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
This office action is responsive to the amendment filed on June 29, 2026. As directed by the amendment: claims 1, 6-10, and 17 have been amended, no claims have been added, claims 3 and 12 have been canceled. Thus claims 1-2, 4-11, and 13-20 are presently pending in this application. Applicant’s amendments to the Claims have overcome each and every 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed March 27, 2026.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 29, 2026, with respect to the provisional rejection(s) of claim(s) 1 under 35 U.S.C. 101 have been fully considered and are persuasive. The amendments to claim 1 change the scope of the claim such that non-statutory double patenting over copending application 18/368805 is no longer applicable. Therefore, the provisional rejection has been withdrawn.
Applicant’s arguments with respect to the rejection(s) of independent claim(s) 1, 10 and 17 under 35 U.S.C. 103 have been fully considered and are persuasive. Soltani, Suijver and Nita do not in combination disclose the amended limitations of the independent claims, namely wherein when the treatment core is in the helical configuration, the plurality of ultrasound transducers are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference. Therefore, the rejections of claims 1, 10, and 17 have been withdrawn. Due to their dependence on one of claims 1, 10, or 17, the rejections of claims 2, 4-9, 11, 13-16, and 18-20 have been withdrawn for similar reasons. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
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.
Claims 1-2, 6-11, 14, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Soltani et al. (US 20070265560), hereinafter Soltani, in view of Nita (US 20120330196) and Schaer (US 20110257562).
Regarding claim 1, Soltani discloses a system for treating a vascular region (Fig. 1 and [0047], catheter 10 for vascular use), the system comprising: an elongate catheter shaft (Fig. 1, tubular body 12) having a distal end region (Fig. 1, distal region 15), the elongate catheter shaft defining an inner lumen extending through the elongate catheter shaft (Fig. 2 and [0055], lumen 51, which extends length of body 12) and a fluid delivery lumen extending adjacent to the inner lumen (Fig. 2, fluid delivery lumen 30 adjacent to central lumen 51); and a treatment core (Fig. 3, inner core 34) disposed within the inner lumen (Fig. 11D and [0056], inner core 34 disposed within central lumen 51), the treatment core includes a plurality of ultrasound transducers (Fig. 5-6, ultrasound radiating members 40).
Soltani fails to disclose the treatment core adapted to move between a straight configuration and a helical configuration. However, Nita discloses the treatment core adapted to move between a straight configuration and a helical configuration ([0075] and Fig. 2C, distal portion of catheter 18, containing the ultrasound transducers and therefore the treatment core, may be configured to transition from a straight configuration to a helical shape, thus transitioning the treatment core to a helical shape).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani to incorporate the disclosures of Nita and modify the treatment core to be adapted to move between a straight configuration and a helical configuration. Doing so would position the ultrasound transducers in a helical shape of the shaft to allow transmission of ultrasound in multiple different directions (Nita, [0075]).
Soltani, in view of Nita, fails to disclose wherein when the treatment core is in the helical configuration, the plurality of ultrasound transducers are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference. However, Schaer discloses wherein when the treatment core is in the helical configuration, the plurality of ultrasound transducers are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference (Figs. 6-7 and [0089], when transducer 34 has an active region helical pattern along its length, the spaced active regions 134 may be spaced/positioned such that energy waves 35 from the neighboring active regions overlap to form constructive interference focal regions 140).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita, to incorporate the disclosures of Schaer and modify the treatment core such that when the treatment core is in the helical configuration, the plurality of ultrasound transducers are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference. Doing so would allow for energy delivery from discrete or continuous regions of the transducer core to allow complete interruption of nerve pathways around the vessel circumference, while minimizing the risk of focused stenosis in the vessel (Schaer, [0089]).
Regarding claim 2, Soltani, in view of Nita and Schaer, discloses the system of claim 1, as explained above. Soltani fails to disclose wherein the elongate catheter shaft is adapted to move between a straight configuration and a helical configuration. However, Nita further discloses wherein the elongate catheter shaft is adapted to move between a straight configuration and a helical configuration ([0075] and Fig. 2C, distal portion of catheter 18 may be configured to transition from a straight configuration to a helical shape).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to further incorporate the disclosures of Nita and modify the elongate catheter shaft to be adapted to move between a straight configuration and a helical configuration. Doing so would position the ultrasound transducers in a helical shape of the shaft to allow transmission of ultrasound in multiple different directions (Nita, [0075]).
Regarding claim 6, Soltani, in view of Nita and Schaer, discloses the system of claim 1, as explained above.
However, Soltani, in view of Nita and Schaer, does not expressly disclose wherein the plurality of ultrasound transducers has a treatment zone length when in the helical configuration that is in a range of 6 centimeters to 50 centimeters.
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 device of Soltani, in view of Nita and Schaer, to have a treatment zone length when in the helical configuration in a range of 6 centimeters to 50 centimeters, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Soltani, in view of Nita and Schaer, would not operate differently with the length range when in the helical configuration and Soltani shows in Figs. 11B-D and [0098-0101] that the ultrasound assembly is configured to be positioned within the lumen and extend a length of the lumen to treat an elongate clot without moving or repositioning the catheter. Additionally, the assembly length, in a linear configuration, is between 30-50 cm, which is a similar, yet longer, length range that the claimed range for the helical configuration (which Soltani does not expressly disclose as stated above). Therefore, the device would function appropriately having the claimed length range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the treatment zone length when in the helical configuration may be "in some cases" within the claimed ranges (instant specification [0064]).
Regarding claim 7, Soltani, in view of Nita and Schaer, discloses the system of claim 1, as explained above.
However, Soltani, in view of Nita and Schaer, does not expressly disclose wherein the plurality of ultrasound transducers has a helical pitch when in the helical configuration that is in a range of 3 centimeters to 6 centimeters.
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 device of Soltani, in view of Nita and Schaer, to have a helical pitch when in the helical configuration that is in a range of 3 centimeters to 6 centimeters, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Soltani, in view of Nita and Schaer, would not operate differently with the pitch range when in the helical configuration and Soltani shows in Figs. 11B-D and [0098-0101] that the ultrasound assembly is configured to be positioned within the lumen and extend a length of the lumen such that the radiating members 40 are spaced over the length in order to treat an elongate clot without moving or repositioning the catheter. Therefore, the device would function appropriately having the claimed pitch range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the helical pitch when in the helical configuration may be "in some cases" within the claimed range (instant specification [0064]).
Regarding claim 8, Soltani, in view of Nita and Schaer, discloses the system of claim 1, as explained above.
However, Soltani, in view of Nita and Schaer, does not expressly disclose wherein the plurality of ultrasound transducers has a helical diameter when in the helical configuration that is in a range of 6 millimeters to 30 millimeters.
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 device of Soltani, in view of Nita and Schaer, to have a helical diameter when in the helical configuration that is in a range of 6 millimeters to 30 millimeters, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Soltani, in view of Nita and Schaer, would not operate differently with the helical diameter range when in the helical configuration and Soltani shows in Figs. 11B-D and [0098-0101] that the ultrasound assembly is configured to be positioned within the within the blood vessel and adjacent to the clot and extend a length of the vessel such that the radiating members 40 are able to treat the clot without moving or repositioning the catheter. Therefore, the device would function appropriately having the claimed helical diameter range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the helical diameter when in the helical configuration may be "in some cases" within the claimed range (instant specification [0064]).
Regarding claim 9, Soltani, in view of Nita and Schaer, discloses the system of claim 1.
However, Soltani, in view of Nita and Schaer, does not expressly disclose wherein each of the plurality of ultrasound transducers are spaced 1 centimeter to 4 centimeters from adjacent ultrasound transducers when the plurality of ultrasound transducers are in the helical configuration.
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 device of Soltani, in view of Nita and Schaer, to have an adjacent transducer spacing when in the helical configuration that is in a range of 1 centimeter to 4 centimeters, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Soltani, in view of Nita and Schaer, would not operate differently with the adjacent transducer spacing range when in the helical configuration and Soltani shows in Figs. 11B-D and [0098-0101] that the ultrasound assembly is configured to be positioned within the lumen and extend a length of the lumen such that the radiating members 40 are spaced over the length in order to treat an elongate clot without moving or repositioning the catheter. Therefore, the device would function appropriately having the claimed transducer spacing range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the transducer spacing when in the helical configuration "may be" within the claimed range (instant specification [0063]).
Regarding claim 10, Soltani discloses an ultrasonic catheter system (Fig. 1 and [0047], ultrasonic catheter 10), comprising: a multi-lumen catheter shaft (Fig. 1-2, multi-lumen tubular body 12) having a central lumen (Fig. 2, central lumen 51) and a plurality of fluid delivery lumens (Fig. 2, fluid delivery lumens 30); and an ultrasound catheter core disposed within the central lumen (Fig. 11D and [0056], inner core 34 disposed within central lumen 51), the ultrasound catheter core including a plurality of ultrasound transducers (Fig. 5-6, ultrasound radiating members 40) and wherein the central lumen is adapted to allow for a cooling media to pass therethrough when the ultrasound catheter core is disposed within the central lumen (Fig. 11D and [0102], central lumen 51 allows cooling fluid 48 to pass through when inner core 34 is in lumen 51).
Soltani fails to disclose wherein the plurality of ultrasound transducers are adapted to move between a straight configuration and a helical configuration. However, Nita discloses wherein the plurality of ultrasound transducers are adapted to move between a straight configuration and a helical configuration ([0075] and Fig. 2C, distal portion of catheter 18, containing the ultrasound transducers, may be configured to transition from a straight configuration to a helical shape, thus transitioning the plurality of transducers to a helical shape).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani to incorporate the disclosures of Nita and modify the plurality of ultrasound transducers to be adapted to move between a straight configuration and a helical configuration. Doing so would position the ultrasound transducers in the helical shape of the shaft during treatment to allow transmission of ultrasound in multiple different directions (Nita, [0075]).
Soltani, in view of Nita, fails to disclose wherein the plurality of ultrasound transducers are spaced apart and positioned such that when the ultrasound catheter core is in the helical configuration, radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference. However, Schaer discloses wherein the plurality of ultrasound transducers are spaced apart and positioned such that when the ultrasound catheter core is in the helical configuration, radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference (Figs. 6-7 and [0089], when transducer 34 has an active region helical pattern along its length, the spaced active regions 134 may be spaced/positioned such that energy waves 35 from the neighboring active regions overlap to form constructive interference focal regions 140).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita, to incorporate the disclosures of Schaer and modify the treatment core such that the plurality of ultrasound transducers are spaced apart and positioned such that when the ultrasound catheter core is in the helical configuration, radiated ultrasound fields from neighboring ultrasound transducers overlap and provide constructive interference. Doing so would allow for energy delivery from discrete or continuous regions of the transducer core to allow complete interruption of nerve pathways around the vessel circumference, while minimizing the risk of focused stenosis in the vessel (Schaer, [0089]).
Regarding claim 11, Soltani, in view of Nita and Schaer, discloses the system of claim 10, as explained above. Soltani is silent to wherein the multi-lumen catheter shaft is adapted to move between a straight configuration and a helical configuration. However, Nita further discloses wherein the multi-lumen catheter shaft is adapted to move between a straight configuration and a helical configuration ([0075] and Fig. 2C, distal portion of catheter 18 may be configured to transition from a straight configuration to a helical shape).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to further incorporate the disclosures of Nita and modify the multi-lumen catheter shaft to be adapted to move between a straight configuration and a helical configuration. Doing so would position the ultrasound transducers in a helical shape of the shaft to allow transmission of ultrasound in multiple different directions (Nita, [0075]).
Regarding claim 14 and Soltani, in view of Nita and Schaer, Soltani further discloses the ultrasonic catheter system of claim 10, wherein the plurality of ultrasonic transducers are arranged for treating a PAO (peripheral arterial occlusion) disease state (Fig. 1 and [0047], catheter 10, and therefore its ultrasound radiating members 40, are configured to treat peripheral arterial occlusions).
Regarding claim 17, Soltani discloses a system for treating a vascular region (Fig. 1 and [0047], catheter 10 for vascular use), the system comprising: an elongate catheter shaft (Fig. 1, tubular body 12) having a distal end region (Fig. 1, distal region 15), the elongate catheter shaft defining an inner lumen extending through the elongate catheter shaft (Fig. 2 and [0055], lumen 51, which extends length of body 12) and a fluid delivery lumen extending adjacent to the inner lumen (Fig. 2, fluid delivery lumen 30 adjacent to central lumen 51); and a treatment core (Fig. 3, inner core 34) disposed within the inner lumen (Fig. 11D and [0056], inner core 34 disposed within central lumen 51), the treatment core including two or more ultrasound radiating members (Fig. 5-6, ultrasound radiating members groups G1-G5).
Soltani fails to disclose the treatment core adapted to move between a straight configuration and a helical configuration. However, Nita discloses the treatment core adapted to move between a straight configuration and a helical configuration ([0075] and Fig. 2C, distal portion of catheter 18, containing the ultrasound transducers and therefore the treatment core, may be configured to transition from a straight configuration to a helical shape, thus transitioning the treatment core to a helical shape).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani to incorporate the disclosures of Nita and modify the treatment core to be adapted to move between a straight configuration and a helical configuration. Doing so would position the ultrasound transducers in a helical shape of the shaft to allow transmission of ultrasound in multiple different directions (Nita, [0075]).
Soltani, in view of Nita, fails to disclose wherein, when the treatment core is in the helical configuration, the two or more ultrasound radiating members are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound radiating members of the two or more ultrasound radiating members overlap and provide constructive interference. However, Schaer discloses wherein, when the treatment core is in the helical configuration, the two or more ultrasound radiating members are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound radiating members of the two or more ultrasound radiating members overlap and provide constructive interference (Figs. 6-7 and [0089], when transducer 34 has an active region helical pattern along its length, the spaced active regions 134 may be spaced/positioned such that energy waves 35 from the neighboring active regions overlap to form constructive interference focal regions 140).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita, to incorporate the disclosures of Schaer and modify the treatment core such that when the treatment core is in the helical configuration, the two or more ultrasound radiating members are spaced apart and positioned such that radiated ultrasound fields from neighboring ultrasound radiating members of the two or more ultrasound radiating members overlap and provide constructive interference. Doing so would allow for energy delivery from discrete or continuous regions of the transducer core to allow complete interruption of nerve pathways around the vessel circumference, while minimizing the risk of focused stenosis in the vessel (Schaer, [0089]).
Regarding claim 19 and Soltani, in view of Nita and Schaer, Soltani further discloses system of claim 17, wherein each of the two or more ultrasound radiating members comprise a two-dimensional array of ultrasound transducers (Fig. 6 and [0061], each group G(n) comprises a 2-D array of radiating members 40).
Regarding claim 20, Soltani, in view of Nita and Schaer, discloses the system of claim 17, as explained above. Soltani, in view of Nita, is silent to wherein one of the two or more ultrasound radiating members emit a radiated ultrasound field that overlaps with the radiated ultrasound field emitted by another of the two or more ultrasound radiating members. However, Schaer further discloses wherein one of the two or more ultrasound radiating members emit a radiated ultrasound field that overlaps with the radiated ultrasound field emitted by another of the two or more ultrasound radiating members (Figs. 6-7 and [0089], one of the spaced active regions 134 may be spaced/positioned such that energy waves 35 from another of the active regions overlap to form constructive interference focal regions 140).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to further incorporate the disclosures of Schaer and modify the two or more ultrasound radiating members such that wherein one of the two or more ultrasound radiating members emit a radiated ultrasound field that overlaps with the radiated ultrasound field emitted by another of the two or more ultrasound radiating members. Doing so would allow for energy delivery from discrete or continuous regions of the transducer core to allow complete interruption of nerve pathways around the vessel circumference, while minimizing the risk of focused stenosis in the vessel (Schaer, [0089]).
Claims 4-5, 13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Soltani (US 20070265560), in view of Nita (US 20120330196) and Schaer (US 20110257562), and further in view of Haworth et al. (US 20200107844), hereinafter Haworth.
Regarding claim 4, Soltani, in view of Nita and Schaer, discloses the system of claim 1.
Soltani, in view of Nita and Schaer, fails to disclose wherein the fluid delivery lumen has a distal end that is proximal of any of the plurality of ultrasound transducers. However, Haworth discloses wherein the fluid delivery lumen has a distal end that is proximal of any of the plurality of ultrasound transducers ([0027], fluid delivery lumen administration port (E.g. end distal end fluid delivery lumen) may be proximal to the ultrasound transducer(s)).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to incorporate the disclosures of Nita and modify the fluid delivery lumen to have a distal end that is proximal of any of the plurality of ultrasound transducers. Doing so would allow the fluid to be delivered proximate the transducers and be activated by the ultrasound transducer when in the blood stream to dissolve oxygen in the blood and treat hypoxic conditions (Haworth, [0022, 0027]).
Regarding claim 5 and Soltani, in view of Nita and Schaer, Soltani further discloses the system of claim 1, wherein the fluid delivery lumen comprises a plurality of fluid delivery lumens (Fig. 2, plurality of fluid lumens 30).
Soltani, in view of Nita and Schaer, fails to disclose wherein at least some of the plurality of fluid delivery lumens has a distal end that is offset from a distal end of others of the plurality of fluid delivery lumens. However, Haworth discloses at least some of the plurality of fluid delivery lumens has a distal end that is offset from a distal end of others of the plurality of fluid delivery lumens (Fig. 3 and [0008, 0027], fluid delivery lumen administration ports (E.g. port at end distal end of each fluid delivery lumen) may both proximal and distal to the ultrasound transducer(s), therefore some lumen distal ends are offset from other lumen distal ends).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to incorporate the disclosures of Nita and modify the fluid delivery lumens such that at least some of the plurality of fluid delivery lumens has a distal end that is offset from a distal end of others of the plurality of fluid delivery lumens. Doing so would allow the fluid to be delivered proximate the transducers and be activated by the ultrasound transducer both when in the blood stream and before leaving the catheter to dissolve oxygen in the blood and treat hypoxic conditions (Haworth, [0022, 0027]).
Regarding claim 13 and Soltani, in view of Nita and Schaer, Soltani further discloses the system of claim 10, wherein the fluid delivery lumen comprises a plurality of fluid delivery lumens (Fig. 2, plurality of fluid lumens 30).
Soltani, in view of Nita and Schaer, fails to disclose wherein at least some of the plurality of fluid delivery lumens has a distal end that is offset from a distal end of others of the plurality of fluid delivery lumens. However, Haworth discloses at least some of the plurality of fluid delivery lumens has a distal end that is offset from a distal end of others of the plurality of fluid delivery lumens (Fig. 3 and [0008, 0027], fluid delivery lumen administration ports (E.g. port at end distal end of each fluid delivery lumen) may both proximal and distal to the ultrasound transducer(s), therefore some lumen distal ends are offset from other lumen distal ends).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to incorporate the disclosures of Nita and modify the fluid delivery lumens such that at least some of the plurality of fluid delivery lumens has a distal end that is offset from a distal end of others of the plurality of fluid delivery lumens. Doing so would allow the fluid to be delivered proximate the transducers and be activated by the ultrasound transducer both when in the blood stream and before leaving the catheter to dissolve oxygen in the blood and treat hypoxic conditions (Haworth, [0022, 0027]).
Regarding claim 15, Soltani, in view of Nita and Schaer, discloses the system of claim 10.
Soltani, in view of Nita and Schaer, fails to disclose wherein the plurality of ultrasonic transducers are arranged for treating DVT (deep vein thrombosis). However, Haworth discloses wherein the plurality of ultrasonic transducers are arranged for treating DVT (deep vein thrombosis) ([0022], the catheter and its ultrasound transducers 32 are configure to treat deep vein thrombosis).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to further incorporate the disclosures of Haworth and modify the plurality of ultrasonic transducers to be arranged for treating DVT (deep vein thrombosis). Doing so would protect the patient against reperfusion injury upon restoration of oxygen to hypoxic tissue (caused by the DVT) thus lowering risk of tissue damage (Haworth, [0022]).
Regarding claim 16, Soltani, in view of Nita and Schaer, discloses the system of claim 10.
Soltani, in view of Nita and Schaer, fails to disclose wherein the plurality of ultrasonic transducers are arranged for treating PE (pulmonary embolisms). However, Haworth discloses wherein the plurality of ultrasonic transducers are arranged for treating PE (pulmonary embolisms) ([0022], the catheter and its ultrasound transducers 32 are configured to pulmonary embolism).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to further incorporate the disclosures of Haworth and modify the plurality of ultrasonic transducers to be arranged for treating PE (pulmonary embolisms). Doing so would protect the patient against reperfusion injury upon restoration of oxygen to hypoxic tissue (caused by the PE) thus lowering risk of tissue damage (Haworth, [0022]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Soltani (US 20070265560), in view of Nita (US 20120330196) and Schaer (US 20110257562), and further in view of Stigall et al. (US 20190053783).
Regarding claim 18, Soltani, in view of Nita and Schaer, discloses the system of claim 17.
Soltani, in view of Nita and Schaer, fails to disclose wherein each of the two or more ultrasound radiating members comprise a one-dimensional array of ultrasound transducers. However, Stigall discloses wherein each of the two or more ultrasound radiating members comprise a one-dimensional array of ultrasound transducers (Fig. 1 and [0029], transducer arrays 120/130 may be one-dimensional arrays of transducers).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Soltani, in view of Nita and Schaer, to incorporate the disclosures of Stigall and modify each of the two or more ultrasound radiating members to comprise a one-dimensional array of ultrasound transducers. Doing so would enable the device to generate two-dimensional images of the area of interest (Stigall, [0055-0056]).
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.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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