DETAILED ACTIONNotice 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 Objections
Claim 6 is objected to because of the following informalities: “wherein interface or the overhang portion comprises...” does not make sense grammatically. It is treated as “wherein an interface or the overhang portion comprises...” as it also corrects an antecedent issues with “the interface” later. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “a electronic tag” is grammatically incorrect. It is treated as “an electronic tag”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, it is unclear how “a fluid connector assembly” on lines 4 and 5 is related to that on lines 2 and 3. The second instance is treated as “the fluid connector assembly”.
In claim 17, it is unclear what “providing, for display based on receiving the indication, a coupling status of the first and second portions of the fluid connector assembly” means. Applicant has already claimed receiving an indication about the threshold status, this limitation stops short of display (as it claims “for display on receiving the indication”), it is thus unclear what is provided.
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.
Claim(s) 1, 2, 8, 13, 14, 17, 18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klimm et al (US 5,626,129).
Regarding claim 1, Klimm discloses a fluid flow disconnect system comprising: a first sensor unit 6 configured to be removably (Col.3 ll 19-22; also when tubes are separated) coupled to a first portion 3 of a fluid connector assembly; and a second sensor unit 5 configured to be removably coupled to a second portion 2 of a fluid connector assembly (when tubes are separated) and configured to be detected by the first sensor unit (Col.2 ll 21-33), wherein the first sensor unit comprises a sensor configured to sense when the second sensor unit is within a threshold distance of the first sensor unit (Col.2 ll 21-33), and comprises a transmitter configured to transmit (device which transmits over line 9), to a device 10 remote from the first and second sensor units (fig 1), an indication regarding whether the first and second portions of the fluid connector assembly are coupled together responsive to the sensing (Col.3 ll 47-55); and wherein the first and second sensor units are configured such that the threshold distance is satisfied when the first and second portions of the fluid connector assembly are coupled together to form the fluid connector assembly and the threshold distance is not satisfied when the first and second portions are not coupled together (Col.2 ll 21-33).
Regarding claim 2, wherein the first sensor unit is configured to be removably coupled to the first portion of the fluid connector assembly via one or more first tabs secured to an exterior the first portion of the fluid connector assembly, and the second sensor unit is configured to be removably coupled to the second portion of the fluid connector assembly via one or more second tabs secured to an exterior of the second portion of the fluid connector assembly (this claim heavily depends on a structure that is claimed as intended use, no matter what form the first and second sensor units take, the first and second fluid connector assemblies are capable of having complementary tabs to secure the sensor units to the connector assemblies).
Regarding claim 8, wherein the transmitter is configured to wirelessly transmit the indication to the remote device (Col.5 ll 4-12).
Regarding claim 13, Klimm discloses a disconnect sensor comprising: a first sensor unit 6 configured to be removably (Col.3 ll 19-22) coupled to a first portion 3 of a fluid connector assembly; and a second sensor unit 5 configured to be removably coupled (when connectors 2 and 3 are separated) to a second portion 2 of the fluid connector assembly and configured to be detected by the first sensor unit (Col.2 ll 21-33), wherein the first sensor unit comprises a sensor 6 configured to sense when the second sensor unit is within a threshold distance of the first sensor unit (Col.2 ll 21-33), and comprises a transmitter (device which transmits over line 9) configured to transmit, to a device 10 remote from the disconnect sensor (fig 1), an indication regarding whether the first and second portions of the fluid connector assembly are coupled together responsive to the sensing (Col.3 ll 47-55); wherein the first and second sensor units are configured such that the threshold distance is satisfied when the first and second portions of the fluid connector assembly are coupled together to form the fluid connector assembly and the threshold distance is not satisfied when the first and second portions are not coupled together (Col.2 ll 21-33).
Regarding claim 14, wherein the first sensor unit is configured to be removably coupled to the first portion of the fluid connector assembly via one or more first tabs secured to an exterior the first portion of the fluid connector assembly, and the second sensor unit is configured to be removably coupled to the second portion of the fluid connector assembly via one or more second tabs secured to an exterior of the second portion of the fluid connector assembly (this claim heavily depends on a structure that is claimed as intended use, no matter what form the first and second sensor units take, the first and second fluid connector assemblies are capable of having complementary tabs to secure the sensor units to the connector assemblies).
Regarding claim 17, Klimm discloses a method, comprising: providing a first sensor unit 6 and a second sensor unit 5, the first sensor unit configured to be removably coupled to a first portion 2 (Col.3 ll 19-22; also via disconnection of tubes 2 and 3) of a fluid connector assembly, and the second sensor unit configured to be removably coupled (via disconnection of tubes 2 and 3) to a second portion 2 of the fluid connector assembly and configured to be detected by the first sensor unit (Col.2 ll 21-33); receiving an indication regarding whether the second sensor unit is within a threshold distance of the first sensor unit (Col.3 ll 47-55); and providing, for display based on receiving the indication, a coupling status of the first and second portions of the fluid connector assembly (Col.3 ll 47-55).
Regarding claim 18, further comprising: wirelessly receiving (Col.5 ll 4-20), from the first sensor unit, at a mobile computing device remote from the first and second sensor units (Col.5 ll 4-20), an indication that the second sensor unit is no longer within the threshold distance of the first sensor unit (Col.2 ll 21-33); and responsive to indication that the second sensor unit is no longer within the threshold distance of the first sensor unit, providing an alarm at the mobile computing device indicating that the first portion of the fluid connector assembly has become decoupled from the second portion of the fluid connector assembly (Col.2 ll 21-33).
Regarding claim 20, Klimm discloses a non-transitory computer-readable memory having instructions stored thereon that, when executed, perform operations that facilitate the method of Claim 17 (such as demodulation and decoding of signals as in Col.5 ll 14-18).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klimm et al (US 5,626,129) in view of Coambs et al (US 2007/0066965).
Regarding claim 9, Klimm discloses the first and second portions of the fluid connection assembly (fig 1).
While Klimm substantially discloses the invention as claimed, it does not disclose wherein the first portion of the fluid connector assembly comprises a first portion of a valve and a first fluid passageway therein; and wherein the second portion of the fluid connector assembly comprises a second portion of the valve and a second fluid passageway therein, the second portion of the fluid connector assembly being configured to become coupled to the first portion of the fluid connector assembly to form a continuous fluid passage from the first and second fluid passageways.
Coambs discloses a different type of medical connector wherein the first portion of the fluid connector assembly comprises a first portion of a valve 18 and a first fluid passageway therein (fig 2); and wherein the second portion of the fluid connector assembly comprises a second portion of the valve 28 and a second fluid passageway therein (fig 2), the second portion of the fluid connector assembly being configured to become coupled to the first portion of the fluid connector assembly to form a continuous fluid passage from the first and second fluid passageways (fig 3).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Klimm such that the first portion of the fluid connector assembly comprises a first portion of a valve and a first fluid passageway therein; and wherein the second portion of the fluid connector assembly comprises a second portion of the valve and a second fluid passageway therein, the second portion of the fluid connector assembly being configured to become coupled to the first portion of the fluid connector assembly to form a continuous fluid passage from the first and second fluid passageways as taught by Coambs to reduce the chance of contamination of the tubes when they are not connected.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klimm et al (US 5,626,129) in view of Tieck et al (US 2016/0015957).
Regarding claim 10, the second sensor unit comprises a tag, and the sensor of the first sensor unit is configured to wirelessly detect a presence of the tag of the second sensor unit while the first and second sensor units are brought together by way of the first and second portions of the fluid connector assembly being coupled together to form the fluid connector assembly, and configured to no longer detect the presence of the electronic tag when the first and second sensor units are moved away from each other by way of the first and second portions of the fluid connector assembly being decoupled, and wherein the first sensor unit is configured to transmit the indication when the presence of the tag is no longer detected (Col.2 ll 21-33 and Col.3 ll 47-55).
While Klimm substantially discloses the invention as claimed, it does not disclose the second sensor unit comprises a(n) electronic tag.
Klimm discloses the sensor uses a magnetic field for detection purposes (Col.2 ll 14-15).
Tieck discloses RFID (which uses inductive coupling, ¶125, which is electronic) is an alternative to magnetic as the detectable feature (¶18).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Klimm such that the tag of the second sensor unit is electronic (and the first sensor is modified to detect the electronic tag) as taught by Tieck as it is a known, alternative sensor arrangement with every expectation of success.
Claim(s) 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klimm et al (US 5,626,129) in view of Balji et al (US 2021/0244932).
Regarding claim 12, while Klimm substantially discloses the invention as claimed, it does not disclose wherein the first sensor unit comprises a piezo-electric circuit configured to, when activated, generate an audible alarm, and wherein when the threshold distance becomes no longer satisfied by way of the first and second portions no longer being coupled together, the first sensor unit is configured to cause the piezo-electric circuit to generate the audible alarm.
Klimm discloses audible alarms, including those with a crystal signal generator (Col.3 ll 50-55; one of ordinary skill would recognize that a crystal signal generator in medical devices often includes piezo-electric signals).
Balji discloses a connection sensor 106 (fig 3) where the sensor includes an indicator 404, which may include a vibrating element (¶83).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Klimm such that the first sensor unit comprises a piezo-electric circuit configured to, when activated, generate an audible alarm, and wherein when the threshold distance becomes no longer satisfied by way of the first and second portions no longer being coupled together, the first sensor unit is configured to cause the piezo-electric circuit to generate the audible alarm as taught by Balji to allow for a user to see if something is wrong without having to look at the remote device.
Regarding claim 19, while Klimm substantially discloses the invention as claimed, it does not disclose further comprising: associating a patient identifier with a first sensor unit and a second sensor unit; obtaining, from at least the first sensor unit, the patient identifier in connection with receiving the indication regarding whether the first and second portions of the fluid connector assembly are coupled together responsive to the sensing; and confirming whether the obtained patient identifier is associated with the first and second sensor units before providing the coupling status; and providing an indication of whether the obtained patient identifier is associated with the first and second sensor units.
Klimm discloses when multiple sensors are being monitored demodulating and decoding the signals to determine which sensor they come from (Col.5 ll 13-17).
Balji discloses patient identifiers being used, including associating the patient identifier with the medical device 102 (which has the connector sensor 106, fig 4). Confirming the patient identifier reduces medication administration errors (¶104). Thus it is considered obvious to use a patient identifier in the device of Klimm as part of the demodulation (confirming whether the obtained patient identifier is associated with the first and second sensor sensors) to reduce medical administration errors.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Klimm such that it includes associating a patient identifier with a first sensor unit and a second sensor unit; obtaining, from at least the first sensor unit, the patient identifier in connection with receiving the indication regarding whether the first and second portions of the fluid connector assembly are coupled together responsive to the sensing; and confirming whether the obtained patient identifier is associated with the first and second sensor units before providing the coupling status; and providing an indication of whether the obtained patient identifier is associated with the first and second sensor units as taught by Balji to reduce medical administration errors.
Allowable Subject Matter
Claims 3-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or suggestion for modifying closest art Klimm such that the first and second sensor units each include a pair of parallel locking appendages that, when the respective sensor unit is coupled to a respective portion of the fluid connector assembly, straddle the respective portion of the fluid connector assembly on opposing sides of the respective portion fluid connector assembly and lock into respective key openings within the tabs of the respective portion of the fluid connector assembly on the opposing sides so that the sensor unit is held against a side of the respective portion of the fluid connector assembly between the tabs absent impermissible hindsight.
Claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or suggestion for modifying the second sensor unit to have a memory device for storing a patient identifier and storing the patient identifier in the memory device due to a computing device and transmitting back to the computing device the patient identifier and the coupling status, absent impermissible hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783