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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/21/2025 has been entered.
Response to Amendment
Applicant's amendment and argument filed 11/21/2025 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 7, 11, 16, 22, 24-31 are pending of which claims 7, 24-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/11/2022.
Claims 1, 11, 16, 22 and 31 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 11, 16, 22 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Soon Hoe Kim et. al. (US10278928B2), hereinafter Kim. This rejection is maintained with slight modifications due to the amendments and arguments filed on 05/27/2025.
Kim’s general disclosure is to film-forming pharmaceutical compositions for wound healing (see abstract).
Regarding claims 1 and 16, Kim teaches a pharmaceutical composition which comprises of chitosan as a film forming substance (see claim 1, (b)) and teaches wherein the composition comprises an acid for dissolving the chitosan (see claim 1 (d)), teaches including different additives such as plasticizer, a thickener, a surfactant, a preservative, a flavoring agent, a stabilizer, a defoamer, an adhesive, a gellant, an emulsifier, an opacifier, a humectant, and mixtures thereof, which when considered and with the broadest reasonable interpretation can act as the instantly claimed excipient, because an excipient is an inactive substance which serves as a vehicle or medium for active substances. Acetic acid can act as the solvent (with water) with 1 to 4 carbon atoms as described by Kim and as an acid for dissolving chitosan in an amount from 0.1 to 10 wt%, because Kim teaches both (see claim 1). Also Kim teaches wherein water is used in the preparations of the film-forming gels (see examples 1-6, 7-9, 10, 11-14 etc. comparative example 1). Kim also teaches wherein chitosan, the film forming substance can be used in amounts of 0.4 to 10 wt % (see column 17, lines 39-42) and chitosan would be the biopolymer being instantly claimed. Kim further teaches that “the content of chitosan in the composition of the present invention shall be an amount sufficient to maintain a proper viscosity and to form a film having a sufficient strength upon application to the skin. The amount of chitosan may preferably be 0.3 wt %” (see column 8, lines 15-24).
Kim teaches that the active ingredient can be a disinfectant or sanitizer (see claim 7) and when considered with the broadest reasonable interpretation can act as the antiseptic as so broadly claimed.
Kim teaches that the composition may include povidone-iodine, ethanol, isopropyl ethanol, silver nitrate, chlorohexidine or salts thereof as disinfectants/sanitizers (see column 7, 2nd para.) and these components would act as the antiseptic as claimed.
Kim further teaches the composition may include an anti-inflammatory agent (see claim 7) and teaches wherein the composition is in a formulation of a gel or ointment during storage period (see column 2, line 53 or column 4, lines 5-10, or column 10, lines 30-32) and turns into a film upon application.
Regarding claim 11, Kim teaches the acid is present in an amount of 0.2 to 20 wt % with respect to the total weight of the composition (see claim 13).
Regarding claim 22, Kim teaches controlling the viscosity to a degree that can supply the insufficient thickening ability of the chitosan (see column 9, lines 26-28).
Kim does not particularly teach wherein the viscosity of the composition is greater than 500 centipoise, however Kim teaches wherein viscosity is intentionally controlled by the amount of chitosan and teaches amounts of chitosan at 0.3 wt% which is within the amount being claimed. Therefore it would have been obvious before the effective filing date to persons skilled in the art to create the instantly claimed composition for treating wounds and to control for the viscosity as instantly claimed because Kim teaches similar compositions and teaches wherein the viscosity can be controlled by the use of the biopolymer chitosan. Optimizing the viscosity to be greater than 500 centipoise is an optimization well within the purview of any skilled artisan and a matter of mere judicious selection, depending on the end products design and formulation. For instance one could create a cream, a gel, a hydrogel or an ointment and controlling the viscosity would be of importance.
It would have also been obvious to select each component and to be within the instantly claimed ranges because Kim teaches the same ingredients within the same ranges and for the same purpose. Also it would have been obvious to select the salt form of chlorhexidine, being that of chlorohexidine digluconate as claimed in claim 7, because this is known to those skilled in the art as the most common form of chlorohexidine used for antiseptic/antibacterial purposes and Kim suggests where either chlorohexidine or its salt form may be used.
It would further have been obvious to create a spray consisting of 0.1 to about 2% chitosan dissolved in 5% acetic acid and chlorhexidine digluconate in an excipient for topical administration. Although Kim does not teach a spray formulation this is a common formulation of the art. Kim teaches each active component and within the instantly claimed ranges. Kim teaches chitosan at 0.3% and being dissolved in acetic acid to be useful as a biopolymer and film-forming substance, and teaches use of chlorhexidine salts as effective sanitizers and disinfectants for early stages of wound healing along with excipients. Therefore it would have been obvious to persons having ordinary skill in the art to create a formulation such as a spray or for being sprayed onto a wound as this can merely comprise of liquid formulations made able to be sprayed onto a surface.
There would have been more than a reasonable expectation of success in arriving at the instant invention because the claimed ingredients are known for having antiseptic/antibacterial properties and combining them into formulation as instantly described for such a purpose has been described in the art.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive. The applicant argues that Kim does not teach a spray. Kim teaches each structural component and creating a spray would have been prima facie obvious as it is a mere formulation of the already described active ingredients and one which is common and conventional in the art. Persons having ordinary skill in the art can determine how to disperse the components through a spray nozzle and this would not structurally be any different than what the instant applicant is claiming or what the art already teaches. The same ingredients within the same ranges would inherently have the same properties of being able to be dispersed as a spray.
The applicant argues that Kim’s working examples include formulations which require other thickeners or thickening agents, such as cream bases, to control for the viscosity of the composition and require chitosan percentages that are more than what is claimed. Kim may teach multiple compositions and give working examples of formulations which are to various compositions outside the range of the instant claims, however Kim also teaches the instant invention and does not necessarily require additional thickening agents as the applicant argues. Kim’s claim 1, does not require there to be a different thickening agent, as can be appreciated from the reliance on a Markush group which describes other additives which can be used as the instantly claimed excipient. Kim is merely giving examples of a variety of composition which include the active ingredients being claimed along with other formulations and actives to be included, however not required.
The applicant argues that Kim requires the inclusion of an additional thickener or cream base which is different from the applicant’s invention because the applicant does not require any additional thickener. Kim specifically claims in claim 1, “a cream base component is not present in the composition” and so the applicant’s argument describeing that Kim requires a cream base as an additional thickening agent appears merely to be one example of one formulation taught by Kim.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655