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 (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.
Claims 2-15 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Willis et al. (U.S. Pub. No. 2005/0203375), hereinafter “Willis.”
Regarding claim 2, Willis discloses a body cavity imaging system (“a system… for graphically displaying a three-dimensional model of a region located within a living body… using at least one probe positioned within the living body” Willis, Abstract), comprising:
a catheter (“mapping catheter” Willis, [0107]) configured for delivery to a body cavity defined by surrounding tissue (at least one probe positioned within the living body” Willis, Abstract; “During use the sheath 54 is moved to the distal position to compress the basket before the catheter 14 is inserted into the patient, so that the basket can be easily moved through the patient's vessels and into the patient's heart. Once the basket is within the desired chamber of the patient's heart, the sheath is withdrawn, the basket is opened into its expanded condition, (either by spring action of the arms 52 or by a separate actuator) and the arms to map electrical activity of the chamber wall” Willis, [0110]);
a plurality of ultrasound transducers (“ultrasound transducers 58” Willis, [0112]) coupled to a distal end (“ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]) of the catheter (“ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that the ultrasound transducers are formed on a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13), wherein the plurality of ultrasound transducers are coupled to a 3D array (“ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that the ultrasound transducers are formed on a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13);
an electronics module (“controller 118 directs the ultrasound ranging hardware 116 to initiate an ultrasound pulse from a selected transmitting transducer” Willis, [0143]-[0145]) configured to selectively turn on/off each ultrasound transducer according to a predetermined activation sequence (“controller 118 directs the ultrasound ranging hardware 116 to initiate an ultrasound pulse from a selected transmitting transducer” Willis, [0143]-[0145]) and to process signals received from each ultrasound transducer to produce a 3D display of the surrounding tissue (“a system… for graphically displaying a three-dimensional model of a region located within a living body… using at least one probe positioned within the living body” Willis, Abstract; “It further directs the hardware 116 to (1) detect, in parallel, voltages corresponding to reception of the ultrasound pulse by the receiving transducers… Data corresponding to catheter position, as calculated from transducer locations, and measured EP signals is shown in graphical form on graphical user interface display 124” Willis, [0143]; “System 124 a further includes a transformation component 125 b that deforms the model based on input 127 a from the localization system concerning the 3-D locations of physical characteristics of the heart and displays the model (as so deformed) on the graphical display 124 (FIG. 1). This input is generated by the localization system using time-of-flight data received from one or more probes positioned within or near the heart” Willis, [0205]-[0216]).
Regarding claim 3, Willis discloses the body cavity is a heart chamber and the surrounding tissue is one or more walls of the heart chamber (“During use the sheath 54 is moved to the distal position to compress the basket before the catheter 14 is inserted into the patient, so that the basket can be easily moved through the patient's vessels and into the patient's heart. Once the basket is within the desired chamber of the patient's heart, the sheath is withdrawn, the basket is opened into its expanded condition, (either by spring action of the arms 52 or by a separate actuator) and the arms to map electrical activity of the chamber wall” Willis, [0110]; “The model preferably includes basic anatomical features, which for the heart may include four chambers with their associated boundaries, valves, major vessels and their orifices… System 124 a further includes a transformation component 125 b that deforms the model based on input 127 a from the localization system concerning the 3-D locations of physical characteristics of the heart and displays the model (as so deformed) on the graphical display 124 (FIG. 1). This input is generated by the localization system using time-of-flight data received from one or more probes positioned within or near the heart” Willis, [0204]-[0205]).
Regarding claim 4, Willis discloses presenting the 3D display of the surrounding tissue on a user interface system having a display screen (“A three-dimensional model of a region of interest is displayed on a graphical display” Willis, Abstract; “Three-dimensional images are shown on a video display” Willis, [0009]; graphical user interface display, #124, Fig. 1) and user control mechanism enabling graphical manipulation of the 3D display of the surrounding tissue (“user by manipulating a cursor using a mouse or other user input device… the user can rotate the display… ‘zoom’ towards or away from the image” Willis, [0173]-[0175]; also see Willis, [0196]-[0197] and [0225]-[0226]).
Regarding claim 5, Willis discloses the 3D array is a basket array (“catheter 14 is of the type known in the art as a ‘basket’ catheter” Willis, [0108]; Figure 13 demonstrates that the ultrasound transducers are formed on a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13).
Regarding claim 6, Willis discloses the ultrasound transducers are disposed on a plurality of splines of the 3D array (“ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that the ultrasound transducers are formed on a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13).
Regarding claim 7, Willis discloses the 3D array includes at least three splines (“The basket 50 is formed of preferably eight arms 52” Willis, [0106]).
Regarding claim 8, Willis discloses at least two ultrasound transducers are disposed on each spline (“ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that at least two ultrasound transducers are formed on a single arm of a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13).
Regarding claim 9, Willis discloses the catheter further comprises a plurality of biopotential electrodes coupled to the distal end of the catheter (“mapping electrodes 56… are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]), wherein the biopotential electrodes are also disposed on the plurality of splines of the 3D array (“mapping electrodes 56… are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that mapping electrodes are formed on the arms of a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13).
Regarding claim 10, Willis discloses at least some of the biopotential electrodes and at least some of the ultrasound transducers are disposed on the same splines (“mapping electrodes 56 and the ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]), the biopotential electrodes are also disposed on the plurality of splines of the 3D array (“mapping electrodes 56 and the ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that mapping electrodes and ultrasound transducers are formed on the arms of a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13).
Regarding claim 11, Willis discloses a biopotential electrode and an ultrasound transducer are disposed together to form an electrode/transducer pair (“Copper leads 62 are formed on the flex circuit and each lead is electrically connected to one of the EP electrodes 56 and one of the ultrasound transducers 58, and to the EP and localization hardware 110 (FIG. 1)” Willis, [0112]), and the system includes a plurality of electrode/transducer pairs (“mapping electrodes 56 and the ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that mapping electrodes and ultrasound transducers are formed on the arms of a three-dimensional array structure, i.e. along the arms of a basket catheter, Willis, Fig. 13).
Regarding claim 12, Willis discloses one or more splines comprise a plurality of electrode/transducer pairs (“mapping electrodes 56 and the ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that at least two pairs of mapping electrodes and ultrasound transducers are formed on at least one arm, Willis, Fig. 13).
Regarding claim 13, Willis discloses a plurality of splines comprise at least one electrode/transducer pair (“mapping electrodes 56 and the ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]; Figure 13 demonstrates that at least two pairs of mapping electrodes and ultrasound transducers are formed on two or more arms, Willis, Fig. 13).
Regarding claim 14, Willis discloses each spline comprises a flexible PCB (“mapping electrodes 56 and the ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52” Willis, [0112]), and each electrode/transducer pair is electrically coupled to the flexible PCB (“the mapping electrodes 56 and ultrasound transducers 58 are preferably formed on a flex circuit 60 which is attached to the arm 52. Copper leads 62 are formed on the flex circuit and each lead is electrically connected to one of the EP electrodes 56 and one of the ultrasound transducers 58, and to the EP and localization hardware 110 (FIG. 1)” Willis, [0012]).
Regarding claim 15, Willis discloses each electrode/transducer pair shares a common communication path (“Copper leads 62 are formed on the flex circuit and each lead is electrically connected to one of the EP electrodes 56 and one of the ultrasound transducers 58, and to the EP and localization hardware 110 (FIG. 1)” Willis, [0012]).
Regarding claim 18, Willis discloses further configured to correlate cardiac or other electrical activity to one or more images generated using an imaging device (“the three-dimensional positions of the integrated ultrasound transducers (such as those on catheters 10, 12, 14 and 16) may be continuously displayed in real-time on the graphical user interface display 124 (FIG. 1)… the three-dimensional when EP signals are recorded from catheters having Integrated localization transducers, the relative position/location information for the EP electrodes is accurate when displayed because all of the location information will have been collected during the same phase of the cardiac cycle… The user preferably has the option of showing the gated position, or the actual (moving) position, or both on the real time display… Similarly, if EP signals are to be displayed in the form of an isochronal map on the three-dimensional display, the position used in the isochronal map to display an activation time for that location should be an EKG gated location” Willis, [0161]-[0172]; also see Willis, [0225]) using an imaging device (“basket catheter 14 (FIG. 13) is next introduced under fluoroscopy into the left ventricle (LV), at a location at which the clinician suspects there may be arrhythmogenic tissue. Step 210. Because the basket arms 52 include ultrasound transducers 58 as well as mapping electrodes 56, the locations of the mapping electrodes can be determined relative to the reference catheters and displayed on the graphical display based on a model of the basket 50 programmed into the system.” Willis, [0185]; also see Willis, [0218]).
Regarding claim 19, Willis discloses the imaging device comprise a fluoroscope (“basket catheter 14 (FIG. 13) is next introduced under fluoroscopy into the left ventricle (LV), at a location at which the clinician suspects there may be arrhythmogenic tissue. Step 210. Because the basket arms 52 include ultrasound transducers 58 as well as mapping electrodes 56, the locations of the mapping electrodes can be determined relative to the reference catheters and displayed on the graphical display based on a model of the basket 50 programmed into the system” Willis, [0185]; also see Willis, [0218]); an MRI; a CT Scanner; an ultrasound imaging device; and combinations of two or more of these.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Willis as in claim 11 above, or, in the alternative, Willis in further view of Salahieh et al. (U.S. Pub. No. 2016/0051321), hereinafter “Salahieh.”
Regarding claim 16, Willis teaches all electrode/transducer pairs on a spline share a common communication path (“Copper leads 62 are formed on the flex circuit and each lead is electrically connected to one of the EP electrodes 56 and one of the ultrasound transducers 58, and to the EP and localization hardware 110 (FIG. 1)” Willis, [0012]).
It is noted that under the BRI of the claim, if only a single electrode/transducer pair is disposed on at least one arm then the common communication between all one pair of the single electrode and single transducer is taught by Willis. Furthermore, it would have been obvious to one having ordinary skill in the art to have modified Willis’ teaching of providing common communication paths between electrode/transducer pairs as the specific feature of a common communication path between one or more electrodes and one or more transducers on a spline would be well-known to one of ordinary skill in the art before the effective filing date of the claimed invention and the teachings of Willis would be easily modified in such a manner.
Additionally, or, in the alternative, while Willis teaches common communication paths between electrode/transducer pairs, Willis may not explictly teach all electrode/transducer pairs on a spline share a common communication path.
However, in solving the same problem of providing electrodes and ultrasound transducers on a catheter, Salahieh teaches all electrode/transducer pairs on a spline share a common communication path (“the elastomeric electrodes may be used as common return… more than one transponding element for use in a phased array configuration” Salahih, [0226]-[0227]; Figures 52A and 52B demonstrate multiple transducers that share a common return line via the elastomeric electrode).
It would have been obvious to one having ordinary skill in the art to have modified Willis’ teaching of providing common communication paths between electrode/transducer pairs with Salahieh’s teaching that a plurality of ultrasound transducers and electrodes may share a common return as Salahieh explictly states that “[a]lthough FIGS. 51A-C illustrate control circuitry associated with single element UTs one skilled in the art can easily modify the disclosure herein to accommodate the additional control circuitry required to control the additional elements. Other configurations incorporating more or fewer UT elements are also conceived herein”. Thus, the specific feature of a common communication path between one or more electrodes and one or more transducers on a spline would be well-known to one of ordinary skill in the art before the effective filing date of the claimed invention and the teachings of Willis and/or Salahieh would be easily modified in such a manner.
Regarding claim 17, Willis teaches all electrode/transducer pairs on a spline share a common ground (“Copper leads 62 are formed on the flex circuit and each lead is electrically connected to one of the EP electrodes 56 and one of the ultrasound transducers 58, and to the EP and localization hardware 110 (FIG. 1)” Willis, [0012], wherein one of the leads in a twisted pair of conductors is ground and the other is signal).
It is noted that under the BRI of the claim, if only a single electrode/transducer pair is disposed on at least one arm then the common communication between all one pair of the single electrode and single transducer is taught by Willis. Furthermore, it would have been obvious to one having ordinary skill in the art to have modified Willis’ teaching of providing common communication paths between electrode/transducer pairs as the specific feature of a common communication path between one or more electrodes and one or more transducers on a spline would be well-known to one of ordinary skill in the art before the effective filing date of the claimed invention and the teachings of Willis would be easily modified in such a manner.
Additionally, or, in the alternative, while Willis teaches common communication paths between electrode/transducer pairs, Willis may not explictly teach all electrode/transducer pairs on a spline share a common ground.
However, in solving the same problem of providing electrodes and ultrasound transducers on a catheter, Salahieh all electrode/transducer pairs on a spline share a common ground (“the elastomeric electrodes may be used as common return… more than one transponding element for use in a phased array configuration” Salahih, [0226]-[0227]; Figures 52A and 52B demonstrate multiple transducers that share a common return line via the elastomeric electrode).
It would have been obvious to one having ordinary skill in the art to have modified Willis’ teaching of providing common communication paths between electrode/transducer pairs with Salahieh’s teaching that a plurality of ultrasound transducers and electrodes may share a common return as Salahieh explictly states that “[a]lthough FIGS. 51A-C illustrate control circuitry associated with single element UTs one skilled in the art can easily modify the disclosure herein to accommodate the additional control circuitry required to control the additional elements. Other configurations incorporating more or fewer UT elements are also conceived herein”. Thus, the specific feature of a common communication path between one or more electrodes and one or more transducers on a spline would be well-known to one of ordinary skill in the art before the effective filing date of the claimed invention and the teachings of Willis and/or Salahieh would be easily modified in such a manner.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Willis as in claim 2 above, or, in the alternative, Willis in further view of Nohara et al. (U.S. Pub. No. 2003/0163046), hereinafter “Nohara.”
Regarding claim 20, Willis teaches the activation sequence comprises a pattern of turning on/off the plurality of ultrasound transducers (“controller 118 directs the ultrasound ranging hardware 116 to initiate an ultrasound pulse from a selected transmitting transducer” Willis, [0143]-[0145]; (“can both transmit and receive ultrasound signals, the close proximity of the transmitting and receiving lines can cause the ringing to cross over to the receiving line… If the transmitting and receiving transducers are far apart, a receive signal on a receiving line (such as twisted pair 26) will be measured by the ultrasound system circuitry despite the ringing, because transmission of the receive signal on the receiving line will happen only after the ringing has diminished. See FIG. 28B. However, if the transmitting and receiving transducers are close together (i.e., separated by less than approximately 2 cm), the receive pulse will be lost in the ringing on the receive line, because the receive pulse will reach the receiving line while the ringing is still occurring. See FIG. 28C” Willis, [0153]-[0154]; “The transducers 18 are piezoelectric transducers capable of transmitting and receiving ultrasound signals. The reference catheters can be integrated with typical EP catheters by providing the ultrasound transducers described above” Willis, [0089] and “transducers 18 are spaced from one another along the catheter 20 (FIG. 3) by a distance of approximately 0.5-10 cm, and most preferably 1-3 cm” Willis, [0093], ], thereby, Willis teaches that sequential activation of a first transducer in a first time period and a second transducer in a subsequent time period wherein the first transducer is in close proximity to the second transducer (i.e., ‘adjacent’ or ‘neighboring’ transducers) must be avoided to prevent the receive pulse being lost on the receive line due to ringing. Willis further teaches that the transducers are, therefore, spaced apart such that each first transducer is not positioned within close proximity to each second transducer, i.e., first and second transducers are spaced apart such that they are not ‘neighboring’ and transducers that are neighboring are, thereby, not sequentially activated during the hold off period after the first of the adjacent transducers is activated; Additionally and alternatively, the sequential activation of ultrasound transducers is implicit to an ultrasound imaging procedure in 2D/3D (e.g. ultrasound beamforming, ring-down, transducer or electrode position relative to ROI) and thus selecting different activation sequences/patterns would be one of several straightforward options the skilled person would consider to obtain 2D/3D images with and ultrasound array (or to minimize interference) without undue burden), that avoids a sequential activation of two neighboring ultrasound transducers (“can both transmit and receive ultrasound signals, the close proximity of the transmitting and receiving lines can cause the ringing to cross over to the receiving line… If the transmitting and receiving transducers are far apart, a receive signal on a receiving line (such as twisted pair 26) will be measured by the ultrasound system circuitry despite the ringing, because transmission of the receive signal on the receiving line will happen only after the ringing has diminished. See FIG. 28B. However, if the transmitting and receiving transducers are close together (i.e., separated by less than approximately 2 cm), the receive pulse will be lost in the ringing on the receive line, because the receive pulse will reach the receiving line while the ringing is still occurring. See FIG. 28C” Willis, [0153]-[0154]; “The transducers 18 are piezoelectric transducers capable of transmitting and receiving ultrasound signals. The reference catheters can be integrated with typical EP catheters by providing the ultrasound transducers described above” Willis, [0089] and “transducers 18 are spaced from one another along the catheter 20 (FIG. 3) by a distance of approximately 0.5-10 cm, and most preferably 1-3 cm” Willis, [0093], thereby, Willis teaches that sequential activation of a first transducer in a first time period and a second transducer in a subsequent time period wherein the first transducer is in close proximity to the second transducer (i.e., ‘adjacent’ or ‘neighboring’ transducers) must be avoided to prevent the receive pulse being lost on the receive line due to ringing. Willis further teaches that the transducers are, therefore, spaced apart such that each first transducer is not positioned within close proximity to each second transducer, i.e., first and second transducers are spaced apart such that they are not ‘neighboring’ and transducers that are neighboring are, thereby, not sequentially activated during the hold off period after the first of the adjacent transducers is activated; Additionally and alternatively, the sequential activation of ultrasound transducers is implicit to an ultrasound imaging procedure in 2D/3D (e.g. ultrasound beamforming, ring-down, transducer or electrode position relative to ROI) and thus selecting different activation sequences/patterns would be one of several straightforward options the skilled person would consider to obtain 2D/3D images with and ultrasound array (or to minimize interference) without undue burden).
Additionally, or, in the alternative, while Willis teaches the activation sequence comprises a pattern of turning on/off the plurality of ultrasound transducer and spacing between two transducers being more than one electrode apart (“transducers 18 are spaced from one another along the catheter 20 (FIG. 3) by a distance of approximately 0.5-10 cm, and most preferably 1-3 cm” Willis, [0093], thereby, transducers that are close together (i.e. adjacent) are not sequentially activated during the hold off period after the first of the adjacent transducers is activated; “Preferably, the mapping electrodes 56 and the ultrasound transducers 58 alternate with each other along the length of each arm 52, although there need not be one-to-one correspondence between the transducers and electrodes” Willis, [0111]), Willis may not explictly teach the activation sequence avoids the sequential activation of two neighboring transducers.
However, in the same field of endeavor of tissue imaging and solving the same problem of performing sequential imaging, Nohara teaches the activation sequence avoids the sequential activation of two neighboring transducers (“transmitted and receive energy along a particular beam or scan line 14, 16… sequential scanning, any given beam line is offset from all of the other beam lines in the azimuth direction.” Nohara, [0007]; Nohara, Fig. 3A demonstrates an activation sequence wherein each subsequently activated transducer is not adjacent to, but is rather offset from, the previously activated transducer by a spacing of at least two transducers).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized Nohara’s teaching of sequential scanning between non-adjacent transducers with Willis’ teaching of selectively activating transducers located along the arms of a basket catheter as locating transducer elements along arms can allow for the transducers to be positioned/moved more easily, and in different configurations including forming a compact shape for easier deployment within the body. Additionally, or, in the alternative, the sequential activation of ultrasound transducers is implicit to an ultrasound imaging procedure in 2D/3D (e.g. ultrasound beamforming, ring-down, transducer or electrode position relative to ROI) and thus selecting different activation sequences/patterns would be one of several straightforward options the skilled person would consider to obtain 2D/3D images with and ultrasound array (or to minimize interference) without undue burden.
Regarding claim 21, Willis teaches the activation sequence avoids the sequential activation of two transducers within two or three neighboring spaces of each other (“can both transmit and receive ultrasound signals, the close proximity of the transmitting and receiving lines can cause the ringing to cross over to the receiving line… If the transmitting and receiving transducers are far apart, a receive signal on a receiving line (such as twisted pair 26) will be measured by the ultrasound system circuitry despite the ringing, because transmission of the receive signal on the receiving line will happen only after the ringing has diminished. See FIG. 28B. However, if the transmitting and receiving transducers are close together (i.e., separated by less than approximately 2 cm), the receive pulse will be lost in the ringing on the receive line, because the receive pulse will reach the receiving line while the ringing is still occurring. See FIG. 28C” Willis, [0153]-[0154]; “The transducers 18 are piezoelectric transducers capable of transmitting and receiving ultrasound signals. The reference catheters can be integrated with typical EP catheters by providing the ultrasound transducers described above” Willis, [0089] and “transducers 18 are spaced from one another along the catheter 20 (FIG. 3) by a distance of approximately 0.5-10 cm, and most preferably 1-3 cm” Willis, [0093], thereby, transducers that are close together (i.e. adjacent) are not sequentially activated during the hold off period after the first of the adjacent transducers is activated; “Preferably, the mapping electrodes 56 and the ultrasound transducers 58 alternate with each other along the length of each arm 52, although there need not be one-to-one correspondence between the transducers and electrodes” Willis, [0111]). Additionally, or, in the alternative, the sequential activation of ultrasound transducers is implicit to an ultrasound imaging procedure in 2D/3D (e.g. ultrasound beamforming, ring-down, transducer or electrode position relative to ROI) and thus selecting different activation sequences/patterns would be one of several straightforward options the skilled person would consider to obtain 2D/3D images with and ultrasound array (or to minimize interference) without undue burden.
Additionally, or, in the alternative, while Willis teaches the activation sequence comprises a pattern of turning on/off the plurality of ultrasound transducer and spacing between two transducers being more than one electrode apart (“transducers 18 are spaced from one another along the catheter 20 (FIG. 3) by a distance of approximately 0.5-10 cm, and most preferably 1-3 cm” Willis, [0093], thereby, transducers that are close together (i.e. adjacent) are not sequentially activated during the hold off period after the first of the adjacent transducers is activated; “Preferably, the mapping electrodes 56 and the ultrasound transducers 58 alternate with each other along the length of each arm 52, although there need not be one-to-one correspondence between the transducers and electrodes” Willis, [0111]), Willis may not explictly teach the activation sequence avoids the sequential activation of two transducers within two or three neighboring spaces of each other.
However, in the same field of endeavor of tissue imaging and solving the same problem of performing sequential imaging, Nohara teaches the activation sequence avoids the sequential activation of two transducers within two or three neighboring spaces of each other (“transmitted and receive energy along a particular beam or scan line 14, 16… sequential scanning, any given beam line is offset from all of the other beam lines in the azimuth direction.” Nohara, [0007]; Nohara, Fig. 3A demonstrates an activation sequence wherein each subsequently activated transducer is not adjacent to, but is rather offset from, the previously activated transducer by a spacing of at least two transducers).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized Nohara’s teaching of sequential scanning between non-adjacent transducers with Willis’ teaching of selectively activating transducers located along the arms of a basket catheter as locating transducer elements along arms can allow for the transducers to be positioned/moved more easily, and in different configurations including forming a compact shape for easier deployment within the body. Additionally, or, in the alternative, the sequential activation of ultrasound transducers is implicit to an ultrasound imaging procedure in 2D/3D (e.g. ultrasound beamforming, ring-down, transducer or electrode position relative to ROI) and thus selecting different activation sequences/patterns would be one of several straightforward options the skilled person would consider to obtain 2D/3D images with and ultrasound array (or to minimize interference) without undue burden.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘366 Patent discloses a body cavity imaging system (col. 24, line 61), comprising:
a catheter configured for delivery to a body cavity defined by surrounding tissue (col. 24, lines 62-63);
a plurality of ultrasound transducers coupled to a distal end of the catheter, wherein the plurality of ultrasound transducers are coupled to a 3D array (col. 24, lines 64-67);
an electronics module configured to selectively turn on/off each ultrasound transducer according to a predetermined activation sequence and to process signals received from each ultrasound transducer to produce a 3D display of the surrounding tissue (col. 25, lines 7-11).
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of the ‘366 Patent discloses the body cavity is a heart chamber and the surrounding tissue is one or more walls of the heart chamber (col. 25, lines 19-21).
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of the ‘366 Patent discloses the 3D display of the surrounding tissue is presented on a user interface system having a display screen and user control mechanism enabling graphical manipulation of the 3D display of the surrounding tissue (col. 25, lines 22-26).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of the ‘366 Patent discloses the 3D array is a basket array, spiral array, a balloon, radially deployable arms, and/or other expandable and compactible structures (col. 25, lines 27-29).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘366 Patent discloses the ultrasound transducers are disposed on a plurality of splines of the 3D array (col. 24, lines 64-66).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of the ‘366 Patent discloses the 3D array includes at least three splines (col. 25, lines 30-31).
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 6 of the ‘366 Patent discloses at least two ultrasound transducers are disposed on each spline (col. 25, lines 32-33).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘366 Patent discloses a plurality of biopotential electrodes coupled to the distal end of the catheter, wherein the biopotential electrodes are also disposed on the plurality of splines of the 3D array (col. 25, lines 1-2).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of the ‘366 Patent discloses at least some of the biopotential electrodes and at least some of the ultrasound transducers are disposed on the same splines (col. 25, lines 34-36).
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘366 Patent discloses a biopotential electrode and an ultrasound transducer are disposed together to form an electrode/transducer pair, and the system includes a plurality of electrode/transducer pairs (col. 25, lines 2-6).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 8 of the ‘366 Patent discloses one or more splines comprise a plurality of electrode/transducer pairs (col. 26, lines 1-2).
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of the ‘366 Patent discloses a plurality of splines comprise at least one electrode/transducer pair (col. 25, lines 3-4).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of the ‘366 Patent discloses each spline comprises a flexible PCB, and each electrode/transducer pair is electrically coupled to the flexible PCB (col. 26, lines 5-7).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of the ‘366 Patent discloses each electrode/transducer pair shares a common communication path (col. 26, lines 8-9).
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of the ‘366 Patent discloses all electrode/transducer pairs on a spline share a common communication path (col. 26, lines 10-12).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 13 of the ‘366 Patent discloses all electrode/transducer pairs on a spline share a common ground (cool. 26, 13-14).
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of the ‘366 Patent discloses further configured to correlate cardiac or other electrical activity to one or more images generated using an imaging device (col. 26, lines 15-17).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 15 of the ‘366 Patent discloses the imaging device comprise an imaging device selected from the group consisting of:
a fluoroscope;
an MRI;
a CT Scanner;
an ultrasound imaging device; and
combinations of two or more of these (col. 26, lines 18-23).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,344,366. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of the ‘366 Patent discloses the activation sequence comprises a pattern of turning on/off the plurality of ultrasound transducers that avoids a sequential activation of two neighboring ultrasound transducers (col. 26, lines 24-27).
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,344,366 in view of Nohara.
Regarding claim 21, while claim 16 of the ‘366 Patent discloses the limitations of claim 20 as detailed above, claim 16 of the ‘366 Patent does not appear to disclose the activation sequence avoids the sequential activation of two transducers within two or three neighboring spaces of each other.
However, in the same field of endeavor of tissue imaging and solving the same problem of performing sequential imaging, Nohara teaches the activation sequence avoids the sequential activation of two transducers within two or three neighboring spaces of each other (“transmitted and receive energy along a particular beam or scan line 14, 16… sequential scanning, any given beam line is offset from all of the other beam lines in the azimuth direction.” Nohara, [0007]; Nohara, Fig. 3A demonstrates an activation sequence wherein each subsequently activated transducer is not adjacent to, but is rather offset from, the previously activated transducer by a spacing of at least two transducers).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized Nohara’s teaching of sequential scanning between non-adjacent transducers with claim 1 of the ‘366 Patent’s teaching of sequential activation of transducers located along the splines of a 3D array such that neighboring ultrasound transducers are not sequentially activated in two consecutive activation periods as locating transducer elements along arms can allow for the transducers to be positioned/moved more easily, and in different configurations including forming a compact shape for easier deployment within the body. Additionally, or, in the alternative, the sequential activation of ultrasound transducers is implicit to an ultrasound imaging procedure in 2D/3D (e.g. ultrasound beamforming, ring-down, transducer or electrode position relative to ROI) and thus selecting different activation sequences/patterns would be one of several straightforward options the skilled person would consider to obtain 2D/3D images with and ultrasound array (or to minimize interference) without undue burden.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,161,398. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘398 Patent discloses a body cavity imaging system (col. 24, line 65), comprising:
a catheter configured for delivery to a body cavity defined by surrounding tissue (col. 24, lines 66-67);
a plurality of ultrasound transducers coupled to a distal end of the catheter, wherein the plurality of ultrasound transducers are coupled to a 3D array (col. 25, lines 1-3);
an electronics module configured to selectively turn on/off each ultrasound transducer according to a predetermined activation sequence (col. 25, lines 4-7) and to process signals received from each ultrasound transducer to produce