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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/22/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 9/22/2025 with respect to claims 1-15 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Swanson (US 20020111548) hereinafter Swanson 2002 and further in view of Swanson (US 5968040) hereinafter Swanson 596.
Regarding claim 1, Swanson 2002 discloses a device (Abstract – “A catheter tube”) comprising:
a sheath (Abstract – “The catheter tube”, the tubing of the catheter is interpreted as a sheath);
an optical scope positioned at the distal end of the sheath ([0182] – “the IAE 50 (and electrode 31)…cannot be withdrawn into the catheter tube bore”, IAE is defined as an image acquisition element in [0069], [0082] – “the IAE 50 can comprise an apparatus for obtaining an image through optical coherence tomography (OCT)”); and
a wire-basket structure surrounding the optical scope ([0048] – “a support structure 20 that carries within it an imaging or visualizing probe 34”, [0050] – “the structure 20 comprises two or more flexible spline elements 22”, [0051] – “each spline element 22 preferably comprises a flexible core body 84”, [0052] – “The core body 84 is made from resilient, inert wire”), wherein the […] the optical scope are fully housed within the structure ([0048] – “a support structure 20 that carries within it an imaging or visualizing probe 34”, [0182] – “the IAE 50 (and electrode 31)…cannot be withdrawn into the catheter tube bore”),
wherein the wire-basket structure comprises three or more wires having a first end and a second end, wherein the first end of each of the wires is attached near a distal end of the sheath and the second end of each of the wires is joined together at a point above the distal end of the sheath […] ([0050] – “the support structure 20 includes eight spline elements 22, [0051] – “each spline element 22 preferably comprises a flexible core body 84”, [0052] – “The core body 84 is made from resilient, inert wire”, [0053] – “The core bodies 84 of the spline elements 22 extend longitudinally between a distal hub 24 and a base 26. The base 26 is carried by the distal end 16 of the catheter tube 12”, Figs. 1, 5A, and 5B).
Conversely Swanson 2002 does not teach wherein the distal end of the sheath […is] fully housed within the structure,
wherein the wire-basket structure […] forming an ovoid shape
wherein the point above the distal end of the sheath where the second end of each of the wires is joined is located at a distance from the first end of each of the wires, the distance being greater than the length of the distal end of the sheath.
However Swanson 596 discloses wherein the distal end of the sheath […is] fully housed within the structure (As cited above Swanson 2002 discloses that the spline elements 22 extend between a distal hub and a base 26, Swanson 596 shows base 26 in Figs. 16 and 17, Col. 21 lines 1-4 – “the base 26 includes an anchor member 88 and a mating lock ring 90 (see FIGS. 16 and 17). The anchor member 88 fits with an interference friction fit into the distal end 16 of the catheter tube 12.”, one with ordinary skill in the art would find it obvious that the male and female connectors between the catheter and the anchor member could be reversed where the distal end of the catheter would fit into the anchor member with an interference friction fit and the distal end of the catheter/sheath would be housed within the structure, this would allow for full use of the entire inner diameter of the catheter to be used for introduction of devices for diagnosis and treatment),
wherein the wire-basket structure […] forming an ovoid shape (see Fig. 7)
wherein the point above the distal end of the sheath where the second end of each of the wires is joined is located at a distance from the first end of each of the wires, the distance being greater than the length of the distal end of the sheath (one with ordinary skill in the art would find it obvious that the male and female connectors between the catheter and the anchor member could be reversed where the distal end of the catheter would fit into the anchor member with an interference friction fit and the distal end of the catheter/sheath would be housed within the structure, this would allow for full use of the entire inner diameter of the catheter to be used for introduction of devices for diagnosis and treatment. Therefore when the male and female mating is reversed the distance between the distal end of the splines and the proximal end of the splines is greater than the length of the distal end of the sheath that would be within the anchor member).
The disclosure of Swanson 596 is an analogous art considering it is in the field of a catheter with a wire basket structure at the distal end.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swanson 2002 to incorporate the base of the spline structure of Swanson 596 to achieve the same results. One would have motivation to combine because it would “provide manufacturing efficiencies, as the number of the components parts required to form the asymmetric electrode support assembly 58 is minimized” (Swanson 596 – Col. 21 lines 16-17).
Regarding claim 2, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 1.
Swanson 2002 further discloses wherein the optical scope comprises a white-light camera and/or a near-infrared camera ([0082] – “the IAE 50 can comprise an apparatus for obtaining an image through optical coherence tomography (OCT)”).
Regarding claim 7, Swanson 2002 discloses a method ([0006] – “The invention provides improved systems and methods”) comprising:
providing a device having a sheath (Abstract – “The catheter tube”, the tubing of the catheter is interpreted as a sheath);
an optical scope positioned at the distal end of the sheath ([0182] – “the IAE 50 (and electrode 31)…cannot be withdrawn into the catheter tube bore”, IAE is defined as an image acquisition element in [0069], [0082] – “the IAE 50 can comprise an apparatus for obtaining an image through optical coherence tomography (OCT)”); and
a wire-basket structure surrounding the optical scope ([0048] – “a support structure 20 that carries within it an imaging or visualizing probe 34”, [0050] – “the structure 20 comprises two or more flexible spline elements 22”, [0051] – “each spline element 22 preferably comprises a flexible core body 84”, [0052] – “The core body 84 is made from resilient, inert wire”) and one or more sensing electrodes positioned on the wire basket structure ([0111] – “each spline 22 carries an array of multiple electrodes 30”, [0148] – “electrodes 30 can also serve to sense electrical impulses in tissue”);
wherein the […] the optical scope are fully housed within the structure ([0048] – “a support structure 20 that carries within it an imaging or visualizing probe 34”, [0182] – “the IAE 50 (and electrode 31)…cannot be withdrawn into the catheter tube bore”); and
wherein the wire-basket structure comprises three or more wires having a first end and a second end, wherein the first end of each of the wires is attached near a distal end of the sheath and the second end of each of the wires is joined together at a point above the distal end of the sheath […] ([0050] – “the support structure 20 includes eight spline elements 22, [0051] – “each spline element 22 preferably comprises a flexible core body 84”, [0052] – “The core body 84 is made from resilient, inert wire”, [0053] – “The core bodies 84 of the spline elements 22 extend longitudinally between a distal hub 24 and a base 26. The base 26 is carried by the distal end 16 of the catheter tube 12”, Figs. 1, 5A, and 5B);
inserting the device in an epicardial space of a subject ([0201] – “an enlarged diameter (see FIG. 13A), makes possible the creation of larger lesions in a controlled fashion to ablate epicardial, endocardial, or intramural VT substrates”); and
acquiring images of a heart and associated structures ([0105] – “acquire images inside a beating heart chamber”).
Conversely Swanson 2002 does not teach wherein the distal end of the sheath […is] fully housed within the structure,
wherein the wire-basket structure […] forming an ovoid shape
wherein the point above the distal end of the sheath where the second end of each of the wires is joined is located at a distance from the first end of each of the wires, the distance being greater than the length of the distal end of the sheath.
However Swanson 596 discloses wherein the distal end of the sheath […is] fully housed within the structure (As cited above Swanson 2002 discloses that the spline elements 22 extend between a distal hub and a base 26, Swanson 596 shows base 26 in Figs. 16 and 17, Col. 21 lines 1-4 – “the base 26 includes an anchor member 88 and a mating lock ring 90 (see FIGS. 16 and 17). The anchor member 88 fits with an interference friction fit into the distal end 16 of the catheter tube 12.”, one with ordinary skill in the art would find it obvious that the male and female connectors between the catheter and the anchor member could be reversed where the distal end of the catheter would fit into the anchor member with an interference friction fit and the distal end of the catheter/sheath would be housed within the structure, this would allow for full use of the entire inner diameter of the catheter to be used for introduction of devices for diagnosis and treatment),
wherein the wire-basket structure […] forming an ovoid shape (see Fig. 7)
wherein the point above the distal end of the sheath where the second end of each of the wires is joined is located at a distance from the first end of each of the wires, the distance being greater than the length of the distal end of the sheath (one with ordinary skill in the art would find it obvious that the male and female connectors between the catheter and the anchor member could be reversed where the distal end of the catheter would fit into the anchor member with an interference friction fit and the distal end of the catheter/sheath would be housed within the structure, this would allow for full use of the entire inner diameter of the catheter to be used for introduction of devices for diagnosis and treatment. Therefore when the male and female mating is reversed the distance between the distal end of the splines and the proximal end of the splines is greater than the length of the distal end of the sheath that would be within the anchor member).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swanson 2002 to incorporate the base of the spline structure of Swanson 596 to achieve the same results. One would have motivation to combine because it would “provide manufacturing efficiencies, as the number of the components parts required to form the asymmetric electrode support assembly 58 is minimized” (Swanson 596 – Col. 21 lines 16-17).
Regarding claim 11, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 7.
Swanson 2002 further discloses further comprising performing targeted ablation of epicardial tissue ([0201] – “ablate epicardial, endocardial, or intramural VT substrates”).
Claims 3-5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Swanson (US 20020111548) hereinafter Swanson 2002 and Swanson (US5968040) hereinafter Swanson 596 as applied to claims 1 and 7 above, and further in view of Chen (US 20160206373).
Regarding claim 3, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 1.
Conversely Swanson 2002 does not teach wherein the device further comprises a transducer coupled to the optical scope.
However Chen discloses wherein the device further comprises a transducer coupled to the optical scope ([0143] – “Using a micro US transducer 112 coupled through an ultrasound wire 116 to ultrasound pulser/receiver 110 and micro OCT probe”).
The disclosure of Chen is an analogous art considering it is in the field of an imaging catheter for the vascular system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swanson 2002 to incorporate the transducer coupled to the optical scope of Chen to achieve the same results. One would have motivation to combine because “the combination of IVUS and OCT enables us to visualize the vulnerability, location and size of the large plaques/large tumor regions.” (Chen – [0037]).
Regarding claim 4, Swanson 2002, Swanson 596, and Chen disclose all the elements of the claimed invention as cited in claims 1 and 3.
Swanson 2002 further discloses wherein the transducer comprises one or more sensing electrodes located on the wire-basket structure ([0148] – “the structure 20 can carry an array of electrodes 30 for the purpose of guiding the IAE 50. These same electrodes 30 can also serve to sense electrical impulses in tissue, like myocardial tissue”).
Regarding claim 5, Swanson 2002, Swanson 596, and Chen disclose all the elements of the claimed invention as cited in claims 1 and 3.
Swanson 2002 does not teach wherein the transducer is configured to transmit sound waves having a frequency ranging from about 3 MHz to about 71 MHz and receive echo signals.
However Chen discloses wherein the transducer is configured to transmit sound waves having a frequency ranging from about 3 MHz to about 71 MHz and receive echo signals ([0143] – “Using a micro US transducer 112 coupled through an ultrasound wire 116 to ultrasound pulser/receiver 110…The center frequency of the ultrasound transducer is preferably in the range of 10 MHz-50 MHz”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swanson 2002 to incorporate the ultrasound frequency of Chen to achieve the same results. One would have motivation to combine because “30 MHz IVUS can image over 5 mm deep inside the tissue to cover the full thickness of the plaques 100 and the entire depth of tumor tissue” (Chen – [0141]).
Regarding claim 13, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 7.
Conversely Swanson 2002 does not teach further comprising: transmitting sound waves having a frequency ranging from about 3 MHz to about 71 MHz from the device, and receiving at the device one or more echo signals.
However Chen discloses further comprising: transmitting sound waves having a frequency ranging from about 3 MHz to about 71 MHz from the device, and receiving at the device one or more echo signals ([0143] – “Using a micro US transducer 112 coupled through an ultrasound wire 116 to ultrasound pulser/receiver 110…The center frequency of the ultrasound transducer is preferably in the range of 10 MHz-50 MHz”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the ultrasound frequency of Chen to achieve the same results. One would have motivation to combine because “30 MHz IVUS can image over 5 mm deep inside the tissue to cover the full thickness of the plaques 100 and the entire depth of tumor tissue” (Chen – [0141]).
Regarding claim 14, Swanson 2002, Swanson 596, and Chen disclose all the elements of the claimed invention as cited in claims 7 and 13.
Swanson 2002 further discloses further comprising generating two-dimensional or three-dimensional images of the heart and the associated structures from the received echo signals ([0104] – “By rotating the transducer crystal 52 in synchrony with the axial translation rate of the translator 104, the system 102 provides axially spaced, 360° data sample slices…Conventional signal processing techniques are used to reconstruct the data slices taken at specified intervals along the axis into three-dimensional images for display”, [0105] – “When used to acquire images inside a beating heart chamber”).
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Swanson (US 20020111548) hereinafter Swanson 2002 and Swanson (US5968040) hereinafter Swanson 596 as applied to claims 1 and 7 above, and further in view of Millett (US 20140200438).
Regarding claim 6, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 1.
Swanson 2002 discloses a roving ablation electrode in [0180] conversely Swanson 2002 does not teach wherein the sheath is configured to have an inner lumen capable of accepting an ablation catheter or other epicardial tool.
However Millett discloses wherein the sheath is configured to have an inner lumen capable of accepting an ablation catheter or other epicardial tool (Fig. 1, [0037] – “the imaging catheter 504 includes a tool lumen 506 and is configured to receive a tool catheter or tool element 516. Through the tool lumen 506, a tool catheter or tool element 516 (e.g. delivery catheter, atherectomy device, ablation device) can be introduced”).
The disclosure of Millett is an analogous art considering it is in the field of an imaging catheter with an ablation element that can be used in the heart.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swanson 2002 to incorporate the inner lumen capable of accepting an ablation catheter of Millett to achieve the same results. One would have motivation to combine because it would allow for the ablation element to be inserted and withdrawn through the imaging catheter and therefore along a known path.
Regarding claim 10, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 7.
Swanson 2002 discloses a roving ablation electrode in [0180] and ablating epicardial tissue in [0201] conversely Swanson 2002 does not teach further comprising inserting an ablation catheter through the sheath into […] the subject.
However Millett discloses further comprising inserting an ablation catheter through the sheath into […] the subject (Fig. 1, [0037] – “the imaging catheter 504 includes a tool lumen 506 and is configured to receive a tool catheter or tool element 516. Through the tool lumen 506, a tool catheter or tool element 516 (e.g. delivery catheter, atherectomy device, ablation device) can be introduced”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the inner lumen capable of accepting an ablation catheter of Millett to achieve the same results. One would have motivation to combine because it would allow for the ablation element to be inserted and withdrawn through the imaging catheter and therefore along a known path.
Claims 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Swanson (US 20020111548) hereinafter Swanson 2002 and Swanson (US5968040) hereinafter Swanson 596 as applied to claim and 7 above, and further in view of Toth (US 20180303414).
Regarding claim 8, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 7.
Swanson 2002 discloses sensing of electrical impulses in tissue like myocardial tissue in [0148] conversely Swanson 2002 does not explicitly teach further comprising measuring epicardial signals.
However Toth discloses further comprising measuring epicardial signals ([0223] – “a sensory component in accordance with the present disclosure (such as may be unipolar, bipolar, multipolar, etc. configured to determine epicardial activity during treatment”).
The disclosure of Toth is an analogous art considering it is in the field of a catheter with a wire basket.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the measuring epicardial signals of Toth to achieve the same results. One would have motivation to combine because it would allow one to determine the effect of the ablation of the epicardial tissue.
Regarding claim 12, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 7.
Conversely Swanson 2002 does not teach further comprising performing ablation of autonomic ganglia and/or scar on the epicardial surface of the heart of the subject.
However Toth discloses further comprising performing ablation of autonomic ganglia and/or scar on the epicardial surface of the heart of the subject ([0024] – “performing a procedure, and/or treating the anatomical site (e.g., via ablation”, [0281] – “localizing such GP [ganglionic plexi] in cardiac tissues so as to guide a diagnostic test, an ablation procedure”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the measuring epicardial signals of Toth to achieve the same results. One would have motivation to combine because it would allow one to treat arrhythmias of the heart.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Swanson (US 20020111548) hereinafter Swanson 2002 and Swanson (US5968040) hereinafter Swanson 596 as applied to claim and 7 above, and further in view of Toth (US 20180303414) and Frangioni (US 20190298151).
Regarding claim 9, Swanson 2002 and Swanson 596 disclose all the elements of the claimed invention as cited in claim 7.
Conversely Swanson 2002 does not teach the method further comprising: administering a fluorescent contrast agent to the subject; and imaging autonomic ganglia and/or scar on the epicardial surface of the heart of the subject with the optical scope, wherein the optical scope comprises a near-infrared camera or a dual band white light and near-infrared camera system.
However Toth discloses the method further comprising: […] imaging autonomic ganglia and/or scar on the epicardial surface of the heart of the subject with the optical scope, wherein the optical scope comprises a near-infrared camera or a dual band white light and near-infrared camera system ([0179] – “one or more optically configured sensors may be configured to monitor for changes in the colorimetric properties of tissues adjacent thereto, such as during an ablation procedure”, [0281] – “High fidelity sensing may be advantageous for localizing such GP in cardiac tissues so as to guide a diagnostic test, an ablation procedure”, paragraph [0185] discloses energy sources such as near infrared and visible directed into the body and one or more optical sensors on the surgical tool to sense light emitted from the energy source).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the measuring epicardial signals of Toth to achieve the same results. One would have motivation to combine because it would allow one to visualize the epicardial tissue to monitor treatment during an ablation procedure of the epicardial tissue.
Conversely Swanson 2002 and Toth do not teach administering a fluorescent contrast agent to the subject.
However Frangioni discloses administering a fluorescent contrast agent to the subject ([0023] – “Prior to imaging subject 116 and/or during the imaging by imaging system 100, subject 116 may be injected with a fluorescent dye”).
The disclosure of Frangioni is an analogous art considering it is in the field of a device to be inserted into the body to view tissue within the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the administering of a fluorescent contrast agent of Frangioni to achieve the same results. One would have motivation to combine because it provides “an aid to general surgery for direct visualization of any function amenable to imaging with fluorescent dyes, including blood flow and tissue viability” (Frangioni – [0038]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Swanson (US 20020111548) hereinafter Swanson 2002, Swanson (US5968040) hereinafter Swanson 596, and Chen (US 20160206373) as applied to claim 13 above, and further in view of Gijsbers (US 20200383661).
Regarding claim 15, Swanson 2002, Swanson 596, and Chen disclose all the elements of the claimed invention as cited in claims 7 and 13.
Conversely Swanson 2002 does not teach further comprising determining one or more of speed and direction of blood flow within chambers of the heart, across valves, and/or in great vessels, using the received echo signals.
However Gijsbers discloses further comprising determining one or more of speed and direction of blood flow within chambers of the heart, across valves, and/or in great vessels, using the received echo signals ([0121] – “The scan converter can overlay a B mode structural image with colors corresponding to motion at points in the image field with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swanson 2002 to incorporate the Doppler-estimated velocities of Gijsbers to achieve the same results. One would have motivation to combine because it allows one to visualize the blood flow to aid in diagnosis and treatment of heart tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797