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 .
Notice of Amendment
The Amendment filed 9/30/2025 has been entered. Claims 1-8 are pending in the application with claim 1 amended, claim 8 withdrawn, claims 9-20 cancelled.
Claim Rejections - 35 USC § 103
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 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 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang et al. (US Patent Application Publication No. 2015/0327754, hereinafter Leeflang) in view of Partridge et al. (US Patent Application Publication No. 2005/0065419, hereinafter Partridge) and Leavitt et al. (US Patent No. 5,779,731, hereinafter Leavitt).
In regard to claim 1, Leeflang discloses an imaging apparatus (8, Fig. 1), comprising:
a sheath (20,30) having an internal channel (18b) associated with a catheter body (Fig. 2A);
an imaging element (40) disposed in the sheath, wherein the sheath includes one or more registration markers (Par. 40), wherein at least one of the one or more registration markers (i) is configured to provide contrast to one or more imaging modalities (Par. 40);
an ancillary channel (18a), wherein the ancillary channel includes an opening (15a) located between a proximal end and a distal end of the sheath to accommodate a tissue retrieval device (the ancillary channel is configured for delivering instruments (70) and therefore is capable accommodating a tissue retrieval device, Fig. 4A), at least a portion of a surface other than an opening in common with a surface of the sheath (Fig. 2A), wherein the ancillary channel is separate from the imaging element (Fig. 2A), the one or more registration markers are located proximate to a distal end of the opening of the ancillary channel (Fig. 2A, Par. 40, both the radiopaque marker and opening are disposed in the distal tip (14));
wherein the tissue retrieval device is disposed in the ancillary channel, the tissue retrieval device configured to be deployable and retractable via the ancillary channel (a tissue retrieval device is capable of being disposed in the ancillary channel and being deployable / retractable within the ancillary channel since the tissue retrieval device is not a positively recited component, Fig. 4A); and
an inflatable balloon (30), coupled to an exterior surface of the sheath (Fig. 2A).
Leeflang does not expressly teach wherein an exterior surface of the balloon is textured to aid in anchoring the sheath to tissue.
Partridge teaches an analogous catheter for placing cardiac leads within a heart of a patient. The catheter includes balloons (240,250) which may be smooth, fluted and/or have texturing or other means of altering the grasping quality and/or shape of the balloons (Par. 19).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the balloon (30) of Leeflang with a textured surface as taught by Partridge in order to improve the grasping quality of the balloon within a cardiac space of a patient (Par. 19).
Leaflang teaches that various sections of the catheter can be formed with radiopaque markers to enhance visibility under fluoroscopy, ultrasound, MRI, or other imaging modalities (Par. 40), but does not expressly teach (ii) includes a common surface to both an interior surface of the sheath and an exterior surface of the sheath.
Leavitt teaches an analogous balloon catheter (10) comprising an elongate shaft (16) with a balloon (20) attached adjacent a distal end of the elongate shaft and an inner shaft (18). The elongate shaft (16) is formed with a proximal marker (68) at a distal end therof that forms parts of the outer surface and inner surface of the elongate shaft (16) and a distal marker (70) position on the inner shaft (18). The proximal and distal makers (68, 70) enabling a physician to visualize a working distance of the balloon (Col. 5, Line 59 – Col. 6, Line 9).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the catheter of Leaflang with the proximal and distal markers (68, 70) of Leavitt enabling a physician to locate the distal end of the catheter within a body cavity and also accurately visualize the working length of the balloon (Col. 5, Line 59 – Col. 6, Line 9).
In regard to claim 2, Leeflang teaches wherein the ancillary channel is alongside of the sheath. (Fig. 2A).
In regard to claim 3, Leeflang teaches wherein the imaging element is disposed in a portion of the sheath associated with a distal exit of the ancillary channel (Fig. 4A illustrates the imaging element configured to image instrument exiting the distal exit of the ancillary channel).
In regard to claim 4, Leeflang teaches wherein the tissue retrieval device is configured to be introducible and removable via the ancillary channel (a tissue retrieval device is capable of being disposed in the ancillary channel and being deployable / retractable within the ancillary channel since the tissue retrieval device is not a positively recited component, Fig. 4A).
In regard to claim 5, Leeflang teaches further comprising an actuation translator coupled to the imaging element, the actuation translator configured to rotate and translate the imaging element (Par. 44, 46 via manipulating steering wires for deflecting / bending to adjust a field of view of the imaging element).
In regard to claim 7, Leeflang teaches wherein the inflatable balloon is configured to be inflatable via the sheath (via inflation lumen (18b), Fig. 2A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang et al. (US Patent Application Publication No. 2015/0327754, hereinafter Leeflang) in view of Partridge et al. (US Patent Application Publication No. 2005/0065419, hereinafter Partridge) and Leavitt et al. (US Patent No. 5,779,731, hereinafter Leavitt), as applied to claim 5, Hopkins JR (US Patent Application Publication No. 2017/0325671, hereinafter Hopkins).
In regard to claim 6, Leeflang does not expressly teach wherein the actuation translator is a member of a group consisting of a motor-and a piezoelectric actuator.
Hopkins teaches an analogous device comprising an image sensor assembly (202) within a distal end of the device. A viewing angle of the image sensor assembly (202) can be changed by manipulating a wire (230) which is actuated via linear actuator (231), see Figs. 2-3 (Par. 34).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the imaging apparatus of Leeflang with the linear actuator (231) of Hopkins as a matter of design choice as an alternate actuator known in the art for applying tension and compression to control wires for changing an angle of view of an image sensor assembly.
Response to Arguments
Applicant’s arguments with respect to claims 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 November 8, 2025