CTNF 19/245,900 CTNF 94546 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 without traverse of Invention II, claims 9-17, in the reply filed on 06/01/2026 is acknowledged. Claims 1-8 and 18-20 are withdrawn from consideration further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions I and III. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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: 07-08-aia AIA 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. 07-15 AIA Claim s 9-12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Saadat et. al. (U.S. 20080015569, January 17, 2008)(hereinafter, “Saadat” ) . Regarding Claim 9 ,Saadat teaches: A system, comprising: a delivery device comprising first and second lumens (“deployment catheter 16”, [0136], see Figs. 1 and 4), the first lumen extending between a proximal end and a distal end of the delivery device and the second lumen extending between the proximal end and an outer surface of the delivery device (see Figs. 1 and 4, [0133][0135][0141]); and a sheath comprising a marker (“sheath 14” [0133][0241],“radio-opaque fiducial markers 664”, [0233]), the marker positioned to indicate, in an ultrasound image, a projected position of a tissue sampling element when the tissue sampling element is extended out of the second lumen (“Imaging hood 12 may be attached at interface 24 to a deployment catheter 16 which may be translated independently of deployment catheter or sheath 14.” [0133]; “A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in FIG. 7A, and into imaging hood 12.”[0146]; “FIGS. 62B and 62C illustrate an imaging instrument, such as a fiberscope 662, advanced at least partially within the intra-atrial balloon 660 to survey the cardiac chamber as well as articulating the fiberscope 662 to obtain closer images of tissue regions of interest as well as to navigate a wide range of motion. FIG. 62D illustrates a variation of balloon 660 where one or more radio-opaque fiducial markers 664 may be positioned over the balloon such that a position and inflation size of the balloon 660 may be tracked or monitored…” [0233]; See for example Fig 7A). Regarding Claim 10 , Saadat teaches the claim limitations as noted above. Saadat further teaches: wherein the first lumen of the delivery device includes a ramped surface (see Fig. 4A, [0141]). Regarding Claim 11 , Saadat teaches the claim limitations as noted above. Saadat further teaches: wherein the ramped surface includes an angle of approximately 5 degrees to approximately 10 degrees relative to a longitudinal axis of the second lumen (see Figs. 3A and 4A, [0141]). Regarding Claim 12 , Saadat teaches the claim limitations as noted above. Saadat further teaches: comprising a tissue sampling device disposed within the first lumen of the delivery device and an ultrasound transducer disposed within the sheath (“A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in FIG. 7A, and into imaging hood 12.”[0146];“…sheath 14 may be advanced at least partially through the atrial septum AS…With a trajectory determined, a penetrating needle 720 having a piercing tip 722 and a hollow lumen sufficiently sized to accommodate hood 12 and deployment catheter 16…” [0241];“…ultrasound transducer 742 may be attached to or through a catheter 740.” [0244]. See for example Figs. 7A and 67) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Sinelnikov et. al. (U.S. 20140350401, November 27, 2014)(hereinafter, “Sinelnikov” ) . Regarding Claim 13 , Saadat teaches the claim limitations as noted above. wherein the tissue sampling element is actuatable between an unactuated state with a distal end of the tissue sampling element within the second lumen and an actuated state with the distal end of the tissue sampling element extended out of the second lumen (“A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in FIG. 7A, and into imaging hood 12.”[0146]) with regards to limitations: and the ultrasound transducer configured to image the marker to generate a first radial image when the tissue sampling element is in the unactuated state and image the marker and the tissue sampling element to generate a second radial image when the tissue sampling element is in the actuated state, Saadat further teaches: “Imaging hood 12 may be attached at interface 24 to a deployment catheter 16 which may be translated independently of deployment catheter or sheath 14.” [0133]; “A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in FIG. 7A, and into imaging hood 12.”[0146]; “FIGS. 62B and 62C illustrate an imaging instrument, such as a fiberscope 662, advanced at least partially within the intra-atrial balloon 660 to survey the cardiac chamber as well as articulating the fiberscope 662 to obtain closer images of tissue regions of interest as well as to navigate a wide range of motion. FIG. 62D illustrates a variation of balloon 660 where one or more radio-opaque fiducial markers 664 may be positioned over the balloon such that a position and inflation size of the balloon 660 may be tracked or monitored…” [0233]. Saadat is silent with regards to the marker position of the tissue sampling element being indicated in a secondary image due to the actuation state. Sinelnikov in the field of catheter treatment systems teaches: "Radiopaque markers visible on X-ray can be added to the design to ensure that the ultrasonic emission cone 51 is pointed in the direction of the target.. For example two markers can be placed on two opposite sides of the shaft and alignment of the markers (e.g., so that they are projected as one or as a cross or other distinct superimposed shape on an imaging screen) can assist the operator in pointing the energy emission in the desired direction." [0185]. The figures in Sinelnikov, for example Figs. 13 and 14. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate into Saadat the imaging teachings of the marker position of the tissue sampling element being indicated in a secondary image due to the actuation state of the tissue sampling element as taught in Sinelnikov to “…assist the operator in pointing the energy emission in the desired direction (Sinelnikov, [0185]). Regarding Claim 14 , the combination of Saadat and Sinelnikov teach the claim limitations as noted above. Saadat further teaches: wherein a position of the marker in the first radial image indicates the projected position of the tissue sampling element in the actuated state (“Imaging hood 12 may be attached at interface 24 to a deployment catheter 16 which may be translated independently of deployment catheter or sheath 14.” [0133]; “A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in FIG. 7A, and into imaging hood 12.”[0146]; “FIGS. 62B and 62C illustrate an imaging instrument, such as a fiberscope 662, advanced at least partially within the intra-atrial balloon 660 to survey the cardiac chamber as well as articulating the fiberscope 662 to obtain closer images of tissue regions of interest as well as to navigate a wide range of motion. FIG. 62D illustrates a variation of balloon 660 where one or more radio-opaque fiducial markers 664 may be positioned over the balloon such that a position and inflation size of the balloon 660 may be tracked or monitored…” [0233]). Regarding Claims 15 and 16 , the combination of Saadat and Sinelnikov teach the claim limitations as noted above. Saadat further teaches: wherein the position of the marker in the first radial image is offset from the position of the tissue sampling element in the second radial image by a predetermined angle; wherein the predetermined angle is approximated 180 degrees (See Figs. 62 CD, [0233-0234]) . 07-22-aia AIA Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Saadat as applied to claim 9 above, and further in view of Klocke et. al. (U.S. 20150335859, November 26, 2015) (hereinafter, “Klocke” ) . Regarding Claim 17 , Saadat teaches the claim limitations as noted above. Saadat teaches a radiopaque marker: (“sheath 14” [0133][0241],“radio-opaque fiducial markers 664”, [0233]). Saadat does not teach: wherein the marker comprises a radiopaque strip. Klocke in the field of catheter systems teaches a catheter with a strip of radiopaque material [0013]. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Saadat to comprise a radiopaque strip as taught in Klocke “…for identifying the location...” of the region of interest (Klocke, [0013]) and/or instrument with respect to the region of interest . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Levy et. al. U.S. 20140213850 teaches a multi-viewing endoscope system . Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMAL FARAG whose telephone number is (571)270-3432. The examiner can normally be reached 8:30 - 5:30 M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AMAL ALY FARAG/Primary Examiner, Art Unit 3798 Application/Control Number: 19/245,900 Page 2 Art Unit: 3798 Application/Control Number: 19/245,900 Page 3 Art Unit: 3798 Application/Control Number: 19/245,900 Page 4 Art Unit: 3798 Application/Control Number: 19/245,900 Page 5 Art Unit: 3798 Application/Control Number: 19/245,900 Page 6 Art Unit: 3798 Application/Control Number: 19/245,900 Page 7 Art Unit: 3798 Application/Control Number: 19/245,900 Page 8 Art Unit: 3798
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