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 .
Response to Amendment
Claims 1-20 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 04/08/2026.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
For claim 1, and similarly for claims 13 and 20, the applicant argues that “amended to recite that the dual lumen region includes a first lumen and a second lumen that axially overlaps with the first lumen. The cited art does not appear to teach or suggest these limitations.” (see pg. 6 of applicant’s remarks), and the examiner disagrees.
Hamm teaches where the first lumen and second lumen overlap axially (Fig. 7B, first lumen LM1 (working channel, imaging core lumen) and second lumen LM2 (guidewire lumen) overlap axially in window section 120 (where window section 120 is included as a distal section)).
However, Yamaguchi is used as a supplement reference to also teach a first lumen (imaging core lumen) and a second lumen (guidewire lumen) overlapping axially at a distal section of an intravascular imaging device, as shown below.
Claim Rejections - 35 USC § 102/103
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hamm et al. (US 20220040454 A1, published February 10, 2022), hereinafter referred to as Hamm, or, in the alternative, under 35 U.S.C. 103 as obvious over Yamaguchi et al. (US 20050101870 A1, published May 12, 2005), hereinafter referred to as Yamaguchi.
Note: Alternative rejections are being entered because the interpretation of the claim(s) is in dispute, i.e., given one interpretation, a rejection under 35 U.S.C. 102 is appropriate and given another interpretation, a rejection under 35 U.S.C. 103 is appropriate.
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 dual lumen region includes a first lumen and a second lumen that axially overlaps with the first lumen (Fig. 7B, first lumen LM1 (imaging core lumen) and second lumen LM2 (guidewire lumen) overlap axially in window section 120 (where window section 120 is included as a distal section));
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.").
Additionally, Yamaguchi, in the same field of endeavor (see para. 0001 – “The present invention relates to a diagnostic catheter used for various kinds of diagnosis by being inserted, into a body cavity or lumen such as a blood vessel…”), teaches wherein the dual lumen region includes a first lumen and a second lumen that axially overlaps with the first lumen (see para. 0024 – “FIG. 2 is an enlarged view of a part of a distal end portion of the ultrasound catheter;”; see para. 0027 – “FIG. 5 is a sectional view, taken along line A-A, of the sheath distal end portion shown in FIG. 2;”; see para. 0065 – “In a first method of producing the sheath distal end portion 21, first, as shown on the left side in FIG. 5, a monolayer tube 26a for constituting the guide wire lumen 26 and a monolayer tube 23a for constituting the imaging core lumen 23 are prepared.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first lumen (imaging core lumen) and second lumen (guidewire lumen), as disclosed in Hamm, by overlapping the lumens axially, as disclosed in Yamaguchi. One of ordinary skill in the art would have been motivated to make this modification in order for the guide wire is set along the distal end of the sheath over a longer distance, so that an operating force exerted at the hub can be easily transmitted to the distal end of the ultrasound catheter, and operationality of the ultrasound catheter can be enhanced, as taught in Yamaguchi (see para. 0070).
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. 3Ashows 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 guidewire lumen and the imaging core lumen overlap (Fig. 7B, first lumen LM1 (imaging core lumen) and second lumen LM2 (guidewire lumen) overlap in window section 120 (where window section 120 is included as a distal section));
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.").
Additionally, Yamaguchi, in the same field of endeavor, teaches wherein the guidewire lumen and the imaging core lumen overlap (see para. 0024 – “FIG. 2 is an enlarged view of a part of a distal end portion of the ultrasound catheter;”; see para. 0027 – “FIG. 5 is a sectional view, taken along line A-A, of the sheath distal end portion shown in FIG. 2;”; see para. 0065 – “In a first method of producing the sheath distal end portion 21, first, as shown on the left side in FIG. 5, a monolayer tube 26a for constituting the guide wire lumen 26 and a monolayer tube 23a for constituting the imaging core lumen 23 are prepared.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first lumen (imaging core lumen) and second lumen (guidewire lumen), as disclosed in Hamm, by overlapping the lumens, as disclosed in Yamaguchi. One of ordinary skill in the art would have been motivated to make this modification in order for the guide wire is set along the distal end of the sheath over a longer distance, so that an operating force exerted at the hub can be easily transmitted to the distal end of the ultrasound catheter, and operationality of the ultrasound catheter can be enhanced, as taught in Yamaguchi (see para. 0070).
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 first lumen includes a guidewire lumen and the second lumen includes 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:
Hirota (US 20110077463 A1, published March 31, 2011) discloses a guidewire lumen that is disposed approximately parallel to the distal part of the imaging core lumen (Fig. 3 and 4).
Sakaguchi et al. (JP-2018033614-A, published March 8, 2018) discloses an image lumen into which the imaging core is inserted and a guide wire lumen into which the guide wire is inserted are formed in a double lumen structure from the distal end side to the proximal end (Fig. 1 and 2).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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