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 September 17,2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
1) Claims 3-4, 6-7, 12, 15-20, 22 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Dehghan et al. (US 20180092817) in view of Ayoola (US 20150157553).
Dehghan et al. disclose an oral composition comprising crosslinked polyvinylpyrrolidone (PVP) and xylitol. The xylitol and the crosslinked PVP are in a ratio of about 5:1, and the oral composition is in the form of a lozenge or lollipop. The composition are used to treat dental erosion, meeting treating a dental disease. The composition can also include green tea extract in an amount of from about 0.01 to about 1%. In some embodiments, the composition can also include green tea extract in an amount of from about 0.01 to about 5% (paragraph 0082). An alkalinizing agent may be used and includes sodium bicarbonate, or potassium bicarbonate. The lozenge or lollipop upon oral administration raises the saliva pH from about 7 to about 10 in about 1 minute (paragraph 0011). The lollipop may be a multi-layer lollipop with an inner core, an outer layer and a stick. The lollipop is configured to be inserted into a patient's mouth to stimulate salivary flow of a patient, neutralize the patient's saliva, and as the patient sucks and continues to suck on the lollipop, the lollipop releases components of the composition to assist in replenishing softened enamel in the teeth. The lollipop is able to stay in the mouth of a patient for a longer period of time than toothpastes and/or mouthwashes, thereby increasing the effectiveness of teeth re-mineralization. In some embodiments, upon oral administration, the lollipop dissolves in about 20 minutes. Fluoride was recorded at a concentration of 34 mg/ml in 120 minutes.
In one embodiment, the inner core of the lollipop comprises xylitol, crosslinked PVP, such as Kollidon® Cl, sodium fluoride, monopotassium phosphate, calcium chloride, glycerin, green tea extract, licorice extract, eucalyptus oil, and casein phosphopeptide (paragraph 0085). A multilayer lollipop comprises an inner core and outer layer. The inner core comprises xylitol (56.473 g, 80.6%), crosslinked PVP (Kollidon® Cl )(11.2945 g, 16.1%), casein phosphopeptide (1.4 g, 2%), CaCl2, (0.0308 g, 0.044%), KH2PO4 (0.0168 g, 0.024%), NaF (0.035 g, 0.05%), glycerin (0.7 g, 1%, 14 drops), green tea extract (solid, 0.025 g, 0.036%), licorice extract (solid 0.025 g, 0.036%) and eucalyptus oil (3 drops). The outer layer comprises xylitol (57.125 g, 81.6%), Kollidon® Cl (11.425 g, 16.3%), glycerin (0.7 g, 1%, 14 drops), green tea extract (solid, 0.025 g, 0.036%), licorice extract (solid, 0.025 g, 0.036%), eucalyptus oil (3 drops) and L-arginine (0.7 g, 1%) (Example 6).
Dehghan et al. differ from the instant claims insofar as they do not disclose matcha green tea.
Ayoola discloses sugar-free confectionery compositions which deliver anti-plaque components to the mouth for oral health benefits and also deliver nutrients for systemic health benefits; wherein such confectionery compositions comprise of: (i) a safe and effective amount of natural tree, plants and tea extracts selected from moringa, matcha green tea, green tea, chia and mixtures thereof; (ii) one or more anti-plaque component or components; (iii) one or more natural, non-cariogenic, tooth-friendly sweetener or mixtures of sweeteners; (iv) a suitable confectionery carrier and (v) less than 10% water (Abstract). The confectionery compositions include low boiled candy, hard boiled candy, pressed tablets, coated candy, lozenges, and the like are well known in the art (paragraph 0008). Green tea is used and contributes to dental health by reducing plaque and fighting cavities and gum disease. Green tea helps prevent cavities, gum disease and resulting halitosis in several ways. First, green tea inhibits the growth of S. mutans and other bacteria associated with plaque. Secondly, green tea polyphenols reduce the risk of cavities by increasing the resistance of the tooth to the actions of cavity-causing bacteria and act in a synergist when fluoride is present. S. mutans produce enzymes such as glucosyltransferase which allow the bacteria to form larger areas of plaque on the tooth surface. Thirdly, polyphenols from green tea can lessen the risk of cavities by arresting the production of glucosyltransferase. Green tea also confers a myriad of systemic health benefits. Polyphenols present in green tea are also known as catechins. They are powerful antioxidant components of the green tea which are responsible for disease prevention and are active components of the treatment capability of green tea. The polyphenols in green tea are epigallocatechin gallate (EGCG), epigallocatechin (EGC), epicatechin gallate (ECG), epicatechin (EC), catechin (C). Of all the polyphenols, ECGC is believed to be the most powerful protector of dental health and the most powerful cavity fighter. Therefore, preferred tea extract mixtures are those with the most content of ECGC (paragraph 0041). Matcha green tea is a fine ground, powdered, high quality green tea that is reported to be much more potent than regular green tea by a ratio of about 1:10. It is distinct from green tea in that it is made from shade-grown tea leaves thus, its qualities and benefits are preserved closely to those of fresh green tea leaves. It is substantially richer in chlorophyll than other green teas, making it a superior daily detox in comparison. Matcha contains a high content of EGCG. It is reported that the concentration of the EGCG available from matcha is at least three times greater than the amount of EGCG available from other commercially available green teas. Preferred green tea extract mixtures used in the composition are those with higher matcha green tea content than regular green tea due to its added benefits and higher potency. Green tea is one of the very few agents that meets majority of the aforementioned qualities of an anti-plaque agent, possessing eight of the nine qualities; the exception being that it does not ordinarily stay in the mouth for an extended period of time (paragraph 0045). The confectionery composition with a suitable carrier medium, into which green tea is incorporated, allows green tea and its beneficial components to be able to stay in the mouth for an extended period of time. Furthermore, green tea is believed to have the potential to ease the pain of a toothache and may also prevent further damage if a root canal has become infected. The matcha green tea may comprise 1% to 5% by weight of the composition (paragraph 0073). Preferred sweeteners include xylitol (paragraph 0065).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used matcha green tea in an amount ranging from 1% to 5% in place of or in combination with green tea in the composition of Dehghan et al. because it has a higher concentration of ECGC, making the composition more effective as an antiplaque composition and cavity fighter.
In regards to claims 13 and 15, the release of the active controls treatment time and effectiveness making it a result effective variable. It would have taken no more than the relative skill in the art by routine optimization to adjust the carrier of the lollipop and lozenge to control the release of fluoride and calcium to achieve the desired release rate of the fluoride and the calcium. See MPEP 2144.05.
Response to Arguments
The Examiner submits that although the Matcha green tea was chosen for its fluoride content, this is not reflected in the claims. 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. The reason to modify the primary reference may not be the same as Applicant, but it would have reasonable to have used the Matcha green tea in place of a green tea because it has a higher concentration of ECGC, making the composition more effective as an antiplaque composition and cavity fighter. In regards to Dehghan not disclosing Matcha as a fluoride source, the claims make no mention of Matcha being a fluoride source for the compositions of the instant claims. Further, Ayoola discloses that Matcha may be used in confectionary products such as lollipops. Therefore, it would have been obvious to have put Matcha in an oral care type of lollipop. Further, in regards to Ayoola, it was used to show that Matcha has oral care benefits. Therefore it would have been obvious to use it in an oral care composition. As stated above, the instant claims does not recite Matcha is a source of fluoride. Therefore it is not required for Dehghan or Ayoola to disclose this limitation. In regards to the amount of Matcha, it has been disclosed the Matcha has a therapeutic benefit. Therefore it would have been in the relative skill of one of ordinary skill in the art through routine experimentation to have adjusted the amount of Matcha to get the desired therapeutic effect. In regards to the rate of release, the composition of Dehghan comprise substantially the same components as the instant claims and therefore, would release fluoride at the same rate.
Obvious-Type Double Patenting (Maintained Rejection)
Claims 3-4, 6-7, 12, 15-20, 22 and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,314,771 in view of Ayoola (US 20150157553). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they both recite an oral composition comprising crosslinked PVP, xylitol in the form of a lozenge or lollipop. The instant claims differ from the patented claims insofar as the instant claims disclose matcha green tea.
Ayoola discloses that matcha green tea has a higher concentration of ECGC, which is removes plaque.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used matcha green tea as the green tea in the composition of the patented claims because it has a higher concentration of ECGC, making the composition more effective as an antiplaque composition and cavity fighter.
Conclusion
Claims 3-4, 6-7, 12, 15-20, 22 and 26-29 are rejected.
No claims 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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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612