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
Applicant's amendment filed 03/24/2025 has been entered. Claims 2-5, 7, 10-15, and 17-18 have been amended. Claims 1 and 19-20 have been cancelled. Claims 21-23 have been added. Claims 2-5, 7, 10-15, 17-18, and 21-23 are pending on the application.
Response to Arguments
Applicant’s arguments filed 03/24/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See the new 103 rejection of Olson (US 20190282116 A1) in view of Basu (US 20170164858 A1) below.
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 (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.
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.
Claims 2-5, 7, 10-15, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20190282116 A1) in view of Basu (US 20170164858 A1).
Regarding Claim 21, Olson discloses:
An apparatus comprising:
a catheter shaft assembly having a proximal end and a distal end (Olson Fig 1A catheter shaft (105) ) assembly including (120,115), par [0054]), the catheter shaft assembly defining a longitudinal axis (Olson par [0054]), the catheter shaft assembly including an outer sheath comprising a distal end (Olson Fig 1G (104) introducer, par [0069] basket catheter within introducer, [0078] sheath or introducer); and
an end effector associated with the distal end of the catheter shaft assembly (Olson Fig 1A (101) end effector, par [0054]), the end effector comprising at least first and second electrode assemblies (Olson Fig 1 electrode assemblies (110), any chosen ones may be considered ‘first’ or ‘second’),
the first electrode assembly comprising:
a first common proximal end strip having a proximal end anchored to the catheter shaft assembly, a first common distal end strip having a distal end anchored to the catheter shaft assembly, and a first intermediate strip extending between the first common proximal end strip and the first common distal end strip (Olson Fig 1 common proximal end strip at proximal end of (110), distal end strip at distal end of (110), and intermediate strip being the electrode (111) bearing strip between the two),
proximal end of the first intermediate strip connected to the first common proximal end strip at a location distal of the proximal end of the first common proximal end strip (Olson Fig 1 common proximal end strip at proximal end of (110), distal end strip at distal end of (110), and intermediate strip being the electrode (111) bearing strip between the two; any chosen location may be the connection point), and
distal end of the first intermediate strip connected to the first common distal end strip at a first distance proximal of the distal end of the first common distal end strip (Any chosen distance may be considered a first distance), and
a plurality of first electrodes positioned on at least the first intermediate strip (Olson Fig 1A (110) splines, (111) electrodes, par [0055] each of the splines includes a plurality of electrodes including the intermediate section),
each of the first electrodes of the plurality of first electrodes being positioned relative to each other such that groups of four of the plurality of first electrodes define a substantially square configuration (Olson Fig 1A (111), par [0059] equal spacing between electrodes both on a spline and in between splines will form square groups of four; see also annotated Fig 1A below);
the second electrode assembly comprising: a second common proximal end strip having a proximal end anchored to the catheter shaft assembly, a second common distal end strip having a distal end anchored to the catheter shaft assembly, and a second intermediate strip extending between the second common proximal end strip and the second common distal end strip (Olson Fig 1 common proximal end strip at proximal end of (110), distal end strip at distal end of (110), and intermediate strip being the electrode (111) bearing strip between the two), proximal end of the second intermediate strip connected to the second common proximal end strip at a location distal of the proximal end of the second common proximal end strip (Olson Fig 1 common proximal end strip at proximal end of (110), distal end strip at distal end of (110), and intermediate strip being the electrode (111) bearing strip between the two; any chosen location may be the connection point), and distal end of the second intermediate strip connected to the second common distal end strip at a second distance proximal of the distal end of the second common distal end strip (Any chosen distance may be considered a second distance), and a plurality of second electrodes positioned on at least the second intermediate strip (Olson Fig 1A (110) splines, (111) electrodes, par [0055] each of the splines includes a plurality of electrodes including the intermediate section), each of the second electrodes of the plurality of second electrodes being positioned relative to each other such that groups of four of the plurality of second electrodes define a substantially square configuration (Olson Fig 1A (111), par [0059] equal spacing between electrodes both on a spline and in between splines will form square groups of four);
the plurality of first intermediate strips and the plurality of second intermediate strips being configured to transition between a first configuration and a second configuration (Olson par [0054] expansion/contraction of basket, with first configuration being contracted/undeployed basket, and second configuration being expanded/deployed basket), in which:
in the first configuration, the plurality of first intermediate strips and the plurality of second intermediate strips are configured to fit within the outer sheath (Olson first configuration shown by Fig 1G (105) outer shaft of basket catheter within (104) introducer, par [0069] basket catheter within introducer, [0078] sheath or introducer), and
in the second configuration, the plurality of first intermediate strips and the plurality of second intermediate strips are exposed distally relative to the distal end of the outer sheath (second configuration shown by Fig 1A (101), par [0067] deployment of basket catheter upon exit from an introducer), and
the plurality of first intermediate strips and the plurality of second intermediate strips are configured to expand outwardly away from the longitudinal axis such that:
the distal end of the first intermediate strip is spaced from the catheter shaft by the first distance of the distal end of the first intermediate strip from the distal end of the first common distal end strip (Olson Fig 1A, the distal ends of the intermediate portion of assembly (110) are spaced apart from the catheter shaft (120) by the length of the distance of the distal portion of each assembly (110)), and the distal ends of the second intermediate strip is spaced from the catheter shaft by the second distance of the distal end of the second intermediate strip from the distal end of the second common distal end strip (Olson).
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Olson fails to explicitly disclose
a plurality of first and second intermediate strips.
However, Basu discloses a similar catheter with multiple electrode assemblies (Basu Fig 1 catheter (10) electrode assemblies (18,20) par [0033]) with equally spaced electrodes (Basu par [0034]) where the assemblies have multiple intermediate strips (Basu Fig 2, various embodiments in Fig 4-7, par [0041-0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Olson with separated intermediate strips such as disclosed by Basu, as doing so allows for different sizes and coverages when in an expanded state to target different anatomy (Basu par [0035])
Regarding Claim 2, Olson in view of Basu discloses the device of claim 21, and further discloses: the one or more electrode assemblies comprising a plurality of electrode assemblies.
further comprising one or more additional electrode assemblies (Olson Fig 1 plurality of assemblies (110), par [0044] may be any number, seven as the embodiment in Fig 1), each additional electrode assembly comprising:
a corresponding common proximal end strip having a proximal end anchored to the catheter shaft assembly, a corresponding common distal end strip having a distal end anchored to the catheter shaft assembly, and a plurality of corresponding intermediate strips extending between the corresponding common proximal end strip and the corresponding common distal end strip Olson Fig 1 common proximal end strip at proximal end of (110), distal end strip at distal end of (110), and intermediate strip being the electrode (111) bearing strip between the two; Basu discloses plurality of intermediate strips), proximal ends of the corresponding intermediate strips converging to connect to the corresponding common proximal end strip at a location distal of the proximal end of the corresponding common proximal end strip, and distal ends of the corresponding intermediate strips converging to connect to the first common distal end strip at a corresponding distance proximal of the distal end of the corresponding common distal end strip (see previous rejection of first and second intermediate strips in claim 21), and a plurality of corresponding electrodes positioned on at least some of the corresponding intermediate strips of the plurality of corresponding intermediate strips, each of the corresponding electrodes of the plurality of corresponding electrodes being positioned relative to each other such that groups of four of the plurality of corresponding electrodes define a substantially square configuration (Olson Fig 1A (111), par [0059] equal spacing between electrodes both on a spline and in between splines will form square groups of four).
Regarding Claim 3, Olson in view of Basu discloses the device of claim 2, and further discloses: the end effector defining a longitudinal axis (Olson par [0054]), the plurality of electrode assemblies being angularly spaced apart from each other about the longitudinal axis (Olson Fig 1C,D assemblies (110)).
Regarding Claim 4, Olson in view of Basu discloses the device of claim 2. Olson includes an embodiment which further discloses an electrode assembly comprising a plurality of strips wherein the plurality of strips of each respective one of the plurality of electrode assemblies are parallel to each other (Olson Fig 2A, strips (210) of each electrode assembly (201) are parallel to each other par [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the disclosure of Olson in view of Basu to include parallel intermediate strips such as disclosed by Olson, as such a parallel arrangement is suitable to conform to tissue while maintaining dense mapping (Olson par [0009]).
Regarding Claim 5, Olson in view of Basu discloses the device of claim 1, and further discloses: each group of four electrodes of the plurality of electrodes including: (A) a first electrode, (B) a second electrode spaced apart from the first electrode along a first dimension by a first distance, (C) a third electrode spaced apart from the second electrode along a second dimension by the first distance, the second dimension being perpendicular to the first dimension, and (D) a fourth electrode spaced apart from the third electrode along the first dimension by the first distance, the fourth electrode being further spaced apart from the first electrode along the second dimension by the first distance (see annotated Fig 2A below, with electrodes 1-4 spaced equally).
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Regarding Claim 7, Olson in view of Basu discloses the device of claim 5, and further discloses an embodiment wherein: the first and third electrodes being positioned along a longitudinal axis (Fig 2A (2102-4, 211), see annotated image with longitudinal axis in dashed line), the first dimension being obliquely oriented relative to the longitudinal axis (Fig 2A (2102-4, 211), see annotated Fig 2A above with red line connecting electrodes labeled (1) and (2)), the second dimension being obliquely oriented relative to the longitudinal axis (Fig 2A (2102-4, 211), see annotated Fig 2A with red line connecting electrodes labeled (2) and (3)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the disclosure of Olson in view of Subramaniam to use such a structure with regularly spaced electrodes in order to maintain a structure with regular spacing (Olson par [0051] regular spacing of electrodes improves the accuracy of various metrics, par [0117] teachings may be readily applied to various other catheter embodiments, par [0123] “particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation”).
Regarding Claims 10-12, Olson in view of Basu discloses the device of claim 5, and further discloses:
(claim 10): the plurality of intermediate strips comprising at least two first intermediate strips, and the first and third electrodes being positioned along a same one of the at least two first intermediate strips of the plurality of intermediate strips (Olson see annotated Fig 2A (2103) with electrodes “1” and “3”, above); or
the plurality of second intermediate strips comprising at least two second intermediate strips, and the first and third electrodes being positioned along a same one of the at least two second intermediate strips of the plurality of second intermediate strips (Olson see annotated Fig 2A (2103) with electrodes “1” and “3”, above).
(claim 11):
the second electrode being positioned on a second one of the at least two first intermediate strips (Olson see annotated Fig 2A (2102) with electrode “2”, above), or the second electrode being positioned on a second one of the at least two second intermediate strips (Olson see annotated Fig 2A (2102) with electrode “2”, above).
(claim 12): the at least two first intermediate strips comprising at least three first intermediate strips, and the fourth electrode being positioned on a third one of the first intermediate strips (Olson see annotated Fig 2A (2102) with electrode “2”, above), or the at least two second intermediate strips comprising at least three second intermediate strips, and the fourth electrode being positioned on a third one of the second intermediate strips (Olson see annotated Fig 2A (2104) with electrode “4”, above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the disclosure of Olson in view of Subramaniam to use such a structure with regularly spaced electrodes in order to maintain a structure with regular spacing (Olson par [0051] regular spacing of electrodes improves the accuracy of various metrics, par [0117] teachings may be readily applied to various other catheter embodiments, par [0123] “particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation”).
Regarding Claim 13, Olson in view of Basu discloses the device of claim 1, and further discloses: the plurality of electrodes being arranged in bipolar pairs (Olson par [0037] adjacent electrodes assigned to bipolar pairs), the bipolar pairs being positioned relative to each other such that groups of four of the bipolar pairs define a substantially square configuration, or the plurality of second electrodes being arranged in bipolar pairs, the bipolar pairs being positioned relative to each other such that groups of four of the bipolar pairs define the generally substantially square configuration (Olson Fig 1A, par [0056] orthogonally oriented bipolar pair combinations, [0074] plurality of bipolar pairs with known spacing, see annotated Fig 1A with bipolar pairs in red, group of four defining a substantially square configuration in black, perspective view; as the electrode pairs denoted consist of the fourth and fifth electrodes from the distal end (115) along every other equally spaced strut (1101, 1103, 1105, 1107), the distance between adjacent pairs may be assumed to be equidistant, any pairs may be termed first or second).
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Regarding Claim 14, Olson in view of Basu discloses the device of claim 21, and further discloses: the strips being resiliently biased to expand (Olson par [0054] splines may be comprised of e.g., nitinol to facilitate expansion) outwardly away from the longitudinal axis (Olson Fig 1A) in the second configuration in response to being exposed distally relative to the distal end of the outer sheath (Olson par [0067] deployment of basket catheter upon exit from an introducer).
Regarding Claim 15, Olson in view of Basu discloses the device of claim 14, and further discloses: each strip including at least one resilient feature integrated into or secured to the flexible body, or each second intermediate strip of the plurality of second intermediate strips including at least one resilient feature integrated into or secured to a flexible body of the second intermediate strip (Olson Fig 1A, par [0054] splines may be comprised of e.g., nitinol to facilitate expansion, [0087] splines may be comprised of shape-memory alloy or each coupled to steering wires to facilitate expansion).
Regarding Claim 17, Olson in view of Basu discloses the device of claim 14, and further discloses an embodiment wherein: the plurality of first electrodes or the plurality of second electrodes comprising at least one pair of bipolar sensing electrodes configured to sense potentials in tissue (Olson par [0037] each bipolar pair samples the electrical characteristics of the tissue, par [0081] array electrodes may include the same type of electrode or a variety of electrode types).
Regarding Claim 18, Olson in view of Basu discloses the device of claim 14, and further discloses: the plurality of electrodes comprising at least one ablation electrode (Olson par [0076] electrodes may perform ablation, par [0081] array electrodes may include the same type of electrode or a variety of electrode types).
Regarding Claims 21-23, Olson in view of Basu discloses the devices of claims 2, 5, and 13, and the rejections are the same, respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Tuesday-Friday, 11:00am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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