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 19, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The Declaration and Remarks filed have been considered and are persuasive to overcome the previous rejections.
Claims
Claim Objections
Claim 15 is objected to because of the following informalities: the claim recites abbreviation after the compound but does not use the abbreviation anywhere else in the claims. It is suggested the abbreviations be removed. See quaternary ammonium polyethyleneimine (QPEI) and povidone (PVP). Appropriate correction is required.
Claim Rejections - 35 USC § 103 – Obviousness (New Rejections)
1) Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Primus et al. (WO 2008100451) in view of Willoughby (US 2010/0316685).
Primus et al. disclose filling root canals with water based materials. The compositions comprise powders. The preferred powder comprises particulate selected from dicalcium silicate, tricalcium silicate, tricalcium aluminate, calcium phosphate, calcium sulfate dihydrate, silica, alumina, calcium oxide, and calcium hydroxide, and combinations thereof (paragraph 0024). Surfactants are added to the compositions and may be formulated into root canal sealers. Surfactants include polyethylene oxide and polyethylene oxide esters and ethers (ref. claim 2). Root canal sealers are interpreted as endodontic sealers. The combinations of powder and liquid carrier compositions have either a putty- like or syrup-like consistency as discussed further below. A root canal sealer is made by mixing calcium powders with a liquid carrier comprising a surfactant (Examples). The composition may also comprise antibacterials (paragraph 0029).
Primus et al. differ from the instant claims insofar as it does not exemplify an example only comprising the calcium salt of the instant claims as the matrix or disclose the antibacterials of the instant claims.
However, Willoughby discloses that chlorhexidine is used in root canal treating compositions.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art to have used chlorhexidine in the composition of Primus et al. because they are suitable antibacterials sued in root canal treating compositions.
Primus et al. suggest using one or combinations of components. Therefore it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used tricalcium silicate hydrate, dicalcium silicate hydrate, calcium hydroxide alone or in mixtures with the liquid carrier comprising a surfactant because this is suggested by Primus et al.
In regards to the liposomes, the claims recite up to 10%. This reads on 0%. Therefore it does not appear that the liposomes are required.
2) Claims 15, 17 and 20-21 and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Primus et al. (WO 2008100451) in view of Willoughby (US 2010/0316685) in further view of Denyer et al. (WO 2015004450).
Primus et al. are discussed above and differ from the instant claims insofar as they do not disclose liposomes or an antibacterial such as chlorhexidine.
However, Willoughby discloses that chlorhexidine is used in root canal treating compositions.
Primus et al. in view of Willoughby differs from the instant claims insofar as it does not disclose liposomes.
However, Denyer et al. disclose liposomal drug delivery system for bone cements. An antibiotic delivery vehicle for impregnating bone cement. The vehicle is an antibiotic encapsulated liposome having a block co-polymer on its surface. In a preferred embodiment of the invention said liposome is less than 600nm in diameter. Liposomes are made from at least one phospholipid selected from at least one of the following groups phosphatidylcholine, phosphatidylethanolamine, sphingomyelin, phosphatidic acid, phosphatidylglycerol, phosphatidylserine and phosphatidylinositol. Alternatively, or additionally, said liposomes are made from at least one cationic (positively charged) lipid including 1 ,2-dioieoyl-sn-glycero-3-phosphoethanolamine DOPE. The liposome lipid is selected having regard to the nature of the antibiotic to be encapsulated. Thus, negatively charged antibiotic is typically, but not exclusively, best encapsulated in a liposome that is predominantly made of positively charged lipids; or alternatively a liposome that is predominantly made of neutrally charged lipids. The liposomes are coated with a Pluronic (a surfactant) and is used in an amount of 2% (page 17, lines 13-15). The Pluronic provides uniform mixing of the liposomes, ideally antibiotic-loaded liposomes, into a polymer such as bone cement. Moreover, the resultant product, or bone cement, shows a greatly improved antibiotic release profile compared to conventional products. Further, bone cements made in this way have unexpected structural advantages without compromising the mechanical strength and/or fatigue properties of the polymer.
It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have added an antibacterial, such as chlorhexidine, to liposomes and used them as the antibacterials for the root sealers of Primus because incorporating the antibacterials in liposomes and adding them to the sealers would result in an improved active release profile compared to conventional products and structural advantages without compromising the mechanical strength and/or fatigue properties of the agents.
In regards to the amount of liposome, the liposomes have and antibacterial activity and therefore are result effective variables. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of liposome through routine experimentation to arrive a therapeutic effective amount of liposome. See MPEP 2144.05.
Conclusion
Claims 15, 17, 20-21 and 31-34 are rejected.
Claims 24-26 are withdrawn.
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612