e.g., RNAi agent) (paragraph bridging pages 10 and 11; page 15, lines 3-4). Zakrewsky discloses that the composition may be selected to deliver a drug to a particular site, such as within the stratum corneum, epidermis and dermis, or through and beyond all of the layers of the skin (page 10, lines3-5). Zakrewsky discloses use of the composition for including treating a wound (page 15, last paragraph). Duft teaches effective amounts of the anti-connexin polynucleotide to promote healing or tissue repair in a subject (paragraph [0011]). Duft teaches that anti-connexin polynucleotide includes siRNA (paragraph [0017]). Duft teaches that anti-connexin agent is applied at concentration of including about 10-200 µM, 200-300 µM, 300-400 µM and 400-500 µM (paragraph [0175]). Kellar teaches that the composition includes an ionic liquid. Kellar teaches that the ionic liquid is antimicrobial and that ionic liquid includes choline geranate. Kellar teaches that the ionic liquid is present in an amount of about 0.1% w/w to about 99% w/w, including 20% w/w (paragraph [0012]). Therefore, from the disclosure of Zakrewsky and the teachings of Duft and Kellar, one of ordinary skill in the art would have been motivated to substitute the siRNA for treatment of wound, taught by Duft, as the drug in the composition of Zakrewsky and optimized the amount of the DES including choline geranate, using the amount taught by Kellar of about 0.1% w/w to about 99% w/w, to obtain a composition with desired delivery of the drug to a desired site of the skin and, additionally, provide a desired antimicrobial effect. The composition that is prima facie obvious is light of the disclosure of Zakrewsky and the teachings of Duft and Kellar contains substantially the same ionic liquid (e.g., choline geranate) as the instantly claimed composition and in substantially the same amount (e.g., about 0.1% w/w to about 99% w/w). Thus, the composition that is prima facie obvious is light of the disclosure of Zakrewsky and the teachings of Duft and Kellar is capable of application to healthy skin surface and would penetrate the healthy skin surface.
Additionally, figure 2A and 2B of Zakrewsky shows that LANL-21 (e.g., cation is choline and anion is geranate) as an ionic liquid was able to provide penetration to the dermis and acceptor solution. Therefore, one of ordinary skill in the art would have been motivated to try at least the choline geranate as the ionic liquid to enhance the penetration of the siRNA of Duft as the active and optimized the amount of the choline geranate using the amount of about 0.1% w/w to about 99% w/w, taught by Kellar, in order to obtain a composition with desired skin penetration and antimicrobial.
Further, Applicant has not provided any objective evidence that there is no expectation of success to substitute the siRNA (e.g., RNAi agent) of Duft as the active in the composition of Zakrewsky, to use the amounts of that Kellar teaches for including ionic liquid into a composition, and to include a carrier including water (e.g., gel base/ointment base) to obtain formulations including a gel or an ointment. Applicant is reminded that objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See MPEP 716.01(c).
Thus, for the reasons of record and for the reasons presented above claims 1-4, 6-15, 23-26, 28 and 30 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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