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
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 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.
(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.
Claims 1-5, 10-11, 14-15, 21-22 and 24-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reiner (US 2017/0231573; hereinafter “Reiner”).
Regarding claim 1, Reiner discloses a medical system, comprising: at least one diagnostic endovascular invasive device comprising at least one lumen, configured to be inserted into the venous vasculature and positioned in proximity to a target tissue (e.g. ¶¶ 87, 102, etc.), at least one sensor configured to be integrated with the at least one diagnostic endovascular invasive device and configured to monitor and detect biochemical and/or physiological changes in a venous fluid, at least partially originated from the target tissue (e.g. ¶¶ 133), and a controller configured to receive the monitored and detected data derived from the at least one sensor, to process and analyze the data and produce medical recommendations and/or conclusions (e.g. ¶¶ 94).
Regarding claim 24, Reiner discloses a medical method comprising the steps of: inserting at least one diagnostic endovascular invasive device comprising at least one lumen and at least one integrated sensor, into a venous vasculature such that the sensor/s is/are placed in proximity to a target tissue (e.g. ¶¶ 87, 102, etc.), monitoring biochemical and/or physiological venous fluid at least partially originated from the target tissue, via the sensors, and detecting biochemical and/or physiological changes in the venous fluid (e.g. ¶¶ 133); and analyzing the monitored and detected data using a controller, for producing medical recommendations and/or conclusions (e.g. ¶¶ 94).
Regarding claim 2, Reiner discloses at least: target tissue is a tumor and where the sensors are configured to monitor biochemical and/or physiological changes in a fluid stream at least partially originated from the tumor (e.g. ¶¶ 133).
Regarding claim 3, Reiner discloses the diagnostic endovascular invasive device comprises at least two lumens, wherein the first lumen comprises the at least one sensor and the second lumen comprises operational means. (e.g. Fig. 5 – 509 to 508 vs 508 to 507).
Regarding claim 4, Reiner discloses the second lumen comprises at least one of: openings configured to draw fluid for external analysis (e.g. Fig. 5, 505/506, etc.)
Regarding claim 5, Reiner discloses at least: the infused substance/s is designated to prevent blood clots in the proximity of the at least one sensor (e.g. ¶¶ 224).
Regarding claim 10, Reiner discloses a therapeutic endovascular invasive device configured to be inserted into an arterial vasculature and administrate a designated substance/s configured for at least: affect the at least one sensor (e.g. ¶¶ 224).
Regarding claim 11, Reiner discloses at least one of the following holds true: the administration is designated to be optimized based on its therapeutic effect detected by the sensor/s (e.g. ¶¶ 116-118).
Regarding claims 14-15, Reiner discloses the at least one sensor is a chemical sensor configured to detect inorganic or organic ions (e.g. ¶¶ 120-121, 130, etc.).
Regarding claim 21, Reiner discloses the at least one sensor is a biological sensor configured to detect cell residues characteristic of cell death. (e.g. ¶¶ 133 – cellular debris).
Regarding claim 22, Reiner discloses the sensor is at least based on fluorescent markers. (e.g. ¶¶ 148).
Regarding claim 25, Reiner discloses inserting another therapeutic endovascular invasive device into the arterial vasculature and administrating a designated substance configured for at least: infusing the target tissue (e.g. ¶¶ 87, 109-115, etc.).
Regarding claim 26, Reiner discloses the steps of monitoring, detecting and analyzing of the venous fluid are provided in real-time, while the target tissue is infused. (e.g. ¶¶ 124, 168, etc.).
Regarding claim 27, Reiner discloses selecting the administrated substance/s, based on the real-time analysis, for optimizing a treatment for the target tissue. (e.g. ¶¶ 168-170).
Regarding claim 28, Reiner discloses detecting cell residues characteristic of cell death. (e.g. ¶¶ 133 – cellular debris).
Regarding claim 29, Reiner discloses the step of inserting comprises placing the sensor/s at the proximity to the target tissue for preventing biochemical signals from being diluted and/or degraded in the fluid stream before the monitoring and detecting. (e.g. Fig. 5, #505).
Regarding claim 30, Reiner discloses at least two lumens and wherein the method further comprising steps of: integrating at least one sensor at the first lumen; and at least one of: guiding the device towards the target tissue, via a guide-wire, at least temporarily integrated in the second lumen (e.g. ¶¶ 152).
Regarding claim 31, Reiner discloses at least: improving the sensor/s sensing capabilities, via the designated substance/s. (e.g. ¶¶ 224).
Regarding claim 32, Reiner discloses removing and/or replacing the integrated sensor/s via the first lumen. (e.g. Fig. 5).
Regarding claim 33, Reiner discloses the step of detecting comprises at least one of: detecting inorganic or organic ions (e.g. ¶¶ 120-121, 130, etc.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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