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 January 2, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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)
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.
1) Claims 1-2, 4-11 and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Prencipe et al. (US 20200009031) in view of Donovan (2016).
Prencipe et al. disclose oral care compositions comprising arginine, in free or salt form; and zinc oxide and zinc citrate. The oral care composition can reduce or inhibit biofilm formation in an oral cavity. Free zinc ions are believed to provide antibacterial efficacy by inhibition of glucose metabolism and/or interaction with the bacterial cell wall, reducing bacterial colonization of the oral cavity. An insoluble zinc compound, zinc oxide, can deliver strong antibacterial efficacy during tooth brushing (paragraph 0003). The total concentration of zinc salts in the composition may be from 0.2 weight % to 5 weight % based on the total weight of the composition (paragraph 0030). The weight ratio or zinc oxide to zinc citrate is 1.5:1 to 4.5:1 or about 2:1 (paragraph 0006). The composition may comprise zinc oxide in an amount of from 0.5 weight % to 1.5 weight % and zinc citrate in an amount of from 0.25 weight % to 0.75 weight %, based on the total weight of the composition. Alternatively, the compositions may comprise zinc oxide in an amount of 0.75 weight % to 1.25 weight % and zinc citrate in an amount of 0.4 weight % to 0.6 weight %, based on the total weight of the composition (paragraph 0031). The arginine may be free form amino acid or salt form. Examples of suitable salts of arginine include arginine phosphate and arginine hydrochloride (paragraph 0025). The arginine comprises from 0.5 weight % to 10 weight %, based on the total weight of the composition (paragraph 0007). The oral care composition may be formulated into a toothpaste (paragraph 0034). The oral care compositions may also comprise a fluoride ion source. Fluoride ion sources include, stannous fluoride and sodium fluoride. Fluoride ion sources may be added to the compositions at a level of about 0.001 wt. % to about 10 wt. % (paragraph 0051). Suitable abrasives which may be added in the compositions and include silica abrasives, insoluble phosphates, natural calcium carbonate, precipitated calcium carbonate and mixtures thereof (paragraph 0032). Suitable surfactants include anionic surfactants and amphoteric surfactants, which include cocoamidopropyl betaine (paragraph 0042). Useful tartar control agents include polycarboxylate polymers and polyvinyl methyl ether/maleic anhydride (PVM/MA) copolymers (paragraph 0033).
Prencipe et al. differ from the instant claims insofar as they do not disclose the actual method steps.
Donovan discloses that one should brush their teeth twice daily for at least 2 minutes.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used the compositions of Prencipe et al. twice a day for 2 minutes because that is the suggested brushing time.
In regards to increasing sIgA, when the composition of Prencipe et al. are applied to the oral cavity with the recommended brushing, one would reasonably conclude that it would result in an increase of sIgA. Therefore the method of the instant claims is obvious.
In regards to claims 20-22, the compositions comprise zinc citrate, zinc oxide and arginine in amount encompassed by the instant claims. Therefore one would reasonably conclude that the compositions of the Prencipe et al. would increase the concentration of sIgA in the individual's mucosa pellicle in the oral cavity; increase phagocytotic activity of phagocytotic cells in the individual's oral cavity; and increase levels of 3-Defensin 1 in the individual's oral cavity.
Response to Arguments
The Examiner submits that although Prencipe discloses biofilm reduction, the compositions of Prencipe have the same components as that of the instant claims. It is common practice to brush the teeth twice a day every day in order to maintain the health of the teeth and oral cavity, which is supported by Donovan. Therefore, the method steps were known in the art. Since Prencipe discloses a toothpaste, it would have been obvious to have used the toothpaste of Prencipe to brush the teeth twice a day. This would lead to an increase in sIgA levels. In regards to impermissible hindsight reasoning, the composition of Prencipe comprises substantially the same components as that of the instant claims. It is also recommended that the teeth are brushed twice daily. Therefore, the combination of Prencipe and Donovan comprising the same methods steps using a composition with substantially the same components, would yield an increase of sIgA levels. Even a minor increase would meet the limitations of the instant claims. In regards to the alleged unexpected results, it would not appear surprising that it would take time to see the effects of the compositions. Further, any affect would meet the limitations of the instant claim. Additionally, the differences between the baseline and Day 3 appear to be within experimental error and could be substantially the same. Even if the results were indeed unexpected, the claims recite an increase of sIgA, however, they do not recite a degree of increase or an amount of time to achieve such increase. One would recognize that brushing teeth twice a day for longer periods of 7 days is recommended and appears to be common practice to ensure overall health of the teeth. That being said, when one used the toothpaste of Prencipe, this would result in an increase of sIgA.
2) Claims 1-2, 4-11 and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 20200206106) in view of Donovan (2016) in further view of Prencipe et al. (US 20200009031).
Chen et al. disclose methods of increasing sIgA and mucin 5B levels in an individual's oral cavity are disclosed. The methods comprise applying to the individual's oral cavity an amount of an oral care composition comprising: a zinc salt, stannous fluoride and optionally, an organic acid buffer system, effective to increase sIgA and mucin 5B levels in the individual's oral cavity. One or more sources of zinc ions in addition to the zinc phosphate may be added to the compositions and include zinc citrate and zinc oxide. The compositions comprise arginine or a salt thereof and includes L-arginine. The arginine is present in an amount ranging from 0.1% to 15% by weight of the total composition weight. Abrasives include sodium bicarbonate, insoluble phosphates, dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate natural calcium carbonate (CC), precipitated calcium carbonate (PCC), silica (e.g., hydrated silica or silica gels or in the form of precipitated silica or as admixed with alumina), and combinations thereof. Surfactants are used and include anionic and amphoteric surfactants such as cocoamidopropyl betaine (paragraph 0039).
Chen et al. differ from the instant claims insofar as they do not disclose the method steps of how often to use the composition.
Donovan discloses that one should brush their teeth twice daily for at least 2 minutes.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used the compositions of Chen et al. twice a day for 2 minutes because that is the suggested brushing time.
Chen et al. in view of Donovan differs from the instant claims insofar as it does not disclose the amount of zinc oxide and zinc citrate that may be used in the compositions.
Prencipe et al. are discussed above and disclose that the composition disclosed therein may comprise zinc oxide in an amount of from 0.5 weight % to 1.5 weight % and zinc citrate in an amount of from 0.25 weight % to 0.75 weight %, based on the total weight of the composition. Alternatively, the compositions may comprise zinc oxide in an amount of 0.75 weight % to 1.25 weight % and zinc citrate in an amount of 0.4 weight % to 0.6 weight %, based on the total weight of the composition (paragraph 0031). The weight ratio or zinc oxide to zinc citrate is 1.5:1 to 4.5:1 or about 2:1 (paragraph 0006).
It would have been obvious to one of ordinary skill in the art to have used 0.5% to 1.5% zinc oxide and 0.25% to 0.75% zinc citrate, where they are in a ratio of 2:1 because they are suitable amounts for oral care compositions comprising zinc and arginine.
In regards to increasing sIgA, when the composition of Chen et al., comprising arginine and a zinc salt, is applied to the oral cavity with the recommended brushing, one would reasonably conclude that it would result in an increase of sIgA and mucin. Therefore the method of the instant claims is obvious.
In regards to claims 20-22, the composition of Chen et al. comprise arginine in an amount encompassed by the instant claims, are applied to the oral cavity, and are used to increase sIgA. Therefore, one would reasonably conclude that the composition of Chen et al. would also increase phagocytotic activity of phagocytotic cells in the individual's oral cavity; and increase levels of 3-Defensin 1 in the individual's oral cavity.
Response to Arguments
The Examiner submits that Chen discloses the method of the instant claims. Prencipe cures the deficiencies of Chen by disclosing the amounts of zinc citrate and zinc oxide. Chen discloses that zinc citrate and zinc oxide may be used in the compositions. Therefore Chen suggests a composition comprising zinc citrate and/or zinc oxide for increasing sIgA. In regards to brushing twice a day for 7 consecutive days, this is recommended for overall dental health. Therefore it would be obvious to use the compositions of Chen twice a day for at least 7 consecutive days. In regards to the alleged unexpected results, the composition of the instant claims are compared to a commercial brand and not a composition comprising a zinc phosphate such as that exemplified by Chen. Therefore, it cannot be clearly determined if the results are indeed unexpected. One would reasonably conclude that since Chen disclose zinc citrate and zinc oxide, that these two zinc salts would also perform the function of increasing sIgA. Therefore, the rejection is maintained.
Conclusion
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.
Claims 1-2, 4-11 and 14-22 are rejected.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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