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 .
Detailed Action
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khawaled (US PG Pub. 2016/0310379A) in view of Khawaled (US PG Pub. 2008/0003540A1) and further in view of Khawaled (WO 2008/001388A1, ‘388 presented in IDS) , Pillai et al. (WO 2018/118553A1, presented in IDS), Prosise et al. (US PG Pub. 2012/0301522A1) and Kim et al. (US PG pub. 2014/0255867A1).
Khawaled teaches a dental bleaching gel composition with high electrical conductivity. The composition includes a peroxide, a sodium percarbonate, a cross-linked polyacrylate polymer as a thickening agent and conductivity enhancing agents such as electrolytes, see abstract. Khawaled further teaches that in an example, the bleaching gel could include an electrical conductivity enhancing ingredient or a number of ingredients. The electrical conductivity enhancing ingredient could be electrolytes, such as for example, potassium nitrate or potassium hydroxide in different amounts or percentage. A mix of both of them could also be used to enhance conductivity of the dental bleaching gel composition. Potassium nitrate could also be used to lower the tooth sensitivity and the potassium hydroxide could be used to adjust the bleaching gel pH. Electric current could be used to accelerate destabilization of the peroxides and facilitate release of oxygen ions and oxygen radical's derivative participating among others in the process of the dental bleaching. Potassium hydroxide concentration in the dental bleach composition could be 1% to 5% by weight. And the Potassium nitrate concentration in the dental bleach composition could be 1% to 5% by weight, see [0033]. Khawaled teaches that the bleaching gel described having electrical conductivity can be activated by a low current, to become efficient enough to allow teeth whitening even with application for a short time, see [0020]. The dental bleaching gels and devices or trays can reduce the cost of dental bleaching and more and more effective in whitening or bleaching teeth, see [0021].
While Khawaled teaches use of potassium nitrate as an electrolyte, Khawaled does not teach use of sodium chloride as an electrolyte.
Khawaled ‘540 teaches electrochemically treating teeth, see title. The reference teaches that sodium chloride is an electrolyte as discussed below: in a preferred embodiment, a commercial fluoride gel having a 2.5% concentration is combined with 0.5 grams of sodium chloride (used as electrolyte) dissolved in 25 ml of distilled water, providing a total percentage of fluoride ions as 1.25%. In an alternative embodiment, 25 grams of Elmex.TM. Gel is mixed with a solution of 0.7 grams of sodium fluoride, followed by combination with 0.5 grams of sodium chloride and dissolution in 25 ml of distilled water. A power supply of 0-12 volts is used. The electrochemical circuit is then activated with a voltage in a range of between about 0.001 volt and about 12 volts. In a preferred embodiment, the voltage is in a range of between about 3 volts to about 9 volts, and most preferably is approximately 6 volts. The electrochemical circuit remains open for a predetermined period of time, in the range of between about 5 minutes and about 20 minutes. The current does not exceed about 30 milliamps (mA), see [0087].
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized sodium chloride as an electrolyte taught by Khawaled’ 540 into the dental conductivity gel of Khawaled et al. One of ordinary skill would have been motivated to do so because potassium nitrate and sodium chloride, both are used in an electrochemically whitening teeth and used as an electrolyte. Substitution of one known electrolyte with another would have provided predictable results of dental treating effect used in a electrochemical process.
Khawaled does not teach use of a dental device comprising a positive and a negative electrode.
Khawaled ‘388 discloses methods for electrochemically whitening the teeth whereby a metal salt solution is applied to the teeth, followed by applying an oxidizing agent to the teeth and transmitting electrical current to the teeth so as to activate and reduce the oxidizing agent for effecting whitening of teeth, see abstract. The reference teaches that a device is used and that the device comprises an applicator for applying a substance to the teeth, applicator having a first end and a second end, with a first electrode, preferably, positively charged, attached to first end and a second electrode, preferably, negatively charged, attached to second end, configured to transmit electrical current through applicator, and an oxidizing agent for placement within applicator, wherein the oxidizing agent undergoes activation and reduction upon transmission of the electrical current there through. The oxidizing agent used can be any of a whitening solution, whitening gel, solution or gel of or including any of : hydrogen peroxide, see abstract. Khawaled teaches use of salt solution comprising copper chloride solution, see page 3, lines 30-31. Khawaled further teaches regarding device that the device further comprises spacers on the first electrode to separate the first electrode from the teeth wherein the spacers are comprised of a biocompatible plastic material and in another embodiment, the second end is a front wall and the second electrode is negatively
charged and the second electrode further comprises a spring mechanism, see entire page 4. Khawaled teaches use of peroxide gel, see 4, 6th paragraph. Khawaled does not teach sulfate compounds. The electrodes are configured to be connected to power source, electric current, see page 15, first paragraph. Use of distilled water is taught on page 17, 4th paragraph.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized the known devices for dental use comprising first and second electrode as taught by Khawaled ‘388 et al. One of ordinary skill would have been motivated to do so because Khawaled teaches that the dental bleaching gel composition can be used with devices or trays and can reduce the cost of dental bleaching and make more and more effective in whitening or bleaching teeth as discussed above and Khawaled’ 388 teaches use of dental device comprising first and second electrode used as an applicator when used with a whitening gel for bleaching purposes.
Khawaled does not teach the exact compositions of the whitening gels comprising the claimed thickener and a surfactant.
Pillai discloses a tooth whitening device for electrochemically whitening the teeth which is used with a toothpaste or a gel. The tooth is contacted with the toothpaste and a current is flown. The toothpastes identified in the examples have been commercialized under many references (experimental part; page 18, lines 4-9). Pillai teaches that oral care composition can comprise hydrogen peroxide, carboxyvinyl polymer, xanthan gum, karaya as a thickener and cocamidopropyl betaine as a surfactant, see [0011], [0013] and [0014], [0101-0102] and [0085]. Additional ingredients such as pH modifying agents can be added, [0108] and [0109].
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized the known ingredients used in tooth whitening composition comprising peroxide, a thickening agent and a surfactant such as cocamidopropyl betaine into the whitening gel of Khawaled et al. One of ordinary skill would have been motivated to do so because Khawaled teaches use of a whitening gel used in the whitening gel comprising hydrogen peroxide and Pillai teaches a whitening device electrochemically used with a toothpaste or a gel comprising hydrogen peroxide, wherein the gel may comprise the known thickener and a surfactant such as carboxyvinyl polymer and betaine as a surfactant. Since Pillai teaches that additional ingredients such as pH modifying agents can be added to the tooth whitening gel, it would be within skill of an artisan to manipulate the pH of the composition in order for it to be administered orally.
While Pillai teaches whitening compositions comprising hydrophobic and hydrophilic thickeners, such as carbomers to comprise 1.5 wt.% in example/table 7 and PVP to be 22.3wt. 5 thickeners, Prosise as discussed below teaches use of the known thickeners in a tooth gel in varying amounts.
Prosise et al. teaches that in preparing abrasive tooth whitening composition, it is essential to add some thickening agents to provide a desirable consistency. Examples of useful thickening agents include carboxyvinyl polymers, carrageenan, hydroxyethyl cellulose, laponite and water soluble salts of cellulose ethers such as sodium carboxymethylcellulose and sodium carboxymethyl hydroxyethyl cellulose, copolymers of lactide and glycolide monomers, carbomers. Natural gums such as gum karaya, xanthan gum, gum arabic, and gum tragacanth can also be used. Thickening agents are usually present in an amount from about 0.1% to about 25% by weight of the total tooth whitening composition. However, the preferred amount of thickening agent for the tooth whitening composition is in the range of about 0.5% to about 15% by weight, most preferably about 2.0%-10.0% by weight of the total composition, see [0049].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized thickeners in an amount ranging from about 0.1% to about 25% by weight into the tooth paste of Khawaled et al. as modified by Pillai et al. One of ordinary skill would have been motivated to do so because Pillai teaches use of the known thickeners in the tooth paste Prosise et al. teaches that in preparing abrasive tooth whitening composition, it is essential to add some thickening agents to provide a desirable consistency wherein the amount of thickeners can range from about 0.1% to about 25% by weight. Given the generic amount by Pillai and Prosise et al., it would have been obvious to one of ordinary skill to have manipulated the amount of the thickeners in the tooth paste composition for optimum consistency.
The references do not teach use of a kit.
Kim teaches a device and system for dental applications and method relating thereto, see title. Kim teaches a kit that includes a device or dental tray and whitening gel, see [0012]. The kit is provided to the end-user comprising whitening gel, strips and applicator, see [0054].
It would have been obvious to one of ordinary skill to have utilized a kit comprising tooth whitening gel and a dental device of Khawaled et al. along with a whitening gel of Pillai et al for the end-user to be used for tooth application motivated by the teachings of Kim et al. disclosing use of a kit for the end-user which comprises an applicator and a tooth whitening gel.
Nonstatutory double patenting rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US 12,151,007. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims recite a tooth whitening kit comprising: a dental device comprising a positive electrode and a negative electrode; a single component whitening gel comprising: a bleaching agent; a thickener composition comprising a non-ionic compound; a surfactant comprising an amphoteric surfactant; and an electrolyte source comprising a conductive salt present in an amount ranging from about 0.5 wt. % to about 6.0 wt. % based on the total weight of the single component whitening gel, wherein the conductive salt is selected from the group consisting of sodium chloride or potassium chloride; wherein the non-ionic compound is present in an amount ranging from about 1.0 wt. % to about 5.0 wt. % based on the total weight of the whitening gel. The patented claims recite a tooth-whitening kit comprising: a dental device comprising a positive electrode and a negative electrode; a single component whitening gel comprising: a liquid carrier comprising water; a bleaching agent; a thickener composition present in an amount ranging from about 0.1 wt. % to about 5.0 wt. % based on the total weight of the single component whitening gel, the thickener comprising a non-ionic compound, the non-ionic compound comprising hydroxyethyl cellulose; a surfactant present in an amount ranging from about 0.5 wt. % to about 6.0 wt. % based on the total weight of the single component whitening gel, the surfactant comprising cocoamidopropyl betaine; a humectant present in an amount ranging from about 1.0 wt. % to about 9.0 wt. % based on the total weight of the single component whitening gel, the humectant comprising glycerin; and an electrolyte source comprising a conductive salt, wherein the conductive salt is selected from the group consisting of sodium chloride or potassium chloride. The patented kit comprising whitening gel reads on the instant kit.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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