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 .
Response to Amendment
Applicant's amendment and argument filed 06/04/2026 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 Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 7, 11, 24-31 are pending of which claim 24-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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.
Election/Restrictions
Claim 7 is being rejoined for examination as it was originally presented as a claim in Group I in the restriction/election filed on 02/14/2022 and elected in the response filed on 05/11/2022 and may have been inadvertently withdrawn during prosecution.
Claims 1, 7, 11 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.
This is a new rejection based on the amendments and arguments filed on 06/04/2026.
Claim 1, is rejected under 35 U.S.C. 103 as being unpatentable over Tianhong Dai et. al. (Chitosan preparations for wounds and burns: antimicrobial and wound-healing effects, Expert. Rev. Anti. Infect. Ther., 2011 July; 9(7): 857-879) and Entsar Rabea et. al. (Chitosan as Antimicrobial Agent: Applications and Mode of Action, The American Chemical Society, November 3rd, 2003, Volume 4, Number 6, pp 1457-1465).
Dai teaches “Chitosan can be used to prevent or treat wound and burn infections not only because of its intrinsic antimicrobial properties, but also by virtue of its ability to deliver extrinsic antimicrobial agents to wounds and burns. It can also be used as a slow-release drug-delivery vehicle for growth factors to improve wound healing. The large number of publications in this area suggests that chitosan will continue to be an important agent in the management of wounds and burns” (see abstract).
Dai teaches that “In a similar study, bio-inspired bilayered physical hydrogels only constituted of chitosan and water were processed and applied for the treatment of full-thickness burn injuries in dogs” (see 3rd para page 12).
Dai teaches “Chitosan generally showed stronger bactericidal effects with Gram-positive bacteria than with Gram-negative bacteria in the presence of 0.1% chitosan. As a chitosan solvent, 1% acetic acid was effective in inhibiting the growth of most of the bacteria tested, except for lactic acid bacteria that were more effectively suppressed with 1% lactic or formic acids. Antibacterial activity of chitosan was inversely affected by pH, with higher activity at lower pH value” (see In vitro studies page 3, para. 4).
Dai teaches “A porous chitosan-silver nanocomposite for increased areas of application in wound dressing and antibacterial application was developed by Vimala et al. [76]. The entire process of development consists of three steps including silver ion-PEG matrix preparation, addition of chitosan matrix, and removal of PEG from the film matrix. Both PEG and chitosan played vital roles in the reduction of metal ions into nanoparticles, and also provided good stability to the formed nanoparticles. The embedded nanoparticles (AgNPs) were clearly observed throughout the film in scanning electron microscopy, and the extracted AgNPs from the porous chitosan-silver nanocomposite showed an average size of approximately 12 nm in transmission electron microscopy. Improved mechanical properties. were observed for porous chitosan-silver nanocomposite than for chitosan blend and chitosan-silver nano-composite films. The examined antibacterial activity results of these films revealed that porous chitosan-silver nanocomposite films exhibited superior inhibition.
A similar synthesis approach was presented by Thomas et al. [77]. In their study, chitosan/ silver nanoparticle films were synthesized by a simple photochemical method of reduction of silver ions in an acidic solution of AgNO3 and chitosan. The presence of silver nanoparticles was confirmed from the transmission electron microscopy, x-ray diffraction and thermogravimetric analysis of the film. The surface plasmon resonance obtained at 400 nm also confirmed the presence of nanosilver in the chitosan film. The developed chitosan nanosilver films demonstrated excellent antibacterial action against E. coli and Bacillus” (see last para. of page 15 and first para. of page 16).
Dai does not teach that the viscosity of the chitosan being greater than 500 centipoise.
Rabea’s general disclosure is a review of Chitosan as an antimicrobial agent (see paper).
Rabea teaches “Chitosan is a polycationic polymer with a specific structure and properties.1 It contains more than 5000 glucosamine units and is obtained commercially from shrimp and crab shell chitin (a N-acetylglucosamine polymer) by alkaline deacetylation2-4 (NaOH, 40-50%) (Figure 1). Recent advances in fermentation technology suggest that the cultivation of fungi (Aspergillus niger) can provide an alternative source of chitosan.5-6 Chitosan is insoluble in most solvents but is soluble in dilute organic acids such as acetic acid, formic acid, succinic acid, lactic acid, and malic acid. The use of chitosan is limited because of its insolubility in water, high viscosity, and tendency to coagulate with proteins at high pH. Many efforts to prepare functional derivatives by chemical modifications to increase the solubility in water have been reported.7-15” (see Introduction, page 1457).
Rabea teaches “The characteristics of chitosan that may be varied as required for a particular application are the degree of deacetylation (compared to chitin) and the molecular weight. The viscosity of solutions containing chitosan is affected by the degree of deacetylation, the molecular weight, the concentration, the ionic strength, the pH, and the temperature. Generally, an increase in temperature causes a decrease in the viscosity of the solution. The effect of the pH on the viscosity depends on the particular acid used. Native chitosan is soluble in organic acids when the pH is > 6 and insoluble in water, in alkaline medium, or in organic solvents. However, water-soluble salts of chitosan may be formed by neutralization with acids such as hydrochloric acid, acetic acid, lactic or formic acid” (see page 1458, first para.).
Rabe teaches that “Chitosan applied by spraying or inoculating leaves protected various plant species against local and systemic infection caused by alfalfa mosaic virus (ALMV), tobacco necrosis virus (TNV), tobacco mosaic virus (TMV), peanut stunt virus (PSV), cucumber mosaic virus (CMC), and potato virus X (PVX). The efficiency of chitosan to inhibit viral infections depends on the host-virus combination, chitosan concentration, and application method.126,127” (see last para. of page 1463 and first para. of page 1464).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to create a spray, a gel or hydrogel consisting of 0.1% chitosan, 1% acetic acid and inclusion of an antiseptic such as silver nanoparticles because the art already teaches creating such compositions and for the same purpose. Optimizing the viscosity would have also been obvious because Rabe teaches wherein it is the deacetylation of the chitosan polymer, the molecular weight, the concentration, the ionic strength, the pH, and the temperature which plays roles in how viscous it will be. Using low deacetylated chitosan with increased molecular weights and crosslinks, and not using high temperatures can thus give viscosities above 500 centipoise. This is an optimization well within the purview of any skilled artisan given the prior art, especially as it does not appear critical to the invention. Additionally, one would want to control the viscosity depending on the formulation type being created such as sprays etc.
There would have been a reasonable expectation of success in creating the instant invention given the prior art as chitosan and acetic acid (within the claimed ranges), along with an antiseptic have been used in wound care and there is plenty of art supporting their combined use in wound care management.
Claims 7, 11 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Tianhong Dai et. al. (Chitosan preparations for wounds and burns: antimicrobial and wound-healing effects, Expert. Rev. Anti. Infect. Ther., 2011 July; 9(7): 857-879) and Entsar Rabea et. al. (Chitosan as Antimicrobial Agent: Applications and Mode of Action, The American Chemical Society, November 3rd, 2003, Volume 4, Number 6, pp 1457-1465) as applied to claim 1 and above, and further in view of Paul J. Rucinski (WO2011056486A2). This is a new rejection based on the amendments and arguments filed on 06/04/2026.
Dai and Rabea teach the instant invention however are silent on the composition containing chlorhexidine digluconate.
Rucinski’s general disclosure is to highly effective methods and devices for convenient and effective wound repair (see abstract).
Rucinski teaches “Chlorhexidine is a chemical antiseptic, and it combats both gram positive and gram-negative microbes. It is bacteriostatic, hampering the growth of bacteria, and bacteriocidal, killing bacteria. It is often used as an active ingredient in mouthwash designed to kill dental plaque and other oral bacteria. Chlorhexidine also has non-dental applications. For example, it is used for general skin cleansing, as a surgical scrub, and as a pre-operative skin preparation. Chlorhexidine is typically used in the form of acetate, gluconate, or hydrochloride, either alone or in combination with other antiseptics such as cetrimide” (see page 3, 2nd para.).
The use of chlorhexidine is particularly advantageous because it is broad spectrum, binds to the skin (to provide residual activity), works rapidly and, when used according to the subject invention, is non-toxic (see page 8, 1st para.).
Chlorhexidine is active against aerobic and anaerobic gram-positive and gram-negative
bacteria. The drug also has some activity against Chlamydia trachomatis, certain fungi, and certain viruses (see page 8, 3rd para.).
“Advantageously, because the methods of the subject invention can be used to accurately and efficiently deliver an active ingredient to a target site in a patient, it is possible, in certain embodiments, to utilize reduced concentrations of active ingredients. Thus, in one embodiment of the subject invention, a low concentration solution of chlorhexidine can be used to effectively reduce infections at, for example, a wound, surgical site, or other tissue opening. In a preferred embodiment, the chlorhexidine solution is less than 4%. In a more preferred embodiment the chlorhexidine is less than 2%, or less than 1 % or even less than 0.1 %. In one embodiment, the chlorhexidine solution is 0.05%. In a further embodiment, the chlorhexidine solution is between 0.02% and 0.05%. Specifically exemplified herein is the use of chlorhexidine gluconate” (see page 9, 3rd para.).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use chlorhexidine digluconate, commonly referred to as chlorhexidine gluconate in a composition for treating wounds because Rucinski teaches it to be effective against aerobic and anaerobic bacteria and some fungi and even viruses.
Response to Arguments
Applicant’s arguments with respect to claim 1, 7, 11 and 31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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