DETAILED ACTION
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.
(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) 15 and 22 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Woodard et al. (US 2021/0298653).
As to claim 15, Woodard teaches a method of monitoring urinary output (Abstract), comprising: coupling (Fig. 2) a urine collection bag (150) to an automated urinary output monitoring device (110); transitioning a locking mechanism from an unlocked configuration to a locked configuration, the locking mechanism configured to prevent decoupling of the urine collection bag from the automated urinary output monitoring device in the locked configuration (Fig. 4 – door open/closed) ; determining a volume of urine collected within the urine collection bag ([0079]); transitioning the locking mechanism from the locked configuration to the unlocked configuration; and decoupling the urine collection bag from the automated urinary output monitoring device ([0023]).
As to claim 22, Woodard teaches a display coupled with the console (218), the method further comprising depicting on the display the volume of the urine collected with the urine collection bag (claim 1).
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) 1-6, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653) in view of Delaney et al. (US 2013/0245498) and Costa et al. (US 2010/0122963).
As to claim 1, Woodard teachers an automated urinary output monitoring system (Abstract) comprising a urine collection bag (154) configured to collect urine excreted by a patient via a urinary catheter (140); an automated urinary output monitoring device (110), comprising: a load cell assembly operatively coupled with the urine collection bag ([0074]), the load cell assembly configured to measure a load defined by urine collected within the urine collection bag ([0074]); a console (1000) coupled with the load cell assembly (Fig. 10 – 1010; [0092]), the console including a processor (1004) and a non-transitory computer readable medium (1007/1008) having logic stored thereon that, when executed by the processor, performs operations ([0078]), and a coupling system configured to detachably couple the urine collection bag to the automated urinary output monitoring device (Fig. 5 – cylindrical part at the top of the collection bag 154).
While Woodard teaches both the use of weight-based measurements and volume-based measurements ([0092]), it does not necessarily teach the determining of a volume of urine based on the load. However, Delaney teaches a system for monitoring urine output using weight-based measurements, and notes that this weight may be converted to volume using an average specific gravity of urine. In addition, it notes that there is only a small variability in the actual specific gravity of urine, with differences within a +/- range of 2% during the conversion, which indicates that weight of the urine may readily be converted to volume without actually having to assess the specific gravity of a specific sample of urine ([0023]). As such, it would have been obvious to modify Woodward with Delaney to utilize use a weight-based measurement and convert it to a volume measurement, to allow the user or clinician to utilize whichever type of unit is desirable.
The above combination fails to teach the specifics of the coupling system as recited. However, Costa et al. (US 2010/0122963) teaches a coupling system including a rail attached to one device (30), a channel attached to the other device (20), the channel configured to longitudinally and slidably receive the rail and prevent lateral separation of the rail from the channel (Fig. 1). While Costa teaches the coupling system is used as part of a hanger assembly, such coupling systems are well known and used in any systems where such attachment is desirable (e.g. a server rack) and is familiar to anyone who has ever assembled their own furniture. Accordingly, it would have been obvious to modify the above combination further with Costa to utilize a sliding rail assembly for a coupling system to allow it to be more secure.
As to claim 2, the combination would result in the channel being attached to a front side of the urinary output monitoring device and the rail being attached to a back side of the urine collection bag.
As to claim 3, the combination would result in the rail extending laterally across a portion of a width of the urine collection bag.
As to claim 4, the combination would result in channel extending laterally across the front side of the automated urinary output monitoring device.
As to claim 5, Costa teaches the channel includes an open end (Fig. 4 – 20 where attachment is initiated) and a closed end (20 – other side, with a bumper preventing further movement).
As to claim 6, Costa teaches a bumper at the closed end, the bumper configured to abut the rail when the rail is received within the channel (Fig. 4)
As to claim 12, while the above combination does not teach that a patient identification device is coupled to the rail, Woodard teaches the attachment of an RFID-bead along the drainage tubing next to the drainage bag (claim 17), the RFID-bead having patient data stored ([0020]). The specific location of the identification device is one of design choice, and any location associated with the collection bag would be expected to perform identically.
As to claim 13, while the RFID bead is a printed circuit board, it would not have electrical contacts as it is utilized as a wireless device, but it enables data exchange between the console and the patient identification device ([0093]). The examiner gives official notice that it would have been obvious to utilize an electronic device requiring physical contacts instead, in case the device needs to be used in a setting where radiofrequency is undesirable or a stricter security protocol is necessary, requiring physical communications.
As to claim 14, Woodard teaches a display coupled with the console (218), the operations further include depicting on the display the volume of the urine collected with the urine collection bag (claim 1).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653), Delaney et al. (US 2013/0245498) and Costa et al. (US 2010/0122963), and further in view of Yang (USP #6,454,372).
As to claim 7, the above combination fails to teach a locking mechanism as recited. Yang teaches a sliding rail assembly with a locking mechanism configured to transition between an unlocked configuration and a locked configuration such that: longitudinal displacement of the rail with respect to the channel is restricted when the locking mechanism is transitioned to the locked configuration, and longitudinal displacement of the rail with respect to the channel is allowed when the locking mechanism is transitioned to the unlocked configuration. (col. 3 lines 46-67). It would have been obvious to modify the above combination with Yang to utilize a locking mechanism to prevent the urine collection bag from being easily slidable, which may cause detachment or pain to the user.
As to claim 8, Yang teaches the locking mechanism includes a deflectable protrusion and a recess counterpart, the recess configured to receive the protrusion when the locking mechanism is transitioned to the locked configuration, thereby restricting longitudinal displacement of the rail with respect to the channel. It is noted that the orientation/attachment of the protrusion vs the recess can be reversed and would still function in identical fashion (in the same way the hook portion of Velcro and the loop fastener portion of Velcro can be reversed in position and work the same way).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653), Delaney et al. (US 2013/0245498), Costa et al. (US 2010/0122963), and Yang (USP #6,454,372), and further in view of Allen et al. (US 2019/0218826).
As to claim 9, the above combination fails to teach that the locking mechanism includes an electro-mechanical actuator to transition the locking mechanism. However, Allen teaches an electro-mechanical locking mechanism which uses recesses with protrusions to lock and unlock the device ([0204]). It would have been obvious to modify the above combination with Allen to utilizer an electro-mechanical actuator to securely lock the collection bag and prevent its removal without authorization.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653), Delaney et al. (US 2013/0245498), Costa et al. (US 2010/0122963), and Yang (USP #6,454,372), and further in view of Chen et al. (US 2014/0166691).
As to claim 10, the above combination fails to teach the locking mechanism as recited. Chen teaches a sliding rail assembly in which a latching member is rotated to locked and unlocked positions ([0028]). It would have been obvious to modify the above combination with Chen to utilize a rotating latch member as an obvious substitution yielding similar and thus expected results.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653), Delaney et al. (US 2013/0245498), Costa et al. (US 2010/0122963), Yang (USP #6,454,372), and Chen et al. (US 2014/0166691), and further in view of Allen et al. (US 2019/0218826).
As to claim 11, the above combination fails to teach that the locking mechanism includes an electro-mechanical actuator to transition the locking mechanism. However, Allen teaches an electro-mechanical locking mechanism which uses recesses with protrusions to lock and unlock the device ([0204]). It would have been obvious to modify the above combination with Allen to utilizer an electro-mechanical actuator to securely lock the collection bag and prevent its removal without authorization.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653) in view Costa et al. (US 2010/0122963).
As to claim 16, Woodard fails to teach coupling the urine collection bag to the automated urinary output monitoring device includes slidably advancing a rail attached to the urine collection bag longitudinally within a channel attached to the automated urinary output monitoring device, the channel configured to prevent lateral separation of the rail from the channel.
As to claim 17, Costa teaches a sliding rail assembly in which a channel (20) is attached to a front side of one device and a rail (30) is attached to a back side of another device (Fig. 5).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653) in view Costa et al. (US 2010/0122963), and further in view of Yang (USP #6,454,372).
As to claim 18, the above combination fails to teach that the locking mechanism is configured to restrict longitudinal displacement of the rail within the channel when the locking mechanism is transitioned to the locked configuration, and allow longitudinal displacement of the rail within channel when the locking mechanism is transitioned to the unlocked configuration.
Yang teaches a sliding rail assembly with a locking mechanism configured to transition between an unlocked configuration and a locked configuration such that: longitudinal displacement of the rail with respect to the channel is restricted when the locking mechanism is transitioned to the locked configuration, and longitudinal displacement of the rail with respect to the channel is allowed when the locking mechanism is transitioned to the unlocked configuration. (col. 3 lines 46-67). It would have been obvious to modify the above combination with Yang to utilize a locking mechanism to prevent the urine collection bag from being easily slidable, which may cause detachment or pain to the user.
As to claim 19, Yang teaches the locking mechanism includes a deflectable protrusion and a recess counterpart, the recess configured to receive the protrusion when the locking mechanism is transitioned to the locked configuration, thereby restricting longitudinal displacement of the rail with respect to the channel. It is noted that the orientation/attachment of the protrusion vs the recess can be reversed and would still function in identical fashion (in the same way the hook portion of Velcro and the loop fastener portion of Velcro can be reversed in position and work the same way).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653), Costa et al. (US 2010/0122963), and , Yang (USP #6,454,372), and further in view of Chen et al. (US 2014/0166691).
As to claim 20, the above combination fails to teach the locking mechanism as recited. Chen teaches a sliding rail assembly in which a latching member is rotated to locked and unlocked positions ([0028]). It would have been obvious to modify the above combination with Chen to utilize a rotating latch member as an obvious substitution yielding similar and thus expected results.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 2021/0298653).
As to claim 21, Woodard teaches the attachment of an RFID-bead along the drainage tubing next to the drainage bag (claim 17), the RFID-bead having patient data stored ([0020]). The specific location of the identification device is one of design choice, and any location associated with the collection bag would be expected to perform identically. Moreover, while the RFID bead is a printed circuit board, it would not have electrical contacts as it is utilized as a wireless device, but it enables data exchange between the console and the patient identification device ([0093]). The examiner gives official notice that it would have been obvious to utilize an electronic device requiring physical contacts instead, in case the device needs to be used in a setting where radiofrequency is undesirable or a stricter security protocol is necessary, requiring physical communications.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 3/19/26