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 .
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 15 and 16 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.
Claim 15 recites the limitation "the lubricant" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the chlorine dioxide is incorporated into a wetting fluid.” It is unclear if this limitation is referring to the chlorine dioxide incorporated into the hydrophilic coating or if this limitation is referring to an additional amount of chlorine dioxide in only the wetting fluid. For the purpose of compact prosecution, this limitation is interpreted as referring to an additional amount of chlorine dioxide in only the wetting fluid.
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)(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.
Claim(s) 1-5, 7, 9-12, and 17-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pollard et al (US 2026/0131107).
Regarding Claim 1, Pollard discloses a catheter system for draining a fluid (¶ [0001-0004, 0027]), the system comprising:
a catheter having an outer surface (¶ [0014-0021, 0150-156]); and
a lubricant in contact with the outer surface of the catheter, wherein the lubricant includes chlorine dioxide (¶ [0014-0020, 0032-0035]; immediately prior to use, the lubricant will coat the outer surface of the catheter).
Regarding Claim 2, Pollard discloses the chlorine dioxide is coated onto the outer surface of the catheter (¶ [0014-0020, 0032-0035]; immediately prior to use, the lubricant will coat the outer surface of the catheter, and therefore the chlorine dioxide will be coated onto the outer surface of the catheter).
Regarding Claim 3, Pollard discloses the chlorine dioxide is incorporated into a hydrophilic coating on the outer surface of the catheter (¶ [0020, 0033, 0038, 0211]; when the lubricant contacts the catheter, it swells the hydrophilic surface and can be considered incorporated into the hydrophilic surface).
Regarding Claim 4, Pollard discloses the chlorine dioxide is incorporated into a wetting fluid to interact with a hydrophilic coating on the outer surface of the catheter (¶ [0152-0154, 0211]).
Regarding Claim 5, Pollard discloses the wetting fluid comprises water (¶ [0032-0035, 0211]; the wetting fluid can be an aqueous chlorine solution, which therefore includes water).
Regarding Claim 7, Pollard discloses a sheath surrounding the catheter, the sheath containing the lubricant (¶ [0014-0020]; packaging surrounds the catheter, and when the fluid reservoir has been ruptured, the sheath/packaging contains the lubricant).
Regarding Claims 9-11, Pollard discloses the chlorine dioxide is used in a concentration of 0.005% – 2.0% (w/v), 0.01% - 0.8% (w/v), or 0.05% - 0.5% (w/v). (¶ [0106]).
Regarding Claim 12, Pollard discloses the lubricant comprises a gel (¶ [0143-0144]).
Regarding Claim 17, Pollard discloses a catheter system for draining a fluid (¶ [0001-0004, 0027]), the system comprising:
a catheter having an outer surface (¶ [0014-0021, 0150-156]); and
a predetermined amount of chlorine dioxide is incorporated into a lubricant in contact with the outer surface (¶ [0014-0020, 0032-0035]; immediately prior to use, the lubricant will coat the outer surface of the catheter; ¶ [0106] indicates the chlorine dioxide is present in a predetermined amount concentration).
Regarding Claims 18-19, Pollard discloses the chlorine dioxide is used in a concentration of 0.005% – 2.0% (w/v) or 0.05% - 0.5% (w/v). (¶ [0106]).
Regarding Claim 20, Pollard discloses a sheath surrounding the catheter, the sheath containing the lubricant (¶ [0014-0020]; packaging surrounds the catheter, and when the fluid reservoir has been ruptured, the sheath/packaging contains the lubricant).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollard et al (US 2026/0131107).
Regarding Claim 6, Pollard is silent whether the wetting fluid comprises saline. However, Pollard indicates that packaged catheters typically use a water or saline-based lubricant (¶ [0008, 0026]). Since Pollard indicates the lubricant is an aqueous chlorine solution (¶ [0032]), one of ordinary skill in the art would have found it obvious to have the lubricant be a saline-based chlorine solution as both water-based and saline-based lubricants are well known in the art, and both water-based and saline-based chlorine solutions would be considered aqueous chlorine solutions.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollard et al (US 2026/0131107) in view of Farrell et al (US 2022/0387673).
Regarding Claim 8, Pollard is silent regarding a collection bag positioned at one end of the catheter.
Farrell teaches a catheter, thus being in the same field of endeavor, where the distal end of the catheter can be connected to a collection bag (¶ [0080]). This allows the user to collect the drained urine in a bag if needed.
Therefore, it would have been obvious to modify the catheter of Pollard to include a collection bag positioned at one end of the catheter, as taught by Farrell, to allow the user to collect the drained urine in a bag if needed.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollard et al (US 2026/0131107) in view of Ryan et al (US 2017/0281824).
Regarding Claim 13, Pollard discloses a catheter system for draining a fluid (¶ [0001-0004, 0027]), the system comprising:
a catheter having an outer surface (¶ [0014-0021, 0150-156]); and
a hydrophilic coating applied to an outer surface of the catheter (¶ [0151-0153]).
Pollard is silent whether chlorine dioxide is incorporated into the hydrophilic coating.
Ryan teaches an anti-microbial material suitable for use in medical devices, thus being in the same field of endeavor, where the material comprises an antimicrobial agent such as chlorine dioxide (¶ [0007, 0034]). Ryan indicates that the material can be used for medical devices such as catheters (¶ [0003-0004, 0042]) and that the material can be used as a coating for a medical device (¶ [0010]).
Therefore, it would have been obvious to modify the hydrophilic coating of Pollard to include an antimicrobial agent such as chlorine dioxide, as taught by Ryan, to provide an additional level of antimicrobial activity to the catheter and therefore further prevent catheter associated infections.
Regarding Claims 14 and 15, Pollard further discloses a lubricant in contact with the outer surface of the catheter, wherein the lubricant includes chlorine dioxide (¶ [0014-0020, 0032-0035]; immediately prior to use, the lubricant will be in contact with the outer surface of the catheter).
Regarding Claim 16, Pollard further discloses the chlorine dioxide is incorporated into a wetting fluid to interact with a hydrophilic coating on the outer surface of the catheter (¶ [0152-0154, 0211]).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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