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 .
Priority
The present application is a National Stage entry of International application PCT/CN2022/101161 filed 06/24/2022, which claims the benefit of Foreign application CN202210420813.0 filed 04/21/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, although it is noted that no English translation was provided.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 10/21/2024, in the matter of Application N° 18/858,575. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 11-25 are pending.
Claims 11-25 are presented for examination and rejected as set forth below.
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.
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.
Claims 11-17, 19-20, 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Primus (US20110104644A1; cited on IDS filed 10/21/2024), and in further view of Fukui (JP2012167033A - machine translation provided; cited on IDS filed 10/21/2024), Nalawade (Journal of International Society of Preventive and Community Dentistry, 2015), and Ferraz (Journal of Endodontics 2001).
Applicant’s claims are directed to a matrix of an anhydrous root canal disinfectant, wherein the matrix comprises, based on the total mass percentage of the anhydrous root canal disinfectant, following components: 0.5-5.0% polyvinylpyrrolidone, 0.1-5.0% nonionic or cationic surfactant, and 32.0- 85.0% polyethylene glycol with a molecular weight of 200-600. Note that “matrix” is considered a term the represents a general “composition”. Regarding intended use: a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). In this case, for the intended use of “root canal disinfectant”, an intended application to the root canal provides no structural weight to the composition (i.e., compositions could originate outside of the field of endeavor, and/or could consider different formulation types such as liquids, gels, pastes, etc. and/or different particular oral/dental uses).
Primus teaches compositions and methods to treat dental pulp and filling root canals (abstract), that have an anti-microbial effect [0036]. Primus teaches a method of applying a composition to a root canal for treatment (Primus – claim 11), that involves irrigating the root canal and using a filling material that prevents bacteria from entering and infecting the root [0007].
Regarding claims 11, 13, 15, and 24: Primus teaches about 5-40 wt% polyvinylpyrrolidone (PVP) [0029], about 1-40 wt% surfactant (including anionic, cationic and nonionic surfactants, which interact with the water-soluble polymers to improve elasticity of the composition, when mixed with the powder) [0030], and polyethylene glycols (PEG) in about 5-40 wt% [0028-0029] (also, Primus – claim 1). Furthermore, calcium hydroxide (Ca hydroxide) is taught in a about 1-80 wt% range (Primus – claim 1). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05 (I)). See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (indicating that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close).
Regarding claims 14, 17 and 23: Primus teaches chlorhexidine gluconate (reads on chlorhexidine, because chlorhexidine gluconate is a common salt form of the general grouping of a chlorhexidine ingredient (which is not explicitly specified as a free base in the claim scope), that a PHOSITA would consider the inclusion of the free base and various salt forms; e.g., see Table 1 of Applicant’s Specification, naming the chlorhexidine acetate salt [0087]) [0063].
Regarding claim 16: Primus teaches zirconium oxide (Zr oxide), as radiopaque component (Primus – claim 6) in 1-60 wt% (Primus – claim 5).
Regarding claim 19: Primus teaches the obviousness of various mixing methods to produce the root canal composition (i.e., including homogenation, dispersions and solutions) [0024, 0026, 0033-0035, 0043] that include PVP and PEG [0028], whereby the instant process method of claim 19 is obvious, because the order of mixing is obvious. See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
In summary, Primus teaches the instant composition for a method of application to a root canal. Notably, Primus allows down to 1 wt% liquid carrier, that comprises water (Primus – claim 1) (i.e., nearly anhydrous compositions are obvious). However, Primus does not teach the completely anhydrous composition aspect (all claims and especially, instant claim 25), the polyethylene glycol (PEG) MW of 200-600 (instant claim 11), the paste aspect (instant claim 12), and the method using injection through an irrigation needle followed by irrigation rinse (instant claim 20).
Fukui teaches polyethylene glycol as a suitable polyhydric alcohol (in the same “carrier” category as glycerin), wherein these polyhydric alcohols improve the handling of calcium-hydroxide-based root canal dressings [0016], for root canal pastes in syringe containers (reads on instant claim 12) [0016]. Fukui also teaches polyhydric alcohol-based compositions (i.e., that are implied as anhydrous, because they are an alternative to aqueous compositions [0036] and water is considered an “additive” [0047]), by specifically stating that the dental treatment can be either in a polyhydric alcohol, or an aqueous solution thereof (see, bullet (1) of [0037]) (i.e., therefore, anhydrous polyhydric alcohol variations of the root canal treatments of Primus are obvious).
Nalawade teaches polyethylene glycol 400 (PEG 400) (i.e., the 400 denotes a 400 g/mol molecular weight, that reads on the instant claim 11), as a suitable carrier, for root canal disinfection via endodontic therapy (abstract) (where Primus and Fukui teach use of PEG generally), where PEG-400 exhibits bactericidal activity at 100% concentration (abstract).
Ferraz teaches the advantage of a viscous irrigant such as anhydrous glycerin, that provides better lubrication action and enhanced microbial properties (pg 452, paragraph 7) (i.e., placing an advantage of anhydrous compositions over aqueous treatment of root canals). Furthermore, Ferraz teaches irrigation needles as a tool for applying disinfecting compositions to root canals (reads on irrigation rinse of instant claim 20) (pg 453, ‘materials and methods).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Primus to produce an anhydrous composition (as taught by Fukui and Ferraz) comprising the PEG 400 of Nalawade, because PEG 400 is taught as a suitable carrier for root canal treatments (that also exhibits bactericidal activity at 100% concentration), whereby Primus generally allows for hydrophilic polymers for incorporation such as PEG in 5-40 wt% [0028-0029], and Primus’s compositions demonstrate water levels down to 1 wt% (Primus – claim 1) (i.e., which is nearly free of water). Furthermore, Ferraz teaches the advantage of a viscous anhydrous irrigants provide better lubrication action and enhanced microbial properties (pg 452, paragraph 7) (i.e., placing an advantage of anhydrous compositions over aqueous treatment of root canals), while Fukui also teaches these polyhydric alcohols improve the handing of calcium-hydroxide-based root canal dressings [0016], for root canal pastes in syringe containers [0016]. Thus, the use of a completely anhydrous composition using ingredients of the Prior Art for oral care would provide the benefits of better lubrication (Ferraz), enhancement of antimicrobial property (Ferraz/Nalawade), and improved handling of the formulations (Fuikui), whereby furthermore, Fukui teaches the general obviousness dental compositions based on polyhydric alcohols, whereby incorporation of water is optional.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Primus by specifying the composition as a paste to be delivered by syringe, followed by further irrigation, as taught by Fukui and Ferraz, because root canal compositions use the paste formulation as one mode of delivery and irrigation is also a common root canal treatment to disinfect root canals (Ferraz – abstract), whereby Primus is non-limiting in the product formulation type (i.e., described as a general composition in Primus – claim 1).
Finally, Regarding claim 25: There is no requirement by the Prior Art to incorporate glycerol. Furthermore, as discussed above, Ferraz and Fukui teach the optionality of water in root canal treatments (whereby Primus teaches water amounts as low as 1 wt%).
Claims 11-25 are rejected under 35 U.S.C. 103 as being unpatentable over Primus (US20110104644A1), Fukui (JP2012167033A - machine translation provided; cited on IDS filed 10/21/2024), Nalawade (Journal of International Society of Preventive and Community Dentistry, 2015), and Ferraz (Journal of Endodontics 2001), as applied to claims 11-17, 19-20, 23-25, and in further view of Yamamoto (WO2017094579A1 - machine translation provided).
As discussed above, the combined Prior Art teaches an anhydrous root canal composition, comprising PVP, PEG-400, Ca hydroxide, Zr oxide, and surfactants and also their general amounts, including methods of making and treatment. However, the Prior Art does not name the specified surfactants (claims 18 and 21-22).
Yamamoto teaches oral dental compositions that comprise polyoxyethylene hydrogenated castor oil as a nonionic surfactant with suitable activity to remove oral biofilm (i.e., bacterial aggregates, and thereby having antimicrobial activity) (abstract) and provide a general cleaning effect (pg 5, paragraph 1), and the average number of moles of ethylene oxide added is in a ratio of 20 to 60 (i.e., the ratio range encompasses the instant 40 and 60 values of claim 22), with additional specificity found in Blaunon RCW-40 and RCW-60 (pg 8, paragraph 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select Yamamoto’s polyoxyethylene hydrogenated castor oil (20-60), as an antimicrobial agent and/or surfactant for the modified composition of the combined Prior Art, because Yamamoto teaches polyoxyethylene hydrogenated castor oil to effectively remove biofilms in oral dental paste applications (pg 1), and additionally it is a known surfactant. Thus, Primus generally teaches the use of surfactants (Primus – claim 1) providing rational to select Yamamoto’s ingredient, because it provides the same functional effect, as applied to oral compositions. Furthermore, Primus is generally concerned with infectious biological agents (abstract, [0005-0007, 00016]), that would benefit from anti-bacterial agents [0031], such as the anti-biofilm agent activity of the Yamamoto’s polyoxyethylene hydrogenated castor oil (20-60) ingredient.
Finally, regarding claim 18, the combined Prior Art (especially Primus) teaches all of the instant amounts of the specific ingredients as obvious (via overlapping and/or encompassing ranges taught by the Prior Art), per the explanations above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 7/27/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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