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 § 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)(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.
Claims 1, 2, 4, 5, 9, 11, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andino (US 2012/0232490).
Regarding claim 1, Andino discloses:
A catheter securement device (100; Fig. 1) comprising: a main body (110) configured to attached around an exterior of a catheter tube (Fig. 12; ¶0058 – the body 110 can attach to the exterior of a medical tube 206); a digital clock (150) integrally connected to the main body (110), the digital clock (150) being operable to record a catheter insertion date and track a time for catheter change or removal (¶0047); and an adhesive patch (102; ¶0034) connected to a base (112; Fig. 8) of the main body (110).
Regarding claim 2, Andino discloses:
The catheter securement device of claim 1 further comprising at least one sensor (¶0052) integrated into the main body (110), the at least one sensor (¶0052 – the sensor can be a flow sensor, fully capable of being operable to monitor a fluid flow within a catheter tube within channel 120).
Regarding claim 4, Andino discloses:
The catheter securement device of claim 2, wherein the digital clock (150) further comprises a display for indicating the fluid flow (¶0047) based on information received from the at least one sensor (¶0052).
Regarding claim 5, Andino discloses:
The catheter securement device of claim 2, wherein the digital clock (150) further comprises an alarm (¶0052) operable to sound off when a blockage is detected by the at least one sensor (¶0052 – when there is no fluid flow sensed by the sensor, the alarm sounds, which means the alarm is fully capable of sounding off when there is a blockage).
Regarding claim 9, Andino discloses:
The catheter securement device of claim 1 further comprising a battery (¶0048) connected to the digital clock (150).
Regarding claim 11, Andino discloses:
A catheter securement device (100; Fig. 1) comprising: a digital clock (150) operable to record a catheter insertion date and track a time for catheter change or removal (¶0047-0049); and at least one sensor (¶0052 – flow sensor) integrated into the catheter securement device (100), the at least one sensor being operable to monitor a fluid flow within a catheter tube (¶0052 – the sensor can be a flow sensor, fully capable of being operable to monitor a fluid flow within a catheter tube within channel 120).
Regarding claim 14, Andino discloses:
The catheter securement device of claim 11, wherein the digital clock (150) further comprises a display for indicating the fluid flow (¶0047) based on information received from the at least one sensor (¶0052).
Regarding claim 15, Andino discloses:
The catheter securement device of claim 11, wherein the digital clock (150) further comprises an alarm (¶0052) operable to sound off when a blockage is detected by the at least one sensor (¶0052 – when there is no fluid flow sensed by the sensor, the alarm sounds, which means the alarm is fully capable of sounding off when there is a blockage).
Regarding claim 16, Andino discloses:
The catheter securement device of claim 11, wherein the digital clock (150) comprises an automated countdown timer (¶0055 – clock 150 can be automatically activated).
Regarding claim 17, Andino discloses:
The catheter securement device of claim 16, wherein the automated countdown timer (¶0055) is activated when the at least one sensor (¶0052) detects the fluid flow within the catheter tube (¶0047 – can be activated by a triggering event such as fluid going through a lumen of the device).
Regarding claim 18, Andino discloses:
The catheter securement device of claim 11 further comprising a battery (¶0048) connected to at least one of the digital clock (150) and the at least one sensor.
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.
Claims 3, 12, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Andino in view of Krivitski et al (US 2005/0166683).
Regarding claim 3, Andino discloses the catheter securement device of claim 2 but is silent regarding “the at least one sensor is at least one of an optical sensor or an ultrasonic sensor.” However, Krivitski teaches a catheter device that uses flow sensors (Abstract), thus being in the same field of endeavor, where the flow sensor can be an optical sensor or an ultrasound (ultrasonic) sensor (¶0090). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the flow sensor of Andino to be an optical or ultrasonic sensor as taught by Krivitski in order to provide sufficient structure for sensing the flow rate in the system.
Regarding claim 12, Andino discloses the catheter securement device of claim 11 but is silent regarding “the at least one sensor is an optical sensor.” However, Krivitski teaches a catheter device that uses flow sensors (Abstract), thus being in the same field of endeavor, where the flow sensor can be an optical sensor (¶0090). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the flow sensor of Andino to be an optical sensor as taught by Krivitski in order to provide sufficient structure for sensing the flow rate in the system.
Regarding claim 13, Andino discloses the catheter securement device of claim 11 but is silent regarding “the at least one sensor is an ultrasonic sensor.” However, Krivitski teaches a catheter device that uses flow sensors (Abstract), thus being in the same field of endeavor, where the flow sensor can be an ultrasound (ultrasonic) sensor (¶0090). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the flow sensor of Andino to be an ultrasonic sensor as taught by Krivitski in order to provide sufficient structure for sensing the flow rate in the system.
Regarding claim 20, Andino discloses the catheter securement device of claim 11 but is silent regarding “further comprising a plurality of sensors, the plurality of sensors including at least one upstream sensor and at least one downstream sensor.” However, Krivitski teaches a catheter device that uses flow sensors (Abstract), thus being in the same field of endeavor, where the flow is monitored by multiple sensors including upstream and downstream positions (¶0115). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the flow sensor of Andino to provide multiple sensors at an upstream and downstream position as taught by Krivitski in order to provide sufficient structure to collect more information about the flow of the system.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Andino in view of Senanayake et al (US 2018/0247569).
Regarding claim 6, Andino discloses the catheter securement device of claim 1 and wherein the digital clock comprises an automated countdown timer (¶0055), but is silent regarding “the automated countdown timer being activated by removing an insulating pull tab from the digital clock.” However, Senanayake teaches a monitoring device for a medical device, thus being in the same field of endeavor, where the battery (212; Fig. 3) of the monitoring device is activated automatically by removing a pull tab (217; Fig. 6) attached to a backing layer (14) (¶0130). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the battery of the digital clock of Andino to incorporate a removable pull tab as taught by Senanayake in order to provide sufficient structure to automatically trigger the clock.
Regarding claim 7, Andino in view of Senanayake discloses:
The catheter securement device of claim 6, wherein the adhesive patch (102) comprises a contact paper (104; Fig. 2).
Regarding claim 8, Andino in view of Senanayake discloses catheter securement device of claim 7, wherein the insulating pull tab taught by Senanayake in the rejection of claim 6 is integrally connected to the contact paper (14) of the device.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Andino in view of Tobescu et al (US 2015/0343173).
Regarding claim 10, Andino discloses the catheter securement device of claim 1 but is silent regarding “the digital clock is operable to transmit alert messages through a transmitter.” However, Tobescu teaches a monitoring system for a catheter (Abstract), thus being in the same field of endeavor, with an alarm signal that can be transmitted by the device through a radio frequency transmitter to an external device (¶0549). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modified the alarm of Andino to incorporate a transmitter to transmit the alarm as taught by Tobescu in order to provide sufficient structure for a medical professional to monitor the alarm system remotely.
Regarding claim 19, Andino discloses the catheter securement device of claim 11 but is silent regarding “the digital clock is operable to transmit alert messages through a transmitter.” However, Tobescu teaches a monitoring system for a catheter (Abstract), thus being in the same field of endeavor, with an alarm signal that can be transmitted by the device through a radio frequency transmitter to an external device (¶0549). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modified the alarm of Andino to incorporate a transmitter to transmit the alarm as taught by Tobescu in order to provide sufficient structure for a medical professional to monitor the alarm system remotely.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783