Patent Application 17761799 - REUSABLE URINARY CATHETER PRODUCTS

Title: REUSABLE URINARY CATHETER PRODUCTS

Application Information

Invention Title: REUSABLE URINARY CATHETER PRODUCTS
Application Number: 17761799
Submission Date: 2025-04-10T00:00:00.000Z
Effective Filing Date: 2022-03-18T00:00:00.000Z
Filing Date: 2022-03-18T00:00:00.000Z
National Class: 604
National Sub-Class: 096010
Examiner Employee Number: 95446
Art Unit: 3781
Tech Center: 3700

Rejection Summary

102 Rejections: 1
103 Rejections: 6

Cited Patents

No patents were cited in this rejection.

Office Action Text

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 .

Status of the Claims
Claims 1-20 are pending in the application and are currently rejected.
Claim Objections
Claims 2-18 are objected to because of the following informalities:
Claim 2 line 1 “the catheter” which should read “the intermittent catheter”
Claims 2-18 line 1 recite “the product” which should read “the reusable urinary catheter product”
Claim 3 line 2 recites “photoactive titanium dioxide” which should read “the photoactive titanium dioxide”
Claim 4 line 3 “photoactive titanium dioxide” which should read “the photoactive titanium dioxide”
Claim 5 line 3 “surface of substrate” which should read “surface of the substrate”
Claim 13 line 2 recites “further an automatic” which should read “further comprising an automatic”
Appropriate correction is required.
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.

Claim 12 is 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.
Claim 12 recites “UV light, near UV-light” which renders the claim indefinite. For instance the term “near” is a relative term that lacks sufficient clarity to define the scope of “UV-light” intended by the claim. For instance, it is not clear if the limitation refers a standard range such as 300-400 nm (commonly associated with UV-A light), extends to wavelength below 300 nm (e.g., UV-B), or includes wavelengths slightly above 400 nm into the visible spectrum.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.

Claims 1, 2, 5, 11, 12, 14 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SEKIGUCHI, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS).
Regarding Claim 1, Sekiguchi teaches a reusable urinary catheter product, comprising:
an intermittent catheter comprising a catheter shaft (pg 426-pg 427 and figure 1, conventional silicone catheter coated with TiO2), wherein the catheter shaft comprises polymer and photoactive titanium dioxide (pg 426 col 1, Silicone catheter coated with TiO2 is activated by light energy, silicone is considered polymer).
Regarding Claim 2, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi further teaches wherein the catheter further includes a drainage member comprised of polymer and photoactive titanium dioxide (pg 426 col 2, silicone catheter tube member coated with titanium dioxide photocatalyst)
Regarding Claim 5, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi further teaches wherein the polymer defines a substrate (pg 426 col 2, silicone forming tube member is a polymer that defines a substrate) and a coating comprising the photoactive titanium dioxide is disposed on a surface of substrate (pg 426 col 1, catheter tube coated with TiO2 film on outer surface of the catheter tube).
Regarding Claim 11, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi further teaches including a light source that produces light that activates the photoactive titanium dioxide (pg 427, figure 1, the product provided with portable box equipped with black light (352 nm wavelength), and pg 426, low-intensity ultraviolet emitted by the light source activate TiO2 ).
Regarding Claim 12, Sekiguchi teaches the reusable urinary catheter product according to claim 11.
Sekiguchi further teaches wherein the light source produces UV-light, visible light and/or mixtures thereof (pg 426, low-intensity ultraviolet emitted by the light source).
Regarding Claim 14, Sekiguchi teaches the reusable urinary catheter product according to claim 11.
Sekiguchi further teaches including a storage and disinfectant case containing the light source and the intermittent urinary catheter (pg 427, figure 1, the catheter is stored in portable box equipped with black light that disinfect the catheter).
Regarding Claim 19, Sekiguchi teaches a method of disinfecting a reusable catheter comprising photoactive titanium dioxide, comprising: exposing the catheter to light to active the photoactive titanium dioxide. (pg 427 figure 1, exposing titanium dioxide coated catheter under sterilizer equipped with black light).

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.

Claims 3, 4, 6, 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over SEKIGUCHI, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS) in view of Singh et al (“Polymer-Supported Titanium Dioxide Photocatalysts for Environmental Remediation: A Review.” Applied catalysis. A, General 462–463 (2013): 178–195. Web).
Regarding Claim 3, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi does not teach wherein the polymer is compounded with the photoactive titanium dioxide.
However, in the same field of endeavor, namely in a field of self-sterilization application, Singh teaches providing polymer compounded with photoactive titanium dioxide (abstract “This review covers over a hundred published papers in the field of polymer-based photocatalysts and presents a comprehensive study on the preparation, photocatalytic activity and reuse of TiO2/polymer photocatalysts. Polymer-supported buoyant TiO2 photocatalysts and biodegradable polymer-supported TiO2 photocatalysts are also discussed”, at least Singh teaches mixture of TiO2 and polymer, where such a mixture is also considered as a compound according to the applicant’s specification [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Singh and provide the polymer is compounded with the photoactive titanium dioxide, and one of skill in the art motivated to do so, for the purpose of providing a drainage member having several advantages such as flexible nature, low-cost, chemical resistance, mechanical stability, low density, high durability and ease of availability as taught by Singh (abstract).
Regarding Claim 4, Sekiguchi, as modified by Singh, teaches the reusable urinary catheter product according to claim 3.
The combination further teaches the catheter shaft includes a coextruded tube including an inner polymer layer and an outer polymer layer (Sekiguchi; pg 426 col 1, silicone catheter tube layer with TiO2 film coated on outside of the catheter tube), wherein the outer polymer layer comprises the polymer compounded with photoactive titanium dioxide (Singh; the combination would have outside TiO2 film coating comprises polymer compounded with photoactive titanium dioxide as taught by Singh, at least Singh teaches mixture of TiO2 and polymer, where such a mixture is also considered as a compound according to the applicant’s specification [0021]).).
Regarding Claim 6, Sekiguchi teaches the reusable urinary catheter product according to claim 5.
Sekiguchi does not teach wherein in the coating comprises a lubricious hydrophilic polymer and the photoactive titanium dioxide is contained in the hydrophilic coating.
However, in the same field of endeavor, namely in a field of self-sterilization application, Singh teaches a coating comprises a lubricious hydrophilic polymer and the photoactive titanium dioxide is contained in the hydrophilic coating (Singh; under section 4.4 TiO2/PVA (polyvinyl alcohol photocatalyst “chemically immobilized TiO2 nanoparticles in PVA matrix.”, and “Moreover, PVA matrix due to its swelling ability in water” PVA matrix having hydrophilic characteristics and combined with TiO2 ).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Singh and provide coating comprises a lubricious hydrophilic polymer and the photoactive titanium dioxide is contained in the hydrophilic coating, and one of skill in the art motivated to do so, for the purpose of providing a drainage member having several advantages such as flexible nature, low-cost, chemical resistance, mechanical stability, low density, high durability and ease of availability as taught by Singh (abstract).
Regarding Claim 8, Sekiguchi, as modified by Singh, teaches the reusable urinary catheter product according to claim 6.
The combination further teaches wherein the lubricious hydrophilic polymer comprises a matrix and the photoactive titanium dioxide is contained within the matrix (Singh; under section 4.4, “chemically immobilized TiO2 nanoparticles in PVA matrix.”).
Regarding Claim 20, Sekiguchi teaches method of claim 19.
Sekiguchi does not teach wherein the catheter comprises polymer that is compounded with the photoactive titanium dioxide.
However, in the same field of endeavor, namely in a field of self-sterilization application, Singh teaches providing polymer compounded with photoactive titanium dioxide (abstract “This review covers over a hundred published papers in the field of polymer-based photocatalysts and presents a comprehensive study on the preparation, photocatalytic activity and reuse of TiO2/polymer photocatalysts. Polymer-supported buoyant TiO2 photocatalysts and biodegradable polymer-supported TiO2 photocatalysts are also discussed”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Singh and provide the polymer is compounded with the photoactive titanium dioxide, and one of skill in the art motivated to do so, for the purpose of providing a drainage member having several advantages such as flexible nature, low-cost, chemical resistance, mechanical stability, low density, high durability and ease of availability as taught by Singh (abstract).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sekiguchi, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS) in view of Singh et al (“Polymer-Supported Titanium Dioxide Photocatalysts for Environmental Remediation: A Review.” Applied catalysis. A, General 462–463 (2013): 178–195. Web), and in further view of Weadock (US 20030065345 A1).
Regarding Claim 7, Sekiguchi, as modified by Singh, teaches the reusable urinary catheter product according to claim 6.
The combination does not teach wherein the lubricious hydrophilic polymer is cross-linked.
However, in the same field of endeavor, namely an implantable medical device, Weadock teaches wherein the lubricious hydrophilic polymer is cross-linked ([0190] “physical and/or chemical cross-linking methods may be applied to improve the bond strength between the polymeric coating containing the drugs, agents or compounds and the surface of the medical device”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi, as modified by Singh, to incorporate the teachings of Weadock and provide the cross-linked polymer, and one of skill in the art motivated to do so, for the purpose of improving bond strength between the substrate and the coating as taught by Weadock ([0190]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over SEKIGUCHI, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS)
Regarding Claim 9, Sekiguchi teaches the reusable urinary catheter product according to claim 5
Sekiguchi further teaches wherein the coating is vapor deposition coating (“Vapor deposition coating” is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to show an unobvious difference. In the instant case, despite Sekiguchi does not expressly teach the claimed steps, Sekiguchi teaches the coating applied on inner and outer surface of catheter tube (pg 426 col 1, catheter tube coated with TiO2 film on outside of the catheter tube), and therefore the coating is considered to be processed with the same step above).
In the alternative, in the event that this interpretation is not envisaged by applicant, although Sekiguchi does not expressly teach the coating is a vapor deposition coating, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi and provide the vapor deposition coating, and one of skill in the art motivated to do so, for the purpose of providing efficient manufacturing process and enhanced coating strength.
Regarding Claim 10, Sekiguchi teaches the reusable urinary catheter product according to claim 5
Sekiguchi further teaches wherein the coating is a chemical vapor deposition coating (“chemical vapor deposition coating” is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to show an unobvious difference. In the instant case, despite Sekiguchi does not expressly teach the claimed steps, Sekiguchi teaches the coating applied on inner and outer surface of catheter tube (pg 426 col 1, catheter tube coated with TiO2 film on outside of the catheter tube), and therefore the coating is considered to be processed with the same step above).
In the alternative, in the event that this interpretation is not envisaged by applicant, although Sekiguchi does not expressly teach the coating is a chemical vapor deposition coating, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi and provide the chemical vapor deposition coating, and one of skill in the art motivated to do so, for the purpose of providing efficient manufacturing process and enhanced coating strength.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over SEKIGUCHI, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS) in view of Lucio (US 20190314532 A1)
Regarding Claim 13, Sekiguchi teaches the reusable urinary catheter product according to claim 11
Sekiguchi does not teach further comprising an automatic shut off switch that shuts off the light source after a selected period of time.
However, in the same field of endeavor, namely a system and method for disinfecting conduit, Lucio teaches an automatic shut off switch that shuts off the light source after a selected period of time ([0049] “the controller may be configured to automatically turn off the UV light source after a predefined time period”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Lucio and provides the automatic shut off switch that shuts off the light source after a selected period of time, and one of skill in the art motivated to do so, for the purpose of saving energy.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over SEKIGUCHI, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS) in view of Huber (US 20190351081 A1).
Regarding Claim 15, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi does not teach wherein the photoactive titanium dioxide comprises anatase, rutile, brookite, or mixtures thereof.
However, in the same field of endeavor, namely a cleaning device for cleaning an endoscope, Huber teaches wherein the photoactive titanium dioxide comprises anatase, rutile, brookite, or mixtures thereof ([0048] “titanium dioxide in anatase modification has a higher photoactivity”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Huber and provide the photoactive titanium dioxide comprises anatase, and one of skill in the art motivated to do so, for the purpose of enhanced photoactivity, which facilitates effective disinfection, as taught by Huber ([0048]).
Regarding Claim 16, Sekiguchi, teaches the reusable urinary catheter product according to claim 1.
Sekiguchi does not teach wherein the photoactive titanium dioxide comprises a mixture of anatase in an amount between 90% and 60% and rutile in an amount between 10% and 40%.
However, in the same field of endeavor, namely a cleaning device for cleaning an endoscope, Huber teaches wherein the photoactive titanium dioxide comprises a mixture of anatase and rutile ([0056] “titanium dioxide in anatase modification can be diluted by means of titanium dioxide in rutile modification”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Huber and provide the mixture of anatase and rutile for the purpose of providing adequate photoactivity for disinfection at a lower manufacturing cost, as taught by Huber ([0056]).
The combination does not expressly teach the mixture comprises anatase in an amount between 90% and 60% and rutile in an amount between 10% and 40%
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi, as modified by Huber, such the photoactive titanium dioxide comprises a mixture of anatase in an amount between 90% and 60% and rutile in an amount between 10% and 40%, as such a modification would have been an obvious to try, with a reasonable expectation of success. as a person of ordinary skill has good reason to peruse the known options within his or her technical grasp and if the modification meads to the anticipated success, it is like that product was not of innovation but of ordinary skill and common sense (MPEP 2143.I.E). One of skill in the art motivated to do so for the purpose of providing adequate photoactivity for disinfection at a lower manufacturing cost, as titanium dioxide in anatase is relative expensive compared to titanium dioxide in rutile, while anatase has a higher photoactivity as taught by Huber ([0048] and [0056]). Furthermore, applicant has not shown unexpected result gleaming from the claimed proportion ([0021]), and therefore the claimed device is not patentably distinct from the prior art device.
Regarding Claim 17, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi does not teach wherein the photoactive titanium dioxide comprises a mixture of 80% anatase and 20% rutile.
However, in the same field of endeavor, namely a cleaning device for cleaning an endoscope, Huber teaches wherein the photoactive titanium dioxide comprises a mixture of anatase ([0056] “titanium dioxide in anatase modification can be diluted by means of titanium dioxide in rutile modification”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Huber and provide the mixture of anatase and rutile for the purpose of providing adequate photoactivity for disinfection at a lower manufacturing cost, as taught by Huber ([0056]).
The combination does not expressly teach the mixture comprises 80% anatase and 20% rutile
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi, as modified by Huber, such the photoactive titanium dioxide comprises a mixture of 80% anatase and 20% rutile as such a modification would have been an obvious to try, with a reasonable expectation of success. as a person of ordinary skill has good reason to peruse the known options within his or her technical grasp and if the modification meads to the anticipated success, it is like that product was not of innovation but of ordinary skill and common sense (MPEP 2143.I.E). One of skill in the art motivated to do so for the purpose of providing adequate photoactivity for disinfection at a lower manufacturing cost, as titanium dioxide in anatase is relative expensive compared to titanium dioxide in rutile, while anatase has a higher photoactivity as taught by Huber ([0048] and [0056]). Furthermore, applicant has not shown unexpected result gleaming from the claimed proportion ([0021]), and therefore the claimed device is not patentably distinct from the prior art device.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over SEKIGUCHI, et al., ("Self-sterilizing catheters with titanium dioxide photocatalyst thin films for clean intermittent catheterization: Basis and study of clinical use", International Journal of Urology, Vol. 14, No. 5, pgs. 426-430, (2007). Provided by IDS) in view of Lucchino et al (US 20160235893 A1).
Regarding Claim 18, Sekiguchi teaches the reusable urinary catheter product according to claim 1.
Sekiguchi does not teach catheter shaft further comprises one of more of zinc oxide, silver oxide and silicon dioxide.
However, in the same field of endeavor, namely an antimicrobial catheters, Lucchino teaches catheter shaft further comprises one of more of zinc oxide, silver oxide and silicon dioxide ([0267] antiseptic agent including silver oxide incorporated in the substrate).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sekiguchi to incorporate the teachings of Lucchino and provide the catheter shaft further comprises silver oxide, and one of skill in the art motivated to do so, for the purpose of further enhancing antimicrobial activity in the environment surrounding the catheter, as taught by Lucchino ([0267]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lovmar (US 20190262579 A1), Bak (US 20120321509 A1), Boyden (US 20110275912 A1) and Yokley (US 20090069790 A1) cited for teaching a medical device comprising disinfecting mean which relatively pertinent to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/S.H./Examiner, Art Unit 3781

/THOMAS C BARRETT/MQAS, TC 3700