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 . Claims included in the prosecution are claims 1-6 and 8-18.
Applicants' arguments, filed 10/07/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
1. Claims 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell) in view of Myers et al. (WO 02/087339 A1, Nov. 7, 2002) (hereinafter Myers) and Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang).
Burrell discloses an anti-microbial coating and method of forming same on medical devices. The coating is formed by depositing a biocompatible metal by vapor deposition techniques to produce atomic disorder in the coating such that a sustained release of metal ions sufficient to produce an anti-microbial effect is achieved (abstract). Suitable metals include Ag, Au, Cu, Zn, or compounds of these metals or alloys containing one or more of these metals. Such metals are referred to as anti-microbial metals (i.e., pathogen disruptive ion releasing material) (col. 5, lines 41-48). Suitable medical devices include dressings (col. 7, line 34). The invention is not limited to such devices and may extend to other devices useful in consumer healthcare (col. 7, lines 37-39). The device may be made of any suitable material (col. 7, line 46). The anti-microbial effect of the coating is achieved when the device is brought into contact with an alcohol or a water-based electrolyte such as, a body fluid or body tissue, thus releasing metal ions, atoms, molecules or clusters (col. 8, lines 46-49). The metal coating is produced as thin films (col. 3, line 6).
Burrell differs from the instant claims insofar as not disclosing a second coating.
However, Myers discloses metallic sheets having an improved antimicrobial property. The surface of the metallic article is afforded antimicrobial properties by coating a dispersion of fine particles made of an antimicrobial ingredient on the surface of the metallic sheet dispersed in a uniform layer and cured or dried to affix to the metallic surface (abstract). The article may additionally be coated with a secondary, protective layer. The secondary, protective layer is coated on the metal-containing particles (¶ [0058]). The protective layer should be sufficiently porous to permit diffusion of the antimicrobial component through the coating at an effective rate and function as a barrier that limits, if not eliminates, interaction between the antimicrobial component and a surrounding matrix (¶ [0059]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have coated the coating of Burrell with the secondary, protective layer of Myers motivated by the desire to provide protection to the coating of Burrell by eliminating interaction between the antimicrobial metals of the coating and a surrounding matrix without blocking the antimicrobial metals from being released as taught by Myers.
The combined teachings of Burrell and Myers do not teach wherein the first coating comprising a surface morphology in which grain peaks project from the surface of the substrate at an angle of between 20 degrees to 40 degrees.
However, Chang discloses a coating solution comprising nano-sized or micro-sized metal particles in a polymer matrix precursor solution, wherein the weight ratio of metal particles to said polymer matrix precursor solution enables at least a portion of said metal particles to project from the surface of a polymer matrix that has been formed during cross-linking of saif polymer matrix precursor solution, to thereby inactivate micro-organisms in contact with said metal particles (abstract). The term “inactivate microorganisms” is used to describe killing of micro-organisms (page 10, lines 22-25). The metal particles may have an average particle size of about 10 nm to about 200 nm (page 16, lines 1-2).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the antimicrobial metals of Burrell to project from the surface motivated by the desire to provide an additional antimicrobial effect by inactivating micro-organisms in contact with said metal particles as taught by Chang. With regards to the claimed angles, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed angles through routine experimentation based on arriving at an angle that would provide optimal contact with the micro-organisms. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
In regards to instant claim 9 reciting wherein an interface between the first coating and the second coating allows for diffusion of ions from the first coating to an upper surface of the second coating, because the protective layer (i.e., second coating) is sufficiently porous to permit diffusion of the antimicrobial component through the coating, there is an interface between the first coating and the second coating that allows for diffusion of ions from the first coating to the an upper surface of the second coating.
2. Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell) in view of Myers et al. (WO 02/087339 A1, Nov. 7, 2002) (hereinafter Myers), Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang), and further in view of Burns (US 2017/0157289, Jun. 8, 2017).
The teachings of Burrell, Myers, and Chang are discussed above. Burrell, Myers, and Chang do not teach wherein the first coating has an average surface roughness in the range of 10 nm to 30 nm and wherein the second coating has an average roughness in the range of 10 nm to 50 nm.
However, Burns discloses a biocompatible antibacterial film that is nano-textured (abstract). The nano-textured surface has a root mean square roughness of greater than or equal to 5 nm and includes nano-scale surface asperities of a dimension between 10 and 1000 nm to provide at least one of inhibition of growth of pathogenic bacteria, promotion of osseointegration, or promotion of epithelial attachment (claim 15). The root mean square roughness may range from 5-100 nm (¶ [0051]). The nano-scale asperities may substantially reduce and/or inhibit the growth of bacteria on the surface of the deposited film (¶ [0052]). An adhesion layer may be formed between the substrate and the deposited film (¶ [0009]). The surface roughness of the deposited antibacterial layer may be greater than that of the adhesion layer (¶ [0047]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have provided the surface of the second coating with a roughness in the range of 5-100 nm motivated by the desire to provide at least one of inhibition of growth of pathogenic bacteria, promotion of osseointegration, or promotion of epithelial attachment as taught by Burns.
It would have been prima facie to one of ordinary skill in the art to have formulated the first coating to also have a roughness in the range of 5-100 nm motivated by the desire to further reduce and/or inhibit growth of bacteria since the second coating is porous and thus parts of the first coating are exposed to the surface. One of ordinary skill would have had a reasonable expectation of success since Burns discloses wherein the adhesive layer under the antibacterial layer may also have a surface roughness.
3. Claims 8, 10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell) in view of Myers et al. (WO 02/087339 A1, Nov. 7, 2002) (hereinafter Myers), Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang), and further in view of Burrell et al. (US 6,333,093, Dec. 25, 2001) (hereinafter Burrell 2).
The teachings of Burrell 1, Myers, and Chang are discussed above. Burrell 1, Myers, and Chang do not teach wherein the dressing is a non-woven substrate, wherein the first coating is a continuous coating at least 80% of the surface of the substrate, and wherein at least 80% of the antimicrobial metals have an average diameter in the range of 5 nm to 50 nm.
However, Burrell 2 discloses a multilayer anti-microbial material comprising a base layer and a top layer (claim 1). The base and top layers are provided on a wound dressing (claim 13). The wound dressing may be formed from a non-woven material (claims 30 and 31). As shown in Fig. 1, the base layer 2 and the top layer 4 coat the substate entirely. The coating may comprise an alloy of silver with an average grain size of 10 nm (col. 17, lines 31-38).
Burrell 1 discloses wherein suitable medical devices include dressings and wherein the device may be made of any suitable material. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the dressing of Burrell 1 from a non-woven material since this is a known and effective material for forming dressings as taught by Burrell 2.
It would have been prima facie obvious to one of ordinary skill in the art to have formulated the first coating to be across the entire surface of the substrate since Burrell 1 does not disclose how much of the substrate is coated and coating the entire substrate is a known and effective method for forming a medical device comprising an antimicrobial coating as taught by Burrell 2.
It would have been prima facie obvious to one of ordinary skill in the art to have formulated the antimicrobial metals of Burrell 1 to be 10 nm since Burrell 1 does not disclose a particle size and 10 nm is a known and effective particle size for antimicrobial metals in a coating as taught by Burrell 2.
In regards to instant claim 12 reciting wherein the inorganic material forms at least 80% by weight of said pathogen inhibiting layer, this limitation would have been obvious since Burrell 1 does not disclose wherein the coating requires any other ingredients besides the antimicrobial metal.
4. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell) in view of Myers et al. (WO 02/087339 A1, Nov. 7, 2002) (hereinafter Myers), Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang), and further in view of Orofino (US 2009/0252647, Oct. 8, 2009).
The teachings of Burrell, Myers, and Chang are discussed above. Burrell, Myers and Chang do not disclose wherein the substrate has a differential pressure of less than 4 mm H2O/cm2.
However, Orofino discloses a liquid impervious substrate having an antimicrobial disposed thereon. The substrate may be a face mask (abstract). The face mask may exhibit a differential pressure less than or equal to 2.5 mm water/cm2 to ensure respiratory comfort of the product (¶ [0141]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the face mask of Orofino as the medical device of Burrell since Burrell does not limit the medical devices to what is disclosed and the face mask of Orofino is a known medical device in need of an antimicrobial coating as taught by Orofino.
5. Claims 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell 1) in view of Burrell et al. (US 6,333,093, Dec. 25, 2001) (hereinafter Burrell 2) and Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang).
Burrell 1 discloses an anti-microbial coating and method of forming same on medical devices. The coating is formed by depositing a biocompatible metal by vapor deposition techniques to produce atomic disorder in the coating such that a sustained release of metal ions sufficient to produce an anti-microbial effect is achieved (abstract). Suitable metals include Ag, Au, Cu, Zn, or compounds of these metals or alloys containing one or more of these metals. Such metals are referred to as anti-microbial metals (i.e., pathogen disruptive ion releasing material) (col. 5, lines 41-48). Suitable medical devices include dressings (col. 7, line 34). The invention is not limited to such devices and may extend to other devices useful in consumer healthcare (col. 7, lines 37-39). The device may be made of any suitable material (col. 7, line 46). The anti-microbial effect of the coating is achieved when the device is brought into contact with an alcohol or a water-based electrolyte such as, a body fluid or body tissue, thus releasing metal ions, atoms, molecules or clusters (col. 8, lines 46-49). The metal coating is produced as thin films (col. 3, line 6).
Burrell 1 differs from the instant claims insofar as not disclosing wherein the dressing is a non-woven substrate.
However, Burrell 2 discloses a multilayer anti-microbial material comprising a base layer and a top layer (claim 1). The base and top layers are provided on a wound dressing (claim 13). The wound dressing may be formed from a non-woven material (claims 30 and 31).
Burrell 1 discloses wherein suitable medical devices include dressings and wherein the device may be made of any suitable material. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the dressing of Burrell 1 from a non-woven material since this is a known and effective material for forming dressings as taught by Burrell 2.
The combined teachings of Burrell 1 and Burrell 2 do not teach wherein the first coating comprising a surface morphology in which grain peaks project from the surface of the substrate at an angle of between 20 degrees to 40 degrees.
However, Chang discloses a coating solution comprising nano-sized or micro-sized metal particles in a polymer matrix precursor solution, wherein the weight ratio of metal particles to said polymer matrix precursor solution enables at least a portion of said metal particles to project from the surface of a polymer matrix that has been formed during cross-linking of saif polymer matrix precursor solution, to thereby inactivate micro-organisms in contact with said metal particles (abstract). The term “inactivate microorganisms” is used to describe killing of micro-organisms (page 10, lines 22-25). The metal particles may have an average particle size of about 10 nm to about 200 nm (page 16, lines 1-2).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the antimicrobial metals of Burrell to project from the surface motivated by the desire to provide an additional antimicrobial effect by inactivating micro-organisms in contact with said metal particles as taught by Chang. With regards to the claimed angles, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed angles through routine experimentation based on arriving at an angle that would provide optimal contact with the micro-organisms. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
In regards to instant claim 12 reciting wherein the inorganic material forms at least 80% by weight of said pathogen inhibiting layer, this limitation would have been obvious since Burrell 1 does not disclose wherein the coating requires any other ingredients besides the antimicrobial metal.
6. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell 1) in view of Burrell et al. (US 6,333,093, Dec. 25, 2001) (hereinafter Burrell 2), Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang), and further in view of Burns (US 2017/0157289, Jun. 8, 2017).
The teachings of Burrell 1, Burrell 2, and Chang are discussed above. Burrell 1, Burrell 2, and Chang do not disclose wherein the coating has a surface roughness in the range of 5 nm to 50 nm.
However, Burns discloses a biocompatible antibacterial film that is nano-textured (abstract). The nano-textured surface has a root mean square roughness of greater than or equal to 5 nm and includes nano-scale surface asperities of a dimension between 10 and 1000 nm to provide at least one of inhibition of growth of pathogenic bacteria, promotion of osseointegration, or promotion of epithelial attachment (claim 15). The root mean square roughness may range from 5-100 nm (¶ [0051]). The nano-scale asperities may substantially reduce and/or inhibit the growth of bacteria on the surface of the deposited film (¶ [0052]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have provided the surface of the coating with a roughness in the range of 5-100 nm motivated by the desire to provide at least one of inhibition of growth of pathogenic bacteria, promotion of osseointegration, or promotion of epithelial attachment as taught by Burns.
7. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell 1) in view of Burrell et al. (US 6,333,093, Dec. 25, 2001) (hereinafter Burrell 2), Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang), and further in view of Orofino (US 2009/0252647, Oct. 8, 2009) and Yeung et al. (US 2017/0275472, Sep. 28, 2017) (hereinafter Yeung).
The teachings of Burrell 1, Burrell 2, and Chang are discussed above. Burrell 1, Burrell 2 and Chang do not teach wherein the substrate is statically charged.
However, Orofino discloses a liquid impervious substrate having an antimicrobial disposed thereon. The substrate may be a face mask (abstract). The face mask may exhibit a differential pressure less than or equal to 2.5 mm water/cm2 to ensure respiratory comfort of the product (¶ [0141]).
Yeung discloses an antimicrobial coating material (abstract). Fig. 6(e) and 6(f) show SEM images of two commercial air filters. They are made up of electrostatically charged fibers and verified to be effective for removing large airborne allergens. The antimicrobial material may be applied on these common porous filtration media to impart bactericidal and sporicidal activities (¶ [0051]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the face mask of Orofino as the medical device of Burrell since Burrell does not limit the medical devices to what is disclosed and the face mask of Orofino is a known medical device in need of an antimicrobial coating as taught by Orofino.
Additionally, it would have been prima facie obvious to have formulated the face mask with electrostatically charged fibers motivated by the desire to remove airborne allergens as taught by Yeung.
8. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Burrell et al. (US 5,681,575, Oct. 28, 1997) (hereinafter Burrell 1) in view of Burrell et al. (US 6,333,093, Dec. 25, 2001) (hereinafter Burrell 2), Chang et al. (WO 2012/015362 A1, Feb. 2, 2012) (hereinafter Chang), and further in view of Herbots et al. (US 2016/0251525, Sep. 1, 2016) (hereinafter Herbots).
The teachings of Burrell 1, Burrell 2, and Chang are discussed above. Burrell 1, Burrell 2 and Chang do not teach wherein the coating is formed by a Stranski-Krastanow growth mode.
However, Herbots discloses wherein the three classical thin film growth modes include the Stranski-Krastanov thin film growth mode (¶ [0075]).
Burrell 1 discloses wherein the metal coating is produced as thin films. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have grown the coating of Burrell 1 by a Stranski-Krastanow thin film growth mode since it is a known and effective method of growing thin films as taught by Herbots.
Response to Arguments
Applicant argues that there is no discussion in Chang of orientation of grain peaks, let alone the orientation within the range of 20° to 40°. The orientation of grains of the deposition is novel and is not the result of mere routine experimentation. The projection of the grain peaks of the metal surface as deposited provides an advantage over the citations and provides for an improved antibacterial effect.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, with regards to the claimed angles, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed angles through routine experimentation based on arriving at an angle that would provide optimal contact with the micro-organisms. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). Thus, it would have been obvious to one of ordinary skill in the art to have arrived at the claimed orientation. Although Applicant argues that the claimed orientation is novel and not the result of mere routine experimentation, Applicant has not provided objective evidence supporting this assertation. As such, since Applicant has not shown wherein the claimed orientation is unexpected, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-6 and 8-18 are rejected.
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.
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/TRACY LIU/Primary Examiner, Art Unit 1614