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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Response to Arguments
Applicant’s amendment filed 03/13/2026 is accepted and entered.
Applicant’s arguments with respect to claim(s) 1 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The combination of Yin/Hossainy is now cited to disclose the claimed limitations as set forth below.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 9, 13, 14, 17, 18, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al (US 2018/0021481) in view of Hossainy (US 2013/0261722).
Regarding Claims 1, 9, 17, and 22, Yin discloses a urinary catheter product (¶ [0018]) for insertion into a urethra (¶ [0018]), the urinary catheter product comprising:
a package (20, Fig. 1) containing:
a catheter (10/100, Figs. 1, 3a) comprising a catheter shaft (104, Fig. 3a) having a hydrophilic outer surface (154, Fig. 3a-3b; ¶ [0062-0063] indicates the hygroscopic coating 156 is optional) that becomes lubricious when hydrated (¶ [0018] indicates the hydrophilic coating can obtain moisture from a moisture source such as a lubricant);
a hydration medium hydrating the hydrophilic outer surface (154, Fig. 3a-3b), the hydration medium being a liquid (¶ [0018] indicates the hydrophilic coating can obtain moisture from a moisture source such as a lubricant which can be interpreted as a liquid); wherein the hydration medium is loose within the package (¶ [0018]);
Yin is silent whether the hydration medium has a mobility and/or swarming impeding additive incorporated therein, where the mobility and/or swarming impeding additive comprises a positively charged polysaccharide; and wherein the positively charged polysaccharide forms a hydrogel located on the hydrophilic outer surface of the catheter and the catheter deposits the hydrogel along the urethra as the catheter is inserted into and withdrawn from the urethra, and the hydrogel impedes motility and/or swarming of bacteria by electrostatically entrapping the bacteria.
Hossainy teaches a medical catheter, thus being in the same field of endeavor, and a lubricant for use with the medical catheter (¶ [0083]) where the lubricating liquid comprises a positively charged polysaccharide such as chitosan (¶ [0087]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the generic lubricating liquid of Yin for the specific positively charged polysaccharide, chitosan, containing lubricating liquid of Hossainy, to provide a catheter system with a lubricating liquid to improve the insertion of the catheter. Since Hossainy indicates that chitosan based lubricants are known in the art, one of ordinary skill in the art would have found it obvious to utilize the chitosan based lubricant with the catheter of Yin. The combination of Yin/Hossainy would have a mobility and/or swarming impeding additive incorporated into the hydration medium, wherein the mobility and/or swarming impeding additive comprises a positively charged polysaccharide, and wherein the positively charged polysaccharide forms a hydrogel located on the hydrophilic outer surface of the catheter and the catheter deposits the hydrogel along the urethra as the catheter is inserted into and withdrawn from the urethra, and the hydrogel impedes motility and/or swarming of bacteria by electrostatically entrapping the bacteria (Yin ¶ [0018] indicates the hydrophilic coating obtains liquid from the lubricant, therefore forming a hydrogel which can be transferred from the catheter to the urethra during insertion and withdrawal; the chitosan lubricant of Hossainy, by having a positive charge, is capable of impeding the mobility and swarming abilities of bacteria by electrostatically entrapping the bacteria).
Regarding Claims 2 and 18, Yin further discloses the hydrophilic outer surface (154, Fig. 3a, b) of the catheter shaft comprises a hydrophilic coating (154, ¶ [0062-0063]).
Regarding Claims 13, 14, 23, and 24, the combination of Yin/Hossainy further discloses the positively charged polysaccharide also forms a physical barrier to bacteria movement and/or swarming, wherein the polysaccharide also physically entraps bacteria (Yin ¶ [0018], Hossainy ¶ [0087]; the increased thickness of the coating after gelling/obtaining moisture from the lubricant will slow down bacterial movement and physically entrap at least some bacteria).
Claim(s) 3 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al (US 2018/0021481) in view of Hossainy (US 2013/0261722) further in view of Thomsen et al (US 2018/0228942).
Regarding Claims 3 and 19, Yin/Hossainy is silent whether the positively charged polysaccharide is also contained in the hydrophilic outer surface.
Thomsen teaches a catheter, thus being in the same field of endeavor, with a hydrophilic outer coating that comprises a biopolymer such as chitosan (¶ [0119]). This reduces the friction against the patient’s body cavity (¶ [0119]).
Therefore, it would have been obvious to substitute the generic hydrophilic coating of Yin/Hossainy for the hydrophilic chitosan coating of Thomsen, as Thomsen indicates that chitosan is a suitable outer coating for medical devices such as catheters (as motivated by Thomsen ¶ [0119]).
Claim(s) 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al (US 2018/0021481) in view of Hossainy (US 2013/0261722) further in view of Gerasimenko et al (Antibacterial effects of water-soluble low-molecular-weight chitosans on different microorganisms, Applied Biochemistry and Microbiology, 2004).
Regarding Claims 7 and 20, Yin/Hossainy is silent whether the positively charged polysaccharide comprises a molecular weight between about 10k MW and about 100k MW.
Gerasimenko teaches the antimicrobial effect of low-molecular-weight chitosans, including chitosans with molecular weights of 10, 12, and 15.7 kDa (Materials and Methods, paragraph 1). These low-molecular-weight chitosans were found to effectively suppress bacterial growth (Results and Discussion, paragraph 3) while still being highly water soluble at neutral pH values (Introduction, paragraph 3).
Therefore, it would have been obvious to substitute the generic chitosan used in the hydration fluid of Yin/Hossainy for the low-molecular-weight chitosan of 10, 12, or 15.7 kDa of Gerasimenko. These low-molecular-weight chitosans were found to effectively suppress bacterial growth (Results and Discussion, paragraph 3) while still being highly water soluble at neutral pH values (Introduction, paragraph 3), and as such would be desirable to utilize in a catheter system.
Claim(s) 8 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al (US 2018/0021481) in view of Hossainy (US 2013/0261722) as evidenced by Yabushita et al (US 5360415).
Regarding Claims 8 and 21, Yin/Hossainy is silent whether the positively charged polysaccharide has an 80% or greater degree of deacetylation.
Yabushita indicates that chitosan is a deacetylation product of chitin, and that chitosan has a deacetylation degree of 80% or more (Col. 2 lines 25-33).
Since chitosan has a deacetylation degree of 80% or more, the combination of Yin/Hossainy will also have a polysaccharide with an 80% or greater degree of deacetylation.
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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