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 .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/28/2025 has been entered.
Response to Arguments
2. Applicant’s arguments/amendments, filed 11/28/2025, with respect to the rejection(s) of the claim(s) under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Massimini view of Salahieh (US 20160051321 A1).
Applicant's arguments regarding claim 24 have been fully considered but they are not persuasive. The Applicant argues none of the applied art teaches there being two energy emitters coupled to two different energy sources. The Examiner respectfully disagrees. The art of Massimini is relied upon to teach a system that has one or more photoacoustic transducers to emit acoustic waves, and that these transducers are connected to an energy source. Massimini, however, does not teach where these energy emitters are two separate energy sources. This is where the Examiner is relying on the art of Diamant. Page 13 teaches "Control signals from the monitoring and control system 101 are transferred to the power supply units 102, 103 [i.e. energy sources] to activate operation of the laser radiation generator 105 and the nanosecond electric pulse generator 104." This can also be seen in Fig 1. While Diamant does not teach the emitters being acoustic, it is not relied upon for this aspect. Diamant is only being used to show that it is known to have different energy emitters and energy sources within a probe system, for the purpose of producing better fragmentation of the target. Per the MPEP, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.
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.
3. Claim(s) 1-3, 14, and 16-19is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimini (US 20220008130 A1) in view of Salahieh (US 20160051321 A1).
In regards to claim 1, Massimini discloses a catheter (Abstract and Par. 0002 disclose a catheter system) comprising:
an elongate member (Par. 0056 discloses the catheter shaft [110], i.e. an elongate member);
an enclosure sealed to the elongate member (Par. 0056 teaches a balloon [104] that can be filled with fluid and is connected to the shaft);
a forward-firing acoustic energy emitter located on the elongate member; and a radially-firing acoustic energy emitter located on the elongate member at least partially inside of the enclosure (Par. 0076-0077 teach one or more photoacoustic transducers [154] that can emit acoustic waves in multiple directions, i.e. they can be fired radially or forward or all in the same direction or all in different directions, etc.; Par. 0093 also teaches that they can be fired radially).
While Massimini teaches one or more photoacoustic transducers that can emit acoustic waves in multiple directions, they do not teach wherein forward firing emitters on outside of the enclosure/balloon so as not to be obstructed or wherein the acoustic emitters can ablate the tissue. However, in the same field of endeavor, Salahieh, teaches a tissue catheter ablation system (Abstract and Par. 0005) wherein acoustic emitters [14] are employed along the outside of the exterior membrane, i.e. enclosure [12] of the catheter system to ablate the tissue (Fig 1a-b and Par. 0088-0090) in order to directly contact the tissue to allow for efficient energy coupling (Par. 0102).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Massimini and modified them by having the emitters on outside of the enclosure/balloon that can ablate tissue, as taught and suggested by Salahieh, in order to directly contact the tissue to allow for efficient energy coupling (Par. 0102 of Salahieh).
In regards to claim 2, the combined teachings of Massimini and Salahieh disclose the catheter of claim 1, wherein the forward-firing acoustic energy emitter, the radially-firing acoustic member, or both is configured to optically couple to a light energy source (Massimini: Par. 0076 teaches that the photoacoustic transducers are connected to light sources and Par. 0015 teaches that the light sources can be lasers).
In regards to claim 3, the combined teachings of Massimini and Salahieh disclose the catheter of claim 2, wherein the light energy source is configured to emit infrared light (Par. 0091 of Massimini teaches the light source can be lasers emitting in the IR spectrum).
In regards to claims 11-13, the combined teachings of Massimini and Salahieh disclose the catheter of claim 1, wherein the forward firing acoustic energy emitter and the radially firing acoustic energy emitter are coupled to a single energy source, can be electrically connected in series, ad can be connected to separate channels of high-voltage generator (Par. 062 of Massimini teaches connection to singular energy sources and wherein the energy source can be a high voltage energy source. Fig 1 shows all of the components connected in a single path, i.e. series).
In regards to claim 14, the combined teachings of Massimini and Salahieh disclose the catheter of claim 1 comprising: a longitudinally movable member mounted at least partially around the elongate member and located inside of the enclosure (Applicant discloses that the moveable member is a balloon [Par. 0118 of Applicants specification]. Par. 0056 of Massimini teaches a balloon [104] that can be filled with fluid and is connected to the shaft);
wherein the radially-firing acoustic energy emitter located on the longitudinally movable member (Fig 1 of Massimini shows the energy emitter being located on the balloon)
In regards to claims 16, the combined teachings of Massimini and Salahieh disclose the catheter of claim 2, wherein the light energy source is configured to emit laser light (Par. 0076 of Massimini teaches that the photoacoustic transducers are connected to light sources and Par. 0015 teaches that the light sources can be lasers).
In regards to claim 17, the combined teachings of Massimini and Salahieh disclose the catheter of claims 16, wherein the laser light comprises a wavelength suitable for treating calcified lesions (Par. 0002 of Massimini teaches treating calcified vascular lesions).
In regards to claim 18, the combined teachings of Massimini and Salahieh disclose the catheter of claims 16, wherein the laser light comprises a wavelength suitable for treating tissue softer than calcium (Applicant teaches in Par. 0088 of their specification that soft tissue is treated with a wavelength of 1400 nm–1520 nm or 1900 nm–2100 nm. Par. 0069 of Massimini teaches using a wavelength of 780-2500 nm).
In regards to claim 19, the combined teachings of Massimini and Salahieh disclose the catheter of claim 1, wherein the enclosure has a working length of at least 30 mm (Par. 0064 of Massimini teaches the length can be from 3mm to 300mm).
4. Claim(s) 4-5, 8, 10, 14, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimini and Salahieh and in further view of Diamant (WO 2016035071 A1)
In regards to claim 4, 8, 10, the combined teachings of Massimini and Salahieh disclose the catheter of claim 1, except for wherein the forward-firing acoustic energy emitter, the radially-firing acoustic energy emitter, or both is configured to electrically couple to a voltage pulse generator; wherein there are two separate energy sources.
While Massimmi teaches using an energy source, they do not explicitly teach using two different energy sources, one being a laser source and one being a voltage source. However, in the same field of endeavor, Diamant teaches a probe system that comprises two separate energy sources (both laser and voltage) within the probe (Page 13) in order to produce better fragmentation of the target.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Massimmi and Salahieh and modified them by having the system comprise two separate energy sources, as taught and suggested by Diamant, in order to produce better fragmentation of the target (Page 12-13 of Diamant).
In regards to claim 5, the combined teachings of Massimini, Salahieh, and Diamant disclose the catheter of claim 4, wherein the forward-firing acoustic energy emitter, the radially-firing acoustic energy emitter, or both comprise an electrode pair (Par. 0062 of Massimini), wherein a first electrode of the electrode pair comprises a conductive surface of a band and a second electrode of the electrode pair comprises a conductive portion of an elongate conductive member (Par. 0062 of Massimini teaches there being an electrode pair that is on the elongate member, electrodes are also inherently conductive).
In regards to claim 31, the combined teachings of Massimini and Salahieh disclose catheter of claim 1, except for wherein one of the forward-firing acoustic energy emitter and the radially-firing acoustic energy emitter is configured to couple to a light energy source, and the other of the forward-firing acoustic energy emitter and the radially-firing acoustic energy emitter is configured to couple to a voltage pulse generator, a second acoustic energy emitter connected to the second energy source and configured to emit acoustic energy when energy is received from the second energy source.
While Massimmi teaches using an energy source, they do not explicitly teach using two different energy sources, one being a laser source and one being a voltage source. However, in the same field of endeavor, Diamant teaches a probe system that comprises two separate energy sources (both laser and voltage) within the probe (Page 13) in order to produce better fragmentation of the target.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Massimmi and Salahieh and modified them by having the system comprise two separate energy sources, as taught and suggested by Diamant, in order to produce better fragmentation of the target (Page 12-13 of Diamant).
5. Claim(s) 24-27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimini (US 20220008130 A1) in view of Diamant (WO 2016035071 A1).
In regards to claim 24, Massimini discloses a catheter system (Abstract and Par. 0002 disclose a catheter system) comprising:
an energy source (Par. 0076 and 0062 teach different energy sources);
a catheter comprising (Abstract teaches a catheter):
a first acoustic energy emitter coupled to the first energy source and configured to emit acoustic energy when energy is received from the energy source; and a second acoustic energy emitter coupled to the second energy source and configured to emit acoustic energy when energy is received from the energy source, the second acoustic shock waves having different acoustic properties than the first acoustic shock waves. (Par. 0076-0077 teach one or more photoacoustic transducers that can emit acoustic waves in multiple directions and are connected to energy sources).
While Massimmi teaches using an energy source, they do not explicitly teach using two different energy sources, one being a laser source and one being a voltage source. However, in the same field of endeavor, Diamant teaches a probe system that comprises two separate energy sources (both laser and voltage) within the probe (Page 13) in order to produce better fragmentation of the target.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Massimmi and modified them by having the system comprise two separate energy sources, as taught and suggested by Diamant, in order to produce better fragmentation of the target (Page 12-13 of Diamant).
In regards to claim 25, the combined teachings of Massimini and Diamant disclose the catheter system of claim 24, wherein the catheter further comprises an elongate member and an enclosure sealed to the elongate member, and the first acoustic energy emitter and the second acoustic energy emitter are enclosed in the enclosure (Par. 0056 teaches a shaft and balloon [104], i.e, enclosure, connected to the shaft. Fig 1 shows the energy emitter [134] enclosed).
In regards to claim 26, the combined teachings of Massimini and Diamant disclose the catheter system of claim 24, wherein the first energy source is a voltage pulse generator and the second energy source is a laser light source (Page 12 and 13 of Diamant teaches a voltage and laser source in order to produce better fragmentation of the target).
In regards to claim 27, the combined teachings of Massimini and Diamant disclose the catheter system of claim 24, except for wherein the first energy source is a first voltage pulse generator and the second energy source is a second voltage pulse generator configured to generate voltage pulses having different electrical properties than voltage pulses generated by the first voltage pulse generator.
However, Diamant does go on to further teach multiple voltage generators (Page 13 of Diamant) in order to transfer energy to the concretion for its fragmentation upon application of the electric energy pulses (Page 13). Therefore it would have been obvious to further modify Massimini and Diamant, as applied to claim 24, to teach the multiple voltage generators, as taught and suggested by Diamant in order to transfer energy to the concretion for its fragmentation upon application of the electric energy pulses (Page 13 of Diamant).
In regards to claim 29, the combined teachings of Massimini and Diamant disclose the catheter system of claim 24, wherein the first energy source is a first laser light source and the second energy source is a second laser light source that generates light having different light energy properties than the light generated by the first laser light source (Par. 0091 of Massimini teaches using different light sources with varying ranges).
6. Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimini and Diamant and in further view of McGovern (US 6517534 B1)
In regards to claim 30, the combined teachings of Massimini and Diamant disclose the catheter system of claim 24, except for it further comprising a third energy source, wherein the catheter includes a third acoustic energy emitter connected coupled to the third energy source).
However, in the same field of endeavor, McGovern teaches a tissue ablation system comprising a catheter (Abstract) wherein the system employs electrodes connected in unison or connected individually by connection elements where it is connected by connector 935 to an external power source or separate multiple power sources (Col. 24 and 25) in order to increase the efficiency of the energy emitters.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Massimini and Diamant and modified them by having the emitters connected to multiple power sources, as taught and suggested by McGovern, in order to increase the efficiency of the energy emitters.
7. Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimini and Diamant and in further view of Salahieh (US 20160051321 A1).
In regards to claim 28, Massimini and Diamant as applied to claim 24 disclose the catheter system of claim 24, except for wherein the first acoustic energy emitter and the second acoustic energy emitter are both unenclosed.
While Massimini teaches one or more photoacoustic transducers that can emit acoustic waves in multiple directions, they do not teach wherein both of the emitters are on outside of the enclosure/balloon so as not to be obstructed. However, in the same field of endeavor, Salahieh, teaches a tissue catheter ablation system (Abstract and Par. 0005) wherein acoustic emitters [14] are employed along the outside of the exterior membrane, i.e. enclosure [12] of the catheter system to ablate the tissue (Fig 1a-b and Par. 0088-0090) in order to directly contact the tissue to allow for efficient energy coupling (Par. 0102).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Massimini and Diamant and modified them by having the emitters on outside of the enclosure/balloon that can ablate tissue, as taught and suggested by Salahieh, in order to directly contact the tissue to allow for efficient energy coupling (Par. 0102 of Salahieh).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792