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 . Claims included in the prosecution are claims 1, 3-18 and 21.
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.
The factual inquiries 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.
1. Claims 1 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. (WO 2021/077119, Apr. 22, 2021) (IDS reference) (hereinafter Allred).
Allred discloses an antimicrobial composition for the treatment of an infection, in a host in need thereof comprising a quaternary ammonium compound (claim 49). The quaternary ammonium compound may have the following formula:
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(i.e., claimed compound XIX) (page 72). The antimicrobial composition is added to a hydrogel (claims 69-71). The hydrogel retains water (i.e., aqueous hydrogel) (page 342, lines 11-12). The antimicrobial composition may comprise a pharmaceutically acceptable carrier (claim 81). The pharmaceutical acceptable carrier comprises an aqueous solution, for example water, or glycerin solution, such as glycerol (page 43, lines 28-29 – page 44, line 1). The solution has at least 0.2% concentration of the quaternary ammonium compound (page 70, lines 20-21). The exact amount of the quaternary ammonium compound will be determined by a health care provider to achieve the desired clinical benefit (page 337, lines 7-9). The antimicrobial composition further includes a poloxamer (i.e., claimed non-ionic adhesion agent) (page 343, line 12) and hydroxypropyl methylcellulose (i.e., claimed non-ionic gelling agent lacking a carboxylic acid group) (page 343, line 21). Hydroxypropyl methylcellulose and poloxamers are gelling agents. Gelling agents are typically used in concentrations of 0.5-10% to allow for easy addition of the active drug before the gel is formed (page 375, lines 13-17).
Allred differs from the instant claims insofar as not disclosing wherein the composition comprises an aqueous solution and glycerin (i.e., claimed non-ionic wetting agent lacking a carboxylic acid group) together.
However, since Allred discloses the use of various pharmaceutically acceptable carriers individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by Allred to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
2. Claims 1, 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. (WO 2021/077119, Apr. 22, 2021) (IDS reference) (hereinafter Allred) in view of Holzer et al. (US 2017/0112935, Apr. 27, 2017) (hereinafter Holzer).
The teachings of Allred are discussed above. Allred does not teach wherein the composition comprises between about 0.5% and about 5% of the non-ionic wetting agent and wherein the poloxamer is poloxamer 407.
However, Holzer discloses the use of a thermoreversible hydrogel composition in a system for delivery of a therapeutic agent to the urinary tract (¶ [0103]). The hydrogel may comprise a plasticizer, such as glycerol in a concentration from 0 to 30% based on the total mass of the gel (¶ [0453]). The nature and amount of plasticizer are chosen so that a particular release and stability is achieved (¶ [0352]). The hydrogel may comprise a poloxamer, such as poloxamer 407 (¶ [0360]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 0 to 30% glycerol (i.e., claimed non-ionic wetting agent) into the hydrogel of Allred motivated by the desire to achieve a particular release and stability of the hydrogel as taught by Holzer.
Also, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated poloxamer 407 into the hydrogel of Allred since the hydrogel comprises poloxamer and poloxamer 407 is a known and effective poloxamer for hydrogel composition as taught by Holzer.
In regards to the claimed amounts of non-ionic gelling agent and non-ionic adhesion agent, as discussed above, Allred discloses wherein the antimicrobial composition includes a poloxamer (i.e., claimed non-ionic adhesion agent) (page 343, line 12) and hydroxypropyl methylcellulose (i.e., claimed non-ionic gelling agent) (page 343, line 21). Hydroxypropyl methylcellulose and poloxamers are gelling agents. Gelling agents are typically used in concentrations of 0.5-10% to allow for easy addition of the active drug before the gel is formed (page 375, lines 13-17). Thus, the claimed amount of each of the non-ionic gelling agent and the non-ionic adhesion agent would have been obvious from one selecting an amount of each of the non-ionic gelling agent and the non-ionic adhesion agent such that the total is within this range.
3. Claims 4-18 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. (WO 2021/077119, Apr. 22, 2021) (IDS reference) (hereinafter Allred) in view of Holzer et al. (US 2017/0112935, Apr. 27, 2017) (hereinafter Holzer), and further in view of Daood et al. (Effect of a novel quaternary ammonium silane cavity disinfectant on cariogenic biofilm formation, May 21, 2019) (hereinafter Daood).
The teachings of Allred and Holzer are discussed above. Allred and Holzer do not teach wherein the quaternary ammonium compound is fully hydrolyzed.
However, Daood discloses wherein the hydrolysis products of SiQAC exhibited antimicrobial activities against a broad range of microorganisms, while chemically bonded to a variety of surfaces (page 2, left column, third paragraph). The QAS is fully hydrolyzed (page 2, right column, first paragraph). Because of the presence of reactive silanol groups generated during hydrolysis, QAS can covalently attach to substrate surfaces via Si-O linkages to exert non-migrating microbiocidal functions (page 11, left column, first paragraph).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have fully hydrolyzed the quaternary ammonium compound of Allred since this would produce another suitable and effective antimicrobial agent and hydrolyzing allows the quaternary ammonium compound to attach to substrate surfaces to exert non-migrating microbiocidal functions as taught by Daood.
In regards to the instant claims reciting trihydroxy-QAS cation of Formula X, counterion
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in the hydrogel, as noted on page 7 of the instant specification, complete hydrolysis of the claimed compounds results in trihydroxy-QAS, an anionic counterion, and a smaller hydroxyl-containing product. Therefore, since Allred teaches substantially the same compound as claimed (i.e., compound XIX) and it would have been obvious to have fully hydrolyzed the compound Allred, the composition of the prior art would comprise substantially the same trihydroxy-QAS cation, counterion, and hydroxyl-containing product as claimed.
In regards to the instant claims reciting between about 0.1% and 5.0% trihydroxy-QAS cation, as noted on page 112 of the instant specification, the hydrogel comprises between about 0.1% and 10% of the quaternary ammonium silane compound. Allred discloses wherein the quaternary ammonium compound may be present at least 0.2%. Therefore, since Allred disclose substantially the amount of compound to be fully hydrolyzed as the claimed invention, the hydrogel of Allred would necessarily comprise substantially the same amount of trihydroxy-QAS cation as claimed.
In regards to instant claim 5 reciting wherein the hydrogel does not comprise a non-ionic osmotic agent, this limitation would have been obvious from Allred not disclosing a non-ionic osmotic agent as a required ingredient.
Response to Arguments
Applicant argues that it has been discovered in this invention that the non-ionic gelling agents which lack a carboxylic acid group are particularly suitable in stabilizing the quaternary ammonium silane from undesired precipitation, which is unexpected, highly advantageous and beneficial feature, as compared to ionic gelling agents that contain a carboxylic group.
The Examiner does not find Applicant’s argument to be persuasive. Examples 11 and 12, which are representative of the claimed invention, use glycerin as the non-ionic wetting agent lacking a carboxylic acid group and HPMC as the non-ionic gelling agent lacking a carboxylic group. It is unclear whether the lack of precipitation was due to the ingredients lacking a carboxylic acid group or whether it was due to specifically HPMC and glycerin being in the composition. Applicant has not presented comparisons using other ingredients lacking a carboxylic acid group. As such, Applicant’s argument is unpersuasive.
Applicant argues that there is no teaching, motivation, guidance, let alone expectation of success, in Allred that would have led a skilled artisan to specifically select non-ionic gelling agent and wetting agents that lack carboxylic acid group among the long lists of ingredients to Allred.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Applicant has not shown wherein non-ionic gelling agent and wetting agents that lack carboxylic acid group are critical. As such, it is not necessary for the prior art to teach criticality of selecting those ingredients. Also, a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Thus, Allred disclosing multiple ingredients does not make any one selection less obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that those skilled in the art would not have turned to Holzer because it does not provide any teaching on stabilizing the quaternary ammonium silane hydrogel formulations against precipitation.
The Examiner does not find Applicant’s argument to be persuasive. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV). Thus, it is not necessary for Holzer to teach stabilizing the quaternary ammonium silane hydrogel formulations against precipitation.
Applicant argues that Daood do not cure the defects of Allred and Holzer.
The Examiner submits that Applicant’s arguments regarding Allred and Holzer are addressed above and are unpersuasive. Therefore, the rejection is maintained.
Conclusion
Claims 1, 3-18 and 21 are rejected.
Claims 2, 19, 20, and 22-25 have been withdrawn.
No claims are allowed.
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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/TRACY LIU/Primary Examiner, Art Unit 1614
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