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 .
Response to Amendment
The amendment filed 16 October 2025 has been entered. Claims 24 and 32-34 are currently amended. Claims 1-23 and 49-56 are canceled, and claims 57-60 are new. Claims 24-48 and 57-60 are pending in the application. Applicant’s amendments to the claims and specification have overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 16 July 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 60 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 60 recites the limitations “the longitudinally displaceable sleeve is in the second position and is completely displaced from and is not in contact with the balloon” and “the longitudinally displaceable sleeve is in the first position and covers the inflatable balloon” but depends on claim 58, in which the first position is defined as wherein at least a portion of the longitudinally displaceable sleeve being entirely displaced from the inflatable balloon and located proximal thereto, and the second position is defined as wherein the longitudinally displaceable sleeve and the plurality of branches cover a portion of an exterior surface of the inflatable balloon. The meaning and scope of the claim are therefore rendered unclear. For examination purposes, this claim will be read as wherein the longitudinally displaceable sleeve is completely displaced from the balloon in first position and covers the balloon in the second position.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 24-39, 41, 43, 46, and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US PGPub No. 2018/0184982), hereinafter Basu, in view of Ben-Ezra et al. (US PGPub No. 2023/0240742, effectively filed 22 Apr 2012), hereinafter Ben-Ezra.
Regarding claims 24-25, 32-33, 57, and 58, Basu teaches an ablation catheter system (Fig. 1: catheter 10) comprising: a balloon ablation catheter including an inflatable balloon coupled to a shaft (Fig. 1: balloon 22 coupled to shaft (Fig. 1: elongated catheter body 12);
and a longitudinally displaceable sleeve (Fig. 1: expander 26) that is configured to move longitudinally along the balloon ablation catheter (par. 0052: “The expander 26 is afforded longitudinal movement relative to the catheter body”),
wherein the longitudinally displaceable sleeve has a proximal end portion, an opposing distal end portion and a plurality of branches that are connected to both the proximal end portion and the distal end portion (Fig. 1: spines 18 connected to proximal and distal ends of expander 26),
wherein the longitudinally displaceable catheter moves between a first position in which the longitudinally displaceable sleeve is located at a more proximal position relative to the inflatable balloon and a second position in which the longitudinally displaceable sleeve is disposed in a more distal position relative to the inflatable balloon in which the longitudinally displaceable sleeve and the plurality of branches cover a portion of an exterior surface of the inflatable balloon, and the plurality of branches are configured to move longitudinally between the first position and the second position (par. 0052: “The expander 26 is afforded longitudinal movement relative to the catheter body so that it can move the distal ends of the spines 18 proximally or distally relative to the catheter body 12 to radially expand and contract, respectively, the electrode assembly. Since the proximal ends of spines 18 are secured to the catheter body 12, relative movement of expander 26 in the proximal direction shortens the distance between the distal and proximal ends of spines 18, causing them to bow outwards into an expanded arrangement”),
wherein at least one branch includes at least one electrode located along an outer surface thereof (Fig. 1: electrodes 20 on spines 18);
wherein the plurality of branches are configured to deploy and radially expand under inflation of the inflatable balloon (Figs. 2, 9-11 and par. 0048: “the pressure to which balloon 22 is inflated may be adjusted to impart different conformations”).
Basu does not explicitly teach wherein the plurality of branches are configured to move specifically along the exterior surface of the inflatable balloon and slide completely off of the inflatable balloon, such that in the first proximal position, the longitudinally displaceable sleeve (including each of the first tubular structure, the plurality of branches and the second tubular structure) is entirely displaced from and located proximal of the balloon, and the second more distal position is such that the longitudinally displaceable sleeve covers at least 50% of the inflatable balloon, wherein in the second position, the second tubular structure is disposed over a distal tip of the shaft at a location distal to the inflatable balloon and the first tubular structure is disposed over the shaft at a location proximal to the inflatable balloon. However, in a related catheter ablation art, Ben-Ezra teaches a combination balloon-basket catheter (Fig. 1: catheter 100) with struts that are configured to slide along the surface of a balloon (par. 0196: “the struts 330 are guided on the balloon or other expandable member 110”) from a completely displaced first proximal position to a second distal position disposed covering the balloon (par. 0226: “the struts 330 are not passed through the urethra URH in parallel to (or surrounding) the expandable member 110, but rather are passed separately, after (or before) the expandable member 110;” examiner notes that passing the struts into the catheter separately after the expandable member necessarily involves a first position completely displaced from and proximal to the expandable member; see also Fig. 31: struts 330 completely covering balloon 110 in second position).
Ben-Ezra teaches that introducing the struts behind the expandable member allows the struts to be made as thin as possible (par. 0227-0228: “the struts 330 are made as thin as possible, giving up the needed structural rigidity needed to push such an element out of a shaft 120 […] the lack of this structural rigidity is compensated for by pulling the struts 330 behind (i.e., following) the expandable member 110 that does comprise an element of axial and/or radial rigidity”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Basu’s plurality of branches to be configured to slide completely on and off the surface of the balloon from a position proximal to the balloon, as suggested by Ben-Ezra, in order that the branches may be made as thin as possible, as taught by Ben-Ezra.
Regarding claim 26, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein the proximal end portion of the longitudinally displaceable sleeve comprises a first tubular structure and the distal end portion of the longitudinally displaceable sleeve comprises a second tubular structure, and first ends of plurality of branches are connected to the first tubular structure and second ends of the plurality of branches are connected to the second tubular structure (Fig. 1: ends of spines 18 connected to proximal tubular structure near lumen 28 and distal tubular structure near sensor 24).
Regarding claim 27, the combination teaches the system of claim 24 as described previously. Basu does not explicitly teach wherein the proximal end portion, the plurality of branches and the distal end portion are formed as a single integral part. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the proximal end portion, the plurality of branches, and the distal end portion as a single integral part, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claims 28-29 and 46, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein a plurality of longitudinal slits are formed between the plurality of branches and the plurality of branches being defined between the longitudinal slits, thereby permitting radial expansion of the plurality of branches under inflation of the inflatable balloon (Figs. 1 and 10: open spaces between plurality of spines 18 permitting radial expansion), and wherein a width of each longitudinal slit is different than a width of each branch (Fig. 1: space between spines 18 wider than width of each spine).
Regarding claim 30, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein the longitudinally displaceable sleeve is formed of a material selected from the group consisting of: a polyimide film, a polyester film; and a urethane film (par. 0052: “the expander 26 comprises braided polyimide tubing”).
Regarding claim 31, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein the first position is a retracted position (Fig. 13: position with expander 26 retracted; examiner interprets a more proximal position of the expander’s distal end as a “retracted position,” as broadly as claimed) and the second position is an extended position in which the plurality of branches are disposed over the inflatable balloon (Fig. 12: extended position in which spines 18 are disposed over balloon 22).
Regarding claim 34, the combination teaches the system of claim 26 as described previously. Basu further teaches wherein a length of the plurality of branches is greater than a length of each of the first tubular structure and the second tubular structure (Fig. 1: spines 18 longer than distal and proximal tubular structures connected to expander 26).
Regarding claim 35, the combination teaches the system of claim 26 as described previously. Basu further teaches wherein the length of the first tubular structure is greater than the length of the second tubular structure (Fig. 1: proximal tubular structure longer than distal tubular structure).
Regarding claims 36-38, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein each of the plurality of branches includes two or more electrodes, wherein the two or more electrodes for each branch are longitudinally spaced apart (Fig. 1: each spine 18 having six electrodes longitudinally spaced apart).
Regarding claim 39, the combination teaches the system of claim 24 as described previously. Basu further teaches including a main controller that is operatively connected to each electrode to permit control over each electrode (Fig. 18: processing unit 70; par. 0071: “Processing unit 70 may also control the delivery of energy to the electrodes for creating one or more lesions;” examiner interprets controlling delivery of energy to the electrodes as controlling each electrode, as broadly as claimed).
Regarding claim 41, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein the plurality of branches are circumferentially arranged (Fig. 2: spines 18 circumferentially arranged; par. 0046: “spines 18 are distributed about the radius of balloon 22 substantially evenly”).
Regarding claim 43, the combination teaches the system of claim 24 as described previously. Basu further teaches wherein each branch is formed of a material that permits the branch to lengthen in a longitudinal direction when a radially outward force is applied by inflation of the inflatable balloon (Figs. 12-13: spines 18 lengthening or contracting in a longitudinal direction).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Ben-Ezra and further in view of Brewster et al. (US PGPub No. 2016/0135690), hereinafter Brewster.
Basu in view of Ben-Ezra teaches systems of claims 24 and 39 as described previously. Basu further teaches including a display (Fig. 18: display 72) but does not explicitly teach wherein an image of the longitudinally displaceable sleeve is displayed on the display, and wherein a graphical user interface is provided that allows a user to select which electrodes of the plurality of electrodes are to be activated, wherein in a first operating mode, all of the electrodes are activated by the main controller and wherein in a second operating mode, less than all of the electrodes are activated. However, in a related ablation art, Brewster teaches a graphical user interface that displays a plurality of electrodes and allows a user to select which electrodes of the plurality of electrodes are to be activated, wherein the user can select any number of electrodes to be activated by the main controller (Figs. 5A-5R: graphical user interface; par. 0236: “if FIG. 5Q represents the completion of definition and display of the graphical path, and FIGS. 5L-5P represent times during the definition and display of the graphical path (e.g., after a graphical-path-initiating first user input and during the motion-based user input), transducers associated with selected transducer graphical elements 502g and 502h may be activated according to the instructions associated with block 614 at the time represented by FIG. 5M or any time thereafter (e.g., at the time of FIG. 5M, 5N, 5O, 5P, 5Q, or thereafter). In some embodiments, all of the transducers corresponding to selected transducer graphical elements 502 may be concurrently queued for activation according to the instructions associated with block 614 by a particular user input”). Brewster teaches that the disclosed graphical user interface provides enhanced capabilities for selection and activation of various electrodes (par. 0009: “device systems and methods executed by such systems exhibit enhanced capabilities for the selection or selection and activation of various transducers”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Basu by incorporating the graphical user interface of Brewster in order to provide enhanced capabilities for selection and activation of various electrodes, as taught by Brewster.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Ben-Ezra and further in view of Govari et al. (US PGPub No. 2021/0169567), hereinafter Govari.
Basu in view of Ben-Ezra teaches the system of claim 24 as described previously but does not explicitly teach wherein each electrode is connected to an insulated conductor wire imbedded in a body of the longitudinally displaceable sleeve. However, in an analogous art, Govari teaches a balloon ablation catheter with electrode wires embedded inside a body of a sleeve (Fig. 3: wires 60 covered by cover membrane 50; par. 0035: “An expandable cover membrane 50, having a border 52, encapsulates wires 60 between cover membrane 50 and expandable membrane 44 so that wires 60 are constrained between membrane 44 and cover membrane 50”), which provides enhanced insulation from the ambient environment (par. 0018: “To achieve sufficient electrical insulation from the ambient environment, such as blood that is also electrically conducting, the wires are disposed between the expandable membrane and an encapsulating cover membrane, with the two membranes attached to each other in such a way that the wires are captured between the two membranes”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Basu by configuring each electrode to be connected to an insulated conductor wire embedded in a body of the longitudinally displaceable sleeve, as suggested by Govari, in order to provide enhanced insulation from the ambient environment, as taught by Govari.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Ben-Ezra and further in view of Melsky et al. (US PGPub No. 2011/0082450), hereinafter Melsky.
Basu in view of Ben-Ezra teaches the system of claim 24 as described previously. Basu further teaches wherein the at least one electrode comprises a plurality of electrodes disposed along an outer surface of the longitudinally displaceable sleeve (Fig. 1: electrodes 20), but does not teach further including an endoscope and wherein the longitudinally displaceable sleeve includes a plurality of electrode markers formed along an inner surface of the longitudinally displaceable sleeve, the plurality of electrode markers being formed opposite the plurality of electrodes to identify locations of the plurality of electrodes, the plurality of electrode markers being visible to the endoscope. However, in a related ablation art, Melsky teaches providing an endoscope for a cardiac ablation system to visualize one or more orientation markers, which aids in determining the location of targeted energy delivery relative to an expandable element (par. 0081: “the expandable element can include one or more orientation markers 57 that can be visualized endoscopically, to aid in determining the location of tissue contact or targeted energy delivery relative to geometric features of the expandable element”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Basu in light of Melsky’s teaching to provide orientation markers and an endoscope for determining the location of energy delivery relative to an expandable element (namely, electrodes positioned on expandable spines), as taught by Melsky.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Ben-Ezra and Melsky and further in view of Brewster.
Basu in view of Ben-Ezra and Melsky teaches the system of claim 44 as described previously. The combination in view of Brewster teaches the limitations of claim 45 for the same reasons set forth previously in the rejection of claim 40.
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Ben-Ezra and further in view of Petersen et al. (US PGPub No. 2010/0286626), hereinafter Petersen.
Basu in view of Ben-Ezra teaches the system of claim 24 as described previously. Basu further teaches wherein the distal end portion comprises a complete circumferential portion (Fig. 2: circumferential portion of expander 26 at distal end), and wherein the proximal end portion includes a complete circumferential section to which the plurality of branches are attached (Fig. 1: spines 18 connected to circumferential collar at proximal section), but does not teach wherein the proximal end portion comprises a partial circumferential section, the partial circumferential section being located proximal to the complete circumferential section of the proximal end portion. However, in an analogous art, Petersen teaches a catheter with a shaft including a proximal partial circumferential section (Figs. 5A-5B: partial circumferential cross-sections of catheter shaft 12; par. 0027: “material may be completely removed from shaft 12 through the use of cut-outs 20. Cutouts 20 may be spaced along the longitudinal axis 13 of shaft 12. Cutouts 20 may comprise slots, slits, or curves having the same, similar, and/or different shapes and sizes, for example. Cutouts 20 may extend through a first portion of shaft 12 (e.g., around approximately 180° of an outer circumference of shaft 12). Cutout 20 may extend fewer or more degrees around the outer circumference of shaft 12 in other embodiments. Referring now to FIGS. 5A-5B cutouts 20 may extend around approximately 90°. (e.g., angle α) to approximately 270.degree. (e.g., angle ß) of an outer circumference of shaft 12”), which Petersen teaches as a means of controlling variable flexibility at the distal end of the shaft (par. 0029: “Variable flexibility at distal end 16 of shaft 12 may be created by changing the quantity of cut-out or removed material”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Basu by providing partial circumferential sections along the proximal portion of the longitudinally displaceable sleeve, as taught by Petersen, in order to control variable flexibility along the shaft, as taught by Petersen.
Claims 59-60 are rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Ben-Ezra and further in view of Swanson et al. (US Patent No. 6,640,120), hereinafter Swanson.
Basu in view of Ben-Ezra teaches the system of claim 58 as described previously. Basu further teaches an energy delivery operating mode in which the longitudinally displaceable sleeve is in the second position and covers the inflatable balloon, and energy is delivered through the at least one electrode of the at least one branch (par. 0051: “electrodes 20 may be configured as unipolar, bipolar or both and may be diagnostic electrodes, ablation electrodes, reference electrodes or others”).
Ben-Ezra further teaches wherein the longitudinally displaceable sleeve may be completely displaced from and not in contact with the balloon, as described previously, and further teaches, in another embodiment, delivering energy to target tissue using the inflatable balloon without struts (Fig. 1 and par. 0095: “the electrodes 132 disposed over the outer wall of the balloon 110 may be configured to ablate the inner wall of a hollow bodily organ such as the bladder to create a variety of patterns”), but the combination does not explicitly teach wherein the ablation includes a movable energy emitter that is disposed within the inflatable balloon, the movable energy emitter being configured to deliver a first type of energy through the inflatable balloon to the target tissue.
However, in an analogous art, Swanson teaches an ablation balloon catheter with a movable energy emitter disposed within an inflatable balloon (Figs. 2, 7: electrode 40 within microporous body 22; col 5, lines 42-47: “Although in the embodiment shown and described, the operative ablative element is a RF electrode 40 and tissue is ablated through the delivery of RF energy, in alternative embodiments, the ablative element may be adapted to ablate body tissue using an ultrasound transmitter, a laser, a cryogenic mechanism, or other similar means;” col 14, lines 54-55: “the main catheter 203 and ablation catheter 202 may be introduced separately to the targeted site;” examiner interprets the electrode within the microporous body as movable, because the ablation catheter 202 comprising both elements is movable, as broadly as claimed). To substitute one known element (balloon with internal electrode as shown in Swanson) for another (balloon with external electrodes as shown in Ben-Ezra) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution would have yielded predictable results, namely, an ablative balloon capable of ablating tissue with lesion geometry corresponding to the micropores in the balloon rather than using external electrode positioning to control lesion geometry.
Response to Arguments
Applicant’s arguments, filed 16 October 2025, with respect to the rejection(s) of claim(s) 24 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ben-Ezra. As described previously, Ben-Ezra teaches a first position of a longitudinally displaceable sleeve that is completely displaced from and proximal to an inflatable balloon.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794