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 Claims
As directed by the amendment filed on 28 January 2026: claim(s) 1 has been amended. Claims 1, 3-7, 9 , and 11-19 are pending.
Response to Arguments
Applicant's arguments filed 28 January 2026 have been fully considered but they are not persuasive.
Regarding the argument that "Nishtala discloses lubricants, antiseptics, antimicrobials, hydrophilic coatings, and sterile insertion sleeves, but nowhere teaches any chemical agent designed to attract bacteria or to stimulate their migratory response" & "nothing in Horvers discloses or suggests using polysaccharides as chemotactic stimuli, nor does it contemplate any bacterial behavior, urethral anatomy, or urinary infection-control context" & "Examiner's reliance on Applicant's own specification-rather than on the teachings of the cited prior art-to characterize polysaccharides as chemotactants reflects an improper substitution of applicant knowledge for piror art evidence" on pg. 6 of Remarks, Horvers is relied upon to teach a chemotactant coating on an intraluminal catheter ("the hydrophilic coating is … polysaccharides" [0048]). While Horvers does not specifically teach that polysaccharides attracts bacteria to promote the chemotaxis of bacteria, the instant disclosure lists polysaccharide as an example of a chemotactant that “stimulates the bacteria to move toward the chemotactant” ([0017], [0022], [0024] of Specification). Therefore, Horvers’ polysaccharide embodies the same bacterial chemotaxis property as the claimed invention and is considered a chemotactant. In this case, the “chemotactant” is “interpreted in light of the specification in giving them their ‘broadest reasonable interpretation” (MPEP 2111). The fact that the inventor has recognized another advantage, i.e. chemotaxis property of polysaccharides, which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the argument that "Wang's disclosure of a lubricity gradient relates strictly to modifications of surface friction and coating thickness for improved mechanical navigation of catheters and other devices-not biochemical manipulation of microorganisms" on pg. 6, Wang teaches that it is “possible to alter the concentration of coating, reactant or overcoating material to produce a lubricity gradient” (col. 4 ln. 9-10). Therefore, Wang teaches modification of chemical concentration to achieve the gradient. Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Wang is relied upon to teach the creation of a gradient coating on a catheter. The remaining limitations are suggested by Nishtala/Horvers.
Regarding the argument that " Horvers is non-analogous art" & "Horvers addresses a completely different field-vascular drug-delivery balloons-and solves a different problem" on pg. 7, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Horvers and the instant invention is directed towards an insertable chemically-coated catheter that is delivered into a lumen of the body. Thus, Horvers is in the field of the inventor’s endeavor, which is medical devices.
Regarding the argument that "there is no teaching, suggestion, or motivation in any of the cited references to create or use a chemotactic gradient-a biological gradient of an attractant designed to direct microbial movement" & "the Examiner reconstructs the claimed invention by using Applicant's own disclosure as a roadmap, precisely the type of hindsight reconstruction prohibited by KSR and the MPEP" on pg. 7, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the teaching, suggestion, or motivation are found in the refences themselves and discussed in each rejection discussion in the Non-Final Rejection (08/28/2025). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The applicant's disclosure is relied upon to provide the broadest reasonable interpretation for the limitation “chemotactant” (MPEP 2111). In this case, placing a polysaccharide gradient coating on a catheter is suggested by Nishtala, Wang, and Horvers. The fact that polysaccharide can also act as a chemotactant is another advantage which would flow naturally from following the suggestion of the prior art and cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 3-7, 9, and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala et al. (US 20100198195 A1) in view of Wang et al. (US 5902631 A), and further in view of Horvers (US 20120232640 A1).
Regarding Claims 1 & 15, Nishtala discloses a urinary catheter product (30, 100) for insertion into a urethra (see Abstract) and for draining urine from a bladder (“for transferring urine from the patient's bladder 60 to the urine storage bag” [0070]), the urinary catheter product (30, 100) comprising:
a catheter 10 including a catheter shaft ("catheter shaft"; [0096]; FIG. 1) having a proximal end portion and a distal end portion ("term "distal" is used in reference to the end of catheter 10 near the patient's body. The term "proximal" is used in reference to the end of catheter 10 near the funnel 24"; [0064]; FIG. 1);
a chemotactant 64 disposed on the catheter shaft ("lubricant and/or antiseptic agent 64 can spread across the catheter shaft as it is advanced through the introducer 80"; [0096]); and
wherein the catheter shaft deposits the chemotactant into the urethra ("lubricant and/or antiseptic agent 64 can spread across the catheter shaft as it is advanced through the introducer 80"; [0096]).
Nishtala fails to specify the chemotactant attracts bacteria to promotes chemotaxis of the bacteria. However, Horvers teaches a composition-eluting balloon catheter comprising a polysaccharide coating ("the hydrophilic coating is … polysaccharides" [0048]). While Horvers does not specifically teach that polysaccharides attracts bacteria to promote the chemotaxis of bacteria, the instant disclosure lists polysaccharide as an example of a chemotactant that “stimulates the bacteria to move toward the chemotactant” ([0017], [0022], [0024] of Specification). Therefore, Horvers’ polysaccharide embodies the same bacterial chemotaxis property as the claimed invention and it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Nishtala as taught by Horvers to suitably “increase the lubricity of the cathether during advancement to the site of treatment” ([0076]).
Nishtala/Horvers fails to specify the catheter shaft creates a chemotactic gradient within the urethra. However, However, Wang teaches a catheter product (col. 2 ln. 2-9) adapted for insertion into the body of a patient comprising a gradient coating (col. 2 ln. 10-31) wherein the catheter shaft creates a chemotactic gradient within the urethra (“The essential characterizing feature of the present invention is that portion 22 displays a lubricity gradient … This lubricity gradient may be expressed as a continuously varying lubricity over the length of portion 22 or as one or more steps of differing lubricity over the length of portion 22”; NOTE: since a chemotactic gradient exists on the catheter shaft, there is a chemotactic gradient within the urethra once the catheter shaft has been inserted into the urethra; col. 3 ln. 37 - col. 4 ln. 4). Therefore, it would have been obvious to modify Nishtala/Horvers’ device to incorporate the claimed features to suitably tailor the catheter properties to specific treatment plan (col. 2 ln. 5-10).
Nishtala/Horvers/Wang fails to specify the chemotactic gradient promotes chemotaxis in a direction away from the bladder. However, Nishtala discloses the goal of keeping bacteria away from the bladder by reducing “incidence of UTIs” and creating “a barrier for bacteria moving from outside of the catheter into the bladder” ([0087] & [0091]). Therefore, it would have been obvious to modify Nishtala/Horvers/Wang’s device to incorporate the claimed features to suitably tailor the chemotactic gradient within the urethra that promotes chemotaxis in a direction away from the bladder ([0087] & [0091]).
Regarding Claims 3 & 16, Nishtala discloses the catheter product further includes an introducer tip ("introducer 80/indwelling segment 78"; [0090]; FIG. 12B) and the chemotactant 64 is associated with the introducer tip ([0093]; FIG. 12B).
Regarding Claim 4, Nishtala discloses the chemotactant 64 is coated on a surface of the introducer tip ([0094]; FIG. 12B).
Regarding Claims 5 & 17, Nishtala discloses the introducer tip includes one or more reservoirs ("opening inside the cap 62 and near the introducer 80 can be used to store a lubricant or antiseptic agent 64"; [0093]; FIG. 12A) and the chemotactant 64 is contained within the one or more reservoirs ([0093]; FIG. 12A).
Regarding Claims 6 & 18, Nishtala discloses the introducer tip is configured to deploy the chemotactant from the reservoir onto the catheter as the catheter passes through the introducer tip ("lubricant and/or antiseptic agent 64 can spread across the catheter shaft as it is advanced through the introducer 80"; [0096]).
Regarding Claim 7, Nishtala discloses the introducer tip is configured to deploy the chemotactant from the reservoir into the urethra ([0092]-[0096]).
Regarding Claim 9, Nishtala discloses catheter shaft includes a proximal end portion and a distal end portion (inherent physical feature of any catheter shaft), but fails to specify an amount of chemotactant disposed at the distal end portion of the catheter shaft is larger than the amount of chemotactant disposed at the proximal end portion of the catheter. However, Wang teaches a catheter product (col. 2 ln. 2-9) adapted for insertion into the body of a patient comprising a lubricity gradient (col. 2 ln. 10-31) wherein an amount of chemotactant disposed at the distal end portion of the catheter shaft is larger than the amount of chemotactant disposed at the proximal end portion of the catheter (col. 3 ln. 37 - col. 4 ln. 4, “The essential characterizing feature of the present invention is that portion 22 displays a lubricity gradient … This lubricity gradient may be expressed as a continuously varying lubricity over the length of portion 22 or as one or more steps of differing lubricity over the length of portion 22”). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Nishtala’s device to incorporate the claimed features to suitably tailor the catheter properties to specific treatment plan (col. 2 ln. 5-10).
Regarding Claim 11, Nishtala discloses an antimicrobial associated with a distal end portion of the catheter ([0109]).
Regarding Claims 12 & 19, Nishtala discloses the catheter shaft includes a hydrophilic coating thereon ([0100]-[0102]; FIG. 7), and the chemotactant is loaded into the hydrophilic coating ([0101]).
Regarding Claim 13, Nishtala discloses an antimicrobial associated with a distal end portion of the catheter ([0109]).
Regarding Claim 14, Nishtala discloses the catheter shaft includes a hydrophilic coating thereon ("polymeric coatings 48, 50 may comprise many agents" & "hydrophilic polymers"; [0101-[0102]), and the chemotactant 64 is loaded into the hydrophilic coating ("antimicrobial compositions that comprise polymeric coatings 48 and 50 may include a polymer and a colloid comprised of the salts of one or more oligodynamic agents "; [0101]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. 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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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781