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 .
Status of Claims
Claims 1-20 are pending in this application. Claims 1-9 are withdrawn, and Claims 10-20 have
been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of claims 1-9 drawn to Invention I in the reply filed on 03/09/26 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being
drawn to a nonelected Invention II drawn to a method for locating a treatment provided in an endoluminal procedure, Invention III drawn to a method for generating a treatment recommendation for an endoluminal procedure for a patient, and Invention IV drawn to a method for generating a treatment recommendation for an endoluminal procedure for a patient, there being no allowable generic or linking claim.
Claim Objections
Claim 2 is objected to because of the following informalities:
In Claim 2, line 1, “activation sensor” should be “treatment activation sensor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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:
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.
Claims 1, 2, 4-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips (US20170120080A1, disclosed in Applicant’s IDS).
Regarding Claim 1,
Phillips teaches a system for locating a treatment provided in an endoluminal procedure (corresponding disclosure in at least [0009], where the treatment is located within an endoluminal procedure, or procedure comprising a catheter “a system including an interventional ultrasound catheter to image and ablate tissue, and provides graphical user interfaces to aid in planning, ablating, and assessing the ablation therapy.”), comprising:
a first flexible elongate instrument comprising a plurality of imaging markers (corresponding disclosure in at least [0068], where there are imaging markers (radiopaque markers) on the flexible elongate instrument (inner shaft) “visualizing the Radiopaque Markers 280 on the Inner Shaft 220 and Outer Shaft 200”);
a second flexible elongate instrument configured for relative movement with respect to the first flexible elongate instrument and comprising a therapeutic delivery device (corresponding disclosure in at least [0030], where the second flexible elongate instrument (outer shaft) moves with respect to, or with the first instrument and comprises a therapeutic delivery device, or the energy beam, which is used for ablation “he Controller 20 controls manipulation of an Inner Shaft Deflecting Section 230 to enable accuracy of motion of Catheter 120 components and an Energy Beam 290”);
a location information sensor disposed at the first flexible elongate instrument or at the second flexible elongate instrument (corresponding disclosure in at least [0030], where the second flexible instrument has a location information sensor “ The Controller 20 controls manipulation of the Inner Shaft Deflecting Section 230 through drive mechanisms and optionally incorporates sensors in or near a Catheter Handle”);
an treatment activation sensor configured to detect an activation energy associated with delivery of a therapy by the therapeutic delivery device (corresponding disclosure in at least [0033], where there are treatment activation sensors, or the ultrasound probe, which monitors the energy, or temperature, of the energy from the therapeutic device “The temperature monitoring may be performed using data from, for example, the Ultrasound Transducer 260, or from a thermocouple or other temperature measurement device on the Catheter 120 or on an ancillary device such as a probe” and further in [0035], where the probe also contains a temperature monitor “The Probe 60 may contain a thermistor or Thermocouple 67 for monitoring temperature of the Tissue 50 or area within the vicinity of the thermistor or Thermocouple”); and a processor configured to:
establish a reference coordinate system based on the plurality of imaging markers, the plurality of imaging markers being visible in a medical image comprising the first flexible elongate instrument disposed in a body lumen (corresponding disclosure in at least [0041] and Figure 3, where there are markers, which are visible in the medical image “Positioning information can be utilized from other sources as well, such as ultrasound information from the Ultrasound Transducer 260 and Radiopaque Markers 280 on the Catheter 120” and further in [0038], where the image data is based on a coordinate system (3D coordinate frame) “the A-mode sensing data in the present disclosure is processed to form a set of points located in a 3D coordinate frame defining a point cloud (‘PC’). Each point is generated from detecting tissue boundaries and other tissue characteristics such as thickness, volume, and angle of incidence”),
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Figure 3 of Phillips
receive therapeutic delivery information at a plurality of locations in the body lumen from the location information sensor, and correlate the therapeutic delivery information with the detected activation energy to determine a position of the delivered therapy within the body lumen based on the reference coordinate system (corresponding disclosure in at least [0052], where the location sensor provides information regarding the therapy for a plurality of locations, or the multiple locations that the device is moved towards, with information on the position being based on the reference coordinate system, or the 3D coordinate frame ([0041]) “The position of the catheter can also be actively monitored and controlled during therapy… at least a portion of the catheter is moved by the system to ablate the body tissue along the lesion path. That is, the system analyzes the position of the catheter, such as by EM sensors on the catheter, and controls the catheter navigation along the planned lesion path”).
Regarding Claim 2,
wherein the activation sensor is a pressure sensor (corresponding disclosure in at least [0033], where there is a pressure sensor, or the ultrasound transducer, which measures the pressure or the sound pressure waves from the tissues “the energy delivery source emits an Energy Beam 290 (such as a sound pressure wave). The properties of the Energy Beam 290 are determined by the characteristics of the energy delivery source which determine the frequency, spectral bandwidth, and pressure amplitude of the Energy Beam 290 (such as a sound wave) propagated into the Tissue... The temperature monitoring may be performed using data from, for example, the Ultrasound Transducer 260, or from a thermocouple or other temperature measurement device on the Catheter 120 or on an ancillary device such as a probe”).
Regarding Claim 4,
Phillips further teaches wherein the processor is further configured to:
receive diagnostic scan information at the plurality of locations in the body lumen from a diagnostic device (corresponding disclosure in at least [0045], where there is a diagnostic scan, or a map of the of the plurality of locations, or the multiple lesion paths in the body “a Graphical User Interface 500 which shows an anatomical reference map as a Lesion Overlay Map 510. The Lesion Overlay Map 510 shows the chamber of Body Tissue 512 with a Catheter 514 and Lesion Path”); and
correlate the diagnostic scan information with the therapeutic delivery information and the detected activation energy to determine a position of the delivered therapy relative to the diagnostic scan information (corresponding disclosure in at least Figure 6 and [0049], where the diagnostic scan information is correlated, or overlaid, with the therapeutic delivery information, which shows the position and the detected energy (the ablation) “the Graphical User Interface 600 is an active ablation screen used in therapy mode, showing the progress of ablation and allowing the user to take actions such as manipulating the speed factor or to pause ablation… A 3D anatomical Reference Map 610 shows a close-up view of a region of the chamber being ablated in real-time by a Catheter 614, along the Lesion Path 616. A Lesion Progress Indicator 618 is a visual depiction of the ablation progress along the active lesion path”).
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Figure 6 of Phillips
Regarding Claim 5,
Phillips further teaches wherein receipt of the diagnostic scan information occurs prior to delivery of the therapy (corresponding disclosure in at least [0080], where scan occurs prior to delivery “the user may desire to run a pre-therapy scan to confirm any or all aspects of the desired Lesion 53 only, or a smaller portion of Tissue 50 than in a larger map, prior to starting ablation”).
Regarding Claim 6,
Phillips further teaches wherein the first flexible elongate instrument comprises the diagnostic device (corresponding disclosure in at least [0069] and Figure 1, where the first elongate instrument (inner shaft) has the diagnostic device, or the probe “. Probe 60 may be, for example, an esophageal probe, and is comprised of a Probe Shaft 61, optional Probe Deflecting Section 62, and Probe Handle 63”).
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Figure 1 of Phillips
Regarding Claim 7,
Phillips further teaches wherein the diagnostic device is configured for relative movement with respect to the first flexible elongate instrument (corresponding disclosure in at least Figure 1 and [0035], where the probe is connected to the first elongate instrument, thus moving relative to the movement of the instrument “ Probe 60 may be, for example, an esophageal probe, and is comprised of a Probe Shaft 61, optional Probe Deflecting Section 62, and Probe Handle 63. Drive mechanisms within the Probe Handle 63 may actuate control cables to deflect the Probe Deflecting Section 62, such as by rotation of the Probe Deflection Knob 64. The Probe 60 may be provided with multiple functions (e.g. position information, temperature information, electrical information, etc.)”).
Regarding Claim 9,
Phillips further teaches a display configured to display a composite image comprising a representation of the position of the delivered therapy for use with subsequent procedures (corresponding disclosure in at least Figure 6 and [0049], where there is a display showing the representation of the position of the delivered therapy “the Graphical User Interface 600 is an active ablation screen used in therapy mode, showing the progress of ablation and allowing the user to take actions such as manipulating the speed factor or to pause ablation… A 3D anatomical Reference Map 610 shows a close-up view of a region of the chamber being ablated in real-time by a Catheter 614, along the Lesion Path 616. A Lesion Progress Indicator 618 is a visual depiction of the ablation progress along the active lesion path” and further in [0052] “The position of the catheter can also be actively monitored and controlled during therapy. For example, the system can mark and/or record the navigation history of the catheter, storing locations where the catheter has delivered energy”).
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Figure 6 of Phillips
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 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US20170120080A1, disclosed in Applicant’s IDS) in view of Wang (US20220000423A1).
Regarding Claim 3, Phillips teaches the limitations of Claim 2, but does not teach wherein the therapeutic delivery device is an inflation device.
Wang, in a similar field of endeavor, teaches a similar concept (treatment tool) of wherein the therapeutic delivery device is an inflation device (corresponding disclosure in at least [0093], where there is an inflatable device “a balloon ablation catheter according to an embodiment of the present invention, wherein the balloon (533) is inflated”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the inflation device as taught by Wang. One of the ordinary skill in the art would have been motivated to incorporate this because the inflation device is commonly used for catheterization for enlarging narrow openings.
Regarding Claim 8, Phillips teaches the limitations of Claim 1, but does not specify wherein the therapy comprises an angioplasty, atherectomy, stent delivery, lithotripsy, or a combination thereof.
Wang, in a similar field of endeavor, teaches a similar concept of wherein the therapy comprises an angioplasty, atherectomy, stent delivery, lithotripsy, or a combination thereof (corresponding disclosure in at least [0024], where the therapy is for angioplasty “catheterization was determined in part by an assessment of renal artery anatomy, renal artery stenosis, prior renal stenting or angioplasty, and dual renal arteries”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have the therapy comprise an angioplasty, atherectomy, stent delivery, lithotripsy, or a combination thereof as taught by Wang. One of the ordinary skill in the art would have been motivated to incorporate this because the methods are well-suited for procedures involving ablation functions.
Conclusion
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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