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
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 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Razavi et al (US Pub 2015/0272451 -cited by applicant).
Re claim 16: Razavi discloses a system for monitoring a medical drainage process, comprising:
a drainage tube extending between a drainage catheter at a distal end and a collection container at a proximal end, the tube configured for transporting a drainage fluid between the drainage catheter and the collection container [0025; see the sheath 12 as a tube, the catheter which is inserted and extended from the end of the sheath such that the tube is between the catheter wherein the catheter is configured for drainage, and a hub 15 as a collection container]; wherein the fluid includes urine and during use, the urine flows through the drainage tube [0025, 0035; while blood is said to flow in the sheath, it is structurally capable of having urine flow in it; also see the urinary catheter as part of the system];
a plurality of electrodes on an inside surface of the tube and spaced apart from each other along a length of the tube [0025, 0031; see electrodes 20a-d, wherein the electrodes are disposed on an inner surface of the sheath]; and
a monitoring module electrically coupled with the plurality of electrodes, the module including logic stored in memory [0046, Figure 6; see the memory as part of the measuring unit] that, when executed by one or more processors, causes performance of operations including:
transmitting an electrical signal between a plurality of first electrodes and a plurality of second electrodes [0026; impedance between electrode pairs can be measured via transmission of electrical signals],
determining an electrical impedance between electrode pairs [0026; see the impedance measurement],
determining from the impedances the presence of a partial occlusion within the drainage tube, wherein the presence of the partial occlusion is determined from the electrical impedance between a first pair of adjacent electrodes being greater than the electrical impedance between a second pair of adjacent electrodes [0042, 0048, 0051; see that the impedances are compared to thresholds which determine if an occlusion is present that can be caused by a kink or occlusion, wherein the impedances between pairs of electrodes determine if bleeding is occurring which indicates occlusion/clot presence].
Re claim 17: The electrodes are disposed along a monitoring length of the medical device [0025; see the sheath or catheter with electrodes 20a-20d].
Re claims 18-20: The operations include determining from the impedance measurements a magnitude of an occlusion of the lumen, wherein the occlusion is one of a thrombotic occlusion, a chemical occlusion, or a mechanical occlusion [0031, 0032, 0067, Figure 5; see the device that is filled with blood and detection of a clot which is a magnitude measurement].
Re claims 21-23: The operations include determining from the impedance measurements presence of an air bubble or air pocket disposed within the lumen including its size, location, and displacement [0023, 0051; see the fluid measurements which can be that of ‘gases’ or air bubbles, wherein the measurement is dependent upon size, location, and displacement].
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Razavi et al (US Pub 2015/0272451 -cited by applicant) in view of White (US Pub 2020/0096464 -previously cited).
Re claim 1: Razavi discloses a system for monitoring a medical drainage process, comprising:
a medical device configured for insertion within a vasculature of a patient [0025; see the sheath 12 or catheter];
a plurality of electrodes coupled with the medical device [0025; see electrodes 20a-d]; and
a monitoring module electrically coupled with the plurality of electrodes, the module including logic stored in memory [0046, Figure 6; see the memory as part of the measuring unit] that, when executed by one or more processors, causes performance of operations including:
transmitting an electrical signal through a fluid including blood that flows in vasculature between a plurality of first electrodes and a plurality of second electrodes [0026; impedance between electrode pairs can be measured via transmission of electrical signals, wherein the fluid is blood in a vasculature],
receiving electrical data from the second electrode [0026; impedance from the second electrode is received];
determining an electrical impedance from the electrical data [0026; see the impedance measurement defined by the fluid between the electrodes], and
providing a notification to an operator when the determined electrical impedance is outside a predefined impedance range [0026, 0042, 0048; see the predetermined threshold wherein the output measurement or the alert is a notification].
Razavi discloses all features including that the predefined range is set to determine if a bleed is occurring [0042], but does not disclose processing signal data from the second electrode via an algorithm stored in the memory, wherein the algorithm correlates the electrical data with known conditions of the fluid including a red blood cell concentration. However, White teaches of an impedance controlled tissue apparatus including a multi-electrode assembly and control unit for processing signal data from the electrode via an algorithm stored in the memory, wherein the algorithm correlates the electrical data with known conditions of the fluid including a red blood cell concentration [0008, 0021; see the electrodes and see the instructions in the memory of the processor 450 that compares the impedance profile to a known impedance profile that correlates a known hematocrit level]. It would have been obvious to the skilled artisan to modify Razavi, to provide for an algorithm to correlate electrical data with known red blood cell concentration as taught by White, in order to facilitate determination of the patient health [0001 of White].
Re claim 2: Razavi discloses the medical device is a catheter, a needle, a stylet, a guidewire, an introducer, or a combination thereof, and wherein the electrodes are disposed along a monitoring length of the medical device [0025; see the sheath or catheter].
Re claim 3: Razavi discloses the operations include: transmitting electrical signals between a plurality of first electrodes and a plurality of second electrodes, determining electrical impedances between a plurality of electrode pairs, and providing a notification to the operator when one or more determined electrical impedances between pairs is outside one or more predefined impedance ranges [0026, 0042, 0048; see the impedance between electrode pairs and the notification of the measurement or alert].
Re claim 4: Razavi discloses at least a subset of the plurality of electrodes is disposed within a lumen of the medical device [0031, Figure 5; see the electrodes within the lumen].
Re claims 5-7: Razavi discloses the operations include correlating impedance measurements of the first and second electrode with a magnitude of an occlusion of the lumen, wherein the occlusion is one of a thrombotic occlusion, a chemical occlusion, or a mechanical occlusion [0031, 0032, 0067, Figure 5; see the device that is filled with blood and detection of a clot which is a magnitude measurement].
Re claim 8: Razavi discloses the operations include correlating one or more impedance measurements with a location of the occlusion along the medical device [0051; wherein the measurement indicates location of the occlusions].
Re claims 9-12: Razavi discloses the operations include correlating impedance measurements of the first and second electrode with an air bubble or air pocket disposed within the lumen including its size, location, and displacement [0023, 0051; see the fluid measurements which can be that of ‘gases’ or air bubbles, wherein the measurement is dependent upon size, location, and displacement].
Re claim 13: Razavi discloses the first and second electrodes are disposed on opposite lateral sides of a cross section of the medical device at a distal end [0025, Figures 1-5; see the electrodes that can be in any of a variety of locations].
Re claim 14: Razavi discloses the first and second electrodes extend only partially around the cross section and are in longitudinal alignment with each other (see Figure 2).
Re claim 15: Razavi discloses the operations include correlating impedance measurement of the first and second electrode with an infiltration of an infusate based on a predefined impedance range with a drug concentration of the infusate and determining that the distal end of the device is outside the vasculature [0027; see that fluids or drugs are administered through the sheath, wherein the measurement indicates location of the medical device].
Response to Arguments
Applicant's arguments filed 9/4/26 have been fully considered but they are not persuasive. In regard to claim 1, Applicant argues that Razavi/White do not meet the claimed limitation of correlating the electrical data with known red blood cell concentration of blood flowing between the electrodes. Respectfully, the Examiner disagrees. While Applicant correctly describes secondary reference White’s ex vivo chip that determines hematocrit from a blood sample that collects red blood cells resting on the electrodes, the rejection relies upon Razavi to disclose a sheath with electrodes that measure electrical data as blood flows between the electrodes. White is used to teach that it is well known that conductivity changes based on red blood cell concentration and the rejection proposes to obtain this concentration data as the blood flows between electrodes. The resulting combination would not result in comparison of the electrical data to known sedimentation curves, but rather the skilled artisan would find it obvious to compare the electrical data to known hematocrit levels of flowing blood in order to make the calculation meaningful. Furthermore, while White does discuss “settling” of red blood cells, it does not indicate the this is required to determine red blood cell concentration. It follows that one cannot show nonobviousness by attacking references individually.
In regard claim 16, Applicant first argues that Razavi’s hub 15 is not a ‘collection container’ because it is an access port which does not collect drainage. However, the Examiner disagrees and finds that the only structural requirement is that the collection container be capable of containing fluid. Razavi’s hub 15 does administer fluids and, therefore, it contains fluid. The hub does include a valve that can be opened and closed but this does not indicate that it is not a collection container. Applicant then argues that there is no drainage tube extending between a drainage catheter and a collection container. However, Razavi’s catheter (drainage catheter) extends through and beyond the sheath and into the blood vessel. The sheath (the drainage tube) that is coupled to the hub (the collection container) is therefore between the distally-extended drainage catheter and the collection container. Since the sheath (the drainage tube) is used to administer fluid and contains the drainage catheter, the sheath is configured to transport fluid between the container and the drainage catheter. Next, Applicant argues that Razavi’s urinary catheter is not a drainage system. However, ‘urine’ is not a structural limitation and Razavi’s sheath/catheter is relied upon as the claim does not require the fluid to be urine. Lastly, Applicant argues that Razavi compares each impedance against a stored threshold – and not against impedance of a different adjacent electrode pair. However, the Examiner disagrees and finds that while Razavi does disclose impedance against a stored value, he also discloses bleed detection by measurement between different electrode pairs to determine the location of a bleed along the length of the device. For example, if there is a clot/occlusion in the device, blood present between one set of electrodes will yield a different impedance measurement compared to another set without blood present [0048, 0051].
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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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