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 in the Appeal Brief filed March 2, 2026, filed June 13, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
In view of the Appeal Brief filed on March 2, 2026, PROSECUTION IS HEREBY REOPENED. A new rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612
Claims
Claim Rejections - 35 USC § 103 – Obviousness
New Rejection
1) Claims 21-25, 28-29 and 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US 20150328094).
Xu et al. disclose oral care compositions that may comprise a combination of zinc oxide ranging from 0.5 wt% to about 2 wt% (1% in example) and zinc citrate (0.5% in Example) ranging from about 0.25 wt% to about 2.5 wt % (paragraph 0042). The composition preferably comprises a fluoride ion source including sodium fluoride and stannous fluoride, ranging from 0.001 wt% to about 10 wt% (paragraph 0073). Preservatives such as chlorhexidine may be used in the compositions and comprise 0 to about 0.5% by weight of the composition (paragraph 0071). The compositions are formulated into toothpaste.
Xu et al. differ from the instant claims insofar as it does not exemplify a composition comprising a guanidine, such as chlorhexidine, with zinc salt and fluoride. However, they do suggests using chlorhexidine in the compositions.
In regards to the amounts of guanidine recited in the instant claims, the guanidine hydrochloride is used as a sweetening enhancer the aids in improving the taste, making it a result effective variable. It would have taken no more than the relative skill of one ordinary skill in the art to have adjusted the amount through routine optimization to arrive at the instantly claimed amounts of 0.1 or 1.5% to obtain the desired therapeutic effect.
Maintained Rejection
Claims 21-25 and 28-38 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Thomson et al. (WO 2017/003856) in view of Itano et al. (JP 2007291084).
Thomson et al. disclose oral care compositions. The compositions may be formulated into a toothpaste or a dentifrice, a mouthwash or a mouth rinse, a topical oral gel, and a denture cleanser, which would clean the teeth and oral cavity. The compositions comprise a combination of zinc salts, fluoride and arginine. The combination of zinc salts is zinc oxide and zinc citrate. Zinc oxide comprises 0.75% wt% to 1.25% wt% based on the weight of the oral care composition and zinc citrate comprises 0.25% to 1.0% wt%. Fluoride includes stannous fluoride and sodium fluoride, and comprises 0.1wt% to 2 wt% of the total composition weight. Arginine comprises 0.1 wt% to 6 wt%. The compositions may comprise flavoring and sweetening agents ranging from 0.01 to 1% by wt. (paragraph 00025-00026). Antibacterials include chlorhexidine, which is a guanidine.
Thomson et al. differ from the instant claims insofar as they does not disclose a guanidine salt such as guanidine HCl.
Itano et al. an oral composition that exhibits strong suppressive actions on co-aggregation of bacteria of the genus Fusobacterium with cariogenic bacteria or periodontal disease-related bacteria and prevents dental caries or periodontal diseases. The composition for oral cavity include toothpaste, mouthwash, gargle tablets, gum massage cream, chewing gum, troches, candy and other food forms can do. The composition may also comprise a protein denaturant and includes guanidine or a salt thereof. Examples of the salt of guanidine include acid addition salts such as hydrochloride and sulfate. It is used in an amount of 0.1% (Example 6 and reference claims). The protein denaturant is used to inhibit oral bacteria (Page 2, TECH-SOLUTION).
It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used chlorhexidine (a guanidine) in the compositions of Thomson et al. because they are suggested by Thomas and to obtain their antimicrobial properties.
It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have added guanidine hydrochloride to the compositions of Thomson et al. because they it can help inhibit oral bacteria.
In regards to the amounts recited in claims 15 and 17, the guanidine hydrochloride is used as a protein denaturant the aids in inhibiting bacteria, making it a result effective variable. It would have taken no more than the relative skill of one ordinary skill in the art to have adjusted the amount through routine optimization to arrive at the instantly claimed amounts of 0.3 or 1.5% to obtain the desired therapeutic effect.
Response to Arguments
The Examiner submits although Thomson does not disclose the guanidine salts disclosed in dependent claim, it does disclose chlorhexidine, which would meet the limitation of a guanidine. Thomson is only deficient insofar as it does not disclose the amount of chlorhexidine. Even if this was not the case, Itano was used for its disclosure of specific guanidine salt that may be used in oral care composition. Therefore, one of ordinary skill in the art would not modify Itano, they would modify Thomson with the guanidine salts of Itano to obtain their properties of a protein denaturant to inhibit oral bacteria.
The compositions of Thomson et al. are oral care compositions to treat the teeth and have antimicrobial activity. Therefore it would have been obvious to add components, such as the guanidine salts of Itano, to the compositions of Thomas et al. to aid in inhibiting oral bacterial adhesion, which would in turn inhibit biofilm such as plaque. Therefore arginine would not need to be removed from the compositions of Thomson.
In regards to the alleged unexpected results, the claims are not commensurate in scope with the results. The independent claim is drawn to a guanidine in general whereas the compositions tested used a specific guanidinium salt. Further, the results use a specific amount of guanidium solution and it is not clear if different amounts of guanidinium solution would yield similar results. Therefore, the rejection is maintained.
Conclusion
Claims 21-25 and 28-38 are rejected.
Claim 39 is withdrawn.
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 on 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
Prosecution Insights