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 .
Applicant’s amendments filed 2/10/2026 have been entered.
Claims 1-12, 14-17, 34-37 are pending.
Claims 34-37 are added in the amendments filed 2/10/2026.
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, 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.
Claim(s) 1-12, 14-17, 34-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2016/0199322 (‘322) and US2013/0089593 (‘593) in view of Eltawil et al., Cartilage 2018, Vol. 9(3) 313–320.
‘322 teaches a method of treating wound for reducing bacterial colonization in or around the area of a wound with a composition comprising an aqueous composition having a pH of from 2 to 4, a total solute concentration of from 1.8 to 4.0 Osm/L, and from 0.9 to 1.7 g/L of a surfactant. ‘322 teaches “Essentially any material having surface active properties in water can be employed, although those that bear some type of ionic charge are expected to have enhanced antimicrobial efficacy because such charges, when brought into contact with a bacteria, are believed to lead to more effective cell membrane disruption and, ultimately, to cell leakage and lysis.”. Useful surfactants include cationic, anionic, and nonionic types. Examples of anionic surfactants include sodium lauryl sulfate (see [0046]). ‘322 also teaches the acidity is achieved by incorporating acids into the water. Examples of acids include citric acids. ‘322 also teaches the salt of the acids (see [0171] and claims 17-19). ‘322 teaches the composition can be applied via a syringe (a container with at least one access point as recited in claim 13) for example (see [0116]).
‘593 teaches a similar method for wound treatment using an aqueous composition, instead of a gel composition, wherein the aqueous composition comprising the same components of ‘322 discussed above. (see the abstract, [0046], [0171]). ‘593 teaches citric acid as one of the suitable acids (see [0065] – [0066]). ‘593 teaches the pH of the composition could be both basic or acidic (see the abstract, [0061]-[0063], [0071], [0142]). ‘593 teaches the composition can be applied via a syringe (a container with at least one access point as recited in claim 13) for example (see [0116]).
The references do not expressly teach the osmolality of the composition. The references do not expressly teach the amount of the ingredients of the composition.
Eltawil et al. teaches hypertonic solution for open joint surgery would provide chondroprotection of the cartilage of the joint (see the abstract). Eltawil et al. teaches osmolality of 600mOsm/L reduce the in vitro and in vivo cartilage damage during the surgery (see the abstract).
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the osmolality of the composition to be used in the method of reducing the bioburden during wound care.
One of ordinary skill in the art would have been motivated to adjust the osmolality of the composition to be used in the method of reducing the bioburden during wound care. Changing the osmolality of the solution to hypertonic (above 300 mOsm to 600mOsm as taught in Eltawil et al.) would be reasonably expected to provide chondroprotection to the patients. When applying the solution composition to open joint surgery wound, the anti-microbial effect would be reasonably expected to reduce the bioburden in and around the wound, as well as providing protection to the cartilage of the joint. Portion of the composition would have been left in the wound cavity after the composition is applied onto the wound.
In addition, the optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). The amount of the buffering agents (i.e., the acid and the salts of the acid forming the buffer system) depending on the target pH of the final composition. Therefore, knowing the final pH of the composition, one of ordinary skill in the art would be motivated to adjust the amount of the buffering agents to what is recited in the claims.
Since the composition suggested by the cited prior art has medical purpose of reducing the bacterial load in the wound, such composition would be reasonably expected to be administered by any medical professionals including emergency medical service provider or surgent performing open joint surgery.
Response to Arguments
Applicant's arguments filed 2/10/2026 averring the cited prior art’s failure to provide motivation to combine the teachings, have been fully considered but they are not persuasive. The motivation to combine the teachings of the cited prior art resides on the fact that the composition of the primary references is known to be able to reducing bacterial colonization in or around the area of a wound; while osmolality of 600mOsm/L reduce the in vitro and in vivo cartilage damage during the surgery. Therefore, employing the composition of the primary references with high osmolality would therefore be able to reducing the bacterial burden as well as protecting the joint during surgery.
Applicant's arguments filed 2/10/2026 averring the cited prior art’s failure to teach the herein claimed method step of the composition being remain in the wound cavity. The examiner notes that once the solution composition is applied to the wound, a portion ( a drop of the solution composition) of the solution would be reasonably expected to be left in the wound cavity.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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