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 .
Election/Restrictions
Claims 7-11 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 15, 2026.
Applicant’s election without traverse of Group I, Species A, claims 1-6 and 12 in the reply filed on July 15, 2026 is acknowledged.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine (US Pub No. 2017/0265839).
With regards to claim 1, Levine discloses a catheter system for blood clot detection, comprising:
a catheter (110) having a proximal end (112) and a distal end (114) (paragraph [0121], referring to the catheter (110) having a proximal portion (112) and a distal portion (114); Figures 1-5, 9-10);
a blood clot sensor (126) coupled to the distal end of the catheter (paragraphs [0115]-[0116], [0120]-[0122], [0129], referring to the use of a sensor (i.e. “density sensor”) to determine the density of the clot in order to determine the composition/type of a blood clot and thus provide an assessment/detection of clots; Figures 9-10); and
a processor configured to process signals from the blood clot sensor (paragraph [0123], referring to the “system processes the time change in sent and received signals to assess density, conducts via an algorithm, a comparative analysis to predetermined density value (e.g., a value of zero), or to predetermined density ranges and then converts it to a numeric value representative of the density within a given range of densities”, wherein the processing, use of an algorithm and analysis/conversion inherently/necessarily requires a processor processing the received signals).
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.
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levine, as applied to claim 1, and further in view of Puckett et al. (“Magnetoelastic transducers for monitoring coagulation, clot inhibition, and fibrinolysis”, March 2005).
With regards to claim 2, as discussed above, Levine meets the limitations of claim 1. However, Levine does not specifically disclose that the blood clot sensor comprises a magnetoelastic sensor.
Puckett et al. discloses that magnetoelastic sensors can be used to detect and monitor the viscosity changes that occur during the biological reactions of coagulation/clotting and fibrinolysis, which allows hemostasis to be monitored in real time (Abstract; pg. 1738, left column, last paragraph-right column, first paragraph; pg. 1743, Section 4, note that the magnetoelastic sensors serve as a blood clot sensor as they detect coagulation/clotting processes). The use of magnetoelastic sensors provides the benefit of simplicity of design which allows for miniaturization and computerized control and being viable for a portable blood coagulation/clotting monitoring system (pg. 1743, right column, first paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the blood clot sensor of Levine with a magnetoelastic sensor, as taught by Puckett et al., as the substitution of one known blood clot sensor for another yields predictable results (i.e. detecting clotting/coagulation) to one of ordinary skill in the art and further allows for real-time monitoring of hemostasis and provides the benefit of simplicity of design which allows for miniaturization and computerized control and being viable for a portable blood coagulation/clotting monitoring system (pg. 1743, right column, first paragraph). One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
With regards to claim 3, Puckett et al. disclose that the catheter system further comprises a pick-up coil configured to receive magnetic flux from the magnetoelastic sensor and generate a signal based on the magnetic flux (pg. 1738, left column, 2nd paragraph, referring to the oscillation of the magnetoelastic sensor creating a magnetic flux which can be detected by a pick-up coil; pg. 1738, Section 2.2).
With regards to claim 4, the above combined references disclose that the pick-up coil is internal to the catheter (see Levine, paragraph [0122], referring to the blood clot sensor (126) being positioned inside the catheter (i.e. internal to the catheter), such as internal of the inner catheter wall or alternatively embedded in the wall of the catheter, wherein Puckett et al. disclose that magnetoelastic device for sensing clotting/coagulation comprises a pick-up coil, and therefore the above combined references would result in the pick-up coil of the blood clot sensor (i.e. magnetoelastic sensor) being internal to the catheter).
With regards to claim 5, the above combined references disclose that the pick-up coil is internal to the proximal end of the catheter (paragraph [0122], referring to the blood clot sensor (126) being alternatively spaced from the distalmost end so that the catheter tip can extend past the clot during use while the sensor is positioned within the clot, and thus the blood clot sensor (126) is in the proximal end of the catheter and referring to the blood clot sensor (126) being positioned inside the catheter (i.e. internal to the catheter), such as internal of the inner catheter wall or alternatively embedded in the wall of the catheter, wherein Puckett et al. disclose that the magnetoelastic device for sensing clotting/coagulation comprises a pick-up coil, and therefore the above combined references would result in the pick-up coil of the blood clot sensor (i.e. magnetoelastic sensor) being internal to the proximal end of the catheter).
With regards to claim 6, the above combined references disclose that the pick-up coil is external to the catheter (see Levine, paragraph [0122], referring to the blood clot sensor (126) being positioned on an outer wall of the catheter (110), and thus is external to the catheter, wherein Puckett et al. disclose that the magnetoeleastic device for sensing clotting/coagulation comprises a pick-up coil, and therefore the above combined references would result in the pick-up coil of the blood clot sensor (i.e. magnetoelastic sensor) being external to the catheter).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levine as applied to claim 1 above, and further in view of Teigen et al. (US Pub No. 2021/0128182).
With regards to claim 12, as discussed above, Levine meets the limitations of claim 1. However, Levine does not specifically disclose that the catheter system outputs an audio cue based, at least in part, on proximity to a blood clot.
Teigen et al. disclose a vacuum aspiration control system for use with an aspiration catheter, wherein an extraction cycle may be automatically initiated when an algorithm of the controller detects a clogged catheter, an occluded catheter, or a catheter positioned in a clot (Abstract; paragraph [0083]). A piezo acoustic chip can convey audible information to the physician regarding the state of the effluent, wherein the signals may include sounds and phrases such as tone/pitch changes, beeping patterns, “clogged”, “occluded”, “clot”, “blood”, “open flow, etc. (paragraph [0102]). One example utilizes a dynamic beeping cadence, where a beeping pattern is steadily increased when an unrestricted flow state is increasing in duration, wherein the speed of the beeps indicates the length of time the system has been in unrestricted flow, alerting the physician to the increasingly problematic nature of the system’s positioning (paragraph [0102]). A signal indicated unrestricted flow indicates that primarily healthy blood or blood free of vessel-obstructing clot is flowing through the connecting tube and/or that the catheter is substantially free from contact with clot or other occlusive material (paragraph [0014], note that the audible information/beeping pattern indicating information on a state of unrestricted flow is thus based, at least in part, on proximity to a blood clot as unrestricted flow can be dependent on proximity to a clot (i.e. free from contact with clot or not)).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the catheter system of Levine output an audio cue based, at least in part, on proximity to a blood clot, as taught by Teigen et al., in order to alert the physician to a status of the system’s positioning (paragraph [0102]), thereby aiding in positioning the catheter to a desired region.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Deshpande et al. (US Patent No. 8,734,345) disclose a real-time tissue sampling and analysis system including a catheter that includes a guidewire including a sampling device (414) at a tip (416) for extracting a small sample “S” of a blood clot “C”, wherein the tissue sample is prepared and processed by a biochip (418) within internal lumen (408) of catheter (400) (Abstract; column 5, lines 10-28).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
