DETAILED ACTION
Claims 33 and 75-98 are pending in the instant application.
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 .
Priority
The instant application claims priority to 371 of PCT/IL2023/050253 filed on 03/12/2023 which claims benefit to Israel 291349 filed on 03/14/2022.
Information Disclosure Statement
The information disclosure statement (IDS) is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
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.
Regarding claims 83, 88, 90, 98, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 33 and 75-85 are rejected under 35 U.S.C. 103 as being unpatentable over Gin et al. (US 2017/0215417 A1), Percival et al. (WO 2011/089379 A2), Dennes et al. (US 2016/031195 A1), and Chen et al. (An Overview on Thermosensitive Oral Gel Based on Poloxamer 407, materials, 2021).
Gin discloses an anti-microbial composition comprising a chelator (such as EDTA and its salts) and a transport enhancer. The combination unexpectedly and beneficially inhibits bacterial or fungal biofilms when administered (Abstract). Examples of diseases caused by biofilms include dental caries, periodontitis ([0005]). Biofilms are responsible for many of the diseases common in the body including dental diseases ([0008]). Methods of inhibiting biofilm formation in medical and industrial settings have previously been developed using meta chelators ([0014]). The method involves administering an effective amount of a formulation comprising a therapeutically effective amount of a chelator agent ([0021]). Suitable biocompatible chelating agents include EDTA, phosphates such as pyrophosphates, tripolyphosphates, and hexametaphosphates ([0063]). Chelating agents can also include amino acid diacetic acid such as tetra sodium salts of L-glutamic acid N,N-diacetic acid (GLDA) ([0070]).
Gin does not explicitly mention sodium hexametaphosphate.
Percival discloses treatment of biofilms – a polyanionic compound and an antimicrobial agent is combined to treat microbial biofilms and for the topical treatment of wounds. The polyanionic compound may be a polyphosphate such as sodium hexametaphosphate. And an antimicrobial agent can be acetic acid (Abstract).
Dennes discloses poly alpha-1,3-glucan ether compounds (Abstract). A hydrocolloid or aqueous solution disclosed herein can be in the form of, and/or comprised in, a personal care product, pharmaceutical product, food product, household product, or industrial product ([0108]). Compositions disclosed herein can be in the form of an oral care composition. Examples of oral care compositions include dentifrices, toothpaste, mouth wash, mouth rinse, chewing gum, and edible strips that provide some form of oral care (e.g., treatment or prevention of cavities [dental caries], gingivitis, plaque, tartar, and/or periodontal disease) ([0177]). An anticalculus or tartar control agent suitable for use in an oral care composition herein includes, for example, phosphates and polyphosphates. Useful inorganic phosphate and polyphosphate salts include, for example, monobasic, dibasic and tribasic sodium phosphates, sodium tripolyphosphate, tetrapolyphosphate, mono-, di-, tri- and tetra-sodium pyrophosphates, disodium dihydrogen pyrophosphate, sodium trimetaphosphate, sodium hexametaphosphate, or any of these in which sodium is replaced by potassium or ammonium ([0182]). One or more anticalculus or tartar control agents can optionally be present at about 0.01-50 wt% ([0182]). A surfactant such as poloxamer can be included in an oral care composition in an amount of about 0.01-10 wt% ([0183]).
Above references do not explicitly mention poloxamer 407.
Chen discloses thermosensitive hydrogels composed of poloxamer in medicine especially for oral cavities. The hydrogels remain fluid at room temperature and at body temperature, they become more viscous gels. A thermosensitive gel based on poloxamer 407 is used to deliver drugs. In conclusion, thermosensitive gels based on poloxamers are suitable and have great potential for oral disease treatment (Abstract).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to arrive at a method of removing microbial biofilm in dental cavities with at least one polyphosphate and an amino acid diacetic acid as taught above. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 75-77, polyphosphate salt is taught above.
Regrading claims 78-79, amino acid diacetic acid such as GLDA is discussed above. Likewise, one of ordinary skill in the art would routinely experiment with alternate amino acid diacetic acids within a biofilm reducing composition.
Regarding claim 80, Gin discloses that the % of chelator within the composition is about 0.1% to 15% (claim 1). One of ordinary skill in the art would envisage that routinely used biofilm removing ingredients such as polyphosphate and/or GLDA can be included in various concentrations within such a composition. Likewise, one of ordinary skill in the art would routinely experiment with different weight ratios of chelators within such a composition.
Regarding claim 81, polyphosphate and poloxamer concentrations are discussed by Dennes above. Furthermore, one of ordinary skill in the art would routinely experiment with various concentrations of a surfactant within an oral care composition. Dennes discloses that an oral care composition may comprise at least one pH-modifying agent; such agent may be selected to acidify, make more basic, or buffer the pH of a composition to a pH range of about 2-10 ([0185]). One of ordinary skill in the art would routinely experiment with different pH levels for an oral care composition.
Regarding claim 82, Gin discloses that the formulation can include poloxamers or ABA block copolymers of ethylene oxide and propylene oxide ([0099]). Poloxamer 407 being thermosensitive is taught above.
Regarding claim 83, poloxamer and polyphosphate/GLDA are discussed above.
Regarding claim 84, Gin discloses that the % of chelator within the composition is about 0.1% to 15% (claim 1). One of ordinary skill in the art would envisage that one or more chelators within an oral care composition can be about 0.1% to 15%. Chen discloses that P407 formulation with 15-30% concentration can appear as a gel at body temperature (pg 5).
Regarding claim 85, one of ordinary skill in the art would routinely experiment with various concentrations of each routinely used ingredient in an oral care composition.
Claims 86-98 are rejected under 35 U.S.C. 103 as being unpatentable over Gin et al. (US 2017/0215417 A1), Percival et al. (WO 2011/089379 A2), Dennes et al. (US 2016/031195 A1), and Chen et al. (An Overview on Thermosensitive Oral Gel Based on Poloxamer 407, materials, 2021) as applied to claims 33 and 75-85 above, and further in view of Penhasi et al. (US 2004/0185009 A1)
Penhasi discloses an oral delivery system for the treatment of periodontal disease comprising a biodegradable polymer, antibacterial agent, and anti-inflammatory agent (Abstract). The composition comprises a biodegradable polymeric matrix and a bioactive agent, wherein the polymeric matrix comprises a plasticizing agent and a cross-linked, water-insoluble protein formed from a water-soluble protein and a crosslinking agent ([0014]). The polymer is preferably present at a concentration of from about 20% to about 70% and the plasticizing agent is present at a concentration of from about 1 % to about 15%. In addition, the weight ratio between the bioactive agents and the polymer in the composition, ranges from about 2:1 to about 1:3, while the weight ratio between the plasticizing agent and the polymer is from about 1: 10 to about 1:2 ([0032]). Penhasi discloses that the composition softens and swells in the mouth ([0033]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have created a solid dosage form comprising crosslinked polymer, plasticizer that can swell and degrade to release active ingredients within. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 87, Penhasi discloses that the polymer can be polylactic acid, polyglycolic acid, copolymers of polylactic and polyglycolic acid ([0049]). Proteins have been found useful as the basis for drug delivery systems since their degradation products are harmless amino acids and their biodegradation is facile in many parts of the body. Useful proteins for drug delivery include proteins derived from connective tissue such as collagen and gelatin and hydrolyzed gelatin ([0050]).
Regarding claim 88, crosslinking agent is aldehydes or dialdehydes ([0051]).
Regarding claim 89, weight ratio is taught above.
Regarding claim 90, polyphosphate and amino acid diacetic acid are taught above.
Regarding claims 91-92, concentration of active ingredients is taught above.
Regarding claim 93, Penhasi discloses that at times, the delivery system may further comprise a cross-linking agent that is present in an amount sufficient to render said polymer water-insoluble, while permitting the release of said active agents from said delivery system ([0028]). One of ordinary skill in the art would routinely experiment with different release profiles for a sustained-release formulation.
Regarding claim 94, Penhasi teaches implants ([0020]).
Regarding claim 95, Penhasi discloses that although the width and length of the implant may vary depending upon the size of the periodontal pocket of the recipient patient, it is preferable to use implants having a width of between 1-5 millimeters, and preferably between 3-5 millimeters. It is preferable to employ implants having a length of between 3-10 millimeters ([0071]).
Regarding claim 96 and 98, a composition comprising a thermosensitive poloxamer polymer, polyphosphate, amino acid diacetic acid would be useful for removing microbial biofilm as taught in combination above.
Regarding claim 97, crosslinked polymer and plasticizer are routinely used in sustained-release formulations as taught above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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