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 .
Election/Restrictions
Applicant’s election of Species 2 and A in the reply filed on 03/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
(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 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Nordholm et al. US 2009/0101531, hereafter Nordholm.
Regarding claim 1, Nordholm discloses a urinary catheter product for insertion into a urethra (para. 0018), wherein the urethra contains urethral mucus having a viscosity (the examiner notes that a urethra would have a mucus), the catheter product comprising: a catheter shaft (132 in figure 1); and a compound for retaining and/or increasing the viscosity of the urethral mucus (para. 0053) The examiner notes that per paragraph 0052 the shaft is coated with a hydrophilic material, where paragraph 0053 discloses that the hydrophilic coating of the catheter is wetted by a wetting fluid. Further per paragraph 0053, the wetting fluid is a water based liquid, where said fluid may be provided with antimicrobial compounds in the fluid (or alternatively on the coating). The examiner notes that materials for the compound include but are not limited to the materials that make up the coating (see para. 0052), where one such material is polyvinyl alcohol. The examiner notes that as polyvinyl alcohol is disclosed to be a hydrophilic material, the compound would increase the viscosity of the mucus due to its hydrophilic properties (thus absorbing moisture). Should applicant argue that the PVA is not specifically disclosed to absorb moisture, the examiner notes per MPEP Section 2114, [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Nordholm discloses a catheter comprising a shaft, and a compound, where the examiner notes that said compound is a hydrophilic material, and the retaining/increasing of viscosity is functional language, it is interpreted that the device of Nordholm would increase the viscosity of the mucus as an absorption of moisture into the hydrophilic material would be removing moisture from the mucus thus increasing the viscosity.
The examiner provides a secondary 102 rejection of claims 1,3,5-6 in view of Farrell.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Farrell et al. US 2019/0290806, hereafter Farrell as evidenced by Fenti Fatmawati, et. al. “Xylitol Properties and Identification.” IOSR Journal of Applied Chemistry (IOSR-JAC), 14(12), (2021): pp 26-31, hereafter IOSR-JAC.
Regarding claim 1, Farrell discloses a urinary catheter product for insertion into a urethra (para. 0024-0025), wherein the urethra contains urethral mucus having a viscosity (the examiner notes that a urethra would have a mucus), the catheter product comprising: a catheter shaft (0025); and a compound for retaining and/or increasing the viscosity of the urethral mucus (para. 0013-0014,0027,0028,0067) The examiner notes that per paragraph 0027 the shaft is coated with a hydrophilic material, where paragraph 0017 discloses that the hydrophilic coating of the catheter is wetted by a wetting fluid. Further per paragraph 0017,0134 and 135, the wetting fluid provides an antimicrobial effect due to it containing at least an alcohol (C12 to C22 alcohol, alternatively sugar alcohols such as xylitol per para. 0067). The examiner notes that xylitol has high hygroscopic properties (thus is highly moisture absorbent, see evidentiary reference from IOSR-JAC page 1 and 2), and as a result of applying the wetting fluid with xylitol the compound would increase the viscosity of the mucus due to its hygroscopic properties (thus absorbing moisture). Should applicant argue that the wetting fluid is not specifically disclosed to absorb moisture from the mucus, the examiner notes per MPEP Section 2114, [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Farrell discloses a catheter comprising a shaft, and a compound, where the examiner notes that said compound is a hygroscopic compound, and the retaining/increasing of viscosity is functional language, it is interpreted that the device of Farrell would increase the viscosity of the mucus as an absorption of moisture into the hygroscopic material would be removing moisture from the mucus thus increasing the viscosity.
Regarding claim 3, Farrell discloses the urinary catheter product of claim 1 further including a hydrophilic coating on the catheter shaft and a hydration medium for hydrating the hydrophilic coating. The examiner notes that as detailed under the rejection of claim 1, Farrell teaches a hydrophilic coating on the shaft and a wetting fluid (interpreted as a hydration medium), wherein the compound (xylitol) is contained in the hydration medium (para. 0067).
Regarding claim 5, Farrell discloses the urinary catheter product of claim 1 wherein the compound comprises a desiccant that removes moisture from the urethral mucus. The examiner notes that as detailed under the rejection of claim 1, xylitol is a hygroscopic material and would remove moisture from the mucus as a result and is thus interpreted as a desiccant, as said moisture removal is “drying” the mucus.
Regarding claim 6, Farrell discloses the urinary catheter product of claim 5, wherein the desiccant comprises one or more of alcohol, volatile solvents, antihistamines, and loperamide hydrochloride. The examiner notes that xylitol is an alcohol and thus Farrell reads to the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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