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 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.
Claims 15, 17-19, 21-24, 26-27, 30-35 are rejected under 35 U.S.C. 103 as being unpatentable over Ashby et al. (GB 2395128 A) in view of Herrera et al. (US 20160287847 A1), Richardson et al. (US 20050256447 A1), and Davis (US 5713877 A).
Regarding Claim 15, Ashby teaches an intermittent urinary catheterisation assembly ('urinary drainage system 40', fig.4, page 8, ll.20-21) comprising:
an intermittent urinary catheter comprising:
a catheter tube ('catheter 2', fig.4, page 8, ll.28) extending between a distal insertable portion insertable into a user's urethra, and a proximal non-insertable portion ('inflation device 7', fig.4, page 4, ll.22) not intended for insertion into the user's urethra ("the catheter 2 includes an insertion mechanism (not 15 shown) for accurate placement of the catheter into the urethra or suprapubic of a patient, with the orifice 4 appropriately placed within the bladder", page 4, ll.14-16), a connecting portion ('catheter outlet 5', fig.4, page 4, ll.13) coupled to the proximal non-insertable portion ('inflation device 7', fig.4, page 4, ll.22); and
a conduit ('lumen 3', fig.4, page 4, ll.12) extending longitudinally within the catheter tube 2 and defining a flow path for urine ("regulating urine flow", page 3, ll.12) from the distal insertable portion to the proximal non-insertable portion 7 of the catheter tube 2; and
a measuring system ('control unit 22' and 'catheter control unit 41' and 'control unit 42' and 'flow meter 45', fig.4, page 8, ll.21 and page 9, ll.6, respectively) comprising:
a signal processing device ('catheter control unit 41', fig.4, page 8, ll.21) comprising a housing with an engagement mechanism (‘inlet port 11’', fig.4, page 4, ll.27-28) for securing the signal processing device 41 in relation to the connecting portion 5 of the intermittent urinary catheter;
at least one valve element ('valve 15', fig.4, page 8, ll.17) in fluid communication with the conduit 3 when the signal processing device 41 is secured to the intermittent urinary catheter, the at least one valve element 15 comprising a cut-off function (valve opens or closes) configured to switch from a closed state disabling liquid flow of the urine ("regulating urine flow", page 3, ll.12) in the conduit 3 to an open state enabling liquid flow of the urine ("regulating urine flow", page 3, ll.12) in the conduit 3 in response to a pressure applied to the cut-off function by the urine ("regulating urine flow", page 3, ll.12) in the conduit 3 ("The valve 15 may be switched to an open configuration in which fluid flow through the conduit 14 is permitted, using an appropriate electrical, mechanical, electromechanical, pneumatic or other operating mechanism", page 5, ll.16-22; "The pressure sensor 21 may override the timer to cause the valve 15 to open if the sensed pressure exceeds a predetermined threshold", page 6, ll.26-27); and
at least one sensor element ('pressure sensor 21', fig.4, page 6, ll.26) configured to measure the pressure applied to the cut-off function (page 6, ll.26-27),
wherein the measuring system (22, 41, 42, 45) is configured to detect a change of state of the cut-off function from the closed state to the open state (fig.4 arrows showing flow direction of fluid).
Ashby fails to teach an engagement mechanism having a protrusion for securing the signal processing device in relation to the connecting portion of the intermittent urinary catheter, and a cut-off element. Herrera teaches a cut-off element (‘ball valve 305’, fig.3B, ¶ 23).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby such that to include a cut-off element as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body.
Ashby/Herrera fail to teach an engagement mechanism having a protrusion for detachably securing the signal processing device in relation to the connecting portion of the intermittent urinary catheter. Richardson teaches an engagement mechanism ('frusto-conical male push connector 2', fig.1, ¶ 72) for detachably securing the signal processing device 10 in relation to the connecting portion 19 of the intermittent urinary catheter.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera to include an engagement mechanism for detachably securing the signal processing device in relation to the connecting portion of the intermittent urinary catheter as taught by Richardson, in order to manually disconnect the connecting portion from the signal processing device such that the apparatus can be removed simply by pulling it out of the catheter opening and the bag opening in the same way as the drainage bag fitting is removed from the catheter, and the catheter may then be connected to the drainage bag in the usual way and bladder drainage resumed without the urinary control apparatus in place (¶ 53).
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Annotated Figures 1-3
Ashby/Herrera/ Richardson fail to teach an engagement mechanism having a protrusion. Davis teaches a protrusion (see annotated figs.1-3).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera/Richardson to include a protrusion as taught by Davis, in order to indicate a location at which a user may cut the valve housing in order to quickly and easily (in one step) deflate the bladder balloon and urethral cuff balloon for removing the catheter (col.5, ll.41-49).
Ashby/Herrera/ Richardson/Davis discloses the claimed invention except for an engagement mechanism having a protrusion. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have an engagement mechanism having a protrusion, since it has been held that constructing a formerly integral structure into various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding Claim 17, Ashby teaches the at least one valve element 15 is configured and controllable to:
apply a force to the cut-off element to disable a liquid flow in the conduit 3 ("the valve is of a normally closed type, in which the conduit 14 is blocked to prevent fluid flow 20 therethrough", page 5, ll.18-20) when the signal processing device 41 is secured in relation to the intermittent urinary catheter; and
wherein the parameter indicative of the pressure applied to the cut-off element (“a pressure sensor 21 to open and close the valve", Abstract) when the cut-off element (valve opens or closes) switches from the closed state to the open state measurable by the at least one sensor element 21 is indicative of the force applied to the cut-off element (valve opens or closes) ("The valve 15 may be switched to an open configuration in which fluid flow through the conduit 14 is permitted, using an appropriate electrical, mechanical, electromechanical, pneumatic or other operating mechanism", page 5, ll.16-22; "The pressure sensor 21 may override the timer to cause the valve 15 to open if the sensed pressure exceeds a predetermined threshold", page 6, ll.26-27).
Ashby fails to teach a cut-off element, and gradually decreasing the force applied to the cut-off element.
Herrera teaches a cut-off element (‘ball valve 305’, fig.3B, ¶ 23) and gradually decreasing the force applied to the cut-off element (NOTE: the force applied would be gradually lessened as the flow subsided).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby to include a cut-off element and such that the applied force would be gradually decreased to the cut-off element as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body.
Regarding Claim 18, Ashby teaches the at least one sensor element 21 is configured to measure the presence of liquid downstream of the at least one valve element 15 ("pressure sensor 21 for sensing urine pressure. Preferably, the pressure is sensed within the fluid flow conduit 14 of the catheter control unit 22, upstream of the valve 15, near the inlet port 11", page.6, ll.16-19).
Regarding Claim 19, Ashby fails to teach the cut-off element comprises a ferromagnetic valve member and at least one electromagnet, the at least one electromagnet being configured to apply a variable force to the ferromagnetic valve member. Herrera teaches the cut-off element (‘ball valve 305’, fig.3B, ¶ 23) comprises a ferromagnetic valve member (' ball 335', fig.3B, ¶ 23) and at least one electromagnet ('magnet 235', fig.3B, ¶ 21), the at least one electromagnet being configured to apply a variable force to the ferromagnetic valve member 335 ("the user utilizes a magnet 235 to open the valve 225 and allows the urine to travel through the urethra 240", ¶ 21).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby to include the cut-off element such that it would comprises a ferromagnetic valve member and at least one electromagnet, the at least one electromagnet being configured to apply a variable force to the ferromagnetic valve member as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body.
Regarding Claim 21, Ashby teaches the measuring system (22, 41, 42, 45) is configured to detect said change of state of the cut-off function when the parameter or a derivate thereof exceeds a predetermined threshold value ("The pressure sensor 21 may override the timer to cause the valve 15 to open if the sensed pressure exceeds a predetermined threshold", page 6, ll.26-27). Ashby fails to teach a cut-off element. Herrera teaches a cut-off element (‘ball valve 305’, fig.3B, ¶ 23).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby to include a cut-off element as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body.
Regarding Claim 22, Ashby teaches the valve element 15, but fails to teach the valve element further comprises a restriction element upstream of the cut-off element; the cut-off element is displaceable relative to the restriction element; and the cut-off element is configured to sealably connect to the restriction element in the closed state of the valve
element. Herrera teaches a restriction element ('distal insert 340', fig.3B, ¶ 23) upstream of the cut-off element (‘ball valve 305’, fig.3B, ¶ 23);
the cut-off element (‘ball valve 305’, fig.3B, ¶ 23) is displaceable relative to the restriction element ('distal insert 340', fig.3B, ¶ 23); and
the cut-off element (‘ball valve 305’, fig.3B, ¶ 23) is configured to sealably connect to the restriction element in the closed state of the valve element ("The spring 325 can be coupled to the distal insert 340 and configured to constantly exert tension during opening and closing of the valve 305", ¶ 24).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby such that the valve element would further comprise a restriction element upstream of the cut-off element; the cut-off element would be displaceable relative to the restriction element; and the cut-off element would be configured to sealably connect to the restriction element in the closed state of the valve element as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body and such that the structure of the valve would prevent reverse flow (or permit flow in only one direction) in the lumen.
Regarding Claim 23, Ashby teaches the valve element 15, but fails to teach the at least one valve element further comprises a retention element downstream of the restriction element; and wherein the retention element is configured to retain the cut-off element in the open state of the valve element. Herrera teaches a retention element ('proximal insert 345', fig.3B, ¶ 23) downstream of the restriction element 340; and
wherein the retention element 345 is configured to retain the cut-off element 305in the open state ("The proximal insert 345 can be configured to trap the ball 335 (e.g. by having a ring shape with an inner radius smaller than the radius of the ball 335)", ¶ 24).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby such that the at least one valve element would further comprise a retention element downstream of the restriction element; and wherein the retention element would be configured to retain the cut-off element in the open state of the valve element as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body.
Regarding Claim 24, Ashby teaches the distal insertable portion of intermittent urinary catheter is configured to rest in the user's urethra ("urethra or suprapubic of a patient", page 4, ll.14-16) for a period of time. However, Ashby fails to teach that the period of time is not exceeding 15 minutes. The device is capable of being rested in the catheter for a period of time not exceeding 15 minutes, and thus meets the claim limitations as set forth by applicant
Regarding Claim 26, Ashby teaches the catheter tube 2 is a single-lumen tube, of which the conduit constitutes the sole passage between the distal insertion end and the proximal outlet end of the intermittent urinary catheter (see fig.4).
Regarding Claim 27, Ashby teaches the signal processing device 41 is configured to determine a fluid flow rate in the conduit on the basis of a measurement performed by the at least one sensor element ("Figure 4 shows a schematic diagram of a multi-sensor urinary drainage system with a timer controlled valve and an integrated pressure control system with flow rate data logging capability", page 4, ll.1-3; "a catheter control unit 41...with the addition of...a flow meter 45 for determining flow rate", page 8, ll.20-24).
Regarding Claim 30, Ashby teaches the engagement mechanism ('balloon 6', fig.4, page 4, ll.22) and the connecting portion ('catheter outlet 5', fig.4, page 4, ll.13), but Ashby/Herrera fail to teach the engagement mechanism includes one or more grooves along an outer circumference configured to engage the connecting portion. Richardson teaches the engagement mechanism ('frusto-conical male push connector 2', fig.1, ¶ 72) includes one or more grooves along an outer circumference configured to engage the connecting portion (see fig.1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera to include the engagement mechanism including one or more grooves along an outer circumference configured to engage the connecting portion as taught by Richardson, in order to manually disconnect the connecting portion from the signal processing device such that the apparatus can be removed (¶ 53).
Regarding Claim 31, Ashby teaches the connecting portion ('catheter outlet 5', fig.4, page 4, ll.13), but Ashby/Herrera fail to teach the one or more grooves are configured to provide tactile feedback upon engagement with the connecting portion. Richardson teaches the one or more grooves (see fig.1) are configured to provide tactile feedback upon engagement with the connecting portion (see fig.1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera such that the one or more grooves would be configured to provide tactile feedback upon engagement with the connecting portion as taught by Richardson, in order to manually disconnect the connecting portion from the signal processing device such that the apparatus can be removed (¶ 53).
Regarding Claim 32, Ashby teaches the engagement mechanism 6, but fails to teach the engagement mechanism includes a magnet. Herrera teaches a magnet (‘magnet 235’, fig.2, ¶ 21).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby such that the engagement mechanism includes a magnet as taught by Herrera, in order to exert a magnetic force to cause the valve to open and allow flow of urine (¶ 21).
Regarding Claim 33, Ashby teaches the at least one valve element ('valve 15', fig.4, page 8, ll.17), the signal processing device ('catheter control unit 41', fig.4, page 8, ll.21), and the cut-off element (valve opens or closes), but Ashby fail to teach the at least one valve element of the measuring system comprises an electronic valve comprising a coil wrapped around a portion of the signal processing device and a ferromagnetic ball valve, where current applied to the coil displaces the ferromagnetic ball valve to switch the cut-off element in the closed state. Herrera teaches the at least one valve element of the measuring system comprises an electronic valve ('valve 305', fig.3B, ¶ 23) comprising a coil ('spring 325', fig.3B, ¶ 23) wrapped around a portion of the signal processing device and a ferromagnetic ball valve ("the valve 305 can be a cylindrical magnetic ball valve", ¶ 23), where current applied to the coil 325 displaces the ferromagnetic ball valve to switch the cut-off element in the closed state ("The spring 325 can be coupled to the distal insert 340 and configured to constantly exert tension during opening and closing of the valve 305. The spring retainer 330 can be concentric to the center of the valve 305. The proximal insert 345 can be configured to trap the ball 335 (e.g. by having a ring shape with an inner radius smaller than the radius of the ball 335)", ¶ 24).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera such that the at least one valve element of the measuring system comprises an electronic valve comprising a coil wrapped around a portion of the signal processing device and a ferromagnetic ball valve, where current applied to the coil displaces the ferromagnetic ball valve to switch the cut-off element in the closed state as taught by Herrera , in order to manually disconnect the connecting portion from the signal processing device such that the apparatus can be removed (¶ 53).
Regarding Claim 34, Ashby teaches the cut-off element (valve opens or closes) and the signal processing device 41, but Ashby fails to teach the pressure applied to the cut-off element from the liquid flow of the urine in the conduit displaces the ferromagnetic ball valve, and the movement of the ferromagnetic ball valve induces a measurable amount of current in the coil that is sensed by the signal processing device to indicate the open state.
Herrera teaches the pressure applied to the cut-off element (valve opens or closes) from the liquid flow of the urine in the conduit displaces the ferromagnetic ball valve ("The spring 325 can be coupled to the distal insert 340 and configured to constantly exert tension during opening and closing of the valve 305. The spring retainer 330 can be concentric to the center of the valve 305. The proximal insert 345 can be configured to trap the ball 335 (e.g. by having a ring shape with an inner radius smaller than the radius of the ball 335)", ¶ 24), and the movement of the ferromagnetic ball valve induces a measurable amount of current in the coil 325 that is sensed by the signal processing device to indicate the open state (¶ 21).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera such that the pressure applied to the cut-off element from the liquid flow of the urine in the conduit displaces the ferromagnetic ball valve, and the movement of the ferromagnetic ball valve induces a measurable amount of current in the coil that is sensed by the signal processing device to indicate the open state as taught by Herrera, in order to manually disconnect the connecting portion from the signal processing device such that the apparatus can be removed (¶ 53).
Regarding Claim 35, Ashby teaches the cut-off element (valve opens or closes), but Ashby fails to teach the cut-off element includes a pushing rod and a least a portion of the conduit includes a flexible valve membrane, wherein the pushing rod depresses a portion of the flexible valve membrane in the closed state. Herrera teaches the cut-off element includes a pushing rod ("the valve 305 can comprise a...pinch, check, plunger...designed to actuate upon user input and/or at a calculated pressure threshold", ¶ 25) and a least a portion of the conduit includes a flexible valve membrane ("the valve 305 can comprise a...diaphragm...flap...designed to actuate upon user input and/or at a calculated pressure threshold", ¶ 25), wherein the pushing rod depresses a portion of the flexible valve membrane in the closed state ("the valve 305 can comprise a...pinch, check, plunger...designed to actuate upon user input and/or at a calculated pressure threshold", ¶ 25; "the valve 305 can comprise a manual squeeze valve (not shown) configured to manually open and close. The manual squeeze valve can comprise an elastic body in a closed state without manual adjustment. When the catheter 300 is inside the patient, the user may squeeze the valve 305 from the skin of the patient to open the valve 305. From squeezing the valve 305, the fluid inside the bladder can be drained", ¶ 25).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera such that the cut-off element includes a pushing rod and a least a portion of the conduit includes a flexible valve membrane, wherein the pushing rod depresses a portion of the flexible valve membrane in the closed state as taught by Herrera, in order to manually disconnect the connecting portion from the signal processing device such that the apparatus can be removed (¶ 53).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ashby in view of Herrera, Walker (US 6102888 A), Richardson, and Davis.
Regarding Claim 16, Ashby teaches the at least one valve element 15, but Ashby/Herrera fail to teach an air outlet upstream of the at least one valve element, the air outlet configured not to allow liquid passage. Walker teaches an air outlet ('air vent and check valve 82', fig.1, col.6, ll.31) upstream of the at least one valve element, the air outlet configured not to allow liquid passage ("Combination air vent and check valve 82 prevents "air lock" and permits graduated fluid reservoir 84 to empty quickly when pinch valve 88 is opened. There thus is provided a means of accumulating a measured amount of irrigation fluid to be released periodically for flushing out the prostate cavity with a rush of irrigant", col.6, ll.31-37).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera such that an air outlet would be upstream of the at least one valve element, the air outlet would be configured not to allow liquid passage as taught by Walker, in order to prevent "air lock" and permit graduated fluid reservoir to empty quickly when pinch valve is opened thus providing a means of accumulating a measured amount of irrigation fluid to be released periodically for flushing out the cavity with a rush of irrigant (col.6, ll.31-37).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ashby in view of Herrera, Mason et al. (US 20200069929 A1), Richardson, and Davis.
Regarding Claim 20, Ashby teaches the at least one sensor element 21, but Ashby fails to teach the at least one sensor element is configured to measure an amount of electrical current conducted through the electromagnet. Herrera teaches the electromagnet ("electromagnet", col.6, ll.59).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby to include the electromagnet as taught by Herrera, in order to open or close the drainage pathway at will such that the patient can control the drainage flow of urine from the body.
Ashby/Herrera fail to teach the at least one sensor element is configured to measure an amount of electrical current conducted through the electromagnet. Mason teaches the at least one sensor element is configured to measure an amount of electrical current ("detector may detect a change in electrical conductivity perpendicular through the lumen of the guide, between two electrodes in DC and/or AC currents", ¶ 222).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby such that the at least one sensor element of Ashby/Herrera would be configured to measure an amount of electrical current as taught by Mason, conducted through the electromagnet of Ashby/Herrera, in order to activate an alarm when the device retracts outward from the predetermined position towards the skin surface during the passing fluid (Mason ¶ 22).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ashby in view of Herrera, Lovmar et al. (US 20180320002 A1), Richardson, and Davis.
Regarding Claim 25, Ashby teaches an outer surface of the insertable portion of the catheter tube ('catheter 2', fig.4, page 8, ll.28), but Ashby/Herrera fail to teach an outer surface of the insertable portion of the catheter tube comprises a hydrophilic surface coating. Lovmar teaches an outer surface of the insertable portion of the catheter tube comprises a hydrophilic surface coating ("a part of the elongate tube, and preferably the entire insertable length, may additionally be provided with a low-friction coating, such as a hydrophilic coating, and preferably arranged on an external surface of the tube", ¶ 67).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby/Herrera such that an outer surface of the insertable portion of the catheter tube would comprise a hydrophilic surface coating as taught by Lovmar, in order that the hydrophobic nature of the Angstrom scale flakes would have a beneficial effect on the killing of the bacteria (¶ 24).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ashby in view of Davis (US 5713877 A).
Regarding Claim 29, Ashby teaches the connecting portion ('catheter outlet 5', fig.4, page 4, ll.13) defines a receiving cavity (cavity within 5), and the protrusion (the area that extends beyond or above the surface of the lumen 3). However, Ashby fails to teach that the protrusion is configured to releasably engage the receiving cavity. Davis teaches the protrusion (surface extending beyond body of the device created by ‘annular protrusion 74’, fig.1, col.5, ll.41) is configured to releasably engage the receiving cavity (“an indentation ring 76 in the valve housing 32 immediately upstream of the inflation-valve for indicating a location at which a user may cut the valve housing 32 in order to quickly and easily (in one step) deflate the bladder balloon and urethral cuff balloon for removing the catheter”, col.5, ll.40-49).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Ashby such that the protrusion is configured to releasably engage the receiving cavity as taught by Davis, in order to quickly and easily (in one step) deflate the bladder balloon and urethral cuff balloon for removing the catheter (col.5, ll.40-49).
Response to Arguments
Applicant's arguments filed 06/18/2025 have been fully considered but they are not persuasive for the following reasons:
On page 8 of the Applicant’s remarks, the Applicant argues that for claim 15, Ashby’s disclosure of a catheter teaching a bladder retention mechanism and teaching of periodic drainage of a urinary catheter is teaching away from the claimed invention, and thus modification of Ashby is improper.
However, the Examiner respectfully disagrees. Applicant has not provided arguments drawn to any specific structure that would preclude Ashby from reading on the claims as written. The urinary catheter taught by Ashby is fully capable of functioning as an intermittent catheter as claimed. Applicant is arguing the intended use of the claimed invention rather than the structural limitations of the claims. Thus, the rejection is maintained.
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 TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 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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/TIMOTHY L FLYNN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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