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 .
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.
Claims 12 and 14 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.
Regarding claim 12, it is unclear what the claim language “wherein respective ones of the second ends of respective ones of the flexible polymer circuit strips are tapered along the width of the respective ones of the flexible polymer circuit strips” means. It is unclear what the first “respective ones” is referring to and it is unclear if the second “respecting ones” refers to all flexible polymer circuit strips or just some respective strips. Clarity is needed.
Regarding claim 14, it is unclear what the claim language “wherein respective ones of the first ends of respective ones of the flexible polymer circuit strips” means. It is unclear what the first “respective ones” is referring to and it is unclear if the second “respecting ones” refers to all flexible polymer circuit strips or just some respective strips. Clarity is needed.
Claim Rejections - 35 USC § 103
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.
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.
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 1-14 and 17 rejected under 35 U.S.C. 103 as being unpatentable over Buesseler et al., US 20150270634, herein referred to as “Buesseler”, in view of Jung et al., US 20160073960, herein referred to as “Jung”.
Regarding claim 1, Buesseler discloses a catheter apparatus (Figure 1), comprising: an elongated deflectable element including a distal end (Figure 1: catheter 23); a coupler connected to the distal end (Figure 3: bushing 81 and [0039]); a pusher including a distal portion (Figure 3: control line 41), and being configured to be advanced and retracted through the deflectable element ([0041]: “To configure the electrode assembly 33 from its collapsed configuration (e.g., as illustrated in FIG. 1) to its expanded configuration (e.g., as illustrated in FIG. 2), rotation of the actuator 37 relative to the handle 25 operatively pulls on the control wire 41 to thereby pull the tip (i.e., the distal end 53) of the electrode assembly toward the proximal end 51 of the electrode assembly along the longitudinal axis X thereof.”); a nose connector connected to the distal portion of the pusher (Figure 3: tip 67 and [0038]: “The control line 41 extends generally along the longitudinal axis X of the electrode assembly 33 through the tip 67 where it is secured to the tip by braising, adhesive, welding, soldering or other suitable securement technique.”), and including a distal receptacle having an inner surface and a distal facing opening ([0038]: “[0038]: “The control line 41 extends generally along the longitudinal axis X of the electrode assembly 33 through the tip 67”; if control line extends though the tip, then the tip must include a distal receptacle having an inner surface and a distal facing opening); and an expandable assembly comprising a plurality of strips (Figure 3: struts 55a-d), each strip including multiple electrodes disposed thereon (Figure 3: electrodes 57 and [0036]: “It is also understood that multiple electrodes 57 may be carried by any one or all of the struts 55a-d”), the strips being disposed circumferentially around the distal portion of the pusher (Figure 3), with first ends of the strips being connected to the coupler ([0039]: “At the proximal end 51 of the electrode assembly 33, longitudinal end segments (not shown) of the struts 55a-d are connected to the catheter shaft 29 by a suitable bushing 81.”) and second ends of the strips comprising respective hinges (Figure 3: hinges 102a-d) entering the distal facing opening and connected to the inner surface of the distal receptacle of the nose connector ([0037]), the strips being configured to bow radially outward when the pusher is retracted expanding the expandable assembly from a collapsed form to an expanded form ([0041]: “To configure the electrode assembly 33 from its collapsed configuration (e.g., as illustrated in FIG. 1) to its expanded configuration (e.g., as illustrated in FIG. 2), rotation of the actuator 37 relative to the handle 25 operatively pulls on the control wire 41 to thereby pull the tip (i.e., the distal end 53) of the electrode assembly toward the proximal end 51 of the electrode assembly along the longitudinal axis X thereof. As the distance between the distal end 53 and the proximal end 51 of the electrode assembly 33 is shortened (i.e., as the length of the electrode assembly decreases), the struts 55a-d are longitudinally compressed and thus forced to bend, or flex transversely outward away from the longitudinal axis X of the electrode assembly to form the expanded configuration of the electrode assembly.”). Buesseler does not explicitly disclose a catheter wherein the strips are flexible polymer circuit strips.
However, Jung teaches a catheter apparatus (Figures 5-6) wherein the strips are flexible polymer circuit strips (Figures 8-20 and [0082] and [0034]).
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the catheter apparatus disclosed by Buesseler so that the strips are flexible polymer circuit strips as taught by Jung so that the catheter can expand and conform to the chamber of the heart it is placed in for optimal electrode contact (Jung [0034]).
Regarding claim 2, Buesseler in view of Jung discloses the apparatus according to claim 1, and Jung further discloses an apparatus wherein the respective hinges are configured to provide a maximum angular range of movement, which is in excess of 80 degrees, between the collapsed form and the expanded form (Figures 5-6: splines 16 have a maximum angular range of movement in excess of 80 degrees between its collapsed state [Figure 5] and its expanded state [Figure 6]).
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Buesseler so that the respective hinges are configured to provide a maximum angular range of movement, which is in excess of 80 degrees, between the collapsed form and the expanded form as taught by Jung so that the catheter can expand and conform to the chamber of the heart it is placed in for optimal electrode contact (Jung [0034]).
Regarding claim 3, Buesseler in view of Jung discloses the apparatus according to claim 1, and Buesseler further discloses an apparatus wherein the hinges have a narrow thickness ([0044]).
Buesseler in view of Jung discloses the claimed invention except for the hinges having a thickness in the range of 10 to 140 microns. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the hinges of Buesseler so that there are in the range of 10 to 140 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 4, Buesseler in view of Jung discloses the apparatus according to claim 1, and Jung further discloses an apparatus further comprising respective elongated resilient support elements connected along a given length of respective ones of the flexible polymer circuit strips providing a shape of the expandable assembly in the expanded form (Figures 8-20: support layer 34).
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Buesseler so that it includes respective elongated resilient support elements connected along a given length of respective ones of the flexible polymer circuit strips providing a shape of the expandable assembly in the expanded form as taught by Jung to provide rigidity and a resilient medium which allows the strips to be set to the pre-shaped deployed configuration (Jung [0112]).
Regarding claim 5, Buesseler in view of Jung discloses the apparatus according to claim 4, and Jung further discloses an apparatus wherein the elongated resilient support elements include Nitinol ([0112]: “The exemplary support layer 34 of the invention comprises a 10 mils (250 um) thick PEEK. It should be appreciated that other materials such as PEEK may be used as a support layer. Nitinol is another example of a support layer with heat settable properties to control shape.”).
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Buesseler so that the elongated resilient support elements include Nitinol as taught by Jung to provide rigidity and a resilient medium which allows the strips to be set to the pre-shaped deployed configuration (Jung [0112]).
Regarding claim 6, Buesseler in view of Jung discloses the apparatus according to claim 4, but does not explicitly disclose an apparatus wherein the elongated resilient support elements include Polyetherimide (PEI).
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the elongated resilient support elements to include Polyetherimide (PEI), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 7, Buesseler in view of Jung discloses the apparatus according to claim 4, and Buesseler further discloses an apparatus wherein the respective elongated resilient support elements extend along the respective strips from the coupler until before the respective hinges ([0044]).
Regarding claim 8, Buesseler in view of Jung discloses the apparatus according to claim 1, and Jung further discloses an apparatus wherein the flexible polymer circuit strips comprise a polyimide layer ([0082]: “These electrodes 20 are deposited on an insulating layer 46 which is made from a polyimide or other suitable insulating material.”).
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Buesseler so that the flexible polymer circuit strips comprise a polyimide layer as taught by Jung to provide insulation (Jung [0082]).
Regarding claim 9, Buesseler in view of Jung discloses the apparatus according to claim 1, with Buesseler disclosing an apparatus wherein the hinges of the flexible polymer circuit strips are supported with a material (Figure 3), but does not explicitly disclose an apparatus wherein the hinges of the flexible polymer circuit strips are supported with a length of yarn.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the hinges to be supported with a length of yarn specifically, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 10, Buesseler in view of Jung discloses the apparatus according to claim 9, but does not explicitly disclose an apparatus wherein the yarn comprises any one or more of the following: an ultra-high-molecular-weight polyethylene yarn; or a yarn spun from a liquid-crystal polymer.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the yarn comprises any one or more of the following: an ultra-high-molecular-weight polyethylene yarn; or a yarn spun from a liquid-crystal polymer, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 11, Buesseler in view of Jung discloses the apparatus according to claim 1, but does not explicitly disclose an apparatus wherein the flexible polymer circuit strips are covered with a thermoplastic polymer resin shrink wrap (PET).
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the flexible polymer circuit strips are covered with a thermoplastic polymer resin shrink wrap (PET), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 12, Buesseler in view of Jung discloses the apparatus according to claim 1 and Buesseler further discloses an apparatus wherein respective ones of the second ends of respective ones of the flexible polymer circuit strips are tapered along the width of the respective ones of the flexible polymer circuit strips ([0044]).
Regarding claim 13, Buesseler in view of Jung discloses the apparatus according to claim 1 and Buesseler further discloses an apparatus wherein the coupler has an inner surface, the first ends of the strips being connected to the inner surface of the coupler (Figure 3 and [0039]).
Regarding claim 14, Buesseler in view of Jung discloses the apparatus according to claim 1 and Buesseler further discloses an apparatus wherein respective ones of the first ends of respective ones of the flexible polymer circuit strips include an electrical connection array ([0034]: “A suitable twisted electrical wire bundle (not shown) also extends through the hollow catheter shaft 29 from the handle to the electrode assembly to deliver power to the electrode assembly.”).
Regarding claim 17, Buesseler in view of Jung discloses the apparatus according to claim 1 and Buesseler further discloses an apparatus further comprising a nose cap covering the distal facing opening of the nose connector (Figure 3: rounded head 71 of tip 67).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Buesseler in view of Jung, further in view of Wu et al., US 20180256109, herein referred to as “Wu”.
Regarding claim 15, Buesseler in view of Jung discloses the apparatus according to claim 1 but does not explicitly disclose an apparatus further comprising a position sensor disposed in the distal receptacle of the nose connector.
However, Wu teaches an apparatus (Figure 1) further comprising a position sensor disposed in the distal receptacle of the nose connector (Figure 1: location sensors 28).
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Buesseler so that it includes a position sensor disposed in the distal receptacle of the nose connector as taught by Wu to help visualize the catheter within a patient (Wu[0036]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Buesseler in view of Jung, further in view of Olson et al., US 20180116539, herein referred to as “Olson”.
Regarding claim 16, Buesseler in view of Jung discloses the apparatus according to claim 1 but does not explicitly disclose an apparatus further comprising a position sensor disposed between the coupler and the pusher.
However, Olson teaches an apparatus comprising a position sensor disposed between the coupler and the pusher (Figure 1C: sensor 116 and [0054]; in combination with Buesseler, the sensor of Olson is in the shaft of Buesseler just proximal of bushing 81, and thus the position sensor is between the coupler and the pusher.
It would have been obvious before the effective filing of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Buesseler so that it includes a position sensor disposed between the coupler and the pusher as taught by Olson so that the electrogram from each bipole pair may be analyzed and various electrical characteristics may be visually indicated on an electrophysiology map by color-coding (Olson [0065]).
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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