DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024, 02/26/2025, 08/21/2025, 11/12/2025, 12/08/2025 was filed after the mailing date of the application on 11/19/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
This application claims priority to 17/812,732 as a continuation (CON) with an effective filing date (EFD) of 02/23/2021, which is a CON of 15/299,640 with EFD 10/21/2016, which is a CON of 13/782,903 with an EFD of 03/01/2013, which is a continuation in part (CIP) of PCT/US2012/022061 with an EFD 01/20/2012, with provisional patent applications 61/515,141 with an EFD 08/04/2011, 61/488,639 with an EFD 05/20/2011, 61/485,987 with an EFD 05/13/2011, and 61/435,213 with an EFD 01/21/2011. The Examiner has found adequate support for the instant application’s claims in the parent and provisional application and therefore have granted the instant application an EFD of 01/21/2011.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 44-51, 58-59, and 61-62 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Vanney (US 2005/0267463), herein after “Vanney” in view of Gelbart (US 2009/0131930), herein after “Gelbart”.
Regarding claim 44, Vanney teaches “A method of controlling a medical device system (Fig. 1), the medical device system including a shaft member comprising a first end portion and a second end portion (p.[0049], Fig. 2, catheter 22, straight section 32, second curved section 36), the medical device system further including a structure comprising a plurality of elongate members (Fig. 1)
each elongate member of the plurality of elongate members comprising a proximal end portion, a distal end portion, and an intermediate portion between the proximal end portion and the distal end portion along a length of the elongate member (p.[0058], transition section 38, cap 47, section between cap and transition section read as intermediate portion),
the proximal end portion of each elongate member of the plurality of elongate members fixedly coupled to the second end portion of the shaft member (p.[0053], transition section 38 connected to curved section 36), the intermediate portion of each elongate member of the plurality of elongate members comprising a respective group of transducer elements of the plurality of transducer elements (Fig. 3A, electrodes 18, p.[0057]),
the method comprising: selectively moving the structure between (a) a delivery configuration in which the structure is sized for delivery through a bodily opening leading to a bodily cavity, (Fig. 3A, p.[0057])
(b) each of a plurality of expanded configurations, wherein, in each of the plurality of expanded configurations, the structure has an enlarged size as compared to a corresponding size of the structure in a state in which the structure is in the delivery configuration (p.[0059-0060], Fig. 5B, deployed state)
circumferentially arranging at least the intermediate portion of each elongate member of the plurality of elongate members about a first axis at least in a state in which the structure is in a first particular expanded configuration of the plurality of expanded configurations, the intermediate portions of the elongate members configured to extend like lines of longitude about the first axis at least in the state in which the structure is in the first particular expanded configuration of the plurality of expanded configuration (Fig. 2)
causing, during a movement between the delivery configuration and a second particular expanded configuration of the plurality of expanded configurations, a region of the distal end portion of each elongate member of the plurality of elongate members to be positioned adjacent a region of the proximal end portion of the elongate member to cause the intermediate portion of the elongate member to form a loop (p.[0053], Fig. 2, sensing limbs 30a,b create a loop, wherein cap 47 is adjacent to the transition section)
the loop formed by the intermediate portion of each elongate member of at least some elongate members of the plurality of elongate members residing in a respective first spatial plane that assumes a skewed orientation relative to the proximal end portion of the elongate member due at least in part to the region of the distal end portion of each elongate member of the plurality of elongate members being positioned adjacent the region of the proximal end portion of the elongate member (Fig. 14)”.
Vanney teaches ablation capabilities, but does not explicitly disclose a plurality of transducer elements. In a related ablation art, Gelbart teaches "a plurality of transducer elements (p.[0088,0090], Fig. 2, transducer elements 206)" and "the intermediate portion of each elongate member of the plurality of elongate members comprising a respective group of transducer elements of the plurality of transducer elements (p.[0088,0090], Fig. 2, transducer elements 206). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the transducers of Gelbart in into Vanney to provide the same predictable result of providing ablation to the target tissue.
Regarding claim 45, the limitations of claim 44 are taught as described above. Vanney teaches “comprising causing, during at least part of the movement between the delivery configuration and the second particular expanded configuration, the regions of the distal end portions of the plurality of elongate members to move along parallel paths (p.[0053, 0077], Fig. 2, ablation web keeps sensing limbs 30a,b parallel).”
Regarding claim 46, the limitations of claim 45 are taught as described above. Vanney teaches “wherein each of the parallel paths comprises an arcuate path (p.[0053,0077] Fig. 2)”.
Regarding claim 47, the limitations of claim 44 are taught as described above. Vanney teaches “comprising angularly arranging at least the intermediate portions of the plurality of elongate members about a second axis in a state in which the structure is in the second particular expanded configuration (Fig. 14)”.
Regarding claim 48, the limitations of claim 47 are taught as described above. Vanney teaches “comprising causing, during the movement between the delivery configuration and the second particular expanded configuration, the region of the distal end portion of at least a first elongate member of the plurality of elongate members to move along a path on a second spatial plane coincident with the first axis to cause the region of the distal end portion of the first elongate member to be positioned adjacent the region of the proximal end portion of the first elongate member (p.[0077], Fig. 2, cap 47 is close to transition area 38)”.
Regarding claim 49, the limitations of claim 44 are taught as described above. Vanney teaches “comprising causing, during the movement between the delivery configuration and the second particular expanded configuration, the region of the distal end portion of at least a first elongate member of the plurality of elongate members to move along a path on a second spatial plane coincident with a longitudinal axis of the shaft member to cause the region of the distal end portion of the first elongate member to be positioned adjacent the region of the proximal end portion of the first elongate member (p.[0077], Fig. 2, cap 47 is close to transition area 38)”.
Regarding claim 50, the limitations of claim 44 are taught as described above. Vanney teaches “wherein, in a state in which the structure is in the second particular expanded configuration, each loop surrounds a volume of space exclusive of any part of the shaft member (Fig. 2, the volume of space being internal to the loop)”.
Regarding claim 51, the limitations of claim 44 are taught as described above. Vanney teaches “wherein each loop formed by the intermediate portion of each elongate member during the movement between the delivery configuration and the second particular expanded configuration is open in a space between the region of the distal end portion of the elongate member and the adjacent region of the proximal end portion of the elongate member (Fig. 2, open space between cap 47 and transition section 38)”.
Regarding claim 58, the limitations of claim 44 are taught as described above. Vanney teaches “wherein at least the intermediate portions of at least three elongate members of the plurality of elongate members extend in a direction along a longitudinal axis of the shaft member in the state in which the structure is in the delivery configuration (p.[0057], Fig. 3A, when deployed from the introducer, the device is moved along the longitudinal axis of the shaft).”
Regarding claim 59, the limitations of claim 44 are taught as described above. Vanney teaches “wherein each elongate member of the plurality of elongate members comprises a front surface and a back surface opposite across a thickness of the elongate member from the front surface of the elongate member, and wherein at least three elongate members of the plurality of elongate members are arranged front surface-toward-back surface in a stacked array in the state in which the structure is in the delivery configuration (Annotated Fig. 13)”
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Annotated Figure 13 of Vanney
Regarding claim 61, the limitations of claim 44 are taught as described above. Vanney does not teach “wherein at least one transducer element in at least one group of the respective groups of transducer elements is activatable to transmit energy sufficient to form a lesion in tissue” but Gelbart does in an analogous electrosurgical device. Gelbart teaches “wherein at least one transducer element in at least one group of the respective groups of transducer elements is activatable to transmit energy sufficient to form a lesion in tissue (p.[0084, 0090])”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Gelbart in Vanney, in order to provide the same effective result of providing ablation to target tissue and produces predictable results of ablating tissue.
Regarding claim 62, the limitations of claim 44 are taught as described above. There does not appear to be any disclosed criticality for the elliptical shape and the circular shape of Vanney provides the same function. Pending a statement of criticality, the recited elliptical shape in the state in which the structure is in the delivery configuration does not patentably distinguish over that of the shape of Vanney.
Claims 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Vanney in view of Gelbart further in view of Redmond (US Patent No. 5,245,987), herein after “Redmond”.
Regarding claim 52, the limitations of claim 44 are taught as described above. Neither Vanney nor Gelbart teaches "wherein the loop formed by the intermediate portion of each elongate member of at least some elongate members of the plurality of elongate members residing in the respective first spatial plane that assumes the skewed orientation relative to the proximal end portion of the elongate member is due at least in part to a twisted portion in the elongate member" but Redmond does in an analogous retractable tissue related art. Redmond teaches "wherein the loop formed by the intermediate portion of each elongate member of at least some elongate members of the plurality of elongate members residing in the respective first spatial plane that assumes the skewed orientation relative to the proximal end portion of the elongate member is due at least in part to a twisted portion in the elongate member (col. 2, lines 42-45; Fig. 1, Fig. 6, blades 16). It would have been obvious to one of ordinary skill in the art before the effective filing date to arrive at the claimed invention in view of Redmond from Vanney/Gelbart in order to automatically fan out the elongate members in the desired configuration and produces predictable results of a desired configuration (col. 2, lines 54-61).
Regarding claim 53, the limitations of claim 52 are taught as described above. Neither Vanney nor Gelbart teaches "wherein, for each elongate member of the at least some elongate members of the plurality of elongate members, the twisted portion is sufficient to rotationally offset the loop formed by the intermediate portion of the elongate member from the proximal end portion by a same angular amount for each of the at least some elongate members of the plurality of elongate members (Fig. 1, Fig. 6 show the same angular amount between the blades)." but Redmond does in an analogous retractable tissue related art. Redmond teaches "wherein, for each elongate member of the at least some elongate members of the plurality of elongate members, the twisted portion is sufficient to rotationally offset the loop formed by the intermediate portion of the elongate member from the proximal end portion by a same angular amount for each of the at least some elongate members of the plurality of elongate members (Fig. 1, Fig. 6 show the same angular amount between the blades)". It would have been obvious to one of ordinary skill in the art before the effective filing date to arrive at the claimed invention in view of Redmond from Vanney/Gelbart in order to automatically fan out the elongate members in the desired configuration and produces predictable results of a desired configuration (col. 2, lines 54-61).
Claim 54 is rejected under 35 U.S.C 103 as being unpatentable over Vanney in view of Gelbart in further view of Edwards (US Patent No. 5,293,869), herein after “Edwards”.
Regarding claim 54, the limitations of claim 44 are taught as described above. Vanney/Gelbart does not teach the limitation "wherein a side-to-side distance between two particular adjacent elongate members of the plurality of elongate members is relatively greater during the state in which the structure is in the first particular expanded configuration than in a state in which the structure is in the second particular expanded configuration” but Edwards does in an analogous catheter device. Edwards teaches wherein a side-to-side distance between two particular adjacent elongate members of the plurality of elongate members is relatively greater during the state in which the structure is in the first particular expanded configuration than in a state in which the structure is in the second particular expanded configuration (Fig. 5, wherein the distance between the splines is smaller than the distance between the splines of Fig. 6, a second expanded configuration)”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Edwards in Vanney. The use of differing side-to-side configurations of the device allows for the splines to adopt both a broad structure during use and collapse into the catheter during delivery and produces predictable results of delivering the elongate members to the desired site.
Claims 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Vanney in view of Gelbart in further view of Bates (US Patent No. 5,496,330), herein after “Bates”.
Regarding claim 55, the limitations of claim 44 are taught as described above. Vanney/Gelbart does not teach "wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration" but Bates does in an analogous catheter device. Bates teaches "wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration (Col. 5, lines 45-51, Fig. 5 where wire 51a is read as the first elongate member that crosses second elongate member)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Vanney/Gelbart in view of Bates in order to form a similarly shaped basket shaped catheter to retrieve an object and produces predictable results of retrieving an object.
Regarding claim 56, the limitations of claim 44 are taught as described above. Vanney/Gelbart does not teach “wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration" but Bates does in an analogous catheter device. Bates teaches "wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration (Col. 5, lines 45-51, Fig. 5 where wire 51a is read as the first elongate member that crosses second elongate member)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Vanney/Gelbart in view of Bates in order to form a similarly shaped basket shaped catheter to retrieve an object and produces predictable results of retrieving an object.
Regarding claim 57, the limitations of claim 56 are taught as described above. Vanney/Gelbart does not teach "wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration" but Bates does in an analogous catheter device. Bates teaches "wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration (Col. 5, lines 45-51, Fig. 5 where wire 51a is read as the first elongate member that crosses third elongate member)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Vanney/Gelbart in view of Bates in order to form a similarly shaped basket shaped catheter to retrieve an object and produces predictable results of retrieving an object.
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Vanney in view of Gelbart in further view of Silwa (US 2002/0173784).
Regarding claim 60, the limitations of claim 44 are taught as described above. Neither Vanney nor Gelbart teaches "wherein the transducer elements in at least one group of the respective groups of transducer elements are individually activatable" but Silwa does in an analogous electrosurgical device. Silwa teaches "wherein the transducer elements in at least one group of the respective groups of transducer elements are individually activatable (p.[0146])”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Silwa in Vanney/Gelbart to arrive at the claimed invention. Doing so allows for the electrodes to electively target points of tissue and produces predictable results of desired tissue ablation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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