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.
(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 1-6, 8-10, 13-14, 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schwartz (E.P. Application No. 3364869 B1).
Regarding independent claim 1, Schwartz discloses a catheter sensor array (see Figs. 12a-12), comprising:
a catheter (1201);
a plurality of sensor elements (1207) positioned at a distal end of the catheter; and
a plurality of sensor controllers (a plurality of microcircuits) each connected to at least one of the sensor elements by a first connection (micro wires embedded in the substrate 1208), each of the sensor controllers is positioned along a length of the catheter closer to the distal end of the catheter than to a proximal end of the catheter opposite the distal end (pa. 0321).
For further clarification, the plurality of microcircuits of Schwartz are being interpreted as the plurality of sensor controllers given that the microcircuits may include signal processing circuitry, a local control circuit, multiplexors, communication hardware, power management, combinations thereof, or the like (pa. 0174). This description aligns with Applicant’s disclosure in paragraph 0021 of the filed Specification, which details how each of the sensor controller comprise a sensor processor, a sensor memory, and a sensor communication device.
Regarding claim 2, Schwartz discloses further comprising a main controller (an extracorporeal system such as a computer, a control system, an RF ablation controller, a data acquisition system, etc.) (pa. 0174) connected to each of the sensor controllers by a second connection (wirelessly) (pa. 0335 & Fig. 14b).
Regarding claim 3, Schwartz discloses wherein a number of the second connections in the catheter sensor array is less than a number of the first connections in the catheter sensor array (pa. 0335 & Fig. 14b).
Since the extracorporeal system of Schwartz is able to wirelessly communicate with the catheter sensor array, then the second connection does not require any type of physical wired connection; thereby, providing the number of the second connections in the catheter sensor array being less than the number of the first connections in the catheter sensor array.
Regarding claim 4, Schwartz discloses wherein the main controller is positioned at the proximal end of the catheter (see the example system shown in Fig. 14b, where the control console is outside, or proximal to, the catheter).
Regarding claim 5, Schwartz discloses wherein each of the sensor controllers receives a sensor signal from the at least one of the sensor elements to which the sensor controller is connected and outputs a digital signal to the main controller (pa. 0174).
Regarding claim 6, Schwartz discloses wherein each of the sensor controllers is positioned at the distal end of the catheter (pa. 0321).
Regarding claim 8, Schwartz discloses wherein at least one of the sensor controllers is connected to a subset of the plurality of sensor elements, the subset includes more than one of the plurality of sensor elements (pa. 0342).
Regarding claim 9, Schwartz discloses wherein the sensor elements of the subset measure different physical quantities (pa. 0016).
Regarding claim 10, Schwartz discloses wherein each of the sensor elements measures a pressure, a force, or a temperature (pa. 0016).
Regarding claim 13, Schwartz discloses wherein the sensor elements and the sensor controllers are disposed on a flexible substrate (1208), the first connection is a plurality of traces (micro wires) on the flexible substrate (pa. 0199, 0321).
Regarding claim 14, Schwartz discloses wherein the flexible substrate extends to the proximal end of the catheter (see Figs. 12a-12b).
Regarding claim 17, Schwartz discloses wherein the second connection is a wireless connection (pa. 0335).
Regarding claim 18, Schwartz discloses wherein the catheter has a handle (1428) at the proximal end (pa. 0335 & Fig. 14b), a plurality of arms (1202) at the distal end, and a lumen extending between the handle and the plurality of arms (pa. 0321 & Fig. 12b).
Regarding claim 19, Schwartz discloses wherein the sensor elements, the sensor controllers, and the first connections are positioned in the arms (pa. 0321-0322).
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 7, 11-12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over a first embodiment of Schwartz as applied to claim 1 above, and further in view of a second embodiment of Schwartz.
Regarding claim 7, Schwartz discloses wherein each of the sensor controllers is positioned within a proximity of the at least one of the sensor elements to which the sensor controller is connected (pa. 0321).
However, this embodiment of Shwartz is silent on the specific distance of the sensor controller to the at least one of the sensor elements, and furthermore is silent on the proximity being is less than a largest dimension of the sensor controller.
A different embodiment shown in Figs. 11a-11b describes a microcircuit/ sensor controller (1137) having a width of less than 2mm (pa. 0307), wherein the sensor controller is embedded within 5mm near tines (1103) which houses one or more sensors (1105) (pa. 0316).
While the proximity (within 5mm) is more than the dimension of the sensor controller (the width of less than 2mm), Examiner notes it would be reasonable to consider the described proximity to include any integers between 0-5mm.
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to move the proximity of the sensor controllers closer to the at least one of the sensor elements, at least by a proximity of approximately 1mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 11, Schwartz discloses the invention substantially as claimed in claims 1-2 discussed above.
However, this embodiment does not disclose wherein the sensor controllers are connected to the main controller in a daisy chain.
A different embodiment of Schwartz teaches a basket catheter (1500) shown in Fig. 15a, utilizing microcircuits/sensor controllers (1503), such as custom ASIC circuits, wherein each of the sensor controllers allow for digitally communicating data from the plurality of sensor elements (1502) into a 3 or 4 wire network on the back end (e.g., the wires that run through the catheter body). Such circuits can be daisy-chained to scale up the number of sensing elements without having to increase the number of wires on the back end. Thus, hundreds or thousands of sensing elements can be simultaneously monitored with only a comparatively few number of wires communicating the data from the basket catheter (pa. 0347).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the daisy chain taught by the second embodiment of Schwartz to the catheter structure of the first embodiment for the purpose of allowing the user to simultaneously monitor hundreds or thousands of sensing elements with only a few number of wires communicating the data from the catheter (pa. 0347).
Regarding claim 12, Schwartz discloses the invention substantially as claimed in claims 1 and 5 discussed above.
However, this embodiment does not disclose wherein the sensor controllers are connected to the main controller by a digital bus.
A different embodiment shown in Fig. 11b of Schwartz teaches a monolithic guidewire tip (1101) including one or more tines (1103), wherein each tine includes one or more sensors elements (1105) configured for interfacing with an anatomical site of interest within a body (pa. 0305). The guidewire tip also includes one or more microcircuits/sensor controllers configured to perform one or more functions such as signal routing, multiplexing, demultiplexing, preamplification, signal amplification, filtering processes, etc. The guidewire further includes a substrate with one or more conducting traces placed so as to interconnect the sensors with the microcircuits (pa. 0307). The microcircuit may be configured to communicate with an outside communication module, a controller, or the like, wherein the communication is in the form of a bus protocol such as I2C, 1-wire, SPI, serial, etc. (pa. 0310).
Examiner notes that although only different examples of a bus protocol are explicitly taught, the mere existence of a bus protocol dictates the presence of a digital bus given that these protocols inherently require a digital architecture to function.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the digital bus taught by the second embodiment of Schwartz to the catheter structure of the first embodiment for the purpose of connecting the multiple sensor elements and sensor controller through a single, shared pathway which drastically reduces wiring complexity and allows for rapid, synchronized data transfer.
Regarding claim 20, Schwartz discloses wherein the second connection is a wireless connection (pa. 0335 & Fig. 14b).
However, this embodiment does not disclose wherein the second connection extends through the lumen to the main controller positioned in the handle.
A different embodiment of Schwartz teaches an alternative mapping system wherein a mapping catheter (1405) is coupled with a control handle (1407), wherein the control handle (1407) is coupled to a connector array (1408) and a signal flow controller/main controller (1409) via a plurality of wires (pa. 0334 & Fig. 14a).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the wireless connection taught by the first embodiment of Schwartz with the wired connection of the second embodiment since they are both equivalent variants in the art and they would both yield the same predictable results of providing connection between two electrical components for the purpose of providing treatment to a targeted tissue of a patient.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz as applied to claim 1 above, and further in view of Rowland (U.S. Application No. 20160324443A1).
Regarding claim 15, Schwartz discloses the invention substantially as claimed in claims 1 and 13 discussed above.
However, Schwartz does not disclose wherein at least one of the sensor elements is connected to the flexible substrate by a solder bump on a surface of the flexible substrate.
Rowland, in the same field of endeavor, teaches a medical device comprising a sensor (40) provided with one or more TSVs (947) in the base (80), to electrically connect a base electrode (997) to a bondpad (996B) located on the bottom side of the base. The device further includes a printed circuit board (90) connected to the bondpad using a flipchip connection, such as ball bumping or stud bumping, or any other flipchip technology (pa. 0091 6 Fig. 23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the connection between the sensor elements and the flexible substrate of Schwartz with the flipchip connection, including the solder bump, taught by Rowland in order to shorten the electrical path between the sensor and the substrate.
Regarding claim 16, Schwartz discloses the invention substantially as claimed in claims 1 and 15 discussed above.
However, Schwartz does not disclose wherein the at least one of the sensor elements has a through silicon via connected to the solder bump.
Rowland, in the same field of endeavor, teaches a medical device comprising a sensor (40) provided with one or more TSVs (947) in the base (80), to electrically connect a base electrode (997) to a bondpad (996B) located on the bottom side of the base. The TSVs are made of an electrically conducting material, such a highly doped silicon (pa. 0099). The device further includes a printed circuit board (90) connected to the bondpad using a flipchip connection, such as ball bumping or stud bumping, or any other flipchip technology (pa. 0091 6 Fig. 23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the connection between the sensor elements and the flexible substrate of Schwartz with the flipchip connection, including the through silicon via connected to the solder bump, taught by Rowland in order to shorten the electrical path between the sensor and the substrate.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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