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 .
Claim Status
Claims 2, 3 and 22 have been cancelled.
Claims 1 and 4-21 are pending. Applicant’s amendment necessitated modification of the existing rejection. Accordingly, this Action is FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/3/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's amendments and arguments filed 12/3/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 4-10 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Nagare et al. (US8030267) and Zhang et al. (J Dent Res 2014;93(12):1283-1289) and Muller et al. (Journal of Antimicrobial Chemotherapy 2008;61:1281-1287) and Stockel et al. (US20100056628) as evidenced by Falk, NA (J Surfact Deterg 2019;22:1119-1127) and Drug Bank Benzethonium chloride ([online] retrieved on 7/1/25 from: https://go.drugbank.com/salts/DBSALT001519; 3 pages).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Note concerning claim interpretation: the limitation: “wherein the network of pores is formed by a process wherein the biologically active agent provides a template for the formation of the network of pores in the metal oxide structure” is interpreted in light of the specification. In the specification, the process is described as: a) mixing a metal oxide and a micellizing, amphiphilic active agent with a solvent to form a synthesis solution; and b) said active agent self-assembles into a micellar system in the synthesis solution for the metal oxide source to assemble around the solution-facing micelle walls to form the composite material with self-assembled pores of said active agent (Page 8, line 22 through page 9, line 8). The specification also teaches: “MSN porosity caused by the self-assembly of the exemplary molecule” (Page 21, line 20); “At step 42A a metal oxide precursor (e.g. silica pre-cursor tetraethyl orthosilicate) is mixed with a templating micellizing amphiphilic biologically active molecule (simply labeled 'drug' in the figure), such as OCT. This molecule performs as a dual agent, acting both as a micelle forming amphiphilic molecule to template pores when present at a concentration above its CMG, while also inherently substantially loading the pore network with itself” (Page 24, lines 2-8); “The resulting structure is a highly porous metal oxide structure” (Page 25, line 3); “The desired structure containing a network of pores may be obtained when, at some point during the synthesis, the concentration of the biologically active agent becomes equal or above the agent's CMC… the biologically active molecules self-assemble as micelles, serving as the template for the network of pores.” (Page 29, lines 3-5 and 12-14); “The amphiphilic biologically active agent of the present invention serves a dual role providing a template for the formation of the metal oxide structure comprising a network of pores” (Page 31, lines 10-12); and “These compounds may organize into a continuous micelle network in order to template a network of pores” (Page 31, lines 21-22). Accordingly, all that is required to achieve the formation of a network of pores in the metal oxide structure is to have the concentration of the amphiphilic agent above its CMC because it will then self-assemble in aqueous conditions and serve as the template for the network of pores.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/dental research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medical/dental medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 7 and 13, Nagare et al. teach micelle/silica composite capsules obtained by mixing a material capable of forming micelles in water and a water-soluble silane derivative having a specific structure in aqueous solution (Abstract; claims 1-6 and 14). The ordinary meaning of the term “silica” means silicon dioxide and organosilicates are claimed. Nagare et al. describe this as an association structure (Column 1, lines 21-26; claims 2 and 14) that can disintegrate during use (Column 13, lines 8-11), thus providing controlled release of the contents. Nagare et al. teach that: “Thus, the polymerization of silica progresses at the outer periphery of the micelle that is formed in aqueous solution, and micelle/silica composite capsules, wherein the micelle is coated with silica, are considered to be formed” (Column 18, lines 52-56). Thus, the surfactant serves as a template for the formation of the silica metal oxide structure. With regard to the “wherein the biologically active agent provides a template for the formation of the network of pores in the metal oxide structure” limitation, Nagare et al. teach: “If the concentration exceeds 30.0 mass %, micelles (emulsion) become too close to each other, and the linking takes place during the silica polymerization process and the formation of a network takes place; as a result, the entire system may solidify.” (Column 9, lines 3-7). Thus, a network of pores is in the biocompatible metal oxide structure of Nagare et al. is provided by micellization of the material capable of forming micelles in water serving as a template and that provides for at least controlled diffusion release from the composite structure. Nagare et al. claim compositions with 20 mass% or higher of the surfactant (Claim 6) and teach a more preferable range of 40 to 60 mass % (Column 13, lines 35-42). This appears to be well above the CMC such that at such a high concentration the mixed compounds can organize into a continuous micelle network in order to template a network of pores. Nagare et al. teach and suggest antibacterial, antifungal and antiviral agents (Column 16, lines 27-28) as well as materials that form micelles including, for example, sodium dodecylbenzenesulfonate (Column 6, lines 38-40) and benzethonium chloride (Column 6, line 62), which are antimicrobial agents as evidenced by Falk et al. (“Sodium dodecyl benzene sulfonate (SDBS) is registered as an antimicrobial active that can be used in organic food processing.” Page 1124, left column 2nd paragraph) and Drug Bank (“Benzethonium is a synthetic quaternary ammonium salt with surfactant, antiseptic, and broad spectrum antimicrobial properties. Its salt form, benzethonium chloride, is primarily used as a skin disinfectant at concentrations of 0.1-0.2 %, which are safe and effective concentrations for the compound specified by the U.S. Food and Drug Administration (FDA).” Nagare et al. also teach and suggest the known antiseptic agents cetylpyridinium chloride and benzalkonium chloride (Column 6, lines 55 and 61-62). Nagare et al. teach application to the skin with good skin compatibility (Column 3, lines 10-14; column 5, lines 8-12; column 21, lines 59-64). Accordingly, Nagare et al. teach and suggest embodiments that have a biocompatible composite material for controlled release comprising a biocompatible metal oxide structure having a network of pores containing an antimicrobial surfactant with amphiphilic characteristics resulting in micellization when placed in aqueous conditions and that serves as a template for the formation of the network of pores in the metal oxide structure.
Regarding claim 6, since the structure taught by Nagare et al. is the same as claimed, the limitations of claim 6 naturally flow from the composite material.
Regarding claim 12, Nagare et al. teach capsules of a particle size of about 0.1 to 50 microns (Column 11, lines 45-55) and since the same materials are employed by Nagare et al. as instantly claimed, then the metal oxide structure would also be spherical.
Regarding claims 1, 7-9, 13-16 and 19, Zhang et al. teach antibacterial amphiphilic active agent chlorhexidine, which has amphiphilic characteristics results in micellization when placed in aqueous conditions, in the particulate filler mesoporous silica (CHX@MSN), which is a metal oxide structure of silicon dioxide containing a network of pores containing the antimicrobial active agent chlorhexidine, dispersed in a dental resin of bisphenol A glycidyl methacrylate (BisGMA), hexanediol dimethacrylate (HDDMA), ethoxylated bisphenol A dimethacrylate (EBPADMA), and urethane dimethacrylates (UEDMA), where BisGMA appears to read on the claimed “bisphenylgycidyl dimethacrylate” as defined by the specification page 37, line 23, hence incorporated into a polymer/resin/resin composite that comprises a methacrylate based polymer or a urethane-based polymer, and salinized glass fillers (Abstract; page 1284, Materials & Methods), thereby disclosing a particulate filler dispersed in the resin with the pores filled with an amphiphilic biologically active agent. Zhang et al. report that it showed controlled release of chlorhexidine (Abstract; Page 1287, top right column: “Light-cured dental composites containing CHX@MSN showed a more sustainable, controlled release of CHX for 16 days”). Zhang et al. instruct the artisan: “we have presented a type of new dental composite consisting of MSN to encapsulate or recharge and sustainably release antimicrobial agents, such as CHX” (Page 1287, right column last paragraph). The term “such as” introduces an example of the broader class of antimicrobial agents and therefore Zhang et al. is open to the inclusion of other antimicrobial agents.
Regarding claim 10, silanized glass fillers were mixed with resin monomers to form a resin paste (Page 1284, Materials & Methods) thus modifying the composite material by attaching silanized glass, which can read on a metal oxide, some of which are implicitly at the surface of the composite material. Especially when the specification does not define how “attachment” is to be achieved.
Regarding claim 12, Zhang et al. cite Samuel et al. who teach Mechanical properties of experimental dental composites containing a combination of mesoporous and nonporous spherical silica as fillers (Page 1289, upper right column) thus rendering spherical shape as obvious.
Regarding claim 20, since the same monomers are disclosed by Zhang et al. as claimed, then the resin of Zhang et al. can also serve as, for example, a tooth bonding agent or dental adhesive or a coating material for various prosthesis or a restorative resin as the claimed uses in Claim 20 are simply intended use of the composite material. An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Furthermore, Zhang et al. teach that the composite is a dental composite restoration (Abstract) which renders obvious coating on at least a dental implant to impart antibacterial and biofilm inhibition properties.
Regarding claim 21, Zhang et al. report more uniform distribution in the composite with CHX@MSN (pages 1286, bottom left column to top right column) as well as characterizing the composition as “well-dispersed MSNs” (Page 1285, Discussion first paragraph).
Regarding claims 1, 4-5 and 17-18, Muller et al. teach chlorhexidine (CHX), polyhexamethylene biquanide (PHMB) and octenidine dihydrochloride (OCT) as antiseptic agents (title; abstract; Tables 1 and 2) where octenidine and polyhexamethylene biquanide were reported as the most suitable antiseptic agents and superior antiseptic agents than chlorhexidine because they had a BI greater than 1 (Abstract).
Regarding claims 4 and 17, Stockel et al. teach:
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The instant specification teaches that “lauric arginate” is LAE (Page 29, line 7; page 32, lines 6 and 20-23).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and: Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Nagare et al. is that Nagare et al. do not expressly teach wherein the biologically active agent is an antimicrobial agent and has a biocompatibility index of greater than 1. However, as noted by the Examiner above, Nagare et al. teach and suggest numerous antimicrobial surfactants that form micelles when placed in aqueous conditions including sodium dodecylbenzenesulfonate and benzethonium chloride which are art recognized as safe and effective as taught by the evidentiary references. It is then merely judicious selection of known antimicrobial active agents that form micelles when placed in aqueous conditions and measure the biocompatibility index. It would be desirable to have a biocompatibility index of greater than 1 because that would infer the antimicrobial is safe and effective. The Examiner cannot ascertain the biocompatibility index of the surfactants taught by Nagare. Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
The difference between the instant application and Nagare et al. is that Nagare et al. do not expressly teach polyhexamethylene biquanide or octenidine or a salt thereof or “lauric arginate”. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyhexamethylene biquanide or octenidine dihydrochloride, as suggested by Muller et al., or “lauric arginate”, as suggested by Stockel et al., in the composite of Nagare et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Nagare et al. is not limited to any particular cationic antimicrobial surfactant that forms micelles, is open to the inclusion of other antimicrobial/antiseptic agents and suggests adding antibacterial agents. As stated above, Nagare et al. teach and suggest cetylpyridinium chloride and benzalkonium chloride (Column 6, lines 55 and 61-62) and Muller et al. teach and suggest that octenidine dihydrochloride and polyhexamethylene biquanide have a BI index of greater than 1 and are superior to cetylpyridinium chloride and benzalkonium chloride. Consequently, it would be desirable to substitute the antimicrobial agents polyhexamethylene biquanide and/or octenidine dihydrochloride into the composite of Nagare et al. for those superior properties with a reasonable expectation of success and have an antimicrobial agent with a biocompatibility index of greater than 1. Furthermore, Stockel et al. report that LAE is non-toxic but has broad spectrum cidal activity and additionally has skin conditioning characteristics which would be desirable in the skin application of Nagare et al. Consequently, it would be obvious to employ LAE in the composition of Nagare et al. for those desirable properties with a reasonable expectation of success.
The difference between the instant application and Nagare et al. as modified by Muller et al. and Stockel et al. is that Nagare et al. as modified by Muller et al. and Stockel et al. do not expressly incorporating the composite material into a polymer, resin or resin composite comprising a methacrylate based polymer or a urethane-based polymer and wherein the resin comprises one or more of hydroxyethyl methacrylate, bisphenylglycidyl dimethacrylate and triethylene glycol dimethacrylate as a dental composite with the active agent substantially uniformly distributed throughout the pores. However, the application of the compositions of Nagare et al. is not limited (Column 16, lines 45-57), and could be used as a particulate filler dispersed in a resin in any of the formulations of claim 20, and Zhang et al. teach employing such compositions as a particulate filler mesoporous silica (CHX@MSN), which is a metal oxide structure of silicon dioxide containing a network of pores containing the antimicrobial active agent chlorhexidine, dispersed in a dental resin of bisphenol A glycidyl methacrylate (BisGMA), hexanediol dimethacrylate (HDDMA), ethoxylated bisphenol A dimethacrylate (EBPADMA), and urethane dimethacrylates (UEDMA), where BisGMA appears to read on the claimed “bisphenylgycidyl dimethacrylate” as defined by the specification page 37, line 23, hence incorporated into a polymer/resin/resin composite that comprises a methacrylate based polymer or a urethane-based polymer, and salinized glass fillers (Abstract; page 1284, Materials & Methods), thereby disclosing a particulate filler dispersed in the resin with the pores filled with an amphiphilic biologically active agent. Consequently, it would obvious to substitute the antimicrobial compositions of Nagare et al. as modified by Muller et al. and Stockel et al. for the mesoporous silica chlorhexidine composite in the dental composite of Zhang et al. with the active agent substantially uniformly distributed throughout the pores and dispersed in the resin and produce the claimed invention with a reasonable expectation of success. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in before the effective filing date, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nagare et al. (US8030267) and Zhang et al. (J Dent Res 2014;93(12):1283-1289) and Muller et al. (Journal of Antimicrobial Chemotherapy 2008;61:1281-1287) and Stockel et al. (US20100056628) as evidenced by Falk, NA (J Surfact Deterg 2019;22:1119-1127) and Drug Bank Benzethonium chloride ([online] retrieved on 7/1/25 from: https://go.drugbank.com/salts/DBSALT001519; 3 pages), as applied to claims 1, 4-10 and 12-21 above, in further view of Xu et al. (Dental Materials 2006;22:1014-1023) and Landuyt et al. (Biomaterials 2007;28:3757-3785).
Applicant claims:
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The reference of Nagare et al., Muller et al., Stockel et al. and Zhang et al. is discussed in detail above and that discussion is incorporated by reference.
Nagare et al. as modified by Muller et al., Stockel et al. and Zhang et al. do not expressly teach wherein the composite material is modified by the attachment of a fluorinated silane to its surface. However, Van Landuyt et al. is directed to contemporary dental adhesives (Title; Abstract) and resin components (Page 3758, 2.1. Resin components; Table 2) that can have functional groups such as carboxyl or phosphonate or fluoro or antibacterial groups (Figure 2, page 3768). Xu et al. is directed to fluoride-releasing dental composites (Title) with silanized fluoroaluminosilicate particles (Abstract) where fluoride-releasing composite resins are known (Page 1015, left column 1st paragraph) and nearly all commercial fluoride-releasing composites use this type of fillers (Page 1015, left column 2nd paragraph). Xu et al. teach that fluoride is a well-documented anti-caries agent (Page 1014, Introduction right column).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to make the composition of Nagare et al. as modified by Muller et al., Stockel et al. and Zhang et al. wherein the composite material is modified by the attachment of a fluorinated silane, as suggested by Xu et al. and Van Landuyt et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the dental artisan is well aware fluoride provides anti-caries benefit. Zhang et al. expressly teach that: “One of the leading causes for the failure of dental composite restorations is secondary caries. Effectively inhibiting cariogenic biofilms and reducing secondary caries could extend the service life of composite restorations.” (Abstract). Therefore, it is desirable to attach the fluorinated silane of Xu et al. to the surface of the composite material of Nagare et al. as modified by Muller et al., Stockel et al. and Zhang et al. for the added anti-caries benefit with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Claim 16 is further rejected under 35 U.S.C. 103 as being unpatentable over Nagare et al. (US8030267) and Zhang et al. (J Dent Res 2014;93(12):1283-1289) and Muller et al. (Journal of Antimicrobial Chemotherapy 2008;61:1281-1287) and Stockel et al. (US20100056628) as evidenced by Falk, NA (J Surfact Deterg 2019;22:1119-1127) and Drug Bank Benzethonium chloride ([online] retrieved on 7/1/25 from: https://go.drugbank.com/salts/DBSALT001519; 3 pages), as applied to claims 1, 4-10 and 12-21 above, in further view of and Altunsoy et al. (J Appl Biomater Funct Mater. 2015;13(2):e100-e105).
Applicant claims:
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The references of Nagare et al., Muller et al., Stockel et al. and Zhang et al. is discussed in detail above and that discussion is incorporated by reference.
Nagare et al. as modified by Muller et al., Stockel et al. and Zhang et al. do not expressly teach wherein the resin comprises one or more of hydroxyethyl methacrylate and triethylene glycol dimethacrylate. However, Altunsoy et al. teach that: “The main monomer systems of dental adhesives are bisphenol A glycidyl methacrylate (Bis-GMA), urethane dimethacrylate (UDMA), triethylene glycol dimethacrylate (TEGDMA) and 2-hydroxyethyl methacrylate (HEMA).” (Page e100; Introduction upper right column). It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to use one or more of bisphenol A glycidyl methacrylate (Bis-GMA)hydroxyethyl methacrylate and triethylene glycol dimethacrylate, as suggested by Altunsoy et al., in the composite of Nagare et al. as modified by Muller et al., Stockel et al. and Zhang et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the dental artisan is well aware that these monomers are the main monomer systems in dental adhesives. Thus, they are familiar elements interchangeable for a desired function of adhesion with a reasonable expectation of success. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 12/3/25 have been carefully considered but are not persuasive.
On pages 6-7 of remarks, Applicant submits that Nagare does not disclose a “network of pores” and asserts that the methods of Nagare do not produce a metal oxide structure containing a network of pores. Applicant argues that Nagare teach a network of silica (not surfactant micelles) is formed such that the entire system may solidify as an undesirable failure of the Nagare process and a method of making a singular spherical micelle encapsulate by silica with no micellar network created. Applicant asserts that the micelle may serve as a template for a metal oxide shell, not a template for a network of pores in a metal oxide structure. Respectfully, Applicant’s arguments have been carefully considered but the Examiner has a different perspective. Initially, the Examiner does not agree that it is an undesirable failure for the system of Nagare et al. to solidify. Nagare et al. simply state that: “If the concentration exceeds 30.0 mass % micelles (emulsion) become too close to each other, and the linking takes place during the silica polymerization process and the formation of a network takes place, as a result, the entire system may solidify (Column 9, lines 3-7). Nagare et al. claim embodiments with 20 mass% or higher of the surfactant (Claim 6). Thus, embodiments of Nagare et al. include high concentrations of surfactant where a solidified network is present. As noted above, Applicant’s own specification teaches: “These compounds may organize into a continuous micelle network in order to template a network of pores” (Page 31, lines 21-22). The Examiner can discern no difference between the network produced by Nagare et al. and the “continuous micelle network” taught and claimed by Applicant. Consequently, Nagare et al. do implicitly teach and suggest that the surfactant is a template for the network of pores in the composite. Since the surfactant is in the pores of the composite, then when the composite disintegrates, the surfactant is released from the network of pores created by the surfactant. Applicant’s arguments are not persuasive.
On page 8 of remarks, Applicant asserts that: “porosity or pores within silica (or any other metal oxide) are not mentioned in Nagare because they do not exist in Nagare.” Respectfully, the Examiner has a different opinion. As per Applicant’s own specification, it appears that all one needs to do to obtain a composite material containing a network of pores templated by an active agent that forms micelles in water is to mix the metal oxide with the active agent at a concentration above the active agents CMC in an aqueous solvent. Nagare et al. do so. Thus, the network of pores is an inherent feature of those embodiments of Nagare et al. where the surfactant is present in greater than its CMC. Since CMC is the minimum concentration of surfactant molecules in a liquid where they spontaneously begin to aggregate and form micelles and adding more surfactant above the CMC forms more micelles and the process of Nagare et al. produces micelles, then Nagare et al. teach and suggest embodiments with a network of pores templated by the surfactant whether Nagre et al. recognized it or not. See MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).”
Applicant’s arguments have been carefully considered but are not persuasive.
On pages 8-9 of remarks, Applicant addresses the rejection over claims 11 and 16 in view of Van Landuyt and Xu and Altunsoy. However, the Examiner is relying upon the references as characterized by the Examiner and not as by Applicant. Respectfully, Applicant’s arguments are not persuasive.
As a final comment, the Examiner notes that Nagare et al. refer to their invention as forming a “silica gel” (Column 3, lines 14-17: “the present inventors have found that silica gel and a polyhydric alcohol are formed, in the formulation, during the solidification reaction of the water-soluble silane derivative.” (Column 15, lines 7-15: “The water-soluble silane derivative forms silica gel and a polyhydric alcohol by the hydrolysis and dehydration condensation reaction in water. Thus, the aqueous phase is solidified and a transparent gel-form composition with a specific surfactant association structure can be obtained by blending a water-soluble silane derivative into the formulation that can take a surfactant association structure with aqueous continuous phase or both of aqueous continuous phase and oil continuous phase.”)
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, including Applicant’s express description on how the network of pores in the metal oxide structure is produced, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613