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 .
Applicants' arguments, filed 12/08/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103--Previous
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.
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.
1) Claim(s) 1-3, 6-10, 14, 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Veyries et al., (Antimicrobial Agents and Chemotherapy, Apr. 2000) in view of Presterl et al., (Journal of Antimicrobial Chemotherapy, Jun. 2007).
Veyries et al. teaches “the antiadhesive effect of Poloxamer 407 (P407), together with modifications in the antimicrobial susceptibility of residual adherent staphylococci” (Abstract). “Furthermore, residual adherent staphylococci appeared to be more susceptible to antibiotic activity, suggesting that combination of P407 with antibiotics could be a promising approach to the prevention of infection of foreign material” (Id.)
“This study illustrates the potential of P407 for inhibiting the attachment of S. aureus and S. epidermidis and for increasing their susceptibility to antibiotics once they are adherent” (p. 1096, last paragraph).
The prior art does not teach where the antibiotic is hydrogen peroxide.
Presterl et al. teaches the effects of hydrogen peroxide on biofilms of Staphylococcus epidermidis (Ti).
“Hydrogen peroxide significantly reduced the biofilm OD after 1 min of incubation; no further reduction was seen at the later time points. Hydrogen peroxide 3% reduced the biofilm (OD baseline: 1) significantly compared with hydrogen peroxide 0.5%” (p. 418, right column, Results, 2nd paragraph).
Generally, 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 that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. See MPEP 2144.06. Thus, combining poloxamer with hydrogen peroxide as claimed in the instant invention would have been prima facie obvious since they are both taught to be useful for treating S. epidermidis.
Since hydrogen peroxide is known for being unstable in storage due to contaminates (see Technological Background), it would have been obvious to keep the components separate until use, as per claim 10, to preserve the efficacy and functionality of the peroxide.
Concerning the concentration of hydrogen peroxide and poloxamer, it would have been obvious to optimize a range for each given their antimicrobial/antibiotic nature. "[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). Modification of the concentrations of peroxide and poloxamer would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Since the prior art teaches a use of poloxamer for the prevention of infection of foreign material, it would have been obvious to formulate a hand wash, oral wash, nasal cleansing solution, sinus cleansing solution or skin cleansing solution as means for keeping the body clean and free of infection.
It would have also been obvious for the composition to comprise water, as per claim 9, as a means for providing concentrations of peroxide as discussed in the prior art.
The obviousness of the combination makes implicit the shelf-life of at least 1 year at room temperature, as per claim 14.
2) Claim(s) 1-4, 6-14, 23 remains rejected under 35 U.S.C. 103 as being unpatentable over Veyries et al., (Antimicrobial Agents and Chemotherapy, Apr. 2000) in view of Presterl et al., (Journal of Antimicrobial Chemotherapy, Jun. 2007) and further in view of Tamarkin et al., (US 8,709,385).
The combination of Veyries et al. and Presterl et al., which taught above, differs from the claims 4, 5, 11-13 insofar as it does not teach a mixture of poloxamers, a hydrogel form for the poloxamer, additional bioactive substances, or additional antimicrobial substances.
Tamarkin et al. teaches, “Pharmaceutical or cosmetic compositions and methods for their use are provided comprising water and a surfactant system comprising a Poloxamer at a concentration of about 0.1% to about 15% by weight” (Abstract). Accordingly, it would have been reasonable to provide 0.1-10 w/v poloxamer, as claimed. The compositions may further comprise “an active agent” (Id.).
The method involves “treating, alleviating or preventing a disorder of mammalian subject in need thereof” (col. 8, lines 39-41).
In regard to claim 4, Tamarkin et al. teaches, “administering a therapeutically effective amount of a gel or foam produced from a Poloxamer composition of claim 1 to an afflicted target site of said mammalian subject” (col. 9, lines 1-4). The gel suffices as a hydrogel insofar as it is network of polymer chains, i.e. poloxamer, that absorb and retain water. Tamarkin et al. further teaches, “in order to attain the fixing property, the Poloxmer is selected such that the formulation may be liquid or semi liquid at room temperature but upon warming to hand or body temperature the viscosity increases”, wherein “the increase in viscosity is sufficient to have a gelling effect” (col. 12, lines 47-52).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a gel form of poloxamer, i.e. a composite hydrogel, as a suitable means for administering the poloxamer for the prevention of infection of foreign material.
In regard to claim 5, Tamarkin et al. teaches, “In certain embodiments the Poloxamer comprises at least one of Poloxamer 124, Poloxamer 188, Poloxamer 237, Poloxamer 338 or Poloxamer 407 or mixtures of two or more thereof, such as 407 and 124” (col. 5, lines 25-28).
“There are provided formulations in which the Poloxamer improves the solubility of or acts to dissolve an active agent in an aqueous phase, wherein such an active agent is not fully soluble in said aqueous phase” (col. 10, lines 62-65). Further, “the Poloxamer is capable of the fixing the composition to a body surface” (col. 11, lines 37-40).
The compositions may further comprise “an antiinfective agent” (additional bioactive and antimicrobial substance) such as “an antibiotic peptide” (col. 29, line 63) and “an oxidizing agent” (col. 30, line 1). As an oxidizing agent, the artisan would have had a reasonable expectation of success combining poloxamer and hydrogen peroxide, as claimed, in view of Tamarkin et al.
The compositions are also taught to have “an acceptable shelf-life of at least about six months, preferably about one year, or more preferably, at least about two years at ambient temperature” (col. 24, lines 10-13).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a mixture of poloxamer for the advantage of improving the solubility of an active agent as well as fixing the composition to a body surface, as taught by Tamarkin et al. It would have also been obvious to provide additional water, bioactive substances and additional antimicrobial substances for the advantage of treating, alleviating or preventing a disorder of mammalian subject in need thereof, as taught by Tamarkin et al.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure USDA (by O PEL, TIP 0606-24, 2010). USDA is pertinent for teaching, “Although pure hydrogen peroxide is very stable, may contaminants, even in very minute amounts, can catalyze its decomposition” (p. 7, at 7th paragraph).
Response to Arguments
i) Applicant argues, “the presently claimed invention is not based on a simple combination of two prior-art compositions, but on the unexpected synergistic effect of the combination” (p. 6). Applicant argues that the micelle forming gel and oxidizing effect of hydrogen peroxide could not have been predicted from the prior art (p. 6).
"[I]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice" (In re De Blauwe, 736 F.2d 699,705 (Fed. Cir. 1984)).
Concerning synergy, the instant specification makes reference to “Figure 2” (shown below) is described as, “Schematic drawing depicting the synergistic effects from mixing pluronic with peroxide” (p. 10), as evidence of synergy:
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(Drawings Fig. 2).
Synergy, by definition is the interaction or cooperation of two or more substances to produce a combined effect greater than the sum of their separate effects.
From the drawing one is unable to appreciate the combined effect being greater than the sum of their separate effects. This is merely a depiction of the combined, or additive effect of pluronic and hydrogen peroxide on a biofilm.
Evidence showing the effect of pluronic and hydrogen peroxide alone versus evidence of their effect together, has not been presented. Accordingly, applicant’s notion of unexpected synergy is merely an argument or conclusory statements in the specification, which is insufficient to overcome the art of record.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612