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
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 1-3, 6-10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 2008/0097288) in view of Gable (US 2006/0188407).
Regarding claim 1, Levin discloses a giving set (figure 9) for use with an arterial or venous monitoring or flush system, the giving set comprising:
a medical or surgical line (202);
a safety warning system (30) for detecting glucose in the medical fluid, the safety warning system comprising:
an indicator (251, [0040]) arranged to contact the fluid and configured to provide an indication of whether the fluid comprises glucose ([0040]).
Levin does not teach a spike for insertion into a bag of medical fluid and configured to couple the bag to the medical or surgical line;
Gable discloses a sampling system comprising a spike (120, figure 9) for insertion into a bag of medical fluid and configured to couple the bag to the medical or surgical line ([0083, the spike can have the intended use of being inserted into the bag and is already connecting the bag with the line).
Gable provides a way to permanently or removably couple the tube with connectors ([0083]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Levin by substituting the luer connector with the spike connector of Gable to establish fluid communication. The connectors are functionally equivalent ways to establish fluid communication.
Regarding claim 2, Levin discloses wherein the safety warning system comprises a receptacle (70, figure 9, [0040]) into which fluid can be displaced from the line.
Regarding claim 3, Levin discloses wherein the receptacle of the safety warning system comprises at least one of: a gas release path (201, figure 9) to enable the fluid to displace gas to contact the indicator (the gas in balloon can be introduced or withdrawn in order for fluid to contact indicator ([0040]).
Regarding claim 6, Levin further discloses the system is configured to receive fluid from
the medical line into the receptacle by bulk flow (bulk flow interpreted as flow that is not drip flow, equivalent part 2020 explained in [0034]).
Regarding claim 7, Levin discloses wherein the safety warning system is configured to provide a back pressure to the line sufficient for arterial monitoring once the receptacle has received the fluid from the medical or surgical line (once the valve 200 is closed after receiving fluid ([0035], this would create back pressure to allow the arterial line to be monitored via housing 30).
Regarding claim 8, Levin discloses wherein the receptacle is configured to provide an indication of whether the fluid comprises glucose when the concentration of glucose in solution is greater than or equal to 10 mMol (intensity of light as function glucose light, [0040], figure 3 shows data of system).
Regarding claim 9, Levin discloses wherein the safety warning system is configured so that the fluid contacts the indicator by at least one of capillary action and diffusion ([0040], since fluid is displaced using balloon, the fluid is moved by capillary action through receptacle and contacts the indicator).
Regarding claim 10, Levin discloses wherein the safety warning system is mechanically coupled to the medical or surgical line (figure 3 and 9).
Regarding claim 12, Levin discloses wherein the indicator comprises an electronic sensor for sensing the presence of glucose in a solution ([0040], the fiber optic connects the sensor to system).
Regarding claim 13, Levin further discloses the indicator is configured to display symbols
(light intensity) in presence of a solution containing glucose ([0040]).
Regarding claim 14, Levin further discloses the device used with a blood monitoring
system ([0012]).
Regarding claim 15, Levin further discloses the device is configured to receive fluid from
the arterial or venous line ([0035-0036]).
Regarding claim 16, Levin further discloses wherein the indicator is arranged to contact fluid in the medical or surgical line (figure 3 and 9).
Regarding claim 17, Levin and does not disclose a sampling connector, and wherein the indicator is provided as part of the sampling connector.
Gable discloses a sampling system comprising a sampling connector ([0083]), and wherein the indicator is provided as part of the sampling connector ([0083]).
Gable provides the sampling system to analyze the blood ([0083]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Levin with the sampling system of Gable in order to sample and analyze different analytes in the blood.
Regarding claim 18, Levin discloses a giving set (figure 9) for use with an arterial or venous monitoring or flush system, the giving set comprising:
a medical or surgical line (202);
a receptacle (70, figure 9, [0040]) into which fluid can be displaced from the line;
an indicator (251, [0040]) arranged to contact the fluid and configured to provide an indication of whether the fluid comprises glucose ([0040]).
Levin does not teach a spike for insertion into a bag of medical fluid and configured to couple the bag to the medical or surgical line;
Gable discloses a sampling system comprising a spike (120, figure 9) for insertion into a bag of medical fluid and configured to couple the bag to the medical or surgical line ([0083, the spike can have the intended use of being inserted into the bag and is already connecting the bag with the line).
Gable provides a way to permanently or removably couple the tube with connectors ([0083]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Levin by substituting the luer connector with the spike connector of Gable to establish fluid communication. The connectors are functionally equivalent ways to establish fluid communication.
Regarding claim 19, Levin further discloses wherein the receptacle allows gas to be flushed from the medical or surgical line and retains medical fluid received from the line (nothing inhibits the movement of gas from the system, gas/air moves necessarily through the system as a function of the balloon catheter inflating and deflating while retaining fluid).
Regarding claim 20, Levin discloses a giving set (figure 9) for use with an arterial or venous monitoring or flush system, the giving set comprising:
a first receptacle (70, figure 9, [0040]) for receiving medical fluid from a medical or surgical line; and
wherein the first receptacle comprises an indicator (251, figure 9) arranged to contact the medical fluid received from the line and configured to provide an indication of whether the fluid comprises glucose ([0040]).
Levin does not disclose a second receptacle for receiving and sampling medical fluid from a medical or surgical line.
Gable discloses a sampling system comprising a second receptacle (receptacle in 400) for receiving and sampling medical fluid from a medical or surgical line ([0083], [0125])),
Gable provides the sampling system to analyze the blood ([0083]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Levin with the sampling system of Gable in order to sample and analyze different analytes in the blood.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Gable further in view of Zeltser (US 2013/0289540).
Regarding claim, 4 Levin discloses a valve (200, [0035]) configured to allow fluid to flow from line to receptacle, but fails to disclose wherein the safety warning system comprises a one-way valve.
Zeltser discloses a bioartificial fluid handling system relatively pertinent to problem
posed by Applicant of controlling flow of fluid to the patient. Zeltser teaches a one way valve (64, figure 2, [0107]) that controls the fluid flow to receptacle.
Zeltser provides a one way valve to control flow of fluid ([0107]). It would have been
obvious to a person of ordinary skill in the art at the effective filling date to modify Levin with the valve of Zeltser in order to control flow of fluid through the device.
Regarding claim 5, Levin discloses wherein the indicator is arranged to contact fluid in the receptacle (figure 9), and wherein the indicator is a chemical indicator ([0040]) and is configured to remain within the receptacle to not contaminate the line ([0040]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Gable further in view of Helliwell (US 2015/0112248).
Regarding claim 11, Levin and Gable does not teach wherein the indicator comprises a colour changing fluid that changes colour in the presence of a solution comprising glucose.
Helliwell discloses a blood monitoring system relatively pertinent to problem posed by Applicant of monitoring blood content. Helliwell teaches a test indicator (56, figure 2, [0034]) to provide indication and change colour in presence of solution comprising glucose ([0034]).
Helliwell uses the indicator to detect the presence of a solution material ([0034]). It would
have been obvious to a person of ordinary skill in the art at the effective filling date to substitute Levin with the indicator of Helliwell to detect presence of glucose since the indicators are functionally equivalent and would not hinder the prior art device from operating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (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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/KAI H WENG/Primary Examiner, Art Unit 3781
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