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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
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 4 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 4 recites the limitation "the handles" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-13, 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gruba et al. (US 2021/0169494).
Regarding claim 11, Gruba discloses a method for occluding portions of a heart (see Figs. 7 and 8), the method comprising: delivering an ablation catheter into the heart such that an intracardial portion of the ablation catheter is positioned adjacent a portion of the heart that is to be ablated (see Figs. 6 and 7), the ablation catheter comprising: an elongate hollow shaft having a shaft proximal end, a shaft distal end, and a lumen extending along the elongate hollow shaft (see elongate body 114 having a distal end, proximal end, and lumen 124, Figs. 1-7); an expandable frame that is detachably disposed at the shaft distal end, the expandable frame (see 212 and 230; [0096], Fig. 6) having a plurality of deployment positions that includes a first deployed position in which the expandable frame is in a focal arrangement and a second deployed position in which the expandable frame is in a wide area arrangement (see collapsed, expanded, and/or deployed configurations, [0092], Figs. 1-8); and a handle that is disposed at the shaft proximal end and operatively connected to the expandable frame (see handle 108, Figs. 1 and 7) such that actuation of the handle moves the expandable frame between the plurality of deployment positions (see control mechanism 122 of the handle being configured to facilitate moving the expandable elements and placement of them at their target tissue location, and being mechanically coupled to the threaded insert and coupling mechanism 232; [0063], Figs. 7-8), and wherein the ablation catheter is configured to direct energy to the expandable frame so as to ablate tissue at or around the expandable frame (see [0064]-[0065], and [0099]-[0100]); and deploying the expandable frame into the portion of the heart that is to be ablated (see Figs. 7-8).
Regarding claim 12, Gruba further discloses positioning a deployed portion of the expandable frame to be adjacent tissue that is to be ablated, and generating ablative energy at the expandable frame to ablate tissue at or around the expandable frame (see [0099]-[0100], Fig. 7).
Regarding claim 13, Gruba further discloses moving the expandable frame into at least one of the focal arrangement and the wide area arrangement (as shown Figs. 7-8, see also collapsed position as a focal arrangement, [0092]).
Regarding claim 15, Gruba further discloses wherein deploying the expandable frame into a portion of the heart that is to be ablated comprises detaching the expandable frame into a portion of the heart that is to be occluded (as shown in Fig. 8).
Regarding claim 16, Gruba discloses the limitations of the claim under the same citations and explanation given as set forth in claim 11 above, and additionally discloses a generator that is operatively connected to the ablation catheter so as to cause the ablation catheter to generate ablative energy at the expandable frame (ablation energy source 252, [0099], Fig. 7).
Regarding claims 17 and 19, Gruba further discloses wherein the generator and the ablation catheter are configured to perform bipolar pulsed field ablation (see monopolar or bipolar IRE pulses, [0065] and [0099]-[0100]).
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 1-10, 14, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gruba in view of Kreidler et al. (US 2004/0220610).
Regarding claim 1, Gruba discloses an ablation catheter (see Figs. 1-8) comprising: an elongate hollow shaft having a shaft proximal end, a shaft distal end, and a lumen extending along the elongate hollow shaft (see elongate body 114 having a distal end, proximal end, and lumen 124, Figs. 1-7); a handle that is disposed at the shaft proximal end (see handle 108, Figs. 1 and 7); a connector assembly having a connector assembly proximal end and a connector assembly distal end (see threaded insert and coupling mechanism 232; [0096]); and an expandable frame that is detachably disposed at the connector assembly distal end (see 212 and 230; [0096], Fig. 6), the expandable frame having a plurality of deployment positions that includes a first deployed position in which the expandable frame is in a focal arrangement and a second deployed position in which the expandable frame is in a wide area arrangement (see collapsed, expanded, and/or deployed configurations, [0092], Figs. 1-8); wherein the connector assembly is operatively connected to both the handle and the expandable frame and is configured to facilitate moving the expandable frame between the plurality of deployment positions (see control mechanism 122 of the handle being configured to facilitate moving the expandable elements and placement of them at their target tissue location, and being mechanically coupled to the threaded insert and coupling mechanism 232; [0063], Figs. 7-8); and wherein the ablation catheter is configured to direct energy to the expandable frame so as to ablate tissue at or around the expandable frame (see [0064]-[0065], and [0099]-[0100]). However, Gruba fails to specifically disclose wherein the connector assembly extends from the handle to the expandable frame.
Kreidler teaches an occlusion implant delivery device (see Fig. 17) comprising an insert (see core 312, [0150]-[0152], Fig. 17) that is used to lock or release the detachable expandable implant, wherein the insert extends from the handle (309, Fig. 17) of the device to the expandable implant to a control device on the handle (as shown in Fig. 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector assembly as taught by Gruba to extend from the handle to the expandable frame, the motivation being to provide the additional advantage of allowing the user to directly control the insert of Gruba using a control provided on the handle to discretely unlock the expandable frame for deployment (see Kreidler [0151]).
Regarding claim 2, Gruba further discloses wherein the expandable frame comprises a threaded socket and the connector assembly comprises a threaded wire (see threaded insert, [0063]) that is receivable within the threaded socket such that the expandable frame is attached by threading the connector assembly into the expandable frame (see internally threaded collar 160, [0073]).
Regarding claim 3, Gruba further discloses wherein the expandable frame is detached by unthreading the connector assembly from the expandable frame (see [0073]).
Regarding claim 4, Gruba in view of Kreidler further teaches wherein the connector assembly includes a hypotube that extends through the handles (see proximal end of the core extending within the catheter in light of the combination) and the threaded wire that is attached to the hypotube and the expandable frame (see threaded insert at the distal end of the core as a result of the combination).
Regarding claim 5, Gruba in view of Kreidler further teaches wherein the handle includes a housing (see handle 309 of Kreidler including a housing for internal components, see Kreidler Fig. 17). Kreidler further teaches a deployment assembly arranged together with the housing such that actuating the handle thereby moves the expandable frame between the plurality of deployment positions (see pull wire controls 330 arranged with the housing for converting the expandable implant between reduced and expanded configurations, [0150]-[0151], Fig. 17). Therefore, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ablation catheter of Gruba to comprise a deployment assembly arranged together with the housing such that actuating the handle thereby moves the expandable frame between the plurality of deployment positions in light of Kreidler, since such a combination of prior art elements could have been made by one of ordinary skill in the art when following the teachings of the prior art and would have only produced the predictable result of providing suitable hand controls for moving the expandable frame into different configurations or releasing the expandable frame.
Regarding claim 6, Gruba in view of Kreidler further teaches wherein the deployment assembly includes a switch and a translator that is operatively connected to both the switch and the connector assembly such that actuating the handle comprises actuating the switch, the translator facilitating movement of the connector assembly relative to the elongate hollow shaft to thereby move the expandable frame between the plurality of deployment positions (see Kreidler: slider switches, which comprise a switch and translator and would move the expandable frame between the plurality of configuration relative to the hollow shaft as claimed when viewed in combination with Gruba, see Kreidler [0150]).
Regarding claim 7, Gruba in view of Kreidler further teaches wherein the deployment assembly comprises a torque knob with which to detach the expandable frame from the ablation catheter (see Kreidler: rotational knobs, [0150]).
Regarding claim 8, Gruba further discloses wherein a biocompatible covering disposed over at least a part of the expandable frame (see PET knit material membrane, [0075], Fig. 3).
Regarding claim 9, Gruba further discloses wherein the expandable frame comprises an electrode that facilitates delivering ablative energy to generate a volume of ablated tissue having a shape and size that corresponds to a deployment position of the expandable frame (see electrode structures 142/exposed conductive portions of the implant 134 that generates a volume of ablated corresponding to the deployment position of the expandable frame, [0064] and [0073], Fig. 3).
Regarding claim 10, Gruba discloses the limitations of claim 1 and further discloses wherein the basket is formed with an ablation electrode positioned at a distal end of the expandable frame (see electrode structures 142/distal exposed conductive portions of the implant 134, [0064] and [0073], Fig. 3), however fails to further disclose wherein the expandable frame is formed as a closed basket.
Kreidler teaches the occlusive catheter device with a detachable implant comprising a closed basket (see struts spanning between a proximal and distal hub; [0034], Fig. 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the open basket as taught by Guba to instead be a closed basket in light of Kreidler since such modification would be a matter of simple substitution to one of ordinary skill in the art for the same purpose of appropriately filling specific geometry and/or size of the patient anatomy at the target area being treated.
Regarding claim 14, Gruba in view of Kreidler teaches the further limitations of claim 14 under the same teachings and rationale as that applied in the rejections of claims 1, 5, and 6 above.
Regarding claims 18 and 20, Gruba in view of Kreidler teaches the further limitations of claims 18 and 20 regarding the closed basket and distal ablation electrode under the same teachings and rationale as that applied in the rejection of claim 10 above. With regard to claim 20, Gruba additionally discloses wherein the ablation catheter further comprises a second ablation catheter that is positioned on the elongate hollow shaft and is proximal to the ablation electrode (see delivery sheath 248; [0098], Fig. 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794