DETAILED ACTION
A complete action on the merits of claims 1-20 follows below.
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 .
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 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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-18, drawn to a medical device, classified in A61B 18/1492.
II. Claims 19-20, drawn to a method of treating a treatment site, classified in A61B 2018/00285.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product without delivering energy to the treatment site to cut, puncture, or perforate one or more layers of tissue at the treatment site; positioning the distal end of the shaft between layers of tissue, and expanding one or more balloons to separate layers of tissue, wherein the one or more balloons are positioned on a distal portion of the shaft and are fluidly connected to one or more balloon fluid ports via one or more balloon fluid tubes and one or more balloon holes; and positioning and energizing the electrode to deliver energy to one or more portions of the treatment site, wherein the one or more portions of the treatment site are between separated layers of tissue as claimed in Group II.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with attorney Matthew Powell on 5/26/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-3, 13 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rashidi (US Pub. No. 2011/0301536).
Regarding Claim 1, Rashidi teaches a medical device (Fig. 1), comprising:
a handle 26, including: an electrical connection (although not shown in the figures based on the teaching of “axially spaced electrodes 36a-f are provided along the body 30 and are each connected to a separate electrical wire (not shown for ease of illustration) that conducts electrical energy to the respective electrode in a manner generally well-known in the art for diagnostic and therapeutic procedures” in [0024] examiner takes the position that there is an electrical connection in the handle); and a balloon fluid port 62 (Figs. 2-5); a shaft 20 extending from a distal portion of the handle (Fig. 1);
an electrode 32 positioned at a distal end of the shaft 20, wherein the electrode is electrically connected to the electrical connection via one or more conductive elements extending through the handle and the shaft (“a distal electrode 32 which is shown as a generally mushroom-shaped configuration … electrical wire (not shown for ease of illustration) that conducts electrical energy to the respective electrode in a manner generally well-known in the art for diagnostic and therapeutic procedures” [0024]); and
at least one inflatable balloon 60 positioned on a portion of shaft 20 (Figs. 2-5), wherein the at least one inflatable balloon 60 is fluidly coupled to the balloon fluid port 62 via one or more tubes extending through the handle and the shaft ([0026]).
Regarding Claim 2, Rashidi teaches wherein the handle 26 further includes one or more deflection elements 28, and wherein at least a portion of the shaft 20 is deflectable via movement of the one or more deflection elements ([0023] and Fig. 1).
Regarding Claim 3, Rashidi teaches “the details are not shown in FIG. 1, it is also contemplated that the catheter assembly can include two main components, a blood-contacting portion and a subassembly that includes the actuator mechanism as shown and described in commonly owned U.S. Pat. No. 5,861,024. The actuator mechanism 22 preferably includes a handle 26 and a delta-shaped (.DELTA.-shaped) actuating member 28 that is selectively manipulated by the user to cause desired deflection or curvature of the distal portion 24 of the catheter assembly. Again, although this particular arrangement of the actuator mechanism and deflectable distal portion are shown and described in the commonly owned prior patents, it will also be appreciated that selective modifications can be made without departing from the scope and intent of the present invention” in [0023], therefore, although the details related to the actuator element are not shown in this application, commonly owned U.S. Pat. No. 5,861,024, incorporated by reference teaches wherein the one or more deflection elements “actuator member” are each coupled to a wheel 51/52 (Figs. 12-13, 16a-16b) that is connected to one or more pull wires 11-12 (Col. 11, ll. 33-46 and Col. 12, ll. 12-19) that extend through the handle and are secured to one or more interior portions of the shaft (Figs. 2b, 3a, 19) such that movement of the one or more deflection elements urges the one or more pull wires proximally to deflect a portion of the shaft (“pull on one of the members 11, 12 for affecting curvature at the distal portion of the catheter” Col. 10, ll. 19-20, also see Col. 11, ll. 62-Col. 12, ll. 11).
Regarding Claim 13, Rashidi teaches wherein the at least one inflatable balloon 60 is fluidly coupled to one or more tubes 62 via at least one balloon hole in an outer surface of a distal portion of the shaft (Figs. 2-5).
Regarding Claim 15, Rashidi teaches wherein the medical device is configured to perform a third space endoscopy procedure ([0024] teaches the use of the device “in a manner generally well-known in the art for diagnostic and therapeutic procedures” therefore, although not specifically disclosed, it is examiner’s position that the device is configured to be used in other minimally invasive procedures such as a third space endoscopy procedure).
Regarding Claim 16, Rashidi teaches a medical device (Fig. 1), comprising:
a handle 26, including: an electrical connection (although not shown in the figures based on the teaching of “axially spaced electrodes 36a-f are provided along the body 30 and are each connected to a separate electrical wire (not shown for ease of illustration) that conducts electrical energy to the respective electrode in a manner generally well-known in the art for diagnostic and therapeutic procedures” in [0024] examiner takes the position that there is an electrical connection in the handle); and
one or more deflection controls 28 (“the details are not shown in FIG. 1, it is also contemplated that the catheter assembly can include two main components, a blood-contacting portion and a subassembly that includes the actuator mechanism as shown and described in commonly owned U.S. Pat. No. 5,861,024. The actuator mechanism 22 preferably includes a handle 26 and a delta-shaped (.DELTA.-shaped) actuating member 28 that is selectively manipulated by the user to cause desired deflection or curvature of the distal portion 24 of the catheter assembly” [0023]); a shaft 20 extending from a distal portion of the handle (Fig. 1); and
an electrode 32 positioned at a distal end of the shaft ([0024]), wherein the electrode is electrically connected to the electrical connection via one or more conductive elements extending through the handle and the shaft ([0024]); wherein at least a portion of the shaft 20 is deflectable via movement of the one or more deflection controls 28 ([0023] and Fig. 1).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rashidi as applied above in view of Truhler (US Pub. No. 2017/0049994).
Regarding Claim 4, Rashidi teaches wherein the one or more deflection elements 28; however, does not teach the deflection element includes two coaxial deflection knobs, wherein each of the two deflection knobs controls a deflection of the portion of the shaft in substantially perpendicular planes.
In the same field of catheter deflection control, Truhler teaches a catheter handle configured to manipulate an elongate catheter shaft 102 comprising “first and second actuation knobs 110, 111. The first actuation knob 110 can be connected to a first pullwire (not shown) that runs through the elongate catheter shaft 102 and is configured to deflect the distal end of the elongate catheter shaft 102. The second actuation knob 111 can be connected to a second pullwire (not shown) that runs through the elongate catheter shaft 102 and is configured to deflect the distal end of the elongate catheter shaft 102 in a second direction” [0032] and Fig. 1.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use knobs for controlling the deflection of the catheter rather than the delta-shaped actuation element 28 since the examiner takes Official Notice of the equivalence of knobs and delta-shaped actuator for their use in the catheter deflection art at the selection of any of these known equivalents to deflect the catheter in different configurations would be within the level of ordinary skill.
Regarding Claim 5, Rashidi teaches wherein the portion of the shaft 20 is deflectable in a substantially semi-spherical range of motion (Fig. 1), and wherein the portion of the shaft is deflectable with the at least one inflatable balloon inflated (the actuator is configured to deflect the distal end of the shaft in a variety of different shapes such as in a substantially semi-spherical range of motion even if the balloon is inflated).
Regarding Claim 6, Rashidi in view of Truhler teaches wherein the handle further includes one or more locks to secure a position of one or more of the two deflection knobs (“actuation member 112 can comprise a locking mechanism. 109, a first actuation knob, and a second actuation knob 111. The locking mechanism 109 can be configured such that when it is turned by a user it causes the actuation member 112 to restrict the movement of the first and second actuation knobs 110, 111” [0032] of Truhler).
Claims 7-12 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rashidi as applied above, in view of Stangenes (US Patent No. 8,206,385).
Regarding Claim 7, Rashidi teaches wherein the electrode 32 includes an electrode lumen 72 (Figs. 2-3) and “second passage may be used to deliver liquid or a medical device to a body cavity on the distal side of the inflatable member” [0009]; however, does not specifically show wherein the handle further includes an electrode fluid port, and wherein the electrode fluid port is fluidly coupled to the electrode lumen via one or more electrode fluid tubes that are configured to deliver a fluid to the electrode lumen from the electrode fluid port.
In the same field of invention, Stangenes teaches a catheter with a front-loaded catheter tip with an electrically active element for ablating cardiac tissues via a deflectable/steerable ablation catheter having a fluid lumen through the tip electrode for facilitating irrigated ablation. Stangenes in specific teaches wherein the handle further includes an electrode fluid port (proximal end of inner shaft 106 coupling the lumen to a fluid source coupled to the handle), and wherein the electrode fluid port is fluidly coupled to the electrode lumen (“saline or heparinized saline can also flow through the internal lumen 152 to facilitate irrigated ablation” Col. 9, ll. 18-20 and Figs. 6-8, 11-12 and 16) via one or more electrode fluid tubes 106 that are configured to deliver a fluid to the electrode lumen from the electrode fluid port 158 (Col. 8, ll. 52-Col. 9, ll. 23 and Figs. 11-12).
Therefore, either Rashidi contemplated coupling lumen 72 through the handle to a fluid port to receive fluid therethrough or alternatively, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a fluid delivery means to the electrode of Rashidi in order to provide irrigation means for “irrigation of the ablation electrode reduces or prevents thrombus formation” as Stangenes teaches in Col. 8, ll. 50-51.
Regarding Claim 8, Rashidi teaches wherein the electrode 32 includes an electrode shaft and a distal end, wherein the distal end is wider relative to a longitudinal axis than the electrode shaft (“generally mushroom-shaped configuration” [0024], see Figs. 2-5 of Rashidi, also see Figs. 11-12 of Stangenes).
Regarding Claim 9, Rashidi in view of Stangenes teaches wherein the handle further includes a trigger, and wherein the electrode is extendable distally and retractable proximally relative to the distal end of the shaft via actuation of the trigger (Figs. 11 vs. 12 of Stangenes and also teaches selectively positioning the tip in an extended position and unextended position in “FIG. 11 shows the catheter assembly 100C in an unextended position. FIG. 12 shows a fragmentary view in partial cross-section of the ablation catheter assembly 100C of FIG. 11 in a partially extended position. When the catheter tip member 120 and inner shaft member 106 are extended from the outer shaft member 108, the channel 128 (see FIG. 12) can be formed to facilitate irrigated ablation such as saline irrigation or heparinized saline irrigation” Col. 9, ll. 6-13 of Stangenes, although a trigger is not shown, Figs. 6-8 show the handle assembly having some sort of a controller/actuator; therefore, either the actuator shown in used for expanding/retracting the distal electrode or alternatively it would have been obvious to one having ordinary skill in the art to include a trigger on the handle for the purpose of easily extending/retracting the distal electrode).
Regarding Claim 10, Rashidi teaches wherein the distal end of the electrode remains positioned distally of the distal end of the shaft when the electrode is in a retracted position (Figs. 1-5, also see Fig. 11 of Stangenes).
Regarding Claim 11, Rashidi in view of Stangenes teaches wherein the trigger is positioned on a distal portion of the handle (similar to the actuation element shown in Figs. 6-8 of Stangenes), wherein the electrode fluid port is positioned on a distal portion of the handle (electrode fluid port is here interpreted to be the proximal end of the inner shaft 106, which is positioned at the distal position where the shaft couples to the handle as seen in Figs. 6-8 of Stangenes), and wherein the electrical connection and the balloon fluid port are positioned on a proximal portion of the handle (although not shown in the figures disclosed by Rashidi as interpreted in claim 1 above based on the teaching of “axially spaced electrodes 36a-f are provided along the body 30 and are each connected to a separate electrical wire (not shown for ease of illustration) that conducts electrical energy to the respective electrode in a manner generally well-known in the art for diagnostic and therapeutic procedures” in [0024] examiner takes the position that there is an electrical connection at the proximal end of the handle coupling the internal electrical connection to a generator).
Regarding Claim 12, Rashidi teaches wherein an entirety of the electrode is conductive (distal electrode 32 is made of a one-piece “generally mushroom-shaped configuration” [0024], see Figs. 2-5; therefore, it is interpreted that an entirety of the electrode is conductive).
Regarding Claim 17, Rashidi teaches wherein the electrode 32 includes an electrode shaft and a distal end, wherein the distal end is wider relative to a longitudinal axis than the electrode shaft (“generally mushroom-shaped configuration” [0024], see Figs. 2-5), and wherein the electrode includes an electrode lumen 72 (Figs. 2-3) and “second passage may be used to deliver liquid or a medical device to a body cavity on the distal side of the inflatable member” [0009]; however, does not show wherein the handle further includes an electrode fluid port, and wherein the electrode fluid port is fluidly coupled to the electrode lumen via one or more electrode fluid tubes that are configured to deliver a fluid to the electrode lumen from the electrode fluid port.
In the same field of invention, Stangenes teaches a catheter with a front-loaded catheter tip with an electrically active element for ablating cardiac tissues via a deflectable/steerable ablation catheter having a fluid lumen through the tip electrode for facilitating irrigated ablation. Stangenes in specific teaches wherein the handle further includes an electrode fluid port (proximal end of inner shaft 106 coupling the lumen to a fluid source coupled to the handle), and wherein the electrode fluid port is fluidly coupled to the electrode lumen (“saline or heparinized saline can also flow through the internal lumen 152 to facilitate irrigated ablation” Col. 9, ll. 18-20 and Figs. 6-8, 11-12 and 16) via one or more electrode fluid tubes 106 that are configured to deliver a fluid to the electrode lumen from the electrode fluid port 158 (Col. 8, ll. 52-Col. 9, ll. 23 and Figs. 11-12).
Therefore, either Rashidi contemplated coupling lumen 72 through the handle to a fluid port to receive fluid therethrough or alternatively, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a fluid delivery means to the electrode of Rashidi in order to provide irrigation means for “irrigation of the ablation electrode reduces or prevents thrombus formation” as Stangenes teaches in Col. 8, ll. 50-51.
Regarding Claim 18, Rashidi teaches further comprising: at least one inflatable balloon 60 positioned on a distal portion of the shaft (Figs. 2-5), wherein the handle 26 further includes a balloon fluid port, wherein the at least one inflatable balloon is fluidly coupled to the balloon fluid port via one or more tubes 62 extending through the handle and the shaft (“balloon 60 communicates through a first passage 62 with a source of liquid such as saline. It will be understood that the passage 62 extends through the length of the catheter body and is in operative communication with a liquid source (not shown)” [0026]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rashidi as applied above, in view of Clark (US Patent No. 8,206,385).
Regarding Claim 14, Rashidi teaches the invention as applied above with at least one balloon hole (going from lumen 62 to the balloon as seen in Figs. 2-5); however, seems to only teach one hole and not wherein the at least one balloon hole includes two balloon holes positioned on circumferentially opposite sides of the shaft.
In the same field of invention, Clark teaches providing “separating an inflow orifice 740 from one or more exhaust orifices 752 positioned along the shaft 122 and in fluid communication with the expansion chamber 143” Col. 20, ll. 67-Col. 21, ll. 3 and as seen in Figs. 7A-7B.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to separate an inflow hole from one or more exhaust holes positioned on circumferentially opposite sides of the shaft as seen in Figs. 7A-7B of Clark in order to easily fill and allow adequate venting of the fluid from the balloon during treatment as Clark teaches.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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