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 .
Election/Restrictions
Applicant’s election of Group I.A. Encompassing Claims 1-13 and 20 and Group II.A. Encompassing Claim 4 in the reply filed 6/5/2026 is acknowledged. In this reply, applicant traverses the restriction requirement mailed on 4/7/2026, but provides no argument for this traversal. As such, the restriction requirement is upheld and made final.
Regarding group I, the restriction requirement is upheld on the grounds that the bumper tip member and the tip member are presented as different species in the specification as noted by unique reference numbers in the figures. Regarding group II, the restriction requirement is upheld on the grounds that the imaging core cannot simultaneously be both an ultrasound transducer and an optical coherence tomography imaging device.
Claims 1-20 are pending in the application, Claims 4 and 14-19 are withdrawn, and Claims 1-3, 5-13, and 20 have been examined on the merits in the current application.
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.
(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.
Claim(s) claims 1-3, 5-8, 12, 13, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciamacco (US 5772642 A).
Regarding claim 1, Ciamacco teaches an intravascular imaging device ((col. 4 lines 21) An intravascular x-ray device 110)
comprising a catheter shaft including a proximal section and a distal section ((col. 2 lines 41-44) FIG. 1A is a longitudinal cross-section of the proximal end of the closed end catheter; FIG. 1B is longitudinal cross-section of the distal end of the closed end catheter)
wherein the distal section includes a dual lumen region ((col. 2 line 45) FIG. 2 is a cross-section taken along the lines 2--2 of FIG. 1B)
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and a distal tip region coupled to the dual lumen region ((col. 2 line 31) The elongated tool has a distal tip and a working portion near the distal tip)
a bumper tip member disposed along the distal tip region; a marker member disposed adjacent to the bumper tip member ((col. 3 lines 34-36) By having a plug 80 as close to the tip as possible, and by having the entire distal end secured by the shrink jacket tubing 30)
a marker member disposed adjacent to the bumper tip member ((col. 3 lines 19-23) Marker bands 60 and 65 located on the exterior surface of the guidewire lumen 70 are used to position the treatment source tool in the distal section 55)
wherein the marker member includes an inner layer ((col. 5 line 21) The guidewire tubing 85 defining the guidewire lumen 70)
a tie layer ((col. 6 line 32) adhesive 90 is wicked under the marker bands 60, 65 to affix them to the exterior of the guidewire tubing 85)
and an outer layer including a radiopaque material ((col. 3 lines 19-22) Marker bands 60 and 65 located on the exterior surface of the guidewire lumen 70)
a sleeve disposed over and coupling the bumper tip member and the marker member (jacket tubing 30)
and an imaging core disposed within the catheter shaft ((col. 5 lines 6-7) Applicant's closed end catheter 5 can be used with an ultrasound device 170 as seen in FIG. 12).
Regarding claim 2, Ciamacco teaches the imaging core is translatable within the catheter shaft ((col. 5 lines 6-12) Applicant's closed end catheter 5 can be used with an ultrasound device 170 as seen in FIG. 12. The closed end catheter 5 prevents the inserted device from coming into direct contact with the patient's blood as well as enabling the use of a separate, potentially less viscous solution to improve image resolution or reduce friction. An IVUS probe could be placed into the catheter to perform intravascular ultrasound during interventional procedures; the closed end being required to prevent the device from coming in contact with the patient’s blood implies the translatable quality of the IVUS device)
Regarding claim 3, Ciamacco teaches the imaging core includes an ultrasound transducer ((col. 5 lines 6-7) Applicant's closed end catheter 5 can be used with an ultrasound device 170 as seen in FIG. 12).
Regarding claim 5, Ciamacco teaches the inner layer of the marker member, the tie layer of the marker member, or both include a polyethylene ((col. 5 lines 26-33) The treatment tubing 10 which defines the treatment lumen 20 is made of High Density Polyethylene (HDPE). The guidewire tubing 85 defining the guidewire lumen 70 is made of High Density Polyethylene (HDPE). The jacket tubing 30 which encases the treatment tubing 10 and the guidewire tubing 85 is made of (HDPE). The plug 80 is made of Linear Low Density Polyethylene (LLDPE))
Regarding claim 6, Ciamacco teaches the inner layer of the marker member includes a high-density polyethylene ((col. 5 lines 26-33) The treatment tubing 10 which defines the treatment lumen 20 is made of High Density Polyethylene (HDPE). The guidewire tubing 85 defining the guidewire lumen 70 is made of High Density Polyethylene (HDPE). The jacket tubing 30 which encases the treatment tubing 10 and the guidewire tubing 85 is made of (HDPE). The plug 80 is made of Linear Low Density Polyethylene (LLDPE))
Regarding claim 7, Ciamacco teaches the tie layer of the marker member includes a low-density polyethylene ((col. 5 lines 26-33) The treatment tubing 10 which defines the treatment lumen 20 is made of High Density Polyethylene (HDPE). The guidewire tubing 85 defining the guidewire lumen 70 is made of High Density Polyethylene (HDPE). The jacket tubing 30 which encases the treatment tubing 10 and the guidewire tubing 85 is made of (HDPE). The plug 80 is made of Linear Low Density Polyethylene (LLDPE)).
Regarding claim 8, Ciamacco teaches the outer layer of the marker member includes a polymer resin loaded with the radiopaque material ((col. 5 line 35) The markers 60, 65 may be made of any radiopaque material)
Regarding claim 12, Ciamacco teaches the dual lumen region includes a guidewire lumen and an imaging core lumen ([abst] the tool lumen and the guidewire lumen are in a biaxial relationship)
Regarding claim 13, Ciamacco teaches ((col. 3 lines 14-16) The guidewire lumen 70 and the treatment lumen 20 could be extruded or could be formed by separate tubes which could be bonded together).
Regarding claim 20, Ciamacco teaches a method for imaging a blood vessel the method comprising disposing an intravascular imaging device within a blood vessel ((col. 4 lines 21) An intravascular x-ray device 110)
the intravascular imaging device comprising a catheter shaft including a proximal section and a distal section ((col. 2 lines 41-44) FIG. 1A is a longitudinal cross-section of the proximal end of the closed end catheter; FIG. 1B is longitudinal cross-section of the distal end of the closed end catheter)
wherein the distal section includes a dual lumen region ((col. 2 line 45) FIG. 2 is a cross-section taken along the lines 2--2 of FIG. 1B)
and a distal tip region coupled to the dual lumen region ((col. 2 line 31) The elongated tool has a distal tip and a working portion near the distal tip)
a bumper tip member disposed along the distal tip region; a marker member disposed adjacent to the bumper tip member ((col. 3 lines 34-36) By having a plug 80 as close to the tip as possible, and by having the entire distal end secured by the shrink jacket tubing 30)
a marker member disposed adjacent to the bumper tip member ((col. 3 lines 19-23) Marker bands 60 and 65 located on the exterior surface of the guidewire lumen 70 are used to position the treatment source tool in the distal section 55)
wherein the marker member includes an inner layer ((col. 5 line 21) The guidewire tubing 85 defining the guidewire lumen 70)
a tie layer ((col. 6 line 32) adhesive 90 is wicked under the marker bands 60, 65 to affix them to the exterior of the guidewire tubing 85)
and an outer layer including a radiopaque material ((col. 3 lines 19-22) Marker bands 60 and 65 located on the exterior surface of the guidewire lumen 70)
a sleeve disposed over and coupling the bumper tip member and the marker member (jacket tubing 30)
and an imaging core disposed within the catheter shaft and translating the imaging core relative to the catheter shaft ((col. 5 lines 6-7) Applicant's closed end catheter 5 can be used with an ultrasound device 170 as seen in FIG. 12. The closed end catheter 5 prevents the inserted device from coming into direct contact with the patient's blood as well as enabling the use of a separate, potentially less viscous solution to improve image resolution or reduce friction. An IVUS probe could be placed into the catheter to perform intravascular ultrasound during interventional procedures).
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) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ciamacco as applied to claim 1 above, and further in view of Hou (US 20220168542 A1).
Regarding claim 9, Ciamacco fails to teach the polymer resin includes a polyether block amide.
However, Hou teaches the polymer resin includes a polyether block amide ([0070] The medical device 10 and/or other components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include … polyether block amide)
Ciamacco and Hou are considered analogous because both disclose intravascular imaging catheters. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a polyether block amide as a construction material for a catheter in order to not substantially distort the image and create substantial artifacts (Hou [0073])
Regarding claim 10, Ciamacco teaches the polymer resin further comprises an ultra-high molecular weight polyethylene ((col. 5 line 26) High Density Polyethylene (HDPE))
Regarding claim 11, Ciamacco fails to teach the radiopaque material includes tungsten.
However, Hou teaches the radiopaque material includes tungsten ([0072] In at least some embodiments, portions or all of the medical device 10 may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the medical device 10 in determining its location. Some examples of radiopaque materials can include, but are not limited to, … tungsten)
Ciamacco and Hou are considered analogous because both disclose intravascular imaging catheters. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a polyether block amide as a construction material for a catheter in order to produce a relatively bright image on a fluoroscopy screen (Hou [0072]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne 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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/GABRIEL VICTOR POPESCU/ Examiner, Art Unit 3797
/ANNE M KOZAK/ Supervisory Patent Examiner, Art Unit 3797
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