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 § 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.
Claim 1, 5-6, 8-10, 13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (US 2015/0209526) in view of DAVIES (US 2020/0008781).
Regarding claim 1, Matsubara discloses a catheter (fig.2A; catheter system 10) for endovascular treatment of a blood vessel, the catheter comprising: a housing (flexible elongate body 12); a treatment portion (distal end of elongated body 12); a fistula forming element (penetrating needle 330); and an intravascular ultrasound imaging device (imaging assembly 38), wherein the intravascular ultrasound imaging device further comprises an array of solid-state transducers [0051]; wherein the intravascular ultrasound imaging device further comprises one or more circuit elements (Matsubara discloses that the entire body 12 is being flexible elongated body, see [0040]) electrically coupled to the array of solid-state transducers (fig.3A-3D, see also [0051]). The current application states that the array of solid-state transducers 2012 may be piezoelectric ultrasound transducers ([0275]). The examiner also noted that Matsubara “The imaging transducers of the imaging element are constructed from piezoelectric components that produce sound energy at 20-50 MHz.”[0078]. Matsubara does not specifically disclose the one or more circuit elements being flexible itself and said flexible circuit elements being adapted to enable front-end processing of data generated by the array of solid-state transducers.
DAVIES teaches the imaging assembly may have a plurality of ultrasound transducer elements disposed around the longitudinal axis (abstract). The imaging assembly includes ultrasound transducer array 124 and a flexible substrate 814 (fig.8A, see also [0061]). The flexible substrate 814 can include conductive traces to facilitate communication between one or more the elements 212, and the controllers 210, 220 [0062]. The flexible circuit elements being adapted to enable front-end processing of data generated by the array of solid-state transducers (fig.8A, see also [0062]). The flexible substrate 814 can also provide support for the elements 212 of the array 124 [0062]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Matsubara with one or more circuit elements being flexible itself and said flexible circuit elements being adapted to enable front-end processing of data generated by the array of solid-state transducers as taught by DAVIES for the purpose of providing support while also supporting the array of transducers.
Regarding claim 5, Matsubara/DAVIES teaches the catheter of claim 2, wherein the array of solid-state transducers are coupled to the housing of the catheter (fig.6B, see also [0051]).
Regarding claim 6, Matsubara/DAVIES teaches the catheter of claim 2, wherein the array of solid-state transducers are disposed circumferentially around the housing of the catheter (fig.6B, see also [0051] of Matsubara).
Regarding claim 8, Matsubara/DAVIES teaches the catheter of claim 7, wherein the one or more flexible circuit elements further comprise one or more multiplexing application-specific integrated circuits ([0051] of Matsubara).
Regarding claim 9, Matsubara/DAVIES teaches the catheter of claim 7, wherein the one or more flexible circuit elements are positioned within the housing of catheter (fig.3A, see also [0051] of Matsubara).
Regarding claim 10, Matsubara/DAVIES teaches the catheter of claim 9, further comprising an intravascular ultrasound imaging device wire extending proximally from the one or more flexible circuit elements through the housing of the catheter ([0051] of Matsubara).
Regarding claim 13, Matsubara/DAVIES teaches the catheter of claim 1, wherein the fistula forming element is an electrode configured to ablate tissue ([0048] of Matsubara).
Regarding claim 14, Matsubara/DAVIES teaches the catheter of claim 13, further comprising an electrode housing (fig.2E-F; needle 330), wherein: the electrode housing is positioned along the treatment portion of the catheter (fig.2E, see also [0047]) and; and the electrode housing is at least partially positioned within the housing of the catheter (fig.3A, see also [0047]-[0048] of Matsubara).
Regarding claim 15, Matsubara/DAVIES teaches the catheter of claim 14, wherein the electrode is housed within the electrode housing when the electrode is in a low-profile configuration (fig.3A, see also [0047] of Matsubara). The penetrating guidewire lumen 36 (which can house electrode). The needle/electrode being housed within electrode (low-profile) and the needle/electrode extending from the lumen 36 (extended configuration).
Regarding claim 16, Matsubara/DAVIES teaches the catheter of claim 14, wherein the electrode is configured to radially extend from the electrode housing and the housing of the catheter when the electrode is in an extended configuration (fig.3A, see also [0047]). The penetrating guidewire lumen 36 (which can house electrode). The needle/electrode being housed within electrode (low-profile) and the needle/electrode extending from the lumen 36 (radially extended configuration).
Regarding claim 18, Matsubara/DAVIES teaches the catheter of claim 14, wherein the intravascular ultrasound imaging device further comprises: an array of solid-state transducers (fig.3A); one or more flexible circuit elements electrically coupled to the array of solid-state transducers [0051]; and an intravascular ultrasound imaging device wire extending proximally from the one or more flexible circuit elements through the housing of the catheter ([0051] of Matsubara).
Regarding claim 19, Matsubara/DAVIES teaches the catheter of claim 18, wherein: the electrode housing further comprises a channel (fig.2F; opening 334) extending therethrough; the array of solid-state transducers are positioned distal the electrode housing (fig.3A, see also [0047]); the one or more flexible circuit elements are positioned distal the electrode housing [0051]; and the intravascular ultrasound imaging device wire extends through the channel extending through the electrode housing (fig.3A-3D, see als0 [0051] of Matsubara).
Regarding claim 20, Matsubara/DAVIES teaches the catheter of claim 18, further comprising: a first lumen (fig.3A; needle lumen 48); lumen extending through the housing of the catheter (fig.3A); and a second lumen (fig.3D; the lumen that holds leads 44, 46) extending through the housing of the catheter, wherein: the electrode further comprises an electrode wire electrically coupled to the electrode and extending proximally from the electrode through the housing of the catheter in the first lumen (fig.2E-3A; see also [0047]-[0049]); and the intravascular ultrasound imaging device wire extends through the second lumen (fig.3D, see also [0051] of Matsubara).
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.
Claim 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (US 2015/0209526) in view of DAVIES (US 2020/0008781) in further view of Salehi et al. (US 2021/0128106).
Regarding claim 4 and 12, Matsubara discloses wherein the array of solid-state transducers and the one or more flexible circuit elements are positioned proximal the array of solid- state transducers (fig.3A; see also [0051]). However, Matsubara/DAVIES does not disclose wherein the array of solid-state transducers are disposed proximal the fistula forming element.
Salehi teaches a medical introducer sheath comprises a tubular shaft and an ultrasonic transducer array. The array of transducers is disposed proximal the fistula forming element (fig.1; see also [0051]). Salehi further teaches he particular configuration of the ultrasonic transducer array 40, e.g., the number, location, orientation and operating characteristics of the ultrasound transducers 70, can be tailored to the particular clinical application. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Matsubara/DAVIES with the array of solid-state transducers are disposed proximal the fistula forming element as taught by Salehi for the purpose of having feedback of the proximal treatment area when desired.
Claim 17, 87-88 are rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (US 2015/0209526) in view of DAVIES (US 2020/0008781) in further view of Danek et al. (US 2009/0143776).
Regarding claim 17 and 87-88, Matsubara discloses the electrode is housed within the electrode housing (fig.2E-F, see also [0047]), to an extended configuration (fig.3A). Matsubara further teaches that the needle 1110 may similarly include one or more ablation elements [0059]. However, Matsubara does not disclose wherein the electrode is spring biased from a low- profile configuration, wherein the electrode is housed within the electrode housing, to an extended configuration, wherein the electrode radially extends from the electrode housing and the housing of the catheter, further including a biasing member coupled to the housing and configured to bias the cutting device against a wall of the blood vessel and wherein the fistula forming element comprises a leaf spring electrode configured to arc to extend outside the housing.
Danek teaches a system that includes a plurality electrode (fig.12; 98) positioned on leaf springs (fig.12; 96) which are outwardly biased. The leaf springs (fig.12; 96) are coupled to a shaft (fig.12: 102) which is positioned within a delivery catheter (fig.12; 94). The leaf springs 96 and electrodes 98 are delivered through the delivery catheter 94 to a treatment site within the airways. When the leaf springs 96 exit the distal end of the delivery catheter 94, the leaf springs bend outward until the electrodes 98 come into contact with the airway walls for application of energy to the target area [0077]. The electrode is housed within the electrode housing, to an extended configuration (fig.12, see also [0077]), wherein the electrode radially extends from the electrode housing(fig.12, see also [0077]) and the housing of the catheter, further including a biasing member coupled to the housing and configured to bias the cutting device against a wall of the blood vessel (fig.12, see also [0077]) and wherein the fistula forming element comprises a leaf spring electrode configured to arc to extend outside the housing (fig.12). Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Matsubara with spring biased configured to have a low- profile configuration and radially extended configuration as taught by Danek for the purpose providing the one and more ablative element different configuration that includes radial expansion to reach more target area.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the amendment necessitated a new ground of rejection.
Conclusion
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 TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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