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 .
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 03/18/2026. Claims 1-20 are pending. Claims 1, 5, and 15 have been amended. Claims 10 and 11 have been cancelled. Claims 1-9, and 12-20 are rejected under 35 U.S.C. 102/103 for the reasons stated in the Response to Arguments and 35 U.S.C. 102/103 sections below.
Response to Arguments
Applicant’s arguments, see Remarks page 7, filed 03/18/2026 with respect to the objections to the drawings and claims have been fully considered and are persuasive.
The examiner acknowledges that the Applicant has filed corrected drawings to include the reference sign 38 in the FIGS. 1-5. Furthermore, the Applicant has filed a correction to the specification to include the label 42 with respect to claim 9. Furthermore, claims 1 and 15 have been amended to chance “the body member” to “the elongated flexible body member” to avoid antecedent basis issues. The objections to the drawings and claims in the non-final rejection of 09/19/2025 has been withdrawn.
Applicant’s arguments, see Remarks page 7-8, filed 03/18/2026 with respect to the rejection of claims 15 and 17-20 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 10-11, and 13 of US 10,231,701 B2 have been fully considered and are persuasive.
The examiner acknowledges that the Applicant has filed a terminal disclaimer with respect to this rejection which obviates/overcomes the rejection of claims 15, and 17-20 under nonstatutory obviousness-type double patenting. Therefore, the double patenting rejection of claims 15, and 17-20 in the non-final rejection of 09/19/2025 has been withdrawn.
Applicant’s arguments, see Remarks page 8-12, filed 03/18/2026 with respect to the rejection of the claims under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive.
Regarding claims 1 and 15, the claims have been amended to recite: “wherein the intravascular catheter is a solid state medical device”.
The Applicant respectfully submits that, as amended, at least this feature is not taught or suggested by the applied prior art as explained below.
The Office Action has argued LENKER teaches an intravascular catheter comprising an elongate body member and at least one annular array of transducers having a plurality of transducers located circumferentially on the elongate body member outer surface. Furthermore, the Office Action has argued LENKER teaches each transducer is configured to: emit a signal away from the respective transducer toward a section of a vascular vessel; receive a reflected signal from the vascular vessel section; and generate an electrical signal representative of a radial distance between the transducers and vascular vessel section.
However, the Applicant notes that LENKER is directed to a "rotationally vibrating imaging catheter and method of utilization has an array of ultrasound transducers and an actuator along with signal processing, display, and power subsystems." See LENKER at Abstract. As stated in LENKER, the principle of operation of the catheter disclosed in LENKER is a "mechanically driven rotating transducer system" in contrast to "stationary electronic systems." See LENKER at [0004].
Conversely, the annular array of transducers disclosed in the amended claims is configured to remain stationary and does not require rotation to produce images of a vessel. In fact, LENKER explicitly teaches away from a stationary transducer array, whereby the transducer array disclosed therein is constructed to "produce more imaging points of the object to be viewed than a non-rotating or a stationary array" (see at least [0009] of LENKER). LENKER also states, "By circumferentially vibrating, the array is caused to move to fill in any gaps in information that exist between adjacent array elements. Lost information between array elements is the reason stationary array systems offer less resolution than rotating transducer systems" (see at least [0013] of LENKER).
As a further point of distinction over LENKER, the intravascular catheter disclosed in the amended claims virtually uses the calculated distances from the vessel wall segments to the adjacent transducers to mathematically determine interpolated segments between the radially outward ends of the distances or the diameters or areas of the lumen without illustrating anything on the computer; essentially the transducer array is not for imaging, but for the collection of multidirectional sonar readings to the vessel wall.
The Office Action admits LENKER does not teach "wherein the intravascular catheter is a solid state medical device." Office Action, p. 18. The Office Action relies on CORL for disclosing this feature. Specifically, the Office Action has argued CORL cures the deficiency of LENKER, whereby CORL teaches an intravascular ultrasound system having a solid state (stationary) catheter. Therefore, the Office Action has argued a person of ordinary skill in the art would be motivated to modify LENKER in view of CORL to achieve an intravascular catheter having a stationary array of transducers. Applicant disagrees.
As stated above, LENKER is reliant on the transducer arrays' rotational capabilities and explicitly teaches away from a stationary transducer array. For example, LENKER explicitly discloses the transducer array therein is constructed to "produce more imaging points of the object to be viewed than a non-rotating or a stationary array" (see at least [0009] of LENKER). As another example, LENKER also states, "By circumferentially vibrating, the array is caused to move to fill in any gaps in information that exist between adjacent array elements. Lost information between array elements is the reason stationary array systems offer less resolution than rotating transducer systems" (see at least [0013] of LENKER). Conversely, CORL explicitly teaches the catheter disclosed therein "...does not require physical rotation of a transducer to facilitate imaging" (see at least [0023] of CORL).
Thus, a person of ordinary skill in the art would not be motivated to modify LENKER in view of CORL to achieve an intravascular catheter having a stationary array of transducers. LENKER clearly indicates their rotating/oscillating transducer array is intended as an alternative design to the stationary transducer array taught by CORL. It would be hard to imagine a person of ordinary skill in the art would combine LENKER with a reference that discloses a design from which LENKER explicitly and consistently avoids.
As explained in M.P.E.P. § 2143 "a hallmark of a proper obviousness rejection based on combining known prior art elements is that one of ordinary skill in the art would reasonably have expected the elements to maintain their respective properties or functions after they have been combined." See MPEP; See also Sundance, Inc., v. DeMonte Fabricating Ltd., 550 F.3d 1356, 89 USPQ2d 1535 (Fed. Cir. 2008). LENKER would not maintain its respective function if combined with CORL as proposed by the Examiner. Further, if the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims obvious. In re Ratti, 123 U.S.P.Q. 349 (C.C.P.A. 1959), M.P.E.P. § 2143.01(VI). The Examiner has not only ignored the hallmark of a proper obviousness rejection, but has also proposed a modification that would change the principle of operation of the prior art invention being modified.
With respect to the Examiner's proposed combination of LENKER and CORL, Applicant respectfully submits that substituting a catheter that "...does not require physical rotation of a transducer to facilitate imaging" from CORL into the "mechanically driven rotating transducer system" of LENKER would change the principle of operation of LENKER. As stated in LENKER, "The invention herein described is an ultrasound imaging and treatment catheter comprising a rotationally vibrating array of ultrasound transducers."[0049] of LENKER (emphasis added). LENKER mentions its unique rotational feature more than 30 times in its specification. The proposed combination would not only change the principle of operation of LENKER but would also obviate the advantages of LENKER, resulting in extra work or greater expense, for no apparent reason. Thus, Applicant respectfully submits that one of ordinary skill in the art would not "modify the intravascular catheter of LENKER such that the intravascular catheter is a solid state medical device as disclosed in CORL" as proposed by the Examiner. Accordingly, the proposed modification would change the principle of operation of the prior art invention being modified and the teachings of the references are not sufficient to render amended Claims 1 or 15 obvious.
Applicant respectfully submits that the cited references do not disclose or teach the combination of elements recited in independent amended Claims 1 or 15. Accordingly, Applicant respectfully requests withdrawal of the rejection of Claims 1 and 15.
The examiner respectfully acknowledges that Lenker does not teach “wherein the intravascular catheter is a solid state medical device”. The examiner respectfully acknowledges that Lenker is directed to a "rotationally vibrating imaging catheter and method of utilization has an array of ultrasound transducers and an actuator along with signal processing, display, and power subsystems” (see [Abstract]). Additionally, the principle of operation of the catheter disclosed in Lenker is a "mechanically driven rotating transducer system" in contrast to "stationary electronic systems (see Lenker at [0004]).
The examiner agrees that, Lenker explicitly teaches away from a stationary transducer array, whereby the transducer array disclosed therein is constructed to "produce more imaging points of the object to be viewed than a non-rotating or a stationary array" (see at least [0009] of LENKER). Additionally, Lenker states, "By circumferentially vibrating, the array is caused to move to fill in any gaps in information that exist between adjacent array elements. Lost information between array elements is the reason stationary array systems offer less resolution than rotating transducer systems" (see at least [0013] of Lenker).
The examiner acknowledges that the Office Action of 09/19/2025 relies on Corl for disclosing this feature. Specifically, the Office Action has argued Corl cures the deficiency of Lenker, whereby Corl teaches an intravascular ultrasound system having a solid state (stationary) catheter (see Corl: [0023]).
The examiner respectfully agrees that a person of ordinary skill in the art would not be motivated to modify Lenker in view of Corl to achieve an intravascular catheter having a stationary array of transducers. Lenker clearly indicates their rotating/oscillating transducer array is intended as an alternative design to the stationary transducer array taught by Corl. It would be hard to imagine a person of ordinary skill in the art would combine Lenker with a reference that discloses a design from which Lenker explicitly and consistently avoids.
Furthermore, the examiner respectfully concedes that substituting a catheter that "...does not require physical rotation of a transducer to facilitate imaging" from Corl into the "mechanically driven rotating transducer system" of Lenker would change the principle of operation of Lenker and would also obviate the advantages of Lenker, resulting in extra work or greater expense, for no apparent reason.
Therefore, the rejection of claims 1 and 15 under 35 U.S.C. 102 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Corl US 2014/0187925 A1 “Corl” as discussed in the 35 U.S.C. 102 section below.
Regarding dependent claims 2-9 and 12-20, these claims inherit the reasoning provided with respect to claims 1 and 15. Therefore, the rejection of claims 2-9 and 12-20 have been updated to reflect the new ground(s) of rejection made in view of Corl US 2014/0187925 A1 as stated in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection sections below.
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.
(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.
Claim(s) 1-2, 6, 8, 12-15, and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Corl US 2014/0187925 A1 “Corl”.
Regarding claims 1 and 15, Corl teaches “An intravascular catheter comprising:” (Claim 1) and “A medical imaging system comprising: an intravascular catheter comprising:” (“FIG. 1 shows an IVUS imaging system 100 according to an embodiment of the present disclosure. In some embodiments the IVUS imaging system 100 is an imaging system including a sensing head 150 having a plurality of ultrasound transducers. The plurality of ultrasound transducers in sensing head 150 may form an array of transducer elements (e.g., 16, 32, 64, 96, 128, or other suitable number) arranged along a circumference centered on the longitudinal axis of catheter 102 (Z-axis in FIG. 1). In some embodiments, an IVUS imaging system may include a solid state IVUS catheter 102, a patient interface module (PIM) 104, an IVUS control system 106, and a monitor 108 to display the IVUS images generated by IVUS control 106” [0026]. Therefore, Corl describes an intravascular catheter (i.e. IVUS catheter 102) and a medical imaging system (i.e. IVUS imaging system 100) comprising an intravascular catheter.);
“an elongated flexible body member having a proximal end, a distal end, an outer surface, and an elongated axis, the elongated flexible body member having a diameter and flexibility to allow the elongated flexible body member to be placed in a vascular vessel of a body” (Claims 1 and 15) (See IVUS catheter 102 in FIG. 1. As shown in FIG. 1, the intravascular catheter 102 has a curved shape. Therefore, the intravascular catheter 102 represents an elongated flexible body member having a proximal end (i.e. attached to PIM 104), a distal end (i.e. where the sensing head 150 is located), an outer surface (i.e. outside surface of the catheter 102, and an elongated axis (i.e. traveling through the catheter 102), the elongated flexible member having a diameter and flexibility to allow the elongated flexible body member to be placed in a vascular vessel of a body.);
“and at least one annular array of transducers having a plurality of transducers located circumferentially on the outer surface of the elongated flexible body member, each transducer being configured to emit a signal away from the respective transducer toward a section of the vascular vessel located perpendicular to the respective transducer, receive a reflected signal from the section of the vascular vessel located perpendicular to the respective transducer” (Claim 1); “and at least one annular array of transducers having a plurality of transducers located circumferentially on the outer surface of the elongated flexible body member, each transducer emitting a signal away from the respective transducer toward a section of the vascular vessel located perpendicular to the respective transducer, receiving a reflected signal from the section of the vascular vessel located perpendicular to the respective transducer” (Claim 15) (See [0026] above and “The IVUS imaging system, which is connected to the IVUS solid state catheter by way of a patient interface module (PIM), processes the received ultrasound echoes to produce a cross-sectional image of the vessel where the solid state catheter is placed” [0003]; “Step 1110 includes receiving a signal from a plurality of transducers. In step 1110, the plurality of transducers may form a synthetic aperture. In step 1110, the signal received may be an echo signal having a frequency band centered on a resonance frequency of the transducers” [0079]. Therefore, the intravascular catheter includes at least one annular array of transducers located circumferentially on the outer surface of the elongated flexible body member, each transducer being configured to emit a signal away from the respective transducer toward a section of the vascular vessel located perpendicular to the respective transducer, receive a reflected signal from the section of the vascular vessel located perpendicular to the respective transducer.);
“generate(ing) an electrical signal representative of a radial distance between the transducer and the section of the vascular vessel located perpendicular to the respective transducer” (Claims 1 and 15) (See [0079] above. Therefore, the echo signal received by the transducers is used to generate an electrical signal representative of a radial distance between the transducer and the section of the vascular vessel located perpendicular to the respective transducer.); and
“a computer configured to receive and process the electrical signals from the intravascular catheter” (Claim 15) (See [0026] above. In this case, the control system 106 in combination with the monitor 108 represents a computer configured to receive and process the electrical signals from the intravascular catheter (i.e. 102).).
“wherein the intravascular catheter is a solid state medical device” (Claims 1 and 15) (See [0026] above and “In an IVUS solid state catheter consistent with embodiments disclosed herein, multiple ultrasound transducers are located around a sensing head. A solid state catheter or a solid state Patience-Interface-Module (PIM) as disclosed herein is understood as a catheter or a PIM that does not require physical rotation of a transducer to facilitate imaging” [0023]. Therefore, the intravascular catheter is a solid state medical device.).
Regarding claim 2, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, and Corl further teaches “wherein each transducer is further configured to pass the electrical signal to the proximal end of the elongated flexible body member” (“The array of transducer elements in sensing head 150 transmits ultrasound signals to the tissue of interest after receiving trigger signals from PIM 104. Ultrasound transducers in sensing head 150 also convert echo signals received from the tissue into electrical signals to be processed by PIM 104” [0029]. As shown in FIG. 1, the PIM 104 is located toward the proximal end of the catheter 102. In order for the echo signals received by the ultrasound transducers to be processed by PIM 104, each transducer must be further configured to pass the electrical signal to the proximal end of the elongated flexible body member (i.e. catheter 102).).
Regarding claim 6, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, and Corl further teaches “further comprising an elongated tip having a proximal end and a distal end, the proximal end of the elongated tip being connected to the distal end of the elongated flexible body member” (See FIG. 1, specifically, the portion of the catheter 102 located after the sensing head 150 and “In some embodiments, a portion of solid state catheter 102 may extend beyond sensing head 150 to form the tip of solid state catheter 102” [0026]. Therefore, the intravascular catheter further comprises an elongated tip having a proximal end and a distal end, the proximal end of the elongated tip being connected to the distal end of the elongated flexible body member (i.e. catheter 102).).
Regarding claim 8, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, and Corl further teaches “wherein the elongated flexible body member is tubular and has a central lumen” (See FIG. 1 and [0029] as discussed with respect to claim 1 above. Therefore, the elongated flexible body member (i.e. catheter 102) is tubular and has a central lumen (i.e. which allows echo signals received from the tissue by the transducer elements and converted to electrical signals in the sensing head 150 to travel to the PIM 104).).
Regarding claims 12 and 19, Corl discloses all features of the claimed invention as discussed with respect to claims 1 and 15 above, and Corl further teaches “wherein the transducers operate in the range of 8 MHz to 50 MHz” (“In some embodiments, PIM 104 supports solid state catheter 102 having a sensing head 150 including up to 128 transducer elements, each operating with a center frequency of about 20 MHz (1 MHz=106 Hz), up to about 30 MHz” [0036]. Therefore, the transducers operate in the range of 8 MHz to 50 MHz (i.e. specifically 20-30 MHz).).
Regarding claim 13, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, and Corl further teaches "wherein the transducers are chosen from the group consisting of piezoelectric transducers, PMUT (Piezoelectric Micromachined Ultrasonic Transducers), CMUT (Capacitive Micromachined Ultrasonic Transducers), and photoacoustic transducers” (“Embodiments consistent with the present disclosure may include different types of transducer in sensing head 150, for example traditional PZT devices, piezo-electric micro-machined ultrasonic transducer (PMUT) devices, capacitive micro-machined ultrasonic transducer (CMUT) devices, and/or combinations thereof” [0035]. Therefore, the transducers are chosen from the group consisting of piezoelectric transducers, PMUT (Piezoelectric Micromachined Ultrasonic Transducers), CMUT (Capacitive Micromachined Ultrasonic Transducers), and photoacoustic transducers.).
Regarding claim 14, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, however Corl teaches “wherein the transducers are optical coherence tomography (OCT) transducers” (“ In some embodiments, clock and timing circuit such as 200 and reconstruction FPGA 250 is included in a modality of PIM 104 using optical techniques, such as intravascular optical coherent tomography (OCT) imaging. In the case of OCT imaging, the transducer may include an optical fiber, a filter element or some other spectrally dispersive optical component, and a photo-detector” [0035]. Therefore, the transducers are optical coherence tomography (OCT) transducers.).
Regarding claim 18, Corl discloses all features of the claimed invention as discussed with respect to claim 15 above, and Corl further teaches “wherein the processing of the electrical signals by the computer comprises processing selected from the group consisting of controlling the transducers, processing data, interpreting the electrical signals coming from the transducers, calculating dimensions from the intravascular catheter to the section of the vascular vessel around the intravascular catheter, and performing co-registration of images, data, and calculations produced by the computer with other images, data, and calculations” (See [0026] as discussed in claims 1 and 15 above and “According to some embodiments, electrical signals 224 are analog signals including echo responses from the vessel tissue as detected by the transducers in sensing head 150. Analog-to-digital converter (ADC) 216 converts an amplified signal from amplifier 214 into a digital signal transferred out of PIM 104 to IVUS control system 106 by communication protocol circuit 218” [0033]. In this case, in order for the IVUS control 106 to generate the IVUS images for display on the monitor 108, the IVUS control system 106 had to have processed/interpreted the electrical signals coming from the transducers (i.e. and transferred out of PIM 104). Therefore, the processing of the electrical signals by the computer comprises interpreting the electrical signals coming from the transducers.).
Regarding claim 20, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, and Corl further teaches “further comprising a Patient Interface Module (PIM) located along a path between the intravascular catheter and the computer” (See [0026] as discussed in claim 11 above and “PIM 104 also includes a pulse transmitter circuit 212 to provide a plurality of pulse signals 223 to transducers in sensing head 150. […] Electrical signals 224 are amplified by receive amplifier 214. According to some embodiments, electrical signals 224 are analog signals including echo responses from the vessel tissue as detected by the transducers in sensing head 150. Analog-to-digital converter (ADC) 216 converts an amplified signal from amplifier 214 into a digital signal transferred out of PIM 104 to IVUS control system 106 by communication protocol circuit 218” [0033]; “Scan conversion and display is performed in IVUS control system 106” [0037]. In this case, the IVUS control system 106 represents a computer. As shown in FIG. 2, the PIM 104 is located between the catheter 102 and the IVUS control system 106 (i.e. computer). Therefore, the intravascular catheter further comprises a Patient Interface Module (PIM) located along a path between the intravascular catheter (i.e. 102) and the computer (i.e. IVUS Control system 106).).
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.
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.
Claim(s) 3, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corl US 2014/0187925 A1 “Corl” as applied to claim 1 above, and further in view of Lenker US 2009/0216125 A1 “Lenker”.
Regarding claim 3, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above. Although Corl discloses “The plurality of ultrasound transducers in sensing head 150 may form an array of transducer elements (e.g., 16, 32, 64, 96, 128, or other suitable number) arranged along a circumference centered on the longitudinal axis of catheter 102 (z-axis in FIG. 1)” [0026], Corl does not teach ““further comprising a plurality of annular arrays of transducers”.
Lenker is within a related field of endeavor to the claimed invention because it involves an intravascular catheter with a plurality of transducers (see FIG. 1
Lenker further teaches “further comprising a plurality of annular arrays of transducers” (“The distal tip 2 of catheter 12 optionally comprises an array of forwardly directed ultrasound transducers 202” [0055]; “As shown in FIG. 5, each transducer in the transducer arrays 4 and 202 comprises a plurality of transducer leads 48” [0056]; “The ultrasound array signal and power supply/controller 28 sends output signals to and receives reflection signals from the transducer arrays 4 and 202 over the cable or wire bundle 20. The information from the ultrasound arrays 4 and 202, in the form of reflection electrical signals, is sent to the decoder/processor system 26 where the electronic data is processed to compensate for jitter, hysteresis, and uneven rotation. The processed data is sent to the display monitor 32 where the ultrasound image of the body lumen or cavity is displayed” [0057]. Therefore, the intravascular catheter further comprises a plurality of annular arrays of transducers, specifically, transducers 4 and transducers 202.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of Corl such that it comprises a plurality of annular arrays of transducers as disclosed in Lenker in order to allow for imaging to be performed in multiple axial locations when the catheter is introduced to the body. Operating a plurality of annular arrays of transducers is one of a finite number of techniques which can be used to obtain intravascular images with a reasonable expectation of success. Thus, modifying the intravascular catheter of Corl such that it comprises a plurality of annular arrays of transducers as disclosed in Lenker would yield the predictable result of allowing for imaging to be performed in multiple axial locations when the catheter is introduced to the body.
Regarding claim 7, Corl discloses all features of the claimed invention as discussed with respect to claim 6 above. However, Corl does not teach “further comprising a guide wire exit port located on the elongated tip”.
Lenker teaches “further comprising a guide wire exit port located on the elongated tip” (“The distal tip 2 of catheter 12 optionally comprises an array of forwardly directed ultrasound transducers 202. It also optionally comprises a distal fluid-tight seal 204, which prevents fluid from passing into the central lumen 18 from the guidewire 40 exit” [0055]. Therefore, the intravascular catheter further comprises a guide wire exit port (i.e. guidewire 40 exit) located on the elongated tip (i.e. distal end of the guidewire 40).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of Corl such that the elongated tip includes a guide wire exit port located thereon as disclosed in Lenker in order to allow an additional procedure, facilitated by a guidewire, to be carried out after performing imaging with the plurality of transducers. A guide wire exit port is one of a finite number of structures which can be included at the tip of a catheter/elongated flexible body member to allow other tools to enter the body with a reasonable expectation of success. Thus, modifying the intravascular catheter of Corl such that the elongated tip includes a guide wire exit port located thereon as disclosed in Lenker in order to allow an additional procedure, facilitated by a guidewire, to be carried out after performing imaging with the plurality of transducers.
Regarding claim 9, Corl discloses all features of the claimed invention as discussed with respect to claim 8 above, however Corl does not teach “wherein the elongated flexible body member has more than one lumen in addition to the central lumen”.
Lenker teaches “wherein the elongated flexible body member has more than one lumen in addition to the central lumen” (“An embodiment of the device, as shown in FIG. 3, is a catheter 12 comprising a catheter shaft 14, a proximal end 16, the distal end or tip 2, a central lumen 18 and a wire bundle or transmission line 20. Additional lumens are optionally added for functions such as dye or fluid injection, fluid removal, electrical or electromagnetic energy delivery, atherectomy control, stent or material deployment or retrieval, balloon inflation and/or deflation. […] The proximal end 16 optionally comprises an inflation port 36, an inflation lumen 350, an inflation system 38 and a guidewire 40. […] The proximal end 16 further optionally comprises an illumination source 218, a power source 220 for X-ray, radio frequency or microwave energy and/or a shutter controller 222 for an ionizing radiation source. A connector 226 is optionally provided at the proximal end of the catheter 12 to seal the guidewire 40 entrance against fluid leakage, using a proximal fluid-tight seal 242, and to allow for attachment of a suction device or vacuum source 224 to remove fluid and excised debris from the body vessel or lumen” [0053]. In this case, additional lumens are optionally added to the catheter 12 to perform functions such as dye or fluid injection, fluid removal, electrical or electromagnetic energy delivery, atherectomy control, stent or material deployment or retrieval, balloon inflation and/or deflation. The inflation lumen 350 shown in FIG. 3, is an example of one such additional lumen. Therefore, the elongated flexible body member (i.e. catheter shaft 14) has more than one lumen (i.e. inflation lumen 350, for example) in addition to the central lumen (i.e. central lumen 18).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of Corl such that the elongated flexible body member has more than one lumen in addition to the central lumen as disclosed in Lenker in order to allow for other functions, such as dye or fluid injection, fluid removal, electrical or electromagnetic energy delivery, atherectomy control, stent or material deployment or retrieval, balloon inflation and/or deflation, to be performed along with imaging. Including multiple lumens within an elongated flexible body member/catheter is one of a finite number of techniques which can be used to facilitate multiple functions with a single device with a reasonable expectation of success. Thus, modifying the intravascular catheter of Corl such that the elongated flexible body member has more than one lumen in addition to the central lumen as disclosed in Lenker would yield the predictable result of allowing for other functions, such as dye or fluid injection, fluid removal, electrical or electromagnetic energy delivery, atherectomy control, stent or material deployment or retrieval, balloon inflation and/or deflation, to be performed along with imaging.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corl US 2014/0187925 A1 “Corl” as applied to claim 1 above, and further in view of Farthing et al. US 2011/0203375 A1 “Farthing”.
Regarding claim 4, Corl discloses all features of the claimed invention as discussed with respect to claim 1 above, however Corl does not teach “wherein the at least one annular array of transducers overlaps with an adjacent annular array of transducers”.
Farthing is within the same field of endeavor as the claimed invention because it involves an intravascular catheter (see FIGS. 8 and 9).
Farthing teaches “wherein the at least one annular array of transducers overlaps with an adjacent annular array of transducers” (“Referring now to FIGS. 8 and 9 a third embodiment of an inspection device 31 is shown in the same borehole with the three concentric strings of casing C1, C2, and C3” [0057]; “The third device 31 has four separate transducers 32, 42, 52 and 62, each stacked axially on top of one another. Each transducer 32, 42, 52 and 62 has multiple rows of transducer elements stacked on top of one another. […] The transducer 62 therefore has a stacked array of transducer elements 65. The transducer elements 65 in each of the separate rows 63 are identical, but the elements 65a in the first row 63a are offset circumferentially from the elements 65b in the second row 63b, so that in each transducer 32, 42, 52, 62, the elements in each row overlap with the elements in at least one of the other rows” [0058]. As shown in FIG. 9, the rows 63a-63f overlap with each other. Therefore, the at least one annular array of transducers overlaps with an adjacent annular array of transducers.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of Corl such that the at least one annular array of transducers overlaps with an adjacent annular array of transducers as discussed in Farthing in order to obtain clear and precise images of the tissue area. When transducers in one annular array overlap with transducers in an adjacent annular, they are able to acquire imaging data from the tissue without gaps therebetween. Thus, modifying the intravascular catheter of Corl such that the at least one annular array of transducers overlaps with an adjacent annular array of transducers as discussed in Farthing would yield the predictable result of obtaining clear and precise images of the tissue area without gaps therebetween.
Regarding claim 5, Corl in view of Farthing discloses all features of the claimed invention as discussed with respect to claim 4 above, and Farthing teaches “wherein the transducers of the at least one annular array of transducers are staggered with transducers in the adjacent annular array along the elongated axis of the elongated flexible body member” (See FIGS. 8 and 9 and [0057]-[0058] as discussed in claim 4 above. As shown in FIG. 9, the transducers 65a-65f are staggered with respect to each other along an elongated axis of the elongated flexible body member (i.e. corresponding to the length of the inspection device 31). Thus, the transducer of the at least on annular array of transducers are staggered with transducers in the adjacent annular array along an elongated axis of the elongated flexible body member.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of Corl such that the transducers of the at least one annular array of transducers are staggered with transducers in the adjacent annular array along an elongated axis of the elongated flexible body member as discussed in Farthing in order to obtain clear and precise images of the tissue area. When transducers in one annular array are staggered with transducers in an adjacent annular, they are able to acquire imaging data from the tissue without gaps therebetween. Thus, modifying the intravascular catheter of Corl such that the transducers of the at least one annular array of transducers are staggered with transducers in the adjacent annular array along an elongated axis of the elongated flexible body member as discussed in Farthing would yield the predictable result of obtaining clear and precise images of the tissue area without gaps therebetween.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corl US 2014/0187925 A1 “Corl” as applied to claim 15 above, and further in view of Taimisto et al. US 5,351,693 A “Taimisto”.
Regarding claim 16, Corl discloses all features of the claimed invention as discussed with respect to claim 15 above, however Corl does not teach “wherein the processing of the electrical signals by the computer comprises calculating a cross-sectional area of a space around the intravascular catheter defined by the section of the vascular vessel around the intravascular catheter opposed to each transducer”.
Taimisto is within the same field of endeavor as the claimed invention because it involves an intravascular catheter (see FIG. 7).
Taimisto teaches “wherein the processing of the electrical signals by the computer comprises calculating a cross-sectional area of a space around the intravascular catheter defined by the section of the vascular vessel around the intravascular catheter opposed to each transducer” (“A first plurality of transducer elements are activated and used to calculate the cross-sectional area of the vessel perpendicular to the catheter tip by echo methods” [Column 2, Lines 54-57]; “The transducer portion alternatively generates a radially oriented signal beam at a first frequency, and then generates a forwardly oriented signal beam at a second frequency. The signal beams are used to calculate cross-sectional area and blood flow velocity, respectively, which are then used to calculate blood flow” [Column 4, Lines 8-13]. Therefore, the processing of the electrical signals by the computer comprises calculating a cross-sectional area of a space around the intravascular catheter defined by the section of the vascular vessel around the intravascular catheter opposed to each transducer.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical imaging system of Corl such that the computer performs the step of calculating a cross-sectional area of a space around the intravascular catheter defined by the section of the vascular vessel around the intravascular catheter opposed to each transducer as disclosed in Taimisto in order to provide a user with information about the blood vessel being inspected by the array of transducers. Calculating the cross-sectional area of a blood vessel is one of a finite number of techniques which can be used to assess characteristics of the blood vessel with a reasonable expectation of success. Thus, modifying the medical imaging system of Corl such that the computer performs the step of calculating a cross-sectional area of a space around the intravascular catheter defined by the section of the vascular vessel around the intravascular catheter opposed to each transducer as disclosed in Taimisto would yield the predictable result of providing a user with information about characteristics of the blood vessel being inspected with the array of transducers.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corl US 2014/0187925 A1 “Corl” as applied to claim 15 above, and further in view of Skinner et al. US 7,940,974 B2 “Skinner”.
Regarding claim 17, Corl discloses all features of the claimed invention as discussed with respect to claim 15 above, however Corl does not teach “wherein the processing of the electrical signals by the computer comprises generating radial distance lines from each transducer to the section of the vascular vessel located perpendicular to that transducer, generating connecting line segments between radially outward ends of circumferentially adjacent distance lines, and generating a map image including at least the connecting line segments between radially outward ends of circumferentially adjacent distance lines”.
Skinner is within a related field of endeavor as the claimed invention because it involves generating a contour of a vessel (see FIG. 7 and [Column 6, Line 33-Column 7, Line 2]).
Skinner teaches “wherein the processing of the electrical signals by the computer comprises generating radial distance lines from each transducer to the section of the vascular vessel located perpendicular to that transducer, generating connecting line segments between radially outward ends of circumferentially adjacent distance lines, and generating a map image including at least the connecting line segments between radially outward ends of circumferentially adjacent distance lines” (“FIG. 7 illustrates a 3D mesh of closed spline curves and open spline curves fit to a contour or surface of the vessel 132. Therefore, two sets of splines in two different directions are used to form a 3D mesh describing the elongated structure, in this case, the vessel 132. The cross-sectional splines form cross-sectional contours 200-206. For example, optimal intersection points 209-222, corresponding to intersections of the first through eighth radial lines 146-160, respectively, with the vessel wall of FIG. 5, are fit with the cross-sectional splines to form the cross-sectional contour 200. Longitudinal contours 224-232 are also illustrated. By way of example, the longitudinal contour 228 may be formed by joining optimal intersection points 220, 234, 236 and 238 identified along the cross-sectional contours 202, 204, 206 and 208, respectively. Although not illustrated in FIG. 7, when displayed to a user on the display 42, the 3D mesh is shown on top of, or super-imposed on, the diagnostic CT dataset of the vessel 132” [Column 6, Line 33-Column 7, Line 2]. Therefore, a 3D mesh of closed spline curves is generated with longitudinal contours a radial distance lines as shown in FIG. 7. Therefore, the processing of the electrical signals by the computer comprises generating radial distance lines (i.e. within each cross-sectional contours 202, 204, 206, 208) from each transducer to the section of the vascular vessel located perpendicular to that transducer, generating connecting line segments (i.e. longitudinal contours 224-232) between radially outward ends of circumferentially adjacent distance lines, and generating a map image including at least the connecting line segments between radially outward ends of circumferentially adjacent distance lines (i.e. map of the vessel 132 shown in FIG. 7).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical imaging system of Corl such that the computer performs the steps of generating radial distance lines from each transducer to the section of the vascular vessel located perpendicular to that transducer, generating connecting line segments between radially outward ends of circumferentially adjacent distance lines, and generating a map image including at least the connecting line segments between radially outward ends of circumferentially adjacent distance lines as disclosed in Skinner in order to provide the user with a model of the vascular vessel to perform assessment thereof.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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