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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/31/2025 and 05/06/2025 has been considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamm et al. (US 20220040454 A1, published February 10, 2022), hereinafter referred to as Hamm.
Regarding claim 1, and similarly for claim 20, Hamm teaches an intravascular imaging device, comprising:
a catheter shaft including a proximal section and a distal section (Fig. 1A, catheter sheath includes mid-shaft section 130 as proximal section, and window section 120 and rapid exchange section 110 as distal section);
wherein the distal section includes a dual lumen region and a distal tip region coupled to the dual lumen region (Fig. 7B, dual lumen region is in windowing section 120 of distal end of catheter as working channel (imaging core) lumen LM1 and guidewire lumen LM2, and distal tip 112 is in rapid exchange section 110 of distal end of catheter);
wherein the distal tip region includes a bumper tip member, a radiopaque member, and a sleeve disposed over and coupling the bumper tip member and the radiopaque member (Fig. 4A, distal tip region includes rapid exchange section 110; see para. 0084 – “The radiopaque marker band 113 [radiopaque member] is embedded within the wall [sleeve] of the Rx section 110 to keep distal profile low.” Where wall of rapid exchange section 110 couples the distal tip 112 to the radiopaque marker band 113; Fig. 6; see para. 0107 – “An atraumatic bullnose tip 609 [bumper tip member] is arranged on (attached to) the distal end of the metal tube or can 615 [sleeve].”); and
an imaging core disposed within the catheter shaft (see para. 0073 – “FIG. 3A shows another embodiment of the catheter 100 which includes an imaging core 200 arranged in the window section 120.”).
Regarding claim 13, Hamm teaches an intravascular imaging device, comprising:
a catheter shaft including a proximal hypotube section (Fig. 1B; see para. 0052 – “The mid-shaft section 130 of catheter sheath 190 comprises a hypotube body reinforced by a multi-layer polymeric structure.”), an imaging window section having a lumen formed therein (see para. 0073 – “FIG. 3A shows another embodiment of the catheter 100 which includes an imaging core 200 arranged in the window section 120.”), and a distal section (Fig. 1A, distal section includes window section 120 and rapid exchange segment 110);
wherein the distal section includes a dual lumen region and a distal tip region coupled to the dual lumen region (Fig. 7B, dual lumen region is in windowing section 120 of distal end of catheter as working channel (imaging core) lumen LM1 and guidewire lumen LM2, and distal tip 112 is in rapid exchange section 110 of distal end of catheter);
wherein the dual lumen region defines a guidewire lumen (see para. 0083 – “FIG. 4A shows an exemplary embodiment of the Rx section 110 with a guidewire 300 inserted along the guidewire lumen LM2.”) and defines an imaging core lumen in fluid communication with the lumen formed in the imaging window section (see para. 0104 – “FIG. 6 illustrates an exemplary embodiment of an imaging core 200 configured to be arranged inside the first lumen (LM1) of catheter 100. According to one embodiment, a multimodality OCT (MMOCT) catheter 100 may include a rotating imaging core 200 arranged inside the catheter sheath 190 at the distal end thereof (i.e., namely in the window section 120).”);
wherein the distal tip region includes a tip member, a radiopaque member, and a sleeve disposed over and coupling the tip member and the radiopaque member (Fig. 4A, distal tip region includes rapid exchange section 110; see para. 0084 – “The radiopaque marker band 113 is embedded within the wall [sleeve] of the Rx section 110 to keep distal profile low.” Where wall of rapid exchange section 110 couples the distal tip 112 to the radiopaque marker band 113; Fig. 6; see para. 0107 – “An atraumatic bullnose tip 609 [bumper tip member] is arranged on (attached to) the distal end of the metal tube or can 615 [sleeve].”); and
an imaging core disposed within the catheter shaft (see para. 0073 – “FIG. 3A shows another embodiment of the catheter 100 which includes an imaging core 200 arranged in the window section 120.”).
Furthermore, regarding claim 2, Hamm further teaches wherein the imaging core is translatable within the catheter shaft (see para. 0087 – “The imaging core is comprised of a drive cable, one or more optical fibers, a distal optics assembly, and other components configured to allow the imaging core to rotate and/or translate within the catheter sheath with minimal friction.”).
Furthermore, regarding claim 3, Hamm further teaches wherein the imaging core includes an ultrasound transducer (see para. 0118 – “Coronary imaging catheters are generally provided as Intravascular Ultrasound (IVUS) catheters or Optical Coherence Tomography (OCT) imaging catheters.”).
Furthermore, regarding claim 4, Hamm further teaches wherein the imaging core includes an optical coherence tomography imaging device (see para. 0118 – “Coronary imaging catheters are generally provided as Intravascular Ultrasound (IVUS) catheters or Optical Coherence Tomography (OCT) imaging catheters.”).
Furthermore, regarding claims 5 and 14, Hamm further teaches wherein the dual lumen region has a distal end and further comprising a spacer member disposed between the radiopaque member and the distal end of the dual lumen region (Fig. 6; see para. 0106 – “At the distal end of the catheter shaft 190, the optical fiber 604 is connected to a focusing element 612 such as a GRIN lens or a ball lens, a transparent spacer 614 which includes one or more reflective surfaces…”).
Furthermore, regarding claims 6 and 15, Hamm further teaches wherein the sleeve extends over at least a portion of the spacer member (Fig. 6, wall (sleeve) of imaging core 200 over transparent spacer 614).
Furthermore, regarding claims 7 and 16, Hamm further wherein the sleeve is thermally bonded to the dual lumen region (see para. 0048 – “In one example embodiment, the proximal stub of the Rx segment is inserted into the open distal end (first lumen LM1) [of dual lumen region] of tubular sheath 190 [sleeve] and melt-bonded [thermally bonded] therein to form a monolithic structure with the tubular sheath.”).
Furthermore, regarding claim 8, Hamm further teaches wherein the dual lumen region includes a guidewire lumen and an imaging core lumen (Fig. 7B, dual lumen region is in windowing section 120 of distal end of catheter as working channel (imaging core) lumen LM1 and guidewire lumen LM2).
Furthermore, regarding claims 9 and 17, Hamm further teaches wherein the dual lumen region has a skived opening in fluid communication with the guidewire lumen (see para. 0070 – “An injection molded Rx section 110 provides a consistent guidewire lumen LM2 with a guidewire entry port 118 and exit port 119 with minimal variations. This allows for minimal post-manufacturing operations to clean up, without having to remove flash or skive (remove) remaining material.”).
Furthermore, regarding claims 10 and 18, Hamm further teaches wherein an imaging window region is coupled to the dual lumen region adjacent to the imaging core lumen (see para. 0090 – “Therefore, there will remain a small gap (unsupported area 220) at the distal end of imaging window 120 because the imaging core 200 is pulled back approximately 1.5 mm during system self-calibration and device “homing” at the start of an imaging procedure.”).
Furthermore, regarding claims 11 and 19, Hamm further teaches wherein a portion of dual lumen region adjacent to the imaging core lumen is disposed along an outer surface of the imaging window region (see para. 0090 – “Therefore, there will remain a small gap (unsupported area 220) at the distal end of imaging window 120 because the imaging core 200 is pulled back approximately 1.5 mm during system self-calibration and device “homing” at the start of an imaging procedure.”).
Furthermore, regarding claim 12, Hamm further teaches wherein the imaging window region has a distal portion having a first outer diameter and a proximal portion having a second outer diameter larger than the first outer diameter (Fig. 1A, tapering of window section 120, proximal portion diameter of window section 120 next to mid-shaft section 130 is larger than distal portion diameter of window section 120 next to Rx section 110).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Stigall et al. (US 20160302762 A1, published October 20, 2016) discloses a dual lumen catheter may also include members for increased torsional rigidity, distally located functional measurement sensors, and patterned radioopaque markers for orientation of the dual lumen exits.
Ciamacco et al. (US 5772642 A, published June 30, 1998) discloses a dual lumen catheter with marker bands located on the exterior surface of the guidewire lumen are used to position the treatment source tool in the distal section.
Yamamoto (US 20170079617 A1, published March 23, 2017) discloses a dual lumen catheter, with one lumen having an ultrasound transducer inserted into the sheath and configured to transmit and receive an ultrasound wave, and another lumen configured for a guidewire and a radiopaque marker (Fig. 3A).
Moore et al. (US 20180235572 A1, published August 23, 2018) discloses a dual lumen catheter, with a first lumen housing a torque coil of the imaging core assembly, and a second lumen housing an optical fiber or a cable for communication with the pressure sensor assembly.
Shaffer et al. (US 20180228502 A1, published August 16, 2018) discloses a dual lumen catheter with a guide wire lumen and a central lumen, where a negative pressure is applied to a proximal end of a central lumen of the shaft to aspirate thrombus through the central lumen, and a radiopaque marker at the distal end of the shaft.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/Nyrobi Celestine/Examiner, Art Unit 3798