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 Objections
Claim 7 is objected to because of the following informalities: the preamble should be amended to recite how the catheter guard is being used (e.g., a method of using, deploying, applying…etc.). Claims 2 and 8 are objected to as they should set forth how the antibacterial saturation is configured (e.g., as an applied solution, coating, or otherwise). Appropriate correction is required.
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, 9, 13, and 15-17 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 a multi-directional catheter guard (800), comprising: attaching 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 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 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).
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 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, 10-12, and 18-20 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).
Regarding claim 1, Schaeffer et al. (henceforth Schaeffer) discloses (Figures 1 and 9-10; and also as set forth above for claims 7 and 13) 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.
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).
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.
Claim(s) 2, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer in view of Cano, and further in view of Bulmer et al. (US 2022/0296857).
Regarding claims 2, 8, and 14, Schaeffer/Cano teach the claimed device substantially as set forth above for claims 1, 7, 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 to comprise the antibacterial properties of the device of Ebnet so as to provide a means of reducing the risk of catheter line infection during treatment as taught by Bulmer (¶ [0075]).
Conclusion
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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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783