DETAILED ACTION
Response to Amendment
The amendment filed July 2, 2026 has been entered. Claims 1, 2, 7, and 13 have been amended. Claims 1-20 are currently pending in the application.
Response to Arguments
Applicant's arguments filed July 2, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the amendment to claim 7 overcomes the previous rejection, the Examiner respectfully disagrees. The method of claim 7 still does not comprise the step of inserting the guard and tubing into a patient for treatment, but only sets forth a method of applying the guard to a tubing assembly. Schaeffer still reads on the limitations since the guard is applied to the tubing and it still resists lateral movement as set forth in the previous rejection. The grounds of rejection with respect to claim 7 are maintained.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1 and 13 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
Claim Rejections - 35 USC § 102
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.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaeffer et al. (US 9,597,152).
Regarding claim 7, Schaeffer et al. (henceforth Schaeffer) discloses a method of application of a multi-directional catheter guard (800; it’s being applied to the tubing), comprising: attaching, by the multi-directional catheter guard (it’s cylindrical and therefore multi-directional as claimed), to a catheter tubing (e.g., probe 200; Col. 6, lines 51-57 disclose the use of a catheter as the probe) in a direction corresponding to a patient male anatomy or patient female anatomy (the element is cylindrical and is equally capable of being used in a male or female anatomy; it is further noted that the claim does not require actual insertion into a patient anatomy or for the shape to conform to any specific tissue); and resisting, by the multi-directional catheter guard, lateral movement from an attached position on the catheter tubing (the tubing cannot be removed from the device laterally after closure as depicted in Figure 10; Col. 11, lines 30-37).
Regarding claim 9, Schaeffer further discloses locking onto the catheter tubing with a locking groove (e.g., elements 816, 830; Figures 9-10).
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.
Claim(s) 1, 3-6, 10-13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer et al. (US 9,597,152) in view of Cano (US 5,860,190), and further in view of Murray et al. (US 2017/0000978).
Regarding claim 1, Schaeffer et al. (henceforth Schaeffer) discloses (Figures 1 and 9-10; and also as set forth above for claims 7) a multi-directional catheter guard (it’s a cylinder and can be used in either direction), comprising: an expandable enclosure (800, it expands via the hinged attachment 832) configured to expand and close for fitment (Figures 9-10; Col. 11, lines 4-18) encompassing a catheter tubing (e.g., probe 200; Col. 6, lines 51-57 discloses that the probe may be any medical device one wishes to control including suction/irrigation devices or catheters) in a direction corresponding to patient anatomy (it’s cylindrical so either direction may be considered to “correspond” to a patient anatomy). Schaeffer fails to explicitly disclose a friction material configured to resist lateral movement of the multi-directional catheter guard from an attached position on the catheter tubing as well as the first end being tapered concave, and the second end being tapered convex.
Cano teaches (Figure 2) a guard device (10) comprising a friction material (24) for resisting lateral movement of the guard from an engaged or attached position on another element (element 24 increases the frictional contact of the guard with the device located therein and will therefore resist movement in axial and lateral direction; Col. 3, lines 20-30; it is noted that Cano is directed to the frictional connection of two elements, one on an outer surface of the other, and is therefore directed to the same stated problem as that of the device of Schaeffer, wherein the guard comprises means for increasing friction between the guard and the internal element to which it is engaged; for this reason, the guard of Cano is considered analogous in function to that of Schaeffer and is thereby reasonably applicable as prior art).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the enclosure of Schaeffer to comprise the friction material of Cano so as to increase the friction between the enclosure and tubing located therein to more sufficiently engage it to prevent slippage between the two elements during use as taught by Cano (Col. 3, lines 20-30).
As above, Schaeffer fails to contemplate a tapered convex portion and a tapered concave portion.
Murray et al. (henceforth Murray) teaches (Figures 8-9) a catheter handle device (12; it’s used for holding to guide a catheter into the urethra as in Figures 12-13) having a first tapered concave side (see e.g., Figure 8 which has a first side at 62 which is tapered and concave), and a second tapered convex side (see e.g., Figure 9 when cap 64 is installed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter handle of Schaeffer to comprise first and second tapered concave and convex features as taught by Murray since such handles are known for use in urethral catheter insertion in both males and females. Furthermore, the shape of the handle of Schaeffer would be obvious to modify into any end configurations since it would not affect the function of the handle in any manner to make such changes. Murray teaches that such handle shapes are known in the field of catheter insertion, and as such, it would have been obvious to utilize such shapes for the handle of Schaeffer. It is further noted that the claims only require the handle to functionally be capable of being fit in male and female patients.
Regarding claim 3, Schaeffer further discloses a locking groove (e.g., recess 830 which receives protuberance 816 as in Figures 9-10) configured to lock the multi-directional catheter guard onto the catheter tubing (Figure 10).
Regarding claims 4, 10, and 18, Cano further teaches that the friction material comprises a spiraling rigidity support configured to maintain a shape of the multi-directional catheter guard (Col. 3, lines 20-30 disclose elements 24 as spiral grooves; in addition, as they increase the thickness of the guard element they will provide additional structural rigidity as claimed).
Regarding claim 5, 11, and 19, Cano further teaches that the friction material comprises grip bands (24 may be considered “bands” as they extend around the circumference of the interior of the grip) extending about an internal circumference of the multi-directional catheter guard to resist lateral movement (Col. 3, lines 20-30).
Regarding claims 6, 12, and 20, Cano further teaches that the friction material may comprise non-slip dots contacting the catheter tubing to resist lateral movement (Col. 3, lines 20-30 disclose that the features may be dimples rather than bands or grooves). It would have been obvious to one of ordinary skill in the art at the time of filing to use the disclosed dimples of Cano rather than the bands as they are disclosed as performing the desired function of retaining the internal element within the grip in the same manner as the bands and are disclosed as a different accepted embodiment of such a feature.
Regarding claim 13, Schaeffer discloses a multi-directional catheter guard (Figures 9-10; Col. 6, lines 51-57 disclose the probe 200 as a catheter) comprising: a first end for fitment with an anatomically male patient; and a second end configured for the fitment with an anatomically female patient (the device is cylindrical and either end will fit within a patient regardless of their sex; the claim does not require insertion or fitment into sex-specific tissue areas or even any bodily insertion at all).
Regarding claim 15, Schaeffer further discloses an expandable enclosure configured to encompass a catheter tubing (Figures 9-10, the guard is hinged to receive the tubing and therefore expands to achieve such a function).
Regarding claim 16, Schaeffer further discloses a friction material configured to resist sliding on a catheter tubing (the function of the device of Schaeffer is to frictionally engage the tubing; any material forming the guard will provide such a function; Col. 11, lines 19-29 provide various materials for the guard, any of which might provide different levels of frictional engagement as a result of their material properties).
Regarding claim 17, Schaeffer further discloses a locking groove (e.g., 830) configured to lock onto a catheter tubing (channel 828 is configured for receiving the tubing).
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer in view of Cano in view of Murray, and further in view of Bulmer et al. (US 2022/0296857).
Regarding claims 2 and 14, Schaeffer/Cano/Murray teach the claimed device substantially as set forth above for claims 1 and 13, but fail to explicitly teach the use of a saturating antibacterial applied to the guard.
Bulmer et al. (henceforth Bulmer) teaches (Figures 2A-2B) a guard (100 comprising clips 110) for retaining a medical device (150, 160) thereon which is formed or coated with an antibacterial agent (¶ [0075] discloses that the retaining clips 110 are coated with an antibacterial material).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the guard of Schaeffer/Cano/Murray to comprise the antibacterial properties of the device of Bulmer so as to provide a means of reducing the risk of catheter line infection during treatment as taught by Bulmer (¶ [0075]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer in view of Bulmer et al. (US 2022/0296857).
Regarding claim 8, Schaeffer discloses the claimed method substantially as set forth above for claims 7, but fail to explicitly teach the use of a saturating antibacterial applied to the guard.
Bulmer et al. (henceforth Bulmer) teaches (Figures 2A-2B) a guard (100 comprising clips 110) for retaining a medical device (150, 160) thereon which is formed or coated with an antibacterial agent (¶ [0075] discloses that the retaining clips 110 are coated with an antibacterial material).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the guard of Schaeffer to comprise the antibacterial properties of the device of Bulmer so as to provide a means of reducing the risk of catheter line infection during treatment as taught by Bulmer (¶ [0075]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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