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 .
Status of Application
The petition to accept color drawing dated March 27, 2025 was granted on July 22, 2025.
Claims 1-20 are pending in this application.
No claim amendments or Information Disclosure Statements have been submitted.
All pending claims are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “wherein the biofilm shock treatment is configured to weaken a matrix of a biofilm and to disinfect causative microbes while promoting biofilm removal”. It is unclear how the treatment composition is “configured” to provide the recited functional property. It is unclear what structural element provides the cited property. After a review of the specification, biofilm shock 306 is recited as providing the benefit of killing and removing biofilm (paragraph 0077). However, it appears biofilm shock 306 comprises at a minimum, the zinc ion source, a disinfecting agent, and a chelating agent. However, a chelating agent is not a require component of claim 1. Clarification is requested.
Regarding claim 4, the claim recites “wherein the zinc ion source is configured to weaken the matrix of the biofilm”. As discussed above, it is unclear how the zinc source is structurally altered to be “configured” to provide the functional property recited. A review of the specification, in paragraph 0054, discloses the zinc ion source of zinc lactate and/or zinc lactate dihydrate which allows the zinc ions or lactic acid to disable, clean, and/or remove the biofilm. Therefore, it is unclear is the zinc ion source is limited to zinc lactate or zinc lactate dihydrate. Clarification is requested.
Regarding claims 12 and 18, the claim recites a surfactant, generically, is present in the biofilm shock solution, however, after a review of the specification, only a non-ionic surfactant is suitable in the method of removing a biofilm. Paragraph 0059 discloses a non-ionic surfactant is preferred because an ionic surfactant, particularly an anionic surfactant, could react with the cations of the ammonium and the resulting compound precipitate out of solution. Therefore, it is unclear if any surfactant can be included in the composition while retaining the functional property recited.
Claims rejected but not specifically recited above are included in this rejection, as they don’t remedy the deficiency discussed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1, 3-6, 9-10, 16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Modak et al. (WO 2011/002929 A1).
Modak discloses antimicrobial preservative compositions. The compositions comprise one more zinc salts (abstract).
Example 45 #32 discloses an aqueous hand sanitizer comprising:
0.2% Benzethenium chloride (disinfectant, an ammonium chloride disinfectant);
0.1% zinc lactate (a zinc ion source); and
80.8% water (page 118-119).
Regarding claim 3, Example 45 additionally contains 1% Glucopon 215UP, which is a non-ionic surfactant.
Regarding claims 4-6, as noted above, zinc lactate is disclosed.
Regarding claim 9, as noted above, is present in the amount of 0.2%.
Regarding claim 10, as noted above, benzethenium chloride is disclosed.
Regarding claim 16, as noted above, Example 45 #32 discloses an aqueous hand sanitizer comprising:
0.2% Benzethenium chloride (disinfectant, an ammonium chloride disinfectant);
0.1% zinc lactate (a zinc ion source); and
80.8% water (page 118-119).
Regarding claim 18, as noted above, Example 45 additionally contains 1% Glucopon 215UP, which is a non-ionic surfactant.
Regarding claim 19, Table 155 discloses the organisms targeted with the formulation of Example 45.
Modak, therefore, anticipates the rejected claims.
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.
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.
Claims 1-12 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Apolla et al. (CA 2874510 A1).
Apolla discloses surface treatment compositions which impart a microbicidal benefit to treated surfaces which compositions comprise a zinc ion source material which releases zinc ions into the treatment composition, at least lower alkyl aliphatic monohydric alcohol which independently of other constituents present exhibits a microbicidal effect, a propellant; and, water (abstract). The composition additionally comprises a cationic quaternary ammonium compound (page 18, lines 4-5). It is noted that a cationic quaternary ammonium compound is a disinfecting agent.
Regarding claim 2, the composition may include one or more chelating agents (page 39, line 25-26).
Regarding claim 3, the composition may additionally comprise a surfactant, non-ionic surfactants are preferred (page 8, line 4-6).
Regarding claim 4, as noted above, the zinc ion source material releases zinc ions into the treatment composition. The recitation of to weaken the matrix of the biofilm is considered a functional property of the composition. Since Apolla discloses the same composition, it would necessarily have the same functional properties.
Regarding claims 5-6, the zinc ion source can be zinc acetate or zinc lactate (page 12, lines 9-23).
Regarding claim 7, the zinc ion source is present in the composition in an amount of at least about 0.001% to about 2.5 % wt. (page 12, lines 28-29).
Regarding claim 8, the chelating agent can be present in the amount of 0.001% to about 5% wt. (page 40, lines 5-6).
Regarding claim 9, the quaternary ammonium compound is present in the amount of 0.001% wt. up to about 10% wt. (page 23, lines 17-21).
Regarding claim 10, examples of quaternary ammonium compound include ammonium chlorides (page 21, lines 13-14). 3
Regarding claim 11, suitable nonionic surfactants include alcohol ethoxylates (page 27, lines 1-20).
Regarding claim 16, as noted above, Apolla discloses compositions comprising a zinc ion source material which releases zinc ions into the treatment composition, at least lower alkyl aliphatic monohydric alcohol which independently of other constituents present exhibits a microbicidal effect, a propellant; and, water (abstract).
Regarding claim 17, as noted above, the composition may include one or more chelating agents (page 39, line 25-26).
Regarding claim 18, as noted above, the composition may additionally comprise a surfactant, non-ionic surfactants are preferred (page 8, line 4-6).
Regarding claim 19, the resultant compositions provide unexpectedly excellent microbicidal efficacy against a range of undesirable microorganisms including certain viruses, bacteria and certain fungi, which has heretofore not been expected from compositions which include the reduced amounts of the alcohol constituent provided in the compositions (page 17, lines 14-18).
Regarding claim 20, as noted above, the zinc ion source is present in the composition in an amount of at least about 0.001% to about 2.5 % wt. (page 12, lines 28-29); the quaternary ammonium compound is present in the amount of 0.001% wt. up to about 10% wt. (page 23, lines 17-21); the chelating agent can be present in the amount of 0.001% to about 5% wt. (page 40, lines 5-6).
While Apolla does not exemplify the formulation of the instant claims, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to have includes the quaternary ammonium compound and the chelating agent since they are disclosed as suitable additional components.
Claims 12-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 20080247973).
Baig discloses compositions and methods for improving overall tooth health and appearance. The composition comprises an antimicrobial agent, preferably a quaternary ammonium compound and polyvalent metal salts, an anti-calculus agent and additional surfactant to provide benefits including superior anti-erosion, anticaries, antiplaque and anti-staining as demonstrated by enhanced fluoride uptake, remineralization, resistance to acid demineralization and antimicrobial activities, resulting in improved overall tooth health, structural integrity and appearance (abstract).
It is noted that quaternary ammonium compounds are disinfecting agents.
It is noted that Baig has defined the terms "tartar" and "calculus" to be mineralized dental plaque biofilms.
The compositions may comprise metal ions including zinc ions (paragraph 0036). Examples include zinc oxide, zinc sulfate, zinc chloride, zinc citrate, zinc lactate, zinc gluconate, zinc malate, zinc tartrate, zinc carbonate, zinc phosphate (paragraph 0039).
The composition can additionally comprise chelating agents. Chelating agents are able to complex calcium found in the cell walls of the bacteria. Chelating agents can also disrupt plaque by removing calcium from the calcium bridges which help hold this biomass intact (paragraph 0060).
Regarding claim 13, the zinc ion can be present in the amount of 0.5 to about 7% by weight (paragraph 0039); the chelating agent can be present in the amount of 0.1% to about 2.5% (paragraph 0061); the disinfecting agent, quaternary ammonium compound are present at levels of at least about 0.035% to at least about 1.0% by weight (paragraph 0034).
Regarding claim 15, the method of use or treatment herein may comprise contacting a subject's dental enamel surfaces and mucosa in the mouth with the oral compositions. The method may comprise brushing with a dentifrice or rinsing with a dentifrice slurry or mouthrinse. Other methods include contacting the topical oral gel, denture product, mouth spray, or other form with the subject's teeth and oral mucosa, to improve overall tooth health, structure and appearance via use of the present compositions, which provide benefits including erosion protection as well as one or more of caries prevention and control of bacterial activity in the oral cavity which cause undesirable conditions including plaque, calculus, gingivitis, periodontal disease and malodor (paragraphs 0088-0089).
While Baig does not exemplify the formulation of the instant claims, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to have combined the quaternary ammonium compound, zinc ions, and the chelating agent since they are disclosed as suitable components to prepare the dental composition.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Samual et al. (A Flexible Anti-Biofilm Hygiene Coating for Water Devices, Applied Biomaterial, 2022, 5, 3991-3998).
Samual discloses a non-nanoparticle, flexible anti-biofilm hygiene coating consisting of lithocholic acid (LCA), zinc pyrithione (Zn), and cinnamaldehyde (Cn) (named as LCA-Zn-Cn) that largely prevents the bacteria adhesion to various water device surfaces such as stainless steel and glass through a synergistic mechanism. The existing chelated groups on LCA and Cn attract plenty of bacteria via hydrophobic interaction. Both the bactericidal reaction by grafting biocidal groups from both LCA and Cn and the bacteriostatic reaction by inhibiting cell division via zinc ions (Zn) lead to a largely improved bacteria/biofilm prevention. By applying either spray or dip-coating, the designed polymer composite can be coated on a variety of irregular water devices (abstract).
A solution was prepared with 1.2 g of poly-(bisphenol A-coepichlorohydrin) glycidyl end-capped resin (epoxy) was dissolved in a solution of 6 mL of dimethylformamide (DMF), 1 mL of divinylbenzene (DVB), 1.0 mL of cinnamaldehyde (Cn), 0.1 g of zinc pyrithione, and 0.27 g of lithocholic acid (LCA).
Lithocholic acid, as one of bile acids that are derived from the cholesterol in mammals, is considered as one of the promising antimicrobials. Cinnamon is an ancient herbal medication that has been used as both a spice and traditional medicine. The major component of cinnamon bark extract, cinnamaldehyde, is effective against bacteria, fungi, and viruses. Zinc pyrithione is a well-known bacteriostatic and antifungal agent.
It is noted cinnamaldehyde is a chelating agent.
It is noted zinc pyrithione is a zinc ion source.
It is noted divinylbenzene is surfactant.
The recitation of dental water line does not provide a structural difference between water lines of any other purpose. Samual discloses the coating can be applied to any pipeline wall and in drinking water distribution systems.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used the solution of Samual in the water lines of claim 14 since Samual discloses the high antibacterial activity of the LCA-Zn-Cn coating is contributed by the synergistically bactericidal and bacteriostatic interactions from the major components of LCA, Zn, and Cn, while the mechanical reliability is benefited from the epoxy resin. First, the coating attracts the bacteria through hydrophobic interaction. Then, the active components may diffuse/penetrate through the bacteria membrane causing membrane depolarization, cytoplasmic leakage, and morphology distortion, leading to the bacteria death. As the results, the surface adhesion and subsequent colonization of pathogenic bacteria such as E. coli and E. faecalis are inhibited, and thus the potential biofilm formation is prevented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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