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 .
This office action is in response to applicant’s communication of 3/27/2024. Currently claims 1-22 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/05/2025 is being considered by the examiner.
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)(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) 1-6, 8-12, 14-17, 19, 21-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zinreich et al. (US 5,628,733).
Zinreich discloses a catheter clearing system (as in figures 1-10), comprising: a catheter (2) having a catheter tube defining a catheter lumen(8); and a lumen clearing system comprising: a shaft (11) extending longitudinally through the catheter lumen; a handle (12) disposed at a proximal end of the shaft; and a head (10) disposed at a distal end of the shaft, an outer surface of the head configured engage an inner surface of the catheter lumen as the head is urged proximally through the catheter lumen to clear a deposit (see figures 1-3 for examples).
Concerning claim 2 and the catheter is one of an intermittent catheter, Foley catheter, balloon catheter, indwelling catheter, peritoneal catheter, or pleural drainage catheter (examiner is of the position that this is an indwelling/peritoneal/drainage type catheter).
Concerning clam 3 and the catheter is configured to drain urine from a bladder of a patient (examiner is of the position that this drainage tube would be capable and configured to drain any fluid and urine from a bladder).
Concerning claim 4 and the catheter further includes a funnel disposed at a proximal end of the catheter tube in fluid communication with the catheter lumen (see near 3).
Concerning claim 5 and the catheter further includes one or more eyelets disposed in a side wall of the catheter tube and provides fluid communication with the catheter lumen (see 7 eyelets).
Concerning claim 6 and a coupling configured to secure one or both of the handle and a proximal portion of the shaft to an outer surface of the catheter, adjacent a proximal end (see coupling 6, 15 or 27).
Concerning claim 8 and the coupling includes a clip molded into an outer surface of the catheter and configured to releasably secure the proximal portion of the shaft using an interference-fit engagement or a snap-fit engagement (see cap 27).
Concerning claim 9 and a grip slidably engaged with an outer surface of the catheter tube (see grips 21-22).
Concerning claim 10 and a proximal surface of the head defines a toroidally-shaped concave surface extending about a central longitudinal axis of the head to define an acute angle to a radial outer edge of the head (see shape of 10).
Concerning claim 11 and a retaining ring (multiple 5/25/24) disposed on an inner surface of the catheter lumen and extending annularly, the retaining ring configured to abut against a portion of the head to releasably secure the head at a distal end of the catheter lumen.
Concerning claim 12 and the head further includes one or more skives (35) extending longitudinally along an outer surface of the head.
Concerning claim 14 Zinreich discloses method of clearing a lumen of a catheter (2), comprising: grasping a handle (12) of a lumen clearing system, the handle coupled to a proximal end of a shaft, the shaft including a head (10) disposed at a distal end; urging the handle proximally to urge the head proximally (figure 2 for example), an outer surface of the head (10) engaging an inner surface of the catheter lumen (2) and removing a deposit therefrom; and urging the head to a proximal end of the catheter lumen to remove the deposit and restore patency to the catheter lumen (figure 3).
Concerning claim 15 and the catheter includes a catheter tube (2) defining the catheter lumen and a funnel (3) disposed at a proximal end of the catheter tube in fluid communication with the catheter lumen.
Concerning claim 16 and draining a fluid through an eyelet disposed in a side wall of the catheter tube to enter the catheter lumen (see eyelet 7s).
Concerning claim 17 and the catheter is a one of an intermittent catheters, Foley catheter, balloon catheter, indwelling catheter, peritoneal catheter, or pleural drainage catheter (examiner is of the position that this is an indwelling/peritoneal/drainage type catheter).
Concerning claim 19 and detaching one or both of the handle and a proximal portion of the shaft from a coupling, prior to urging the handle proximally, the coupling releasably securing the one or both of the handle and the proximal portion of the shaft to an outer surface of the catheter (see coupling 6, 15 or 27).
Concerning claim 21 and a proximal surface of the head defines a toroidally-shaped concave surface extending about a central longitudinal axis of the head to define an acute angle to a radial outer edge (see shape of 10).
Concerning claim 22 and urging the head proximally further includes disengaging the head from a retaining ring (multiple 5/25/24) disposed at a distal end of the catheter lumen, the retaining ring abutting against the head to releasably retain the head at a distal end of the catheter lumen.
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.
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) 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinreich et al. (US 5,628,733).
Concerning claim 7 and the coupling includes an adhesive tape having a tear line and configured to adhere the proximal portion of the shaft to the outer surface of the catheter and concerning claim 20 and the coupling is an adhesive tape and detaching one or both of the handle and a proximal portion of the shaft from the coupling further includes breaching a tear line extending through the adhesive tape; Examiner is of the position that it is well known to a PHOSITA and medical personnel that adhesive tape can secure device parts that one wants to temporarily secure. The device of Zinreich is temporarily secured at its proximal end by interference fit. A PHOSITA would know that an obvious modification to temporarily secure one piece is an adhesive tape. Examiner is of the position that a PHOSITA would know an obvious modification to include adhesive tape to the couplings to provide a more secure temporary means for securing the device.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinreich et al. (US 5,628,733).
Concerning claim 13 and a loading jig configured to urge the head and a distal portion of the shaft distally through the catheter lumen and position the head at a distal most point of the catheter lumen. It is examiner position that a PHOSITA would know that in order to construct and form the catheter as shown in Zinreich a device to load the head 10 would be needed and this device would be the jig as claimed. A PHOSITA would know of ramrods, rods, straight loaders in order to load the distal end of a catheter with a device. This would be a loading jig teaching as claimed.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinreich et al. (US 5,628,733). Zinreich discloses the claimed invention except for explicitly stating that the drainage method if for urine from a bladder. It would have been obvious to one having ordinary skill in the art at the time the invention was made to drain urine from a bladder since it was known in the art that catheters are used to drain bladders and a drainage catheters like Zinreich could be used for this well known procedure in order to make sure a urine drainage catheter does not have clogs to prevent backflow and complications.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, 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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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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