DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claims 1-6, 8, 12-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. (US 2022/0226114; hereinafter Hou), in view of Athanasiou et al. (US 2023/0363652; hereinafter Athanasiou).
Regarding claim 1, Hou discloses a balloon valvuloplasty catheter with IVUS. Hou shows an intravascular imaging catheter for imaging a blood vessel (see abstract; par. [0073]), comprising: an elongate catheter shaft (see 110 in fig. 5) having a distal end region and a proximal region (see fig. 5; par. [0079]); wherein a guidewire lumen is defined in the elongate catheter shaft (see 112 in fig. 5; par. [0079]; wherein catheter shaft includes an imaging window disposed proximally of the distal end region and the imaging window being defined by an open gap in the catheter shaft (see fig. 5; par. [0083]) that is open to the blood vessel (see par. [0080]); an imaging core (see 130 in fig. 5) disposed within the elongate catheter shaft (see fig. 5; par. [0083]); and wherein the imaging core includes an imaging device (see 132 in fig. 5) configured to be axially aligned with the imaging window (see fig. 5 and par. [0083]).
Furthermore, Hou teaches wherein the imaging core is configured to shift between a delivery position disposed within the distal end region around the imaging window (see fig. 5) and an imaging position where the imaging device is disposed along the image window (see fig. 5; par. [0083]), but Hou fails to explicitly state that the delivery position where the imaging device is disposed withing the distal end distally of the imaging window.
Athanasiou discloses an ultrasound imaging system (see par. [0036]). Hastings teaches that imaging core is configured to shift between delivery position where the imaging device is disposed within distal end region distally of imaging window (see par. [0053], [0056] and fig. 4) and imaging position where the imaging device is disposed along the imaging window (see par. [0053], [0056] and fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention that imaging core is configured to shift between delivery position where the imaging device is disposed within distal end region distally of imaging window and imaging position where the imaging device is disposed along the imaging window in the invention of Hou, as taught by Athanasiou, to be able to provide fast image data collection at multiple locations in a single pullback procedure.
Regarding claim 2, Hou shows wherein the distal end region is connected to the proximal region by a bridge region of the elongate catheter shaft (see fig. 5).
Regarding claim 3, Hou shows wherein the guidewire lumen is defined by a guidewire lumen shaft extending from the proximal region of the elongate catheter shaft to the distal end region of the elongate catheter shaft (see fig. 5; par. [0079]).
Regarding claim 4, Hou shows wherein the distal end region is coupled to the proximal region by the guidewire lumen shaft (see fig. 5).
Regarding claim 5, Hou shows wherein the open gap is formed by a cutout in the elongate catheter shaft (see fig. 5; par. [0083]).
Regarding claim 6, Hou shows wherein the distal end region of the elongate catheter shaft has a proximal end (see fig. 5), wherein the proximal region of the elongate catheter shaft has a distal end (see fig. 5, and wherein the open gap is disposed between the proximal end of the distal end region and the distal end of the proximal region (see fig. 5).
Regarding claim 8, Hou shows wherein shifting the imaging core from the delivery position to the imaging position includes axially shifting the imaging core relative to the elongate catheter shaft (see fig. 5).
Regarding claim 12, Hou shows wherein the imaging device includes an ultrasound transducer (see par. [0083]).
Regarding claim 13, Hou discloses a balloon valvuloplasty catheter with IVUS. Hou shows an intravascular imaging catheter for imaging an interior of the blood vessel (see fig. 5 and abstract; par. [0073]), comprising: an elongate imaging catheter sheath having a distal end region (fig. 5 and par. [0079], [0099]), a proximal region (see fig. 5), an imaging window region disposed between the distal end region and the proximal region (see fig. 5; par. [0083]); wherein the imaging window region is defined by an opening in the elongate imaging catheter sheath (see fig. 5; par. [0079], [0083]) that is fluid communication with the interior of the blood vessel (see par. [0080]); a guidewire lumen shaft extending from the proximal region of the elongate imaging catheter sheath to the distal end region of the elongate imaging catheter sheath (see fig. 6; par. [0079]); an imaging core (see 130 in fig. 5) disposed within the elongate imaging catheter sheath (see fig. 5 and par. [0083]); wherein the imaging core includes an ultrasound imaging device (see par. [0083]).
Furthermore, Hou teaches wherein the imaging core is configured to shift between a delivery position disposed within the distal end region around the imaging window (see fig. 5) and an imaging position where the imaging device is disposed along the image window (see fig. 5; par. [0083]), but Hou fails to explicitly state that the delivery position where the imaging device is disposed withing the distal end distally of the imaging window.
Athanasiou discloses an ultrasound imaging system (see par. [0036]). Hastings teaches that imaging core is configured to shift between delivery position where the imaging device is disposed within distal end region distally of imaging window (see par. [0053], [0056] and fig. 4) and imaging position where the imaging device is disposed along the imaging window (see par. [0053], [0056] and fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention that imaging core is configured to shift between delivery position where the imaging device is disposed within distal end region distally of imaging window and imaging position where the imaging device is disposed along the imaging window in the invention of Hou, as taught by Athanasiou, to be able to provide fast image data collection at multiple of in a single pullback procedure.
Regarding claim 14, Hou shows wherein the distal end region of the elongate imaging catheter sheath is coupled to the proximal region of the elongate imaging catheter sheath by the guidewire lumen shaft (see fig. 5).
Regarding claim 15,Hou shows wherein the opening is formed by a cutout in the elongate imaging catheter sheath (see fig. 5; par. [0083]).
Regarding claim 16, Hou shows wherein the distal end region of the elongate imaging catheter sheath has a proximal end (see fig. 5), wherein the proximal region of the elongate imaging catheter sheath has a distal end (see fig. 5), and wherein the opening is disposed between the proximal end of the distal end region and the distal end of the proximal region (see fig. 5).
Regarding claim 17, Hou shows wherein shifting the imaging core from the delivery position to the imaging position includes axially shifting the imaging core relative to the elongate imaging catheter sheath (see fig. 5).
Regarding claim 18, Hou discloses a balloon valvuloplasty catheter with IVUS. Hou shows the method comprising: advancing an intravascular imaging catheter through a blood vessel to a position adjacent to an area of interest (see fig. 5; par. [0079], [0083]); wherein the intravascular imaging catheter comprises: an elongate catheter shaft (see 110 in fig. 5) having a distal end region and a proximal region (see fig. 5; par. [0079]), wherein a guidewire lumen is defined in the elongate catheter shaft (see 112 in fig. 5; par. [0079]), wherein the distal end region includes an imaging window defined by an open gap in the elongate catheter shaft (see fig. 5; par. [0083]) that is open to the blood vessel (see par. [0080]), an imaging core (see 130 in fig. 5) disposed within the elongate catheter shaft (see fig. 5; par. [0083]), and wherein the imaging core includes an imaging device (see 132 in fig. 5); aligning the imaging device with the imaging window (see fig. 5); and imaging the blood vessel using the imaging device and while proximally retracting the elongate catheter shaft (see abstract; fig. 5; par. [0079], [0083]).
Furthermore, Hou teaches wherein the imaging core is configured to shift between a delivery position disposed within the distal end region around the imaging window (see fig. 5) and an imaging position where the imaging device is disposed along the image window (see fig. 5), wherein aligning the imaging device with the imaging window includes shifting the imaging core from the delivery position to the imaging position (see fig. 5; par. [0083]), but Hou fails to explicitly state that the delivery position where the imaging device is disposed withing the distal end distally of the imaging window.
Athanasiou discloses an ultrasound imaging system (see par. [0036]). Hastings teaches that imaging core is configured to shift between delivery position where the imaging device is disposed within distal end region distally of imaging window (see par. [0053], [0056] and fig. 4) and imaging position where the imaging device is disposed along the imaging window (see par. [0053], [0056] and fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention that imaging core is configured to shift between delivery position where the imaging device is disposed within distal end region distally of imaging window and imaging position where the imaging device is disposed along the imaging window in the invention of Hou, as taught by Athanasiou, to be able to provide fast image data collection at multiple of in a single pullback procedure.
Regarding claim 20, Hou shows wherein imaging the blood vessel using the imaging device and while proximally retracting the elongate catheter shaft includes proximally retracting the elongate catheter shaft and the imaging core (see abstract; fig. 5).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. (US 2022/0226114; hereinafter Hou), in view of Athanasiou et al. (US 2023/0363652; hereinafter Athanasiou) as applied to claim 1 above, and further in view of Stigall et al. (US 2020/0037985; hereinafter Stigall).
Regarding claim 9, Hou and Athanasiou discloses the invention substantially as described in the 103 rejection above, but fails to explicitly state wherein the imaging device is coupled to an imaging housing.
Stigall discloses a IVUS device. Stigall teaches that the imaging device is coupled to an imaging housing (see par. [0035], [0036]; 116 in fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the imaging device is coupled to an imaging housing in the invention of Hou and Athanasiou, as taught by Stigall, to be able to protect the ultrasound element, and housing for the ultrasound transducer components.
Regarding claim 10, Hou, Athanasiou and Stigall disclose the invention substantially as described in the 103 rejection above, furthermore, Hou teaches wherein the imaging device has a proximal section that extends into the proximal region of the elongate catheter shaft (see fig. 5), and Stigall teaches the imaging housing. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the imaging housing in the invention of Hou and Athanasiou, as taught by Stigall, to be able to protect the ultrasound element, and housing for the ultrasound transducer components.
Regarding claim 11, Hou, Athanasiou and Stigall disclose the invention substantially as described in the 103 rejection above, furthermore, Hou teaches wherein the imaging device has a distal section that extends into the distal end region of the elongate catheter shaft (see fig. 5), and Stigall teaches the imaging housing. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the imaging housing in the invention of Hou and Athanasiou, as taught by Stigall, to be able to protect the ultrasound element, and housing for the ultrasound transducer components.
Response to Arguments
Upon further consideration, the previous claim interpretation under 35 USC 112 (f) for claim element “imaging device” has been withdrawn.
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive. The examiner maintains that combined invention of Hou and Athanasiou does disclose all the claim limitation set forth in independent claims. The examiner maintains that Athanasiou does teach the imaging core is configured to shift between delivery position where in the imaging device is disposed within distal end region distal of imaging window and imaging position where the imaging device is disposed along the imaging window (in fig. 4, Athanasiou disclose the imaging device 168 is placed at the distal end distally from the imaging window and then when the imaging procedure starts, the imaging device 168 is pulled back from the delivery position/distal end and disposed along the imaging window during imaging).
Furthermore, the examiner maintains that Hou does show the imaging window being defined by an open gap in the catheter shaft (see fig. 5; par. [0083]) that is open to the blood vessel (Fig. 5 shows the imaging window being defined by the open gap and par. [0080] states that the balloon 120 is permeable/open to blood/liquid in the blood vessel).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stigall et al. (US 2014/0163361) disclose a in vivo imaging device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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