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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112b
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 7, 11, 13, and dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and recites limitations relating to the drain wire that is deemed indefinite, specifically “wherein the drain wire is configured to comprise a less restrictive route than the shield strip”. It is understood in the art that drain wires are a reliable path to ground for electrical noise captured by a cable’s metallic shield and it is interpreted in the claim to function as such.
It is unclear what “a less restrictive route” is to be interpreted as. It could be a physical path or an electrical path. Either is considered a viable interpretation and as such, this term is considered indefinite.
If it is to be interpreted in an electrical sense, it is indefinite as to where the route leads or ends. Presumably in order to function as a drain wire it must eventually connect to ground, but the claim’s later limitations indicate that the drain wire is isolated from the ground and the shield strip. This appears to be a contradiction.
Claim 1 further recites “wherein the drain wire is isolated from the ground, and wherein the drain wire is isolated from the shield strip”. This is indefinite since “isolated” can be interpreted in more than one manner, i.e. at least physical, electrical, and possibly other viable interpretations. If it is meant to be interpreted in an electrical sense, it is interpreted to mean that the drain wire is electrically floating since it is not connected to ground and as such it is unclear then how it would function as a drain wire.
Claim 13 contains related indefiniteness issues regarding how “to attract noise away from the ground and the shield strip” and the drain wire being isolated from the ground and shield strip.
Claim 4 is deemed indefinite since claim 1 requires that cable bundle comprises the shield strip but claim 4 requires that the shield strip is disposed over the cable bundle, i.e. interpreted as not part of the cable bundle, which is in contradiction to claim 1.
Claim 7 is deemed indefinite. It is unclear what this claim limitation means: “cable bundle extends radially outside of a plurality of printed circuit boards”.
Claim 11 recites “reduce a centerline”. It is unclear what a “centerline” is. The specification appears to mention this only once at 0155 and does not adequately describe it. It is unclear if it is something related to imaging or a function of an imager or if it simply is a noise artifact the lines up in the center of the image.
Indefiniteness will be interpreted as provided in the rejection.
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.
Claim(s) 1-7, 11-16, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parchak US2008/0306380 and further in view of Suzuki 20090235521.
Parchak discloses for claim 1, “An ultrasound imaging catheter (fig 1; 0032), comprising:
an elongate shaft (fig 1; 0032 catheter 22 comprises an insertion tube) sized and configured to be advanced within a patient;
a handle (connector assembly 28; fig 1; 0031, 0040) sized and positioned to remain outside of the patient;
a distal tip including an ultrasound transducer (sensor 36; 0033, 0042, and 0045; distal end 34 of catheter 22 may also comprise one or more functional elements... For example an ultrasound transducer; sensor 36; Examples of such sensors may include… ultrasonic transducers);
an elongate cable bundle in communication with the ultrasound transducer, the elongate cable bundle passing through the elongate shaft and extending into the handle (fig 7; 0042; connected via cables 64 running through catheter 22),
wherein the elongate cable bundle comprises a shield strip (fig 7 shows the shield layer 70), a ground (ground line 74)”.
Parchak does not disclose “a drain wire, wherein the drain wire is configured to comprise a less restrictive route than the shield strip, wherein the drain wire is configured to comprise a less restrictive route than the ground, wherein the drain wire is isolated from the ground, and wherein the drain wire is isolated from the shield strip”. Suzuki teaches in the same field of endeavor, providing a drain wire so that electrical noise can be effectively reduced (0208). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Suzuki into the invention of Parchak in order to configure the imaging catheter e.g. as claimed because it helps to reduce electrical noise (0208).
Parchak discloses for claim 2, “The ultrasound imaging catheter of Claim 1, wherein the shield strip is isolated from the ground (based on the indefiniteness, it is interpreted that the shield strip is eventually connected to the ground, fig 7 shows the shield layer 70)”.
Parchak does not disclose for claim 3, “The ultrasound imaging catheter of Claim 1, wherein the shield strip is braided”, but rather does not detail the configuration of the shield strip. Suzuki teaches in the same field of endeavor, a braided shield layer (0005). Since Parchak fails to disclose the nature of the shield strip, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable configuration known in the art, including the one taught by Suzuki to achieve the predictable result of a braided shield layer.
Parchak discloses for claim 4, “The ultrasound imaging catheter of Claim 3, wherein the shield strip is disposed over the elongate cable bundle (fig 7 shows shield strip 70 as an outer covering for the cables 64)”.
Parchak discloses for claim 5, “The ultrasound imaging catheter of Claim 1, wherein the elongate cable bundle is coupled to a plurality of printed circuit boards that are secured within the handle” a circuit board 50; fig 6; 0039. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parchak to utilize multiple circuit boards as necessitated by the need to add additional electrical components or to split the circuit board into multiples ones in order to provide modularity.
Parchak discloses for claim 6, “The ultrasound imaging catheter of Claim 1, wherein the elongate cable bundle extends from a proximal end of an elongate shaft that is disposed within the handle (fig 7)”.
Parchak discloses for claim 7, “The ultrasound imaging catheter of Claim 1, wherein the elongate cable bundle extends radially outside of a plurality of printed circuit boards that are disposed within the handle (fig 6 shows a radial component of the extension of the cable, i.e. perpendicular to the board)”.
Modified Parchak discloses for claim 11, “The ultrasound imaging catheter of Claim 1, wherein the drain wire is configured to reduce a centerline on an image captured by the ultrasound transducer (Suzuki: 0208 centerline considered to be electrical noise)”.
Parchak discloses for claim 12, “The ultrasound imaging catheter of Claim 1, wherein the drain wire is configured to reduce grating lobe noise artifact on an image captured by the ultrasound transducer (Suzuki: 0208 drain wire is considered to help reduce noise artifacts)”.
Modified Parchak discloses for claim 13 (as provided in claim 1), “An ultrasound imaging catheter, comprising:
an elongate shaft (fig 1; 0032 catheter 22 comprises an insertion tube) sized and configured to be advanced within a patient;
a handle (connector assembly 28; fig 1; 0031, 0040) sized and positioned to remain outside of the patient;
a distal tip including an ultrasound transducer (sensor 36; 0033, 0042, and 0045; distal end 34 of catheter 22 may also comprise one or more functional elements... For example an ultrasound transducer; sensor 36; Examples of such sensors may include… ultrasonic transducers);
an elongate cable bundle in communication with the ultrasound transducer, the elongate cable bundle passing proximally through the elongate shaft and extending into the handle (fig 7; 0042; connected via cables 64 running through catheter 22),
wherein the elongate cable bundle comprises a shield strip (fig 7 shows the shield layer 70), a ground (ground line 74), and a drain wire, wherein the drain wire is configured to attract noise away from the ground and the shield strip, wherein the drain wire is isolated from the ground, and wherein the drain wire is isolated from the shield strip (Suzuki: 0208)”.
Parchak discloses for claim 14, “The ultrasound imaging catheter of Claim 13, wherein the cable bundle is coupled to a plurality of printed circuit boards that are disposed within the handle” a circuit board 50; fig 6; 0039. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parchak to utilize multiple circuit boards as necessitated by the need to add additional electrical components or to split the circuit board into multiples ones in order to provide modularity.
Parchak discloses for claim 15, “The ultrasound imaging catheter of Claim 13, wherein the cable bundle extends from a proximal end of an elongate shaft within the handle (fig 7)”.
Parchak discloses for claim 16, “The ultrasound imaging catheter of Claim 15, wherein the cable bundle extends radially outside of a plurality of printed circuit boards that are disposed within the handle (fig 6 shows a radial component of the extension of the cable, i.e. perpendicular to the board)”.
Modified Parchak discloses for claim 20, “The ultrasound imaging catheter of Claim 13, wherein the drain wire is configured to reduce a centerline on an image captured by the ultrasound transducer (Suzuki: 0208 centerline considered to be electrical noise)”.
Claim(s) 8, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parchak and Suzuki as applied to claim 1 above, and further in view of Masters US2007/0167827.
Parchak does not disclose for claim 8. The ultrasound imaging catheter of Claim 1, wherein the elongate cable bundle passes between first and second of a plurality of printed circuit boards that are disposed within the handle.
Masters, however, teaches an ultrasound imaging catheter (Paragraphs [0026] and [0030]; medical imaging system) wherein the cable bundle (Paragraphs [0027]-[0029] and [0037]; Coax line and STP, Fig. 4 #1110 and 1120) passes between first (Paragraph [0028]; first PCB, Fig. 4) and second of a plurality of printed circuit boards (Paragraph [0029]; second PCB, Fig. 5 #1200; Examiner notes the coax line and STP run between the two PCBs as shown in Figs. 4 and 5 where the two cables connect the hub to the MDU) that are disposed within the handle (Paragraph [0026]; Fig. 3, portion of the device comprising the hub #1040 and MDU #1010; The first and second PCBs are within the hub and MDU as shown in Figs. 4 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Parchak in view of Masters such that the cable bundle passes between first and second of a plurality of printed circuit boards that are disposed within the handle as it would allow the second PCB to electrically isolate the signals from the catheter from the systems ground, resulting in the desirable patient isolation which helps reduce noise in the system (Masters, Paragraph [0031]).
Parchak does not disclose for claim 17, “The ultrasound imaging catheter of Claim 15, wherein the cable bundle passes between first and second of a plurality of printed circuit boards that are disposed within the handle”.
Masters, however, teaches an ultrasound imaging catheter (Paragraphs [0026] and [0030]; medical imaging system) wherein the cable bundle (Paragraphs [0027]-[0029] and [0037]; Coax line and STP, Fig. 4 #1110 and 1120) passes between first (Paragraph [0028]; first PCB, Fig. 4) and second of a plurality of printed circuit boards (Paragraph [0029]; second PCB, Fig. 5 #1200; Examiner notes the coax line and STP run between the two PCBs as shown in Figs. 4 and 5 where the two cables connect the hub to the MDU) that are disposed within the handle (Paragraph [0026]; Fig. 3, portion of the device comprising the hub #1040 and MDU #1010; The first and second PCBs are within the hub and MDU as shown in Figs. 4 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Parchak in view of Masters such that the cable bundle passes between first and second of a plurality of printed circuit boards that are disposed within the handle as it would allow the second PCB to electrically isolate the signals from the catheter from the systems ground, resulting in the desirable patient isolation which helps reduce noise in the system (Masters, Paragraph [0031]).
Claim(s) 9, 10, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parchak and Suzuki as applied to claim 1 above, and further in view of Schaer US2018/0279994.
Parchak does not disclose for claim 9, “The ultrasound imaging catheter of Claim 1, wherein the cable bundle includes a movable portion that is axially moveable within the handle”.
Schaer, however, teaches an ultrasound imaging catheter (Paragraph [0099]; ultrasound tool), wherein the cable bundle (Paragraph [0161]; conductor bundle, Fig. 19 #2020) is axially moveable within the handle (Paragraph [0195]; the bundle 2020 with or without shaft 1210 such that it may rotationally wind or unwind and translate axially back and forth).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Parchak in view of Aoki such that the cable bundle is axially moveable within the handle as it would allow accommodation of the translation and rotation of the tool during use, thus relieving strain from the tool (Schaer, Paragraph [0195]).
Parchak does not disclose for claim 10, “The ultrasound imaging catheter of Claim 1, wherein the cable bundle is not adapted to be moved axially within the handle after the handle is assembled”.
Schaer, however, teaches an ultrasound imaging catheter (Paragraph [0099]; ultrasound tool), wherein the cable bundle (Paragraphs [0160] and [0161]; conductor bundle, Fig. 19 #2020; the tool portion #1212 comprises the conductor bundle #2020) is axially immoveable within the handle (Paragraphs [0134] and [0210]; Tool lock #1955, which in FIG. 8 is disposed within the body of handle #1206, is secured to tool portion #1212 and may have one or more functions to constrain movement within sheath #1202; constraining the axial motion of tool #1212).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Parchak in view of Aoki such that the cable bundle is not adapted to be moved axially within the handle after the handle is assembled as it would have prevented the tip of the tool from entering the sheath where it may be rendered non-functional (Schaer, Paragraph [0134]).
Parchak does not disclose for claim 18, “The ultrasound imaging catheter of Claim 13, wherein the cable bundle is axially moveable within the handle”.
Schaer, however, teaches an ultrasound imaging catheter (Paragraph [0099]; ultrasound tool), wherein the cable bundle (Paragraph [0161]; conductor bundle, Fig. 19 #2020) is axially moveable within the handle (Paragraph [0195]; the bundle 2020 with or without shaft 1210 such that it may rotationally wind or unwind and translate axially back and forth).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Parchak in view of Aoki such that the cable bundle is axially moveable within the handle as it would allow accommodation of the translation and rotation of the tool during use, thus relieving strain from the tool (Schaer, Paragraph [0195]).
Parchak does not disclose for claim 19, “The ultrasound imaging catheter of Claim 13, wherein the cable bundle is axially immoveable within the handle”.
Schaer, however, teaches an ultrasound imaging catheter (Paragraph [0099]; ultrasound tool), wherein the cable bundle (Paragraphs [0160] and [0161]; conductor bundle, Fig. 19 #2020; the tool portion #1212 comprises the conductor bundle #2020) is axially immoveable within the handle (Paragraphs [0134] and [0210]; Tool lock #1955, which in FIG. 8 is disposed within the body of handle #1206, is secured to tool portion #1212 and may have one or more functions to constrain movement within sheath #1202; constraining the axial motion of tool #1212).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Parchak in view of Aoki such that the cable bundle is not adapted to be moved axially within the handle after the handle is assembled as it would have prevented the tip of the tool from entering the sheath where it may be rendered non-functional (Schaer, Paragraph [0134]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/27/26
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