DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Non-Final Office action is in response to Appeal Brief Conference Request filed November 13, 2025.
Status of Claims
1. Claims 1-18 are pending and currently under consideration for patentability.
Claims 19-36 are cancelled, as of the May 8, 2025 claim amendment.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted August 29, 2025, December 12, 2025 and March 11, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
3. Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Applicant’s arguments with respect to claim(s) 1-18 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
A new grounds of rejection over previously cited Rome et al. (USPGPUB 2005/0256460) in view of Villari et al. (US 3,707,972) is presented below in rejecting the instant claims.
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.
4. Claim(s) 1-3, 6-9, 11-12, 14-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rome et al. (USPGPUB 2005/0256460) in view of Villari et al. (US 3,707,972).
5. With regard to claims 1 and 6, Rome discloses a connector for coupling a catheter (not shown) to a drainage tube (via luer fitting, not shown; [0021]; [0026]; abstract; Figs. 1A-1G; [0010-0011]; [0023]; [0025]), comprising: a body (valved connector, 10) defining a drainage lumen (through 10) extending along a longitudinal axis from a distal portion (inlet, 17) to a proximal portion (outlet, 18); and a valve (valve assembly, 12, 13) including one or more legs (protrusions, 13-5) and formed of a resilient material (silicone; [0021]; [0035]), the valve (12, 13) slidably engaged (via disk, 13-1) with a proximal end (within 17) of the body (10) along the longitudinal axis between a first position (Fig. 1B, 1D) and a second position (Fig. 1A, 1C), wherein: the valve (12, 13) in the first position provides fluid communication between the distal portion (17) and the proximal portion (18) of the drainage lumen; and the valve (12, 13) in the second position (Fig. 1A, 1C) occludes fluid communication between the proximal portion (18) and the distal portion (17) of the drainage lumen ([0026-0028]).
With further regard to claims 1 and 6, while Rome discloses a valve housing (housing, 11; Fig. 1A), Rome is silent in regard to a positive air pressure inlet; and an inlet housing engaged with a proximal end of a valve housing, the inlet housing including the positive air pressure inlet, a distal end of the valve housing engaged with an outer surface of the proximal end of the body.
However, within the same field of endeavor, Villari discloses an irrigation connector with shut-off valve (abstract; col. 1, lines 43-67; Figs. 1-3), comprising: a body (irrigation connector, 20) defining a drainage lumen (main channel, 28) extending along a longitudinal axis from a distal portion (end, 46 connected to drainage tube, 24) to a proximal portion (end, 32 connected to catheter, 22); the body (20) including a valve (stem, 30) and valve housing (body member, 26); a positive air pressure inlet (side arm channel, 52); and an inlet housing (outwardly projecting side-arm, 50) engaged with a proximal end (at connection between 11 and 92) of the valve housing (26, at 48), the inlet housing (50) including the positive air pressure inlet (52), a distal end of the valve housing (26) engaged with an outer surface of the proximal end of the body (20, at 24/46; Figs. 1, 2; col. 3, line 8 – col. 4, line 60).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connector disclosed by Rome to include a positive air pressure inlet and housing arranged similar to that disclosed by Villari, in order to periodically irrigate the catheter, or force liquid through it in the reverse direction, to alleviate a blocked condition in the catheter due to the accumulation of sediments and clots, or to apply medication to the cavity through the catheter for the purpose of minimizing infection, as suggested by Villari in column 1, lines 17-26.
6. With regard to claim 2, Rome discloses that the valve (12, 13) includes a valve plate (element disk, 13-1; Fig. 1E) defining a proximal face (side of 13-1 facing outlet, 18) and a distal face (side of 13-1 facing inlet, 17), each extending perpendicular to the longitudinal axis (Fig. 1B, 1C, 1D), the distal face (side of 13-1 facing inlet, 17) configured to engage the proximal end (17) of the body (10) in the second position and create a fluid tight seal therebetween (Figs. 1A, 1C; [0027]).
7. With regard to claim 3, Rome discloses that the one or more legs (13-5) extend distally from the distal face (of 13-1) and are configured to slidably engage an inner surface of a valve recess (within inlet, 17 or within 11) disposed in the proximal end of the body (10; [0026-0028]; Fig. 1C, 1D, 1E).
configured to slidably engaged an inner surface of a valve recess (at least within 11) disposed in the proximal end of the body (10; [0026-0028]; Fig. 1C, 1D).
8. With regard to claims 7-9, Rome, as modified by Villari above, results in a connector having a positive air pressure inlet (52 of Villari) with an axis angled at about 450 (as required by claim 7) relative to the longitudinal axis of the connector (Fig. 1-3; col. 4, lines 39-60 of Villari).
However, Rome and Villari fail to explicitly disclose an axis of the positive air pressure inlet being angled at 900 (as required by claim 8) relative to the longitudinal axis
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the angle of entry of the positive air pressure inlet disclosed by Rome in view of Villari to be angled at 900 relative to the longitudinal axis, similar to the positive pressure air inlet disclosed by Villari, in order to periodically irrigate the catheter, or force liquid through it in the reverse direction, to alleviate a blocked condition in the catheter due to the accumulation of sediments and clots, or to apply medication to the cavity through the catheter for the purpose of minimizing infection, as suggested by Villari in column 1, lines 17-26. One having ordinary skill in the art would recognize that a positive pressure inlet angled closer to perpendicular to the longitudinal axis of the connector will provide more direct irrigation at the point of entry for positive pressure, further assisting in minimizing clogging at the valve.
With these teachings in mind, Rome and Villari are silent in regard to an axis of the positive air pressure inlet defining an S-shape (as required by claim 9).
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified an axis of the positive air pressure inlet disclosed by Rome in view of Villari to define an S-shape, since it is well-known in the art that S-shaped tubing provides increased flexibility and helps evenly distributed stresses along the tubing, for easier installation and movement between fixed points while maintaining a secure connection; allowing for slight tubing adjustments without compromising the overall structure or function. Further, applicant has not provided, within the Specification as originally filed, any advantages or reasoning as to why the S-shaped inlet axis should be utilized, as it is merely listed as one of many possible inlet axis arrangements along with linear and non-linear axes.
9. With regard to claims 11-12 and 14-15, Rome discloses that the connector (Figs. 1A-1G) further includes a distal coupling (thread or luer fitting of 17; Fig. 1A; [0026]) disposed at a distal end of the body (10) and configured to releasably engage a proximal end of the catheter (not shown) to provide fluid communication between the catheter and the distal portion of the drainage lumen (within 10; [0021]), wherein the distal coupling (thread or luer of 17) is one of a luer slip fit, threaded, spin-nut, interference fit, press-fit, or snap-fit coupling ([0021]; [0026]); and a proximal coupling (thread or luer fitting of 18; Fig. 1A; [0026]) disposed at a proximal end of the connector (10) and configured to engage a distal end of the drainage tube (not shown), the drainage tube in fluid communication with a collection container (within 10; [0021]), wherein the distal coupling (thread or luer of 18) is one of a luer slip fit, threaded, spin-nut, interference fit, press-fit, or snap-fit coupling ([0021]; [0026]).
10. With regard to claim 17, Rome discloses that the valve assembly (12, 13) is engaged with the body (11) in one of an interference fit, press-fit, or snap-fit ([0009]; [0024]; [0026-0027]; [0038-0039]; “valve may also be designed to be incorporated within a small housing that is compatible with multiple fittings, i.e., luer lock, slip fit, compression, etc.”).
11. With regard to claim 18, Rome discloses an embodiment (Figs. 4A, 4B) wherein the valve housing (portion of connector, 40 housing valve element, 44 and support disk, 43) further includes an abutment (“funnel shaped outlet at the base of the valved connector”; [0035]) extending radially inward from an inner surface (see Figs. 4A, 4B) and configured to abut against the valve (at 43) in the first position to prevent any further proximal movement of the valve (43, 44).
12. Claim(s) 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rome in view of Villari, as applied to claims 1 and 6 above, and further in view of Fillmore et al. (US PGPUB 2002/0000253).
13. With regard to claim 10, Rome and Villari are silent in regard to the valve housing being formed of a transparent material.
However, Fillmore discloses medical flush valve (100) for a fluid drainage system for coupling a catheter to a drainage tube (abstract; Figs. 4-6; [0006]; [0014]), comprising a body (housing, 102) defining a drainage lumen (106) extending in a longitudinal axis from a distal portion (18) to a proximal portion (16; [0040]; [0059]; [0060]); and that the valve housing (300; Figs. 6, 7) is formed of a transparent material ([0073]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the valve housing disclosed by Rome in view of Villari to be formed of a transparent material, similar to that disclosed by Fillmore, in order allow for patient or medical practitioner viewing of the valve to determine whether the interior passageway of the valve remains unobstructed and that materials such as particulates and/or residues are not built up on the surface of the lumen; and if such build-up is observed, the medical practitioner can commence with flushing of the lumen, as suggested by Fillmore in paragraphs [0007] and [0008].
14. With regard to claim 13, Rome and Villari are silent in regard to the catheter being a Foley catheter configured to drain urine from a bladder of a patient.
However, Fillmore discloses that the connector is to be used with drainage catheters which carry various bodily fluids, including urinary fluids ([0006]; [0071]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter disclosed by Rome in view of Villari to be a Foley catheter, similar to that suggested by Fillmore, in order to make use of the valved connector with various types of drainage catheters, including those which are quite prevalent, such as Foley catheters for drainage of urine, as suggested by Fillmore in paragraph [0006].
15. Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rome in view of Villari, as applied to claim 3 above, and further in view of Christensen et al. (US 8,337,475).
16. With regard to claim 4, Rome and Villari fail to explicitly disclose that the leg further includes a pawl disposed at a distal end thereof and configured to engage a lip extending radially inwards from a rim of the valve recess, the pawl configured to prevent further proximal movement of the valve when in the first position.
However, Christensen discloses a corporeal drainage system (10; abstract; Figs. 1, 21, 22), comprising a drainage line connector (270) including valve legs (sealing element, 240), wherein the legs (240) further include a pawl (retaining element, 250) disposed at a distal end thereof and configured to engage a lip extending radially inwards from a rim of the valve recess (formed by lipped distal end of positioning sleeve, 280; see Figs. 21, 22), the pawl (250) configured to prevent further proximal movement of the valve legs (240)when in the first position (col. 10, lines 20-34).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the valve legs disclosed by Rome in view of Villari to include a pawl to engage a lip extending radially inward from a rim of the valve recess, similar to that disclosed by Christensen, in order to resist movement of the sealing element toward a distal end of the body during use, as suggested by Christensen in column 10, lines 25-27.
17. Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rome in view of Villari, as applied to claim 1 above, and further in view of Goswami (US 9,814,866).
18. With regard to claim 5, Rome and Villari fail to explicitly disclose a biasing member configured to bias the valve towards the first position.
However, Goswami discloses a flushable drainage device (210) and method of use (abstract; Figs. 4A-4C; col. 3, lines 34-54), comprising a body defining a drainage lumen (channel, 250; Fig. 3A-E); a positive air pressure inlet (flushing access port, 260); a valve (valve plate, 220) movably engaged between a first open drainage position (Fig. 4A) and a second closed flushing position (Fig. 4B); and a biasing member (tension spring, 290; Fig. 4C) configured to bias the valve (220) towards the first position (col. 8, lines 52-65).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the valve disclosed by Rome in view of Villari to include a biasing member, similar to that disclosed by Goswami, in order to bias the valve toward an open drainage position, and to return the valve to the open drainage position following cessation of positive pressure application, as suggested by Goswami in column 3, lines 50-54.
19. Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rome in view of Villari, as applied to claim 1 above, and further in view of McDaniel (US PGPUB 2014/0200588).
20. With regard to claim 16, Rome and Villari fail to explicitly disclose a sample port or a pressure sensor port in fluid communication with the distal portion of the drainage lumen.
However, McDaniel discloses a pressure controlled magnetic valve for a catheter (abstract; Fig. 1, 2A, 2B), comprising a urine control device (10) to be placed intermediate a catheter and a collection bag ([0008]); wherein a sample port (sampling port, 16) is provided in fluid communication with the distal portion of the drainage lumen (central passageway, 86; abstract; [0012]; [0058]; [0077]; [0079]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connector disclosed by Rome in view of Villari to further include a sample port in fluid communication with the distal portion of the drainage lumen, similar to that disclosed by McDaniel, in order to permit access to take a sample of urine coming from the patient for any medical testing that may be required, as suggested by McDaniel in paragraph [0077].
Conclusion
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781