DETAILED ACTION
This Office Action is in response to the request for continued examination, filed on March 18, 2026. Primary Examiner acknowledges Claims 1-24 are pending in this application, with Claims 1, 3, 5, 6, 12, 14, and 24 having been currently amended.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 18, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 2, Lines 5 and 7 recite the limitation “the conduct”; however, this term appears to lack antecedent basis in the claims. Primary Examiner is unclear of the breadth and scope of the limitation “the conduct”. Primary Examiner is unsure if perhaps the limitation should be “the conduit”. However, appropriate correction and clarification is required.
Specifically, Claim 2, Line 8 recites the limitation “and”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if there is a missing additional limitation or perhaps if this “and” is a typo. Additionally, pursuant to MPEP 608.01(m): Form of Claims “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” In this particular case, the limitation “and” does not include the required period punctuation. Appropriate correction and clarification is required.
Specifically, Claim 24, Line 8 recites “the tubing element”; however, this term appears to lack antecedent basis in the claims. It appear this limitation should read “the single-walled tubing element” to provide consistency with the remaining limitations of the claims. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 12, 14, 21, and 24 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Levius (5,887,593).
As to Claim 1, Levius discloses a method, comprising forming an antimicrobial and hydrophobic blend including: (a) a quantity of an antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) combined (“mixed with or impregnated into” Column 4, Line 60 thru Column 5, Line 15) with (b) a quantity of a hydrophobic polymer (“Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) comprising polyethylene, polypropylene, or silicone (“silicone”); and forming a medical device (10, “Urinary Incontinence Device” Title, best seen Figures 1-4, “Depicted in FIG. 1 is one embodiment of a device 10 incorporating features of the present invention and being designed for controlling and regulating urinary incontinence in women.” Column 3, Line 50, thru Column 4, Line 5) from the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”), wherein the medical device (10) has a first exposed surface (defined as the exterior perimeter of 22 - as exposed to the ambient – ex situ, and the body of the patient – in situ, “Depicted in FIG. 2, insert 12 comprises a flexible tube 22 longitudinally extending between proximal end 14 and distal end 16. Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) and a second exposed surface (24 as exposed to the fluid - urine, “Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) opposite the first exposed surface (defined as the exterior perimeter of 22 - as exposed to the ambient – ex situ, and the body of the patient – in situ), wherein each of the first exposed surface (defined as the exterior perimeter of 22 - as exposed to the ambient – ex situ, and the body of the patient – in situ) and the second exposed surface (24) of the medical device (10) exhibits antimicrobial and hydrophobic properties (“silver compounds” “mixed with or impregnated into” “silicone”) of the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
As to Claim 6, Levius discloses the antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprises “silver compounds”. The scope of “silver compounds” includes at least the claimed “silver” and “silver oxide”.
As to Claim 12, Levius discloses the hydrophobic polymer (“Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) is “silicone”.
As to Claim 14, Levius discloses a medical device (10, “Urinary Incontinence Device” Title, best seen Figures 1-4, “Depicted in FIG. 1 is one embodiment of a device 10 incorporating features of the present invention and being designed for controlling and regulating urinary incontinence in women.” Column 3, Line 50, thru Column 4, Line 5), comprising: an antimicrobial structure (22, “Depicted in FIG. 2, insert 12 comprises a flexible tube 22 longitudinally extending between proximal end 14 and distal end 16. Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) formed from an antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone” - “It is also contemplated that a surface layer 34 can be deposited over foam layer 32. Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15” Column 4, Line 60 thru Column 5, Line 15; wherein 32 - “Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) comprising a mixture of a hydrophobic polymer (“silicone”, “Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70); and an antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprising “silver compounds” -- The scope of “silver compounds” includes at least the claimed “silver” and “silver oxide”; wherein an exposed surface (34 as exposed to the ambient – ex situ, and the body of the patient – in situ, wherein “silver compounds” “mixed with or impregnated into” “silicone”, “It is also contemplated that a surface layer 34 can be deposited over foam layer 32. Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15” Column 4, Line 60 thru Column 5, Line 15) of the antimicrobial structure (22) exhibits antimicrobial and hydrophobic properties (“silver compounds” “mixed with or impregnated into” “silicone”) of the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
As to Claim 21, Levius discloses the antimicrobial structure (22) comprises a conduit (26, “Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) for carrying a fluid (“urine”, “The urine thus remains within the urethra or passes into channel 26 through openings 15 or 17.” Column 6, Lines 50 thru Column 7, Line 5) away from a user.
As to Claim 24, Levius discloses a medical device (10, “Urinary Incontinence Device” Title, best seen Figures 1-4, “Depicted in FIG. 1 is one embodiment of a device 10 incorporating features of the present invention and being designed for controlling and regulating urinary incontinence in women.” Column 3, Line 50, thru Column 4, Line 5), comprising: a single – walled tubing element (22, “Depicted in FIG. 2, insert 12 comprises a flexible tube 22 longitudinally extending between proximal end 14 and distal end 16. Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) to carry a fluid (“urine” via 26, “The urine thus remains within the urethra or passes into channel 26 through openings 15 or 17.” Column 6, Lines 50 thru Column 7, Line 5), the single-walled tubing element (22) formed from a hydrophobic and antimicrobial blend (“silver compounds” “mixed with or impregnated into” “silicone” - “It is also contemplated that a surface layer 34 can be deposited over foam layer 32. Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15” Column 4, Line 60 thru Column 5, Line 15; wherein 32 - “Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) including: a hydrophobic polymer (“silicone”, “Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) of “silicone”; and an antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15); wherein the single-walled tubing element (22) has (a) an exposed outer surface (defined as the exterior perimeter of 22 - as exposed to the ambient – ex situ, and the body of the patient – in situ, “Depicted in FIG. 2, insert 12 comprises a flexible tube 22 longitudinally extending between proximal end 14 and distal end 16. Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) exposed to an environment (the ambient – ex situ, and the body of the patient – in situ) outside the single-walled tubing element (22) and (b) an exposed inner surface (24 as exposed to the fluid - urine, “Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) exposed to a fluid (“urine”, “The urine thus remains within the urethra or passes into channel 26 through openings 15 or 17.” Column 6, Lines 50 thru Column 7, Line 5), wherein each of the exposed outer surface (defined as the exterior perimeter of 22 - as exposed to the ambient – ex situ, and the body of the patient – in situ) and the exposed inner surface (24 as exposed to the fluid – urine) of the single-walled tubing element (22) exhibit hydrophobic and antimicrobial properties (“silver compounds” “mixed with or impregnated into” “silicone”) of the hydrophobic and antimicrobial blend (“silver compounds” “mixed with or impregnated into” “silicone”).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Levius (5,887,593) in view of Freeman (4,809,676).
As to Claim 11, Levius discloses the hydrophobic polymer (“Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) is “silicone”.
Yet, Levius does not expressly disclose the explicit polymer to be “a thermoplastic polymer”.
Freeman teaches a medical device (“Heart Assist Device And Method Of Implanting It” Title) constructed of silicone (“All the segments are composed of metal material and are embedded in a resilient sleeve body 54, which is composed of any suitable thermoplastic material not rejectable by the body, such material as, a medical grade silicone rubber.” Column 6, Lines 1-20). In light of the teachings of Freeman, it is unequivocally clear that “silicone” is a known “thermoplastic polymer” which is known for use in medical device because it is “not rejectable by the body”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the silicone of Levius to be utilized with a thermoplastic polymer, as taught by Freeman to be a known material suitable for use in medical devices that is “not rejectable by the body”.
Claims 2-4, 7-10, 15, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Levius (5,887,593) in view of Reisdorf et al. (6,361,526).
As to Claim 2, Levius discloses the medical device (10) comprises a conduit (26, “Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) configured to carry a fluid (“urine”, “The urine thus remains within the urethra or passes into channel 26 through openings 15 or 17.” Column 6, Lines 50 thru Column 7, Line 5); and forming the medical device (10) with the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”) to make the conduit (26) from the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”); wherein the first exposed surface (defined as the exterior perimeter of 22 - as exposed to the ambient – ex situ, and the body of the patient – in situ) comprises an outer surface of the conduit (26) exposed to an environment (the ambient – ex situ, and the body of the patient – in situ) outside the conduit (26); and the second exposed surface (24 as exposed to the fluid) comprises an inner surface of the conduit (26) exposed to the fluid (“urine”).
Yet, Levius does not expressly disclose the method of manufacturing to make the medical device includes the use of “an extruder to extrude the conduit”.
Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title) whereby the device is “molded” (Column 4, Lines 25-50) and additionally Reisdorf teaches further known methods of manufacturing of the medical device (“Antimicrobial Tympanostomy Tube” Title) to include “The milled product is then formed into a hollow tube by any conventional tube forming process such as transfer molding, extrusion or casting.” (Column 3, Lines 45-55) whereby “transfer molding, extrusion or casting” are functionally equivalent alternative formation methods suitable for the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title).
As Reisdorf teaches “extrusion” as a known functionally equivalent alternative formation methods suitable for the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title), the modification of the unknown method of manufacturing of Levius to include the use of “an extruder” as claimed to perform the act of “extrusion” as taught by Reisdorf is a functionally equivalent alternative formation methods suitable for the formation of a medical device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manufacturing method of Levius to include the claimed “extruder” as taught by Reisdorf to be a known method suitable for the formation of a medical device.
As to Claim 3, Levius discloses the forming of the medical device (10) with the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”) to form the medical device (10) from the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”), wherein an exposed surface (34 as exposed to the ambient – ex situ, and the body of the patient – in situ, wherein “silver compounds” “mixed with or impregnated into” “silicone”, “It is also contemplated that a surface layer 34 can be deposited over foam layer 32. Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15.” Column 4, Line 60 thru Column 5, Line 15) of the medical device (10) exhibits antimicrobial and hydrophobic properties (“silver compounds” “mixed with or impregnated into” “silicone”) of the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
Yet, Levius does not expressly disclose the method of manufacturing including the use of “a molding system to perform the molding process to form the medical device”.
Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title) whereby the device is “molded” (Column 4, Lines 25-50) and additionally Reisdorf teaches further known methods of manufacturing of the medical device (“Antimicrobial Tympanostomy Tube” Title) to include “The milled product is then formed into a hollow tube by any conventional tube forming process such as transfer molding, extrusion or casting.” (Column 3, Lines 45-55) whereby “transfer molding, extrusion or casting” are functionally equivalent alternative formation methods suitable for the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manufacturing method of Levius to include the claimed “molding system to perform the molding process” as taught by Reisdorf to be a known method suitable for the formation of a medical device.
As to Claim 4, Levius discloses the forming of the medical device (10) with the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”) to make the medical device (10) form the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
Yet, Levius does not expressly disclose the method of manufacturing to include the use of “an additive printer to print the medical device”.
Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title) whereby the device is “molded” (Column 4, Lines 25-50) and additionally Reisdorf teaches further known methods of manufacturing of the medical device (“Antimicrobial Tympanostomy Tube” Title) to include “The milled product is then formed into a hollow tube by any conventional tube forming process such as transfer molding, extrusion or casting.” (Column 3, Lines 45-55) whereby “transfer molding, extrusion or casting” are functionally equivalent alternative formation methods suitable for the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title).
As Reisdorf teaches “extrusion” as a known functionally equivalent alternative formation methods suitable for the formation of the medical device (“Antimicrobial Tympanostomy Tube” Title), the modification of the unknown method of manufacturing of Levius to include the use of “an additive printer” as claimed to perform the act of “extrusion” as taught by Reisdorf effectively acts as a printer providing deposits of medium to create the medical device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manufacturing method of Levius to include the claimed “additive printer” as taught by Reisdorf to be a known method suitable for the formation of a medical device.
As to Claims 7-10, Levius discloses the antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprises “silver compounds”.
Yet, Levius does not expressly disclose the explicit percentage by weight of to be “in the range of 0.5 to 10%” (Claim 7), “at least 2.5%” (Claim 8), “in the range of 2.5 to 10%” (Claim 9), nor “in the range of 3.5 to 5%” (Claim 10).
Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the explicit percentage by weight of the medical device to be “silver oxide concentrations were about 5, 9 and 13% by weight”. With respect to Claim 7, the concentrations of “about 5, 9” meet the limitations of the claimed “in the range of 0.5 to 10%” . With respect to Claim 8, the concentrations of “about 5, 9 and 13% by weight” meet the limitations of the claimed “at least 2.5%”. With respect to Claim 9, the concentrations of “about 5, 9” meet the limitations of the claimed “in the range of 2.5 to 10%”. With respect to Claim 10, the concentration of “about 5” meets the limitations of the claimed in the range of 3.5 to 5%”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the antimicrobial additive percentage by weight of the medical device of Levius to include each of the claimed valuations, as taught by Reisdorf to be known concentrations suitable for imparting antimicrobial properties to the medical device.
As to Claims 15, 16, and 18, Levius discloses the antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprises “silver compounds”.
Yet, Levius does not expressly disclose the explicit percentage by weight of to be “in the range of 0.5 to 10%” (Claim 15), “in the range of 2.5 to 10%” (Claim 16), nor “in the range of 3.5 to 5%” (Claim 18).
Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the explicit percentage by weight of the medical device to be “silver oxide concentrations were about 5, 9 and 13% by weight”. With respect to Claim 15, the concentrations of “about 5, 9” meet the limitations of the claimed “in the range of 0.5 to 10%” . With respect to Claim 16, the concentrations of “about 5, 9” meet the limitations of the claimed “in the range of 2.5 to 10%”. With respect to Claim 18, the concentration of “about 5” meets the limitations of the claimed in the range of 3.5 to 5%”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the antimicrobial additive percentage by weight of the medical device of Levius to include each of the claimed valuations, as taught by Reisdorf to be known concentrations suitable for imparting antimicrobial properties to the medical device.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levius (5,887,593) in view of Reisdorf et al. (6,361,526), as applied to Claims 16 and 18, and further in view of Sun et al. (2009/0324536).
As to Claim 17, the modified Levius, specifically Levius discloses the exposed surface (34 as exposed to the ambient – ex situ, and the body of the patient – in situ, wherein “silver compounds” “mixed with or impregnated into” “silicone”) of the medical device, and further Reisdorf teaches the explicit percentage by weight of the medical device to be “silver oxide concentrations were about 5, 9 and 13% by weight” (Column 4, Lines 25-50) suitable for imparting antimicrobial properties to a medical device.
Yet, the modified Levius does not expressly disclose the effectiveness of the antimicrobial structure with respect to its bactericidal properties to reduce the colonies of "E. coli" and "S. Aureus".
Sun teaches the composition of "antimicrobial polymers" (Title) for medical applications to provide biocidal reduction properties (Abstract), utilizing a silver based composition (Page 18 "Silver Sulfadiazine Results").
Regarding the effectiveness of the silver based composition, as shown within the Table of Para 0156 on Page 18, 5 minutes of contact time is effective for a 99.9% reduction the colonies of "E. coli" and "S. Aureus"; whilst, 10 minutes of contact time and beyond is effective for a "Total Kill" 100% reduction the colonies of "E. coli" and "S. Aureus".
By convention, a "Log 2 efficacy" is equal to 99% reduction, whilst a "Log 4 efficacy" is equal to 99.99 % reduction.
The colonies of "E. coli" require 5 minutes of contact time to meet the "Log 2 efficacy"; whilst, the colonies of "S. Aureus" require 10 minutes of contact time to meet the "Log 4 efficacy".
Therefore, it would have been obvious to one having ordinary skill in the art to modify the antimicrobial additive of silver of the modified Levius to a composition suitable to achieve the desired biocidal reduction properties as taught by Sun.
As to Claim 19, the modified Levius, specifically Levius discloses the exposed surface (34 as exposed to the ambient – ex situ, and the body of the patient – in situ, wherein “silver compounds” “mixed with or impregnated into” “silicone”) of the medical device, and further Reisdorf teaches the explicit percentage by weight of the medical device to be “silver oxide concentrations were about 5, 9 and 13% by weight” (Column 4, Lines 25-50) suitable for imparting antimicrobial properties to a medical device.
Yet, the modified Levius does not expressly disclose the effectiveness of the antimicrobial structure with respect to its bactericidal properties to reduce the colonies of "E. coli" and "S. Aureus".
Sun teaches the composition of "antimicrobial polymers" (Title) for medical applications to provide biocidal reduction properties (Abstract), utilizing a silver based composition (Page 18 "Silver Sulfadiazine Results").
Regarding the effectiveness of the silver based composition, as shown within the Table of Para 0156 on Page 18, 5 minutes of contact time is effective for a 99.9% reduction the colonies of "E. coli" and "S. Aureus"; whilst, 10 minutes of contact time and beyond is effective for a "Total Kill" 100% reduction the colonies of "E. coli" and "S. Aureus".
By convention, a "Log 2 efficacy" is equal to 99% reduction, whilst a "Log 4 efficacy" is equal to 99.99 % reduction.
The colonies of "E. coli" and "S. Aureus" require 10 minutes of contact time to meet the "Log 4 efficacy".
Therefore, it would have been obvious to one having ordinary skill in the art to modify the antimicrobial additive of silver of the modified Levius to a composition suitable to achieve the desired biocidal reduction properties as taught by Sun.
Claims 5, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Levius (5,887,593) in view of Martens et al. (2006/0118122).
As to Claim 5, Levius discloses the antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprises “silver compounds”.
Yet, Levius does not expressly disclose the explicit compound of silver to be “silver phosphate glass oxide”.
Martens teaches a method (defined by the process of extrusions as shown in Figure 3, utilizing "extruder 300" Para 0066), comprising forming an antimicrobial and polymer blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046) including a quantity of an antimicrobial additive ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037) with a quantity of polymer ("polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), and forming a medical device (100, best seen Figures 2 and 4, where Figure 2 shows the entire medical device, and Figure 4 shows a cross section, "In FIG. 2 is shown a medical device 100 according to a first embodiment of the invention. Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052, also see: "Medical device 100 may have a conduit 102 for a fluid and an inflatable cuff 104 disposed at a first end 114 of conduit 102. As shown in section 4-4 shown in FIG. 4, a wall 412 of conduit 102 is made of a hydrophobic polymer with an outer layer 406 composed of a hydrophilic polymer and an antimicrobial compound disposed on an outer surface 408 of wall 412. An inner layer 404 composed of a hydrophilic polymer and an antimicrobial compound may further be disposed on an inner surface 410 of wall 412. Outer surface 408 may also be an outer surface of cuff 104." Paras 0053 and 0054; "A head 310 collects the material streams from the individual satellite extruders, combines them with the flow of material for wall 412 and extrudes them into a medical device 100." Para 0066, wherein "FIG. 3 may include a main extruder 302 to extrude hydrophobic polymer for the wall 412, a satellite extruder 304 for the AM material, and a satellite extruder 306 for a radio-opaque material." Para 0066), with the antimicrobial blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), wherein a surface (404/406, "In one embodiment, a wall 412 and either an inner or outer antimicrobial compound layers 404 and 406 may be forced into a mold cavity to form the medical device. In another embodiment, a wall 412 made of hydrophobic polymer is placed in a mold and the hydrophilic polymer and the antimicrobial compound layers 404 and 406 are molded around it." Para 0065) of the medical device (100) exhibits antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Regarding the remaining limitations of the claims, Martens teaches the functional equivalence of “silver”, “silver oxide (AgO)”, and “a silver bearing phosphorus-based glass material” for imparting antimicrobial properties ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the silver oxide of the Levius to be in the form of the claimed “silver phosphate glass oxide”, as taught by Martens to be a known functionally equivalent alternative medium suitable for imparting antimicrobial properties to the medical device.
As to Claim 22, Levius discloses a conduit (26) of a medical device (10) formed with antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
Yet, Levius does not expressly disclose the configuration of the conduit as “a component of a CPAP system, BiPAP system, or ventilator system”.
Martens teaches a method (defined by the process of extrusions as shown in Figure 3, utilizing "extruder 300" Para 0066), comprising forming an antimicrobial and polymer blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046) including a quantity of an antimicrobial additive ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037) with a quantity of polymer ("polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), and forming a medical device (100, best seen Figures 2 and 4, where Figure 2 shows the entire medical device, and Figure 4 shows a cross section, "In FIG. 2 is shown a medical device 100 according to a first embodiment of the invention. Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052, also see: "Medical device 100 may have a conduit 102 for a fluid and an inflatable cuff 104 disposed at a first end 114 of conduit 102. As shown in section 4-4 shown in FIG. 4, a wall 412 of conduit 102 is made of a hydrophobic polymer with an outer layer 406 composed of a hydrophilic polymer and an antimicrobial compound disposed on an outer surface 408 of wall 412. An inner layer 404 composed of a hydrophilic polymer and an antimicrobial compound may further be disposed on an inner surface 410 of wall 412. Outer surface 408 may also be an outer surface of cuff 104." Paras 0053 and 0054; "A head 310 collects the material streams from the individual satellite extruders, combines them with the flow of material for wall 412 and extrudes them into a medical device 100." Para 0066, wherein "FIG. 3 may include a main extruder 302 to extrude hydrophobic polymer for the wall 412, a satellite extruder 304 for the AM material, and a satellite extruder 306 for a radio-opaque material." Para 0066), with the antimicrobial blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), wherein a surface (404/406, "In one embodiment, a wall 412 and either an inner or outer antimicrobial compound layers 404 and 406 may be forced into a mold cavity to form the medical device. In another embodiment, a wall 412 made of hydrophobic polymer is placed in a mold and the hydrophilic polymer and the antimicrobial compound layers 404 and 406 are molded around it." Para 0065) of the medical device (100) exhibits antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Regarding the remaining limitations of the claims, Martens teaches the conduit (102) comprise a component of a CPAP system, BiPAP system, or ventilator system ( "an ET tube, a circuit, an airway accessory" - "Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052)
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit of the medical device of Levius to be utilized in a component of a CPAP system, BiPAP system, or ventilator system, as taught by Martens to impart a medical device with antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
As to Claim 23, Levius discloses an antimicrobial structure (22, “Depicted in FIG. 2, insert 12 comprises a flexible tube 22 longitudinally extending between proximal end 14 and distal end 16. Tube 22 has an interior surface 24 that bounds a channel 26 also extending between ends 14 and 16.” Column 4, Lines 1-15) of a medical device (10) formed with antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
Yet, Levius does not expressly disclose the configuration of the antimicrobial structure as “a respiratory mask or component of a respiratory mask”.
Martens teaches a method (defined by the process of extrusions as shown in Figure 3, utilizing "extruder 300" Para 0066), comprising forming an antimicrobial and polymer blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046) including a quantity of an antimicrobial additive ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037) with a quantity of polymer ("polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), and forming a medical device (100, best seen Figures 2 and 4, where Figure 2 shows the entire medical device, and Figure 4 shows a cross section, "In FIG. 2 is shown a medical device 100 according to a first embodiment of the invention. Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052, also see: "Medical device 100 may have a conduit 102 for a fluid and an inflatable cuff 104 disposed at a first end 114 of conduit 102. As shown in section 4-4 shown in FIG. 4, a wall 412 of conduit 102 is made of a hydrophobic polymer with an outer layer 406 composed of a hydrophilic polymer and an antimicrobial compound disposed on an outer surface 408 of wall 412. An inner layer 404 composed of a hydrophilic polymer and an antimicrobial compound may further be disposed on an inner surface 410 of wall 412. Outer surface 408 may also be an outer surface of cuff 104." Paras 0053 and 0054; "A head 310 collects the material streams from the individual satellite extruders, combines them with the flow of material for wall 412 and extrudes them into a medical device 100." Para 0066, wherein "FIG. 3 may include a main extruder 302 to extrude hydrophobic polymer for the wall 412, a satellite extruder 304 for the AM material, and a satellite extruder 306 for a radio-opaque material." Para 0066), with the antimicrobial blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), wherein a surface (404/406, "In one embodiment, a wall 412 and either an inner or outer antimicrobial compound layers 404 and 406 may be forced into a mold cavity to form the medical device. In another embodiment, a wall 412 made of hydrophobic polymer is placed in a mold and the hydrophilic polymer and the antimicrobial compound layers 404 and 406 are molded around it." Para 0065) of the medical device (100) exhibits antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Regarding the remaining limitations of the claims, Martens teaches the conduit (102) comprise a respiratory mask or a component of a respiratory mask ("an ET tube, a circuit, an airway accessory" - "Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052) .
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit of the medical device of Levius to be utilized in a component of a respiratory mask or a component of a respiratory mask, as taught by Martens to impart a medical device with antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Levius (5,887,593) in view of Martens et al. (2006/0118122) and Reisdorf et al. (6,361,526).
As to Claim 13, Levius discloses the antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprises “silver compounds” and a hydrophobic polymer (“Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) to impart a medical device (10) with the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
Yet, Levius does not expressly disclose the explicit composition of the antimicrobial additive to be “silver phosphate glass oxide”, nor the percentage by weight of the “silver phosphate glass oxide” to be “2.5 to 10%”.
Regarding the use of “silver phosphate glass oxide”, Martens teaches a method (defined by the process of extrusions as shown in Figure 3, utilizing "extruder 300" Para 0066), comprising forming an antimicrobial and polymer blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046) including a quantity of an antimicrobial additive ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037) with a quantity of polymer ("polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), and forming a medical device (100, best seen Figures 2 and 4, where Figure 2 shows the entire medical device, and Figure 4 shows a cross section, "In FIG. 2 is shown a medical device 100 according to a first embodiment of the invention. Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052, also see: "Medical device 100 may have a conduit 102 for a fluid and an inflatable cuff 104 disposed at a first end 114 of conduit 102. As shown in section 4-4 shown in FIG. 4, a wall 412 of conduit 102 is made of a hydrophobic polymer with an outer layer 406 composed of a hydrophilic polymer and an antimicrobial compound disposed on an outer surface 408 of wall 412. An inner layer 404 composed of a hydrophilic polymer and an antimicrobial compound may further be disposed on an inner surface 410 of wall 412. Outer surface 408 may also be an outer surface of cuff 104." Paras 0053 and 0054; "A head 310 collects the material streams from the individual satellite extruders, combines them with the flow of material for wall 412 and extrudes them into a medical device 100." Para 0066, wherein "FIG. 3 may include a main extruder 302 to extrude hydrophobic polymer for the wall 412, a satellite extruder 304 for the AM material, and a satellite extruder 306 for a radio-opaque material." Para 0066), with the antimicrobial blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), wherein a surface (404/406, "In one embodiment, a wall 412 and either an inner or outer antimicrobial compound layers 404 and 406 may be forced into a mold cavity to form the medical device. In another embodiment, a wall 412 made of hydrophobic polymer is placed in a mold and the hydrophilic polymer and the antimicrobial compound layers 404 and 406 are molded around it." Para 0065) of the medical device (100) exhibits antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Regarding the remaining limitations of the claims, Martens teaches the functional equivalence of “silver”, “silver oxide (AgO)”, and “a silver bearing phosphorus-based glass material” for imparting antimicrobial properties ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Thus, the application of “silver phosphate glass oxide” is a known functionally equivalent alternative medium suitable for imparting antimicrobial properties to the medical device.
Regarding the percentage by weight, Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the explicit percentage by weight of the medical device to be “silver oxide concentrations were about 5, 9 and 13% by weight”. Whereby the concentrations of “about 5, 9” meet the limitations of the claimed “in the range of 2.5 to 10%”.
Thus, the use of “silver oxide” within the recited percentage by weight is a known concentrations suitable for imparting antimicrobial properties to the medical device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the silver oxide of the Levius to be in the form of the claimed “silver phosphate glass oxide”, as taught by Martens to be a known functionally equivalent alternative medium suitable for imparting antimicrobial properties to the medical device, and further to supply the “silver phosphate glass oxide” of the now modified Levius at the claimed valuations, as taught by Reisdorf to be known concentrations suitable for imparting antimicrobial properties to the medical device.
As to Claim 20, Levius discloses the antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprises “silver compounds” and a hydrophobic polymer (“Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) to impart a medical device (10) with the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
Yet, Levius does not expressly disclose the explicit composition of the antimicrobial additive to be “silver phosphate glass oxide”, nor the percentage by weight of the “silver phosphate glass oxide” to be “3.5 to 10%”.
Regarding the use of “silver phosphate glass oxide”, Martens teaches a method (defined by the process of extrusions as shown in Figure 3, utilizing "extruder 300" Para 0066), comprising forming an antimicrobial and polymer blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046) including a quantity of an antimicrobial additive ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037) with a quantity of polymer ("polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), and forming a medical device (100, best seen Figures 2 and 4, where Figure 2 shows the entire medical device, and Figure 4 shows a cross section, "In FIG. 2 is shown a medical device 100 according to a first embodiment of the invention. Medical device 100 may be a catheter, a stent, a feeding tube, an intravenous tube, an ET tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, or a prosthetic, in various embodiments." Para 0052, also see: "Medical device 100 may have a conduit 102 for a fluid and an inflatable cuff 104 disposed at a first end 114 of conduit 102. As shown in section 4-4 shown in FIG. 4, a wall 412 of conduit 102 is made of a hydrophobic polymer with an outer layer 406 composed of a hydrophilic polymer and an antimicrobial compound disposed on an outer surface 408 of wall 412. An inner layer 404 composed of a hydrophilic polymer and an antimicrobial compound may further be disposed on an inner surface 410 of wall 412. Outer surface 408 may also be an outer surface of cuff 104." Paras 0053 and 0054; "A head 310 collects the material streams from the individual satellite extruders, combines them with the flow of material for wall 412 and extrudes them into a medical device 100." Para 0066, wherein "FIG. 3 may include a main extruder 302 to extrude hydrophobic polymer for the wall 412, a satellite extruder 304 for the AM material, and a satellite extruder 306 for a radio-opaque material." Para 0066), with the antimicrobial blend (defined by the co-extrusion which "combines" "a silver bearing phosphorus-based glass material" with "polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane" Para 0046), wherein a surface (404/406, "In one embodiment, a wall 412 and either an inner or outer antimicrobial compound layers 404 and 406 may be forced into a mold cavity to form the medical device. In another embodiment, a wall 412 made of hydrophobic polymer is placed in a mold and the hydrophilic polymer and the antimicrobial compound layers 404 and 406 are molded around it." Para 0065) of the medical device (100) exhibits antimicrobial properties ("The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Regarding the remaining limitations of the claims, Martens teaches the functional equivalence of “silver”, “silver oxide (AgO)”, and “a silver bearing phosphorus-based glass material” for imparting antimicrobial properties ("The AM layer may be comprised of, e.g. polyurethane, such as a medical grade hydrophilic thermoplastic polyurethane into which has been substantially dispersed a silver bearing phosphorus-based glass material." Para 0046; "The hydrophilic layer may therefore further contain a metal such as copper, silver, or gold in a metal bearing material. In several exemplary embodiments, the metal may be elemental silver, powdered silver, silver ions (Ag.sup.+), or a silver bearing material like silver oxide (AgO). The hydrophilic layer may thus be an antimicrobial (AM) layer. In this way the colonization-inhibiting properties of the hydrophilic surface can be reinforced by anti-microbial properties." Para 0037).
Thus, the application of “silver phosphate glass oxide” is a known functionally equivalent alternative medium suitable for imparting antimicrobial properties to the medical device.
Regarding the percentage by weight, Reisdorf teaches a medical device (“Antimicrobial Tympanostomy Tube” Title) constructed of an antimicrobial and hydrophobic blend (“silver oxide” “mixing”/ “blended” “silicone paste”, “An antimicrobial tympanostomy tubing having a sidewall thickness of 0.2 millimeters (mm) and an inner diameter of 0.9-1.25 mm containing varying concentrations of silver as silver oxide (Ag.sub.2 O) dispersed throughout the tube sidewalls was prepared by mixing purified silver oxide with paste silicone available from the Dow Chemical Company under the designation Dow Silicone MDX4-4515 Paste Silicone. Other equivalent silicone gum resins from various suppliers can also be used. The silicone paste and a purified silver oxide powder having a 5-50 micron diameter particle size were blended together and milled thoroughly to insure full and complete dispersion of the silver oxide throughout the silicone. The silver oxide concentrations were about 5, 9 and 13% by weight. The milled product was transfer molded into a common tympanostomy tube shape and post cured at 120.degree. C. for 1.5 hours. The cured product was then tumble deflashed, washed with deionized water, Liquinox (Alconox, Inc.) and alcohol. The washed product was then sterilized with ethylene oxide in a 12/88 cycle at 60.degree. C. for 61/2 h hour exposure before testing.” Column 4, Lines 25-50).
Regarding the remaining limitations of the claims, Reisdorf teaches the explicit percentage by weight of the medical device to be “silver oxide concentrations were about 5, 9 and 13% by weight”. Whereby the concentrations of “about 5, 9” meet the limitations of the claimed “in the range of 3.5 to 10%”.
Thus, the use of “silver oxide” within the recited percentage by weight is a known concentrations suitable for imparting antimicrobial properties to the medical device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the silver oxide of the Levius to be in the form of the claimed “silver phosphate glass oxide”, as taught by Martens to be a known functionally equivalent alternative medium suitable for imparting antimicrobial properties to the medical device, and further to supply the “silver phosphate glass oxide” of the now modified Levius at the claimed valuations, as taught by Reisdorf to be known concentrations suitable for imparting antimicrobial properties to the medical device.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot.
Upon reconsideration of Applicant’s arguments, a updated search was preformed and prior art Levius (5,887,593) was located which appears to disclose the claimed construction of a medical device (10) with an antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone” - “It is also contemplated that a surface layer 34 can be deposited over foam layer 32. Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15” Column 4, Line 60 thru Column 5, Line 15; wherein 32 - “Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70) comprising a mixture of a hydrophobic polymer (“silicone”, “Foam layer 32 should also remain sufficiently soft and flexible to provide patient comfort, as well as exhibiting good biocompatibility characteristics. Suitable foam materials include silicone, polyurethane, polyvinyl acetal polymer (PVA), and polyvinyl formyl sponge.” Column 4, Lines 50-70); and an antimicrobial additive (“Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15) comprising “silver compounds” -- The scope of “silver compounds” includes at least the claimed “silver” and “silver oxide”; wherein an exposed surface (34 as exposed to the ambient – ex situ, and the body of the patient – in situ, wherein “silver compounds” “mixed with or impregnated into” “silicone”, “It is also contemplated that a surface layer 34 can be deposited over foam layer 32. Surface layer 32 [sic: 34] can comprise an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. … Furthermore, rather then being deposited on foam layer 32, the above surface layer materials can mixed with or impregnated into foam layer 32.” Column 4, Line 60 thru Column 5, Line 15” Column 4, Line 60 thru Column 5, Line 15) of the antimicrobial structure (22) exhibits antimicrobial and hydrophobic properties (“silver compounds” “mixed with or impregnated into” “silicone”) of the antimicrobial and hydrophobic blend (“silver compounds” “mixed with or impregnated into” “silicone”).
As Applicant has relied upon the Markush grouping of “hydrophobic polymer comprising polyethylene, polypropylene, and silicone”, the disclosure of Levius utilizing “silicone” meets the requirements of the claimed “hydrophobic polymer”.
In the interest of advancing prosecution, Applicant is cautioned the deletion of “silicone” from the Markush grouping of “hydrophobic polymer comprising polyethylene, polypropylene, and silicone” WILL NOT yield allowable subject matter as an additional reference Crossley (4,054,139) – not applied in this instant office action – clearly states an additional medical device (“Oligodynamic Catheter” Title) constructed with an antimicrobial and hydrophobic blend (“Among the silver-bearing materials useful in the process of the invention are metallic silver, organic compounds like silver citrate and silver lactate, inorganic compounds like silver oxide and silver nitrate. … These may be mixed into polymeric matrix quite easily because only relatively small loadings, e.g. 10% by weight or less are usually required. Indeed, the quantity of silver on the oligodynamic surfaces of the catheter may be as low as 1% or less of the total area if it is reasonably well distributed thereover. It is believed the lower limit of oligodynamic material will usually be dictated by the manipulative steps by which the catheter is manufactured, that is by a need for reliability in manufacturing a product with an economically suitable amount of active material on the surface thereof, rather than by the absolute minimal amount of oligodynamic metal required on the surface of the device effective oligodynamic activity. A particularly advantageous mode of making a catheter according to the invention is to form a body of the catheter from a silverfree material and form a thin sleeve or coating on the surface thereof with the silver-bearing material. The coating may be formed with, for example, proteinaceous matrix or a matrix formed of such organic plastics as polyethylene, polyvinyl-chloride, and polytetrafluoroethylene.” Column 2, Line 65 thru Column 3, Line 40).
Consequently, in light of the aforementioned reasoning, the rejection of the claims has been maintained and made FINAL.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Seder et al. (7,520,897) discloses an additional medical device (“voice prosthesis” Abstract) formed by an antimicrobial and hydrophobic blend (“silver oxide … dispersed in medical grade silicone elastomer” Abstract; also see: “The silver oxide, silver, copper, copper oxide, metallic copper, and gentian violet materials were mixed with silicone elastomer, in the concentrations listed.” Column 10, Lines 55-70).
Crossley (4,054,139) discloses an additional medical device (“Oligodynamic Catheter” Title) constructed with an antimicrobial and hydrophobic blend (“Among the silver-bearing materials useful in the process of the invention are metallic silver, organic compounds like silver citrate and silver lactate, inorganic compounds like silver oxide and silver nitrate. … These may be mixed into polymeric matrix … proteinaceous matrix or a matrix formed of such organic plastics as polyethylene, polyvinyl-chloride, and polytetrafluoroethylene.” Column 2, Line 65 thru Column 3, Line 40).
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 ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785