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 .
Election/Restrictions
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/19/2025.
Applicant's election with traverse of Group III in the reply filed on 09/19/2025 is acknowledged. The traversal is on the ground(s) that:
(i) “Weber does not disclose each and every one of the special technical features”. This is found to not be persuasive because as described in the previous Office Action the Special Technical feature is an ultrasonic catheter assembly comprising an outer sheath with a distal taper and an inner hypotube transmission member with a corresponding taper coupled to an ultrasonic transducer, and Weber discloses an ultrasonic catheter assembly (ultrasonic liposuction device 10) comprising an outer sheath (handle 11, with removable section 24) with a distal taper (taper of removable section 24 — shown in Fig. 1) and an inner hypotube transmission member (cannula shaft 12) with a corresponding taper (taper of cannula shaft 12 corresponding to the taper of removable section 24 — shown in Fig. 1) coupled to an ultrasonic transducer (ultrasonic generator 14) (abstract, col. 8 lines 12 — 45, and Fig. 1);
(ii) “Further, assuming arguendo, that there is not unity of invention of all Groups Applicant respectfully requests at least some of the Groups be examined together. For example, Groups II and III include multiple common features , as evidenced by claims 3, 4, 8, 15, 16, 19 and 20 which are generic to Groups II and III. Accordingly, art relevant to Group III would likely be relevant to Group II as well. Similarly, claims 19 and 20 are generic to Groups I-IV. Accordingly, art relevant to Group III would likely be relevant to Groups I-IV as well”, this is found to be persuasive, and the Examiner has withdrawn the species restriction between Groups I-IV. Therefore, Claims 1 – 13 and 15 – 20 have been examined.
As stated in (ii), the species restriction between Groups I-IV has been withdrawn. However, the species restriction between each one of Groups I, II, III, and IV and Group V has been maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 6, and 9 – 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamada et al (US 2013/0060169 A1).
Regarding claim 1, Yamada discloses a catheter assembly (treatment apparatus 10) (abstract, paragraphs [0032 – 0035], and Figs. 1 – 3), comprising:
an outer sheath (sheath 36 and designated in annotated Fig. 2) having a first end, a second end, a frustoconical side wall portion located proximal to the second end, and having a sheath lumen that extends from the first end to the second end (paragraph [0033], Fig. 2, and annotated Fig. 2); and
a hypotube ultrasonic transmission member (probe 34 and designated in annotated Fig. 2) disposed in the sheath lumen of the outer sheath (paragraph [0033], Fig. 2, and annotated Fig. 2), the hypotube ultrasonic transmission member having a hypotube side wall, a proximal hypotube portion, a distal hypotube portion, and a tapered intermediate portion (see annotated Fig. 2), the proximal hypotube portion configured to be operatively coupled to an ultrasonic transducer (transducer 32) (paragraphs [0033 – 0034] and Figs. 1, 2, annotated Fig. 2), the proximal hypotube portion having a first diameter, the distal hypotube portion having a second diameter less than the first diameter (see annotated Fig. 2), and the tapered intermediate portion configured to transition from the first diameter of the proximal hypotube portion to the second diameter of the distal hypotube portion (see annotated Fig. 2), and wherein the tapered intermediate portion is located proximate (i.e., next to / near) the frustoconical side wall portion of the outer sheath (see annotated Fig. 2).
Annotated Figure 2 of Yamada
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Regarding claim 2, Yamada discloses further comprising a first thickness of the hypotube side wall measured at the distal hypotube portion and a second thickness of the hypotube side wall measured at the proximal hypotube portion, wherein the first thickness is less than the second thickness (Examiner’s note: as shown in annotated Fig. 2 the sidewall thickness of the side wall of the distal portion (i.e., the first thickness) is smaller than the sidewall thickness of the side wall of the proximal portion (i.e., the second thickness)).
Regarding claim 5, Yamada discloses an ultrasonic catheter system (treatment apparatus 10) (abstract, paragraphs [0032 – 0035], and Figs. 1 – 3), comprising:
an ultrasonic transducer (transducer 32) (paragraphs [0033 – 0034] and Figs. 1, 2);
an outer sheath (sheath 36 and designated in annotated Fig. 2) having a first end, a second end, a frustoconical side wall portion located proximal to the second end, and having a sheath lumen that extends from the first end to the second end (paragraph [0033], Fig. 2, and annotated Fig. 2); and
a hypotube ultrasonic transmission member (probe 34 and designated in annotated Fig. 2) disposed in the sheath lumen of the outer sheath (paragraph [0033], Fig. 2, and annotated Fig. 2), the hypotube ultrasonic transmission member having a hypotube side wall, a proximal hypotube portion, a distal hypotube portion, and a tapered intermediate portion (see annotated Fig. 2), the proximal hypotube portion operatively coupled to the ultrasonic transducer (transducer 32) (paragraphs [0033 – 0034] and Figs. 1, 2, annotated Fig. 2), the proximal hypotube portion having a first diameter, the distal hypotube portion having a second diameter less than the first diameter (see annotated Fig. 2), and the tapered intermediate portion configured to transition from the first diameter of the proximal hypotube portion to the second diameter of the distal hypotube portion (see annotated Fig. 2), and wherein the tapered intermediate portion is located proximate (i.e., next to / near) the frustoconical side wall portion of the outer sheath (see annotated Fig. 2).
Annotated Figure 2 of Yamada
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Regarding claim 6, Yamada discloses wherein a first thickness of the hypotube side wall at the distal hypotube portion is less than a second thickness of the hypotube side wall at the proximal hypotube portion (Examiner’s note: as shown in annotated Fig. 2 the sidewall thickness of the distal portion (i.e., the first thickness) is smaller than the sidewall thickness of the proximal portion (i.e., the second thickness)).
Regarding claim 9, Yamada discloses an ultrasonic catheter system (treatment apparatus 10) (abstract, paragraphs [0032 – 0035], and Figs. 1 – 3), comprising:
an ultrasonic transducer (transducer 32) configured to produce vibrational energy (paragraphs [0033 – 0034] and Figs. 1, 2);
a catheter assembly (treatment apparatus 10) comprising:
an outer sheath (sheath 36 and designated in annotated Fig. 2) having a first end, a second end, a frustoconical side wall portion located proximal to the second end, and having a sheath lumen that extends from the first end to the second end (paragraph [0033], Fig. 2, and annotated Fig. 2); and
a hypotube ultrasonic transmission member (probe 34 and designated in annotated Fig. 2) disposed in the sheath lumen of the outer sheath (paragraph [0033], Fig. 2, and annotated Fig. 2), the hypotube ultrasonic transmission member having a hypotube side wall, a proximal hypotube portion, a distal hypotube portion, and a tapered intermediate portion (see annotated Fig. 2), the proximal hypotube portion operatively coupled to the ultrasonic transducer (transducer 32) (paragraphs [0033 – 0034] and Figs. 1, 2, annotated Fig. 2), the proximal hypotube portion having a first diameter, the distal hypotube portion having a second diameter less than the first diameter (see annotated Fig. 2), and the tapered intermediate portion configured to transition from the first diameter of the proximal hypotube portion to the second diameter of the distal hypotube portion (see annotated Fig. 2), and wherein the tapered intermediate portion is located proximate (i.e., next to / near) the frustoconical side wall portion of the outer sheath (see annotated Fig. 2),
wherein the distal hypotube portion is configured for longitudinal, transverse, or longitudinal and transverse displacement in accordance with the vibrational energy (longitudinal – Fig. 3C).
Annotated Figure 2 of Yamada
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Regarding claim 10, Yamada discloses further comprising a first thickness of the hypotube side wall measured at the distal hypotube portion and a second thickness of the hypotube side wall measured at the proximal hypotube portion, wherein the first thickness is less than the second thickness (Examiner’s note: as shown in annotated Fig. 2 the sidewall thickness of the distal portion (i.e., the first thickness) is smaller than the sidewall thickness of the proximal portion (i.e., the second thickness)).
Regarding claim 11, Yamada discloses wherein the distal hypotube portion is configured to convert the vibrational energy received from the ultrasonic transducer into cavitation bubbles (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, because the distal hypotube portion vibrates ultrasonically within a liquid medium it is capable of converting the vibrational energy into cavitation bubbles when vibrated at the required frequency to do so. Therefore, the device of Yamada is configured as claimed).
Regarding claim 12, Yamada discloses wherein the ultrasonic transducer (transducer 32) has a center lumen (channel 46) configured to allow a guide wire to be guided therethrough (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, because the transducer has a lumen, it is capable of receiving / allowing a guidewire to be guided therethrough. Therefore, the device of Yamada is configured as claimed).
Claims 1, 5, 9, 11, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nita (US 2012/0130233 A1).
Regarding claim 1, Nita disclose a catheter assembly (ultrasound catheter device 10) (abstract, paragraphs [0017 – 0020], [0027], and Figs. 1 – 3), comprising:
an outer sheath (catheter body 11 and designated in annotated Fig. 2) (paragraph [0027] and Figs. 1, 2) having a first end, a second end, a frustoconical side wall portion located proximal to the second end, and a sheath lumen that extends from the first end to the second end (see annotated Fig. 2); and
a hypotube ultrasonic transmission member (ultrasound transmission member 16 and designated in annotated Fig. 2) disposed in the sheath lumen of the outer sheath (paragraphs [0020], [0027] and Figs. 2 and 3) (Examiner’s note: as stated in paragraph [0020] the ultrasound transmission member transmits ultrasonic energy, therefore, it is considered a ultrasonic transmission member), the hypotube ultrasonic transmission member having a hypotube side wall, a proximal hypotube portion, a distal hypotube portion, and a tapered intermediate portion (see annotated Fig. 2), the proximal hypotube portion being configured to be operatively coupled to the ultrasonic transducer (ultrasonic transducer 24) (paragraph [0020] and Fig. 1), the proximal hypotube portion having a first diameter, the distal hypotube portion having a second diameter less than the first diameter, and the tapered intermediate portion configured to transition from the first diameter of the proximal hypotube portion to the second diameter of the distal hypotube portion (see annotated Fig. 2), and wherein the tapered intermediate portion is located proximate (i.e., located near) the frustoconical side wall portion of the outer sheath (see annotated Fig. 2).
Annotated Figure 2 of Nita
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Regarding claim 5, Nita discloses an ultrasonic catheter system (ultrasound catheter device 10) (abstract, paragraphs [0017 – 0020], [0027], and Figs. 1 – 3), comprising:
an outer sheath (catheter body 11 and designated in annotated Fig. 2) (paragraph [0027] and Figs. 1, 2) having a first end, a second end, a frustoconical side wall portion located proximal to the second end, and a sheath lumen that extends from the first end to the second end (see annotated Fig. 2); and
a hypotube ultrasonic transmission member (ultrasound transmission member 16 and designated in annotated Fig. 2) disposed in the sheath lumen of the outer sheath (paragraphs [0020], [0027] and Figs. 2 and 3) (Examiner’s note: as stated in paragraph [0020] the ultrasound transmission member transmits ultrasonic energy, therefore, it is considered a ultrasonic transmission member), the hypotube ultrasonic transmission member having a hypotube side wall, a proximal hypotube portion, a distal hypotube portion, and a tapered intermediate portion (see annotated Fig. 2), the proximal hypotube portion being operatively coupled to the ultrasonic transducer (ultrasonic transducer 24) (paragraph [0020] and Fig. 1), the proximal hypotube portion having a first diameter, the distal hypotube portion having a second diameter less than the first diameter, and the tapered intermediate portion configured to transition from the first diameter of the proximal hypotube portion to the second diameter of the distal hypotube portion (see annotated Fig. 2), and wherein the tapered intermediate portion is located proximate (i.e., located near) the frustoconical side wall portion of the outer sheath (see annotated Fig. 2).
Annotated Figure 2 of Nita
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Regarding claim 9, Nita discloses an ultrasonic catheter system (ultrasound catheter device 10) (abstract, paragraphs [0017 – 0020], [0027], and Figs. 1 – 3), comprising:
an ultrasonic transducer (ultrasound transducer 24) configured to produce vibrational energy;
a catheter assembly (ultrasound catheter device 10) comprising:
an outer sheath (catheter body 11 and designated in annotated Fig. 2) (paragraph [0027] and Figs. 1, 2) having a first end, a second end, a frustoconical side wall portion located proximal to the second end, and a sheath lumen that extends from the first end to the second end (see annotated Fig. 2); and
a hypotube ultrasonic transmission member (ultrasound transmission member 16 and designated in annotated Fig. 2) disposed in the sheath lumen of the outer sheath (paragraphs [0020], [0027] and Figs. 2 and 3) (Examiner’s note: as stated in paragraph [0020] the ultrasound transmission member transmits ultrasonic energy, therefore, it is considered a ultrasonic transmission member), the hypotube ultrasonic transmission member having a hypotube side wall, a proximal hypotube portion, a distal hypotube portion, and a tapered intermediate portion (see annotated Fig. 2), the proximal hypotube portion being operatively coupled to the ultrasonic transducer (ultrasonic transducer 24) (paragraph [0020] and Fig. 1), the proximal hypotube portion having a first diameter, the distal hypotube portion having a second diameter less than the first diameter, and the tapered intermediate portion configured to transition from the first diameter of the proximal hypotube portion to the second diameter of the distal hypotube portion (see annotated Fig. 2), and wherein the tapered intermediate portion is located proximate (i.e., located near) the frustoconical side wall portion of the outer sheath (see annotated Fig. 2),
wherein the distal hypotube portion is configured for longitudinal, transverse, or longitudinal and transverse displacement in accordance with the vibrational energy (paragraph [0025]).
Annotated Figure 2 of Nita
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Regarding claim 11, Nita discloses wherein the distal hypotube portion is configured to convert the vibrational energy received from the ultrasonic transducer into cavitation bubbles (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, because the distal hypotube portion vibrates ultrasonically within a liquid medium it is capable of converting the vibrational energy into cavitation bubbles when vibrated at the required frequency to do so. Therefore, the device of Yamada is configured as claimed).
Regarding claim 17, Nita discloses further comprising the outer sheath having an exterior surface (see annotated Fig. 2); a guide wire lumen (guide wire lumen 60) formed in part with the exterior surface of the outer sheath (see annotated Fig. 2), wherein the guide wire lumen is connected to the second end of the outer sheath (see annotated Fig. 2).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al (US 2013/0060169 A1) as applied to claim 12 above, and further in view of Kagawa er al (US 5,163,433) and Kubota et al (US 5,255,669).
Regarding claim 13, as discussed above, Yamada discloses the ultrasonic catheter system of claim 12.
However, Yamada is silent regarding (i) a roller pump and (ii) wherein the roller pump is configured to provide saline irrigation to the catheter assembly through the center lumen of the ultrasonic transducer.
As to (ii), Kagawa teaches, in the same field of endeavor, am ultrasonic catheter system (ultrasound type treatment apparatus) comprising a ultrasonic transducer (ultrasonic oscillation device 10), an outer sheath (sheath 22), a hypotube ultrasonic transmission member (probe 3) (abstract, col. 5 lines 3 – 34, and Figs. 1, 2, 24); wherein the ultrasonic transducer has a center lumen (water supply tube 122 within the suction passage 123; which equates to the center lumen through the ultrasonic transducer of Yamada) for the purpose of cooling the probe and further lowing the amount of water/saline/solution supplied toward a visual field of observation at the distal end of the probe 3, ensuring a better field of observation (col. 12 lines 11 – 17 and lines 46 – 66).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Yamada to incorporate a saline irrigation through a center lumen in the ultrasonic transducer, based on the teachings of Kagawa, for the purpose of cooling the ultrasonic transmission member and further lowing the amount of water/saline/solution supplied toward a visual field of observation at the distal end of the probe 3, ensuring a better field of observation (col. 12 lines 11 – 17 and lines 46 – 66 – Kagawa).
As to (i), Kubota teaches, in the same field of endeavor, an ultrasonic catheter system (ultrasonic treatment apparatus) comprising a hypotube ultrasonic transmission member (horn 7), an ultrasonic transducer (ultrasonic oscillator 2), and a roller pump (roller pump 36) for providing irrigation through the liquid supply tube (which is equated to the saline irrigation lumen of Yamada in view of Kagawa) (abstract, col. 3 lines 24 – 55, col. 4 lines 18 – 25). It should be understood that Yamada and Kubota are known references in the art that teach an ultrasonic catheter system comprising fluid / irrigation pump (abstract, paragraphs [0032], [0039], and Fig. 1 – Yamada ; abstract, col. 3 lines 24 – 55, col. 4 lines 18 – 25 – Kubota); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one fluid pump for another, and the results of the substitution would have been predictable and resulted in the modified system of Yamada being able to function as intended to properly to pump irrigation fluid to the surgical site. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nita (US 2012/0130233 A1) as applied to claims 5 and 9, respectively, above, and further in view of Nita et al (US 2019/0216487 A1) (herein referred to as Nita ‘487).
Regarding claims 7 and 18, as discussed above, Nita discloses the ultrasonic catheter system of claims 5 and 9, respectively. Additionally, Nita discloses wherein the hypotube ultrasonic transmission member (ultrasound transmission member 16) having an exterior surface (Fig. 2 and annotated Fig. 2).
However, Nita is silent regarding (i) a guide wire tube connected directly to the exterior surface of the hypotube ultrasonic transmission member.
As to the above, Nita 487’, teaches in the same field of endeavor, an ultrasonic catheter system (ultrasound catheter device 120; which produces ultrasonic energy) (abstract, paragraphs [0032], [0047], and Fig. 4), comprising an outer sheath (catheter body 126), a hypotube ultrasonic transmission member (ultrasound transmission member 128; which transmits ultrasonic energy and is thus an ultrasonic transmission element – paragraph [0047]) with an exterior surface and within the outer sheath (Fig. 4), and a guidewire tube (guidewire tube 124) connected directly to the exterior surface of the hypotube ultrasonic transmission member (ultrasound transmission member 128) for the purpose of connecting the guidewire to the ultrasonic transmission member so that the ultrasonic energy can pass to the guidewire, thereby enhancing the penetration of the guidewire through the occlusion (paragraph [0047] and Fig. 4).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Nita to incorporate a guidewire tube connected to the exterior surface of the ultrasonic transmission member, as taught by Nita 487’, for the purpose of connecting the guidewire to the ultrasonic transmission member so that the ultrasonic energy can pass to the guidewire, thereby enhancing the penetration of the guidewire through the occlusion (paragraph [0047] – Nita 487’).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nita (US 2012/0130233 A1) as applied to claim 9 above, and further in view of Nita et al (US 2019/0216487 A1) (herein referred to as Nita ‘487) and Ehr et al (US 5,706,827).
Regarding claim 19, as discussed above, Nita discloses the ultrasonic catheter system of claim 9. Additionally, Nita discloses a guidewire (guidewire 25) (paragraph [0017] and Fig. 2) and wherein the hypotube ultrasonic transmission member (ultrasound transmission member 16) having an exterior surface (Fig. 2).
However, Nita is silent regarding (i) the guide wire coupled to the distal hypotube portion, and (ii) wherein the guide wire is a magnetic guidewire magnetically coupled to the distal hypotube portion and wherein the distal hypotube portion is made from a magnetic material.
As to (i), Nita 487’, teaches in the same field of endeavor, an ultrasonic catheter system (ultrasound catheter device 120; which produces ultrasonic energy) (abstract, paragraphs [0032], [0047], and Fig. 4), comprising an outer sheath (catheter body 126), a hypotube ultrasonic transmission member (ultrasound transmission member 128; which transmits ultrasonic energy and is thus an ultrasonic transmission element – paragraph [0047]) within the outer sheath and with an exterior surface (Fig. 4), and a guidewire tube (guidewire tube 124) connected directly to the exterior surface of the hypotube ultrasonic transmission member (ultrasound transmission member 128) for the purpose of connecting the guidewire to the ultrasonic transmission member so that the ultrasonic energy can pass to the guidewire, thereby enhancing the penetration of the guidewire through the occlusion (paragraph [0047] and Fig. 4).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Nita to incorporate a guidewire tube connected to the exterior surface of the ultrasonic transmission member, as taught by Nita 487’, for the purpose of connecting the guidewire to the ultrasonic transmission member so that the ultrasonic energy can pass to the guidewire, thereby enhancing the penetration of the guidewire through the occlusion (paragraph [0047] – Nita 487’). It should be noted that Nita 487’ is silent as to the type of connection between the ultrasound transmission member and the guidewire.
As to (ii), Ehr teaches a magnetic guidewire (guidewire 20) comprising a magnetic material, wherein the magnetic guidewire is coupled magnetically to a magnetic catheter (which equates to the ultrasound transmission member of Nita in view of Nita 487’) (abstract, col. 4 line 28 – col. 5 line 10, and claim 1).
It should be understood that Nita in view of Nita 487’ and Ehr are known references in the art that teach coupling a guidewire to the distal portion of a rod/tube/shaft/medical system (paragraph [0047] – Nita 487’ ; abstract, col. 4 line 28 – col. 5 line 10, and claim 1 – Ehr); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of coupling the guidewire to a shaft for another, and the results of the substitution would have been predictable and resulted in the modified guidewire and ultrasound transmission member of Nita in view of Nita 487’ being able to function as intended to properly transmit the ultrasonic energy to the guidewire. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. The modification above makes obvious modifying the guidewire of Nita to be made of a magnetic material and modifying the ultrasound transmission member to be made of a magnetic material so that the two members can be magnetically coupled as intended; therefore, the modified device encompasses the limitations of claim 19.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nita (US 2012/0130233 A1) in view of Nita et al (US 2019/0216487 A1) (herein referred to as Nita ‘487) and Ehr et al (US 5,706,827), as applied to claim 19 above, and further in view of Eton et al (US 5,624,430) and Wolfe (US 2012/0239022 A1).
Regarding claim 20, as discussed above, Nita 487’ and Ehr makes obvious modifying the device of Nita to magnetically couple the guidewire to the ultrasound transmission member (i.e., the hypotube ultrasonic transmission member), such that the guidewire and ultrasound transmission member are made out of magnetic material (i.e., the hypotube ultrasonic transmission member).
However, the combination of Nita, Nita 487’, and Ehr is silent regarding (i) the magnetic guide wire having a surface coating of Teflon or silicone, wherein the Teflon or silicone are configured to reduce the friction between the hypotube ultrasonic transmission member and the magnetic guide wire.
As to the above, Eton teaches coating a magnetic element on a guidewire for the purpose of adding mechanical strength to the surface of the magnet and prevent the [magnetic] material from chipping (abstract and col. 4 line 57 – col. 5 line 25).
Additionally, Wolfe teaches applying an silicone covering over a magnetic coil on a guidewire used within the body (paragraph [0055]), thereby teaching silicone is a known material used for covering for a magnetic device used within the body.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the magnetic guidewire of Nita in view of Nita 487’ and Ehr to incorporate a silicone covering for the guidewire, based on the teachings of Eton and Wolfe, for the purpose of adding mechanical strength to the surface of the magnet and to prevent the [magnetic] material from chipping (abstract and col. 4 line 57 – col. 5 line 25 – Eton). It should be understood that the with the modification, the structure of the modified device is structurally the same as the structure claimed in claim 20; therefore, the modified device encompasses wherein the silicone coating reduces the friction between the hypotube ultrasonic transmission member and the magnetic guide wire. Thus, the prior art makes obvious the limitations above.
Allowable Subject Matter
Claims 3, 4, 8, 15, and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claims 3 and 4, the prior art alone or in combination fails to disclose or make obvious the ultrasonic catheter system of claim 3 and, separately, claim 4, wherein the ultrasonic catheter system of claims 3 and 4 comprise, inter alia, the system of claim 1 and a rapid exchange port formed in the hypotube side wall configured for a guidewire to extend therethrough.
With respect to claim 8, the prior art alone or in combination fails to disclose or make obvious the ultrasonic catheter system of claim 8, wherein the ultrasonic catheter system of claim 8 comprises, inter alia, the system of claim 5 and a rapid exchange port formed in the hypotube side wall distal portion, wherein a guidewire extend therethrough.
With respect to claims 15 and 16, the prior art alone or in combination fails to disclose or make obvious the ultrasonic catheter system of claim 15 and, separately, claim 16, separately, wherein the ultrasonic catheter system of claims 15 and 16 comprise, inter alia, the system of claim 9 and a port formed in the hypotube side wall configured for a guidewire to extend therethrough.
Regarding claims 3, 4, 8, 15, and 16, the closest prior art, Nita (cited above) discloses an ultrasonic catheter system as defined in claims 1, 5, and 9 (as detailed in the rejection of said claims above) and a guidewire (guidewire 25) (Fig. 2). However, the hypotube ultrasonic transmission member of Nita is a solid, non-hollow, rod; and it would not have been obvious to modify the non-hollow ultrasonic transmission member of Nita to incorporate a port in a sidewall for the guidewire as there is no motivation, absent hindsight, to do so. Additionally, no other references, or reasonable combination thereof, could be found which discloses or suggests these features in combination with other limitations in the claims.
Regarding claims 3, 4, 8, 15, and 16, the next closest prior art, Yamada (cited above) discloses an ultrasonic catheter system as defined in claims 1, 5, and 9 (as detailed in the rejection of said claims above) and wherein the ultrasonic transmission member is hollow with a lumen extending therethrough. However, Yamada does not teach or make obvious wherein the sidewall of Yamada has a port configured for a guidewire. Furthermore, it would not have been obvious to modify the ultrasonic transmission member of Yamada to incorporate a port in a sidewall for a guidewire as the ultrasonic transmission member of Yamada is not used intravascularly and thus has no use for a guidewire. Additionally, no other references, or reasonable combination thereof, could be found which discloses or suggests these features in combination with other limitations in the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sakurai et al (US 5,391,144) and Banko (US 2015/0025451 A1) teaches an ultrasonic catheter system comprising an outer sheath and an inner hypotube ultrasonic transmission member.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771