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 Arguments
1. Applicant’s arguments/amendments, filed 04/24/2026, 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 Therefore, the rejection has been withdrawn.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 Massimino view of Pandian (US 20190159792 A1).
The Applicant argues that the art of Massimino does not teach there being forward-firing acoustic energy emitters located on a portion of an elongate member of the catheter, wherein the portion of the elongate member is distal to and outside of the enclosure. The Examiner notes that Massimino was not relied upon to teach this portion of the claim, but rather Salahieh was relied on for this. After considering the Applicant’s arguments and amendments, the art of Salahieh has been withdrawn and the art of Pandian (see above) is applied instead. The portions of the claims rejected by Massimino still stand.
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.
2. Claim(s) 1-3, 14, 16, and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimino (US 20220008130 A1) in view of Pandian (US 20190159792 A1).
In regards to claim 1, Massimino 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 coupled 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 Massimino 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 elongate member so as not to be obstructed or wherein the acoustic emitters can ablate the tissue. However, in the same field of endeavor, Pandian, teaches a catheter system for treating and ablating tissue (Abstract, Par. 0002, 0026) wherein emitting member [301] is located at a distal end of the catheter and is located outside of the lumen (Par. 0047-0050, Claim 22, and Fig. 3 – Par. 0047 teaches this configuration can be used without a balloon, thus allowing the energy emitter to be completely on the outside of the system) in order to directly target the tissue.
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 Massimino and modified them by having the emitters on outside of the elongate member that can ablate tissue, as taught and suggested by Panain, in order to directly target the tissue.
In regards to claim 2, the combined teachings of Massimino and Panain 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 (Massimino: 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 Massimino and Panain disclose the catheter of claim 2, wherein the light energy source is configured to emit infrared light (Par. 0091 of Massimino teaches the light source can be lasers emitting in the IR spectrum).
In regards to claims 11-13, the combined teachings of Massimino and Panain 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 Massimino 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 Massimino and Panain disclose the catheter of claim 1 comprising: a longitudinally movable member mounted at least partially around the elongate member wherein the longitudinally movable member is located inside of the enclosure (Applicant discloses that the moveable member is a balloon [Par. 0118 of Applicants specification]. Par. 0056 of Massimino 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 and is longitudinally movable within the enclosure (Fig 1 of Massimino shows the energy emitter being located on the balloon)
In regards to claims 16, the combined teachings of Massimino and Panain disclose the catheter of claim 2, wherein the light energy source is configured to emit laser light having a wavelength suitable for treating calcified lesions or tissue softer than calcium (Par. 0076 of Massimino teaches that the photoacoustic transducers are connected to light sources and Par. 0015 teaches that the light sources can be lasers. 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 Massimino teaches using a wavelength of 780-2500 nm).
In regards to claims 32, the combined teachings of Massimino and Panain disclose the catheter of claim 1, wherein the portion of the elongate member comprises a distal tip of the elongate member (Par. 0080 of Massimino teaches there being a tip of the elongate member).
In regards to claims 33, the combined teachings of Massimino and Panain disclose the catheter of claim 1, wherein the forward-firing acoustic energy emitter comprises a light emitting region of an optical fiber (Par. 0073 of Massimino teaches there being an optical fiber to deliver the light) .
In regards to claims 34, the combined teachings of Massimino and Panain disclose the catheter of claim 1, wherein the forward-firing acoustic energy emitter comprises an electrohydraulic emitter including an electrode pair separated by a gap associated with generating shock waves (Par. 0012 of Massimino teaches an electrode pair separated by a gap, Par. 0004 teaches the electrodes providing hydraulic shock).
3. Claim(s) 4-5, 8, 10, 14, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimino and Panain and in further view of Diamant (WO 2016035071 A1)
In regards to claim 4, 8, 10, the combined teachings of Massimino and Panain 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 Panain 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 Massimino, Panain, 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 Massimino), 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 Massimino 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 Massimino and Panain 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 Panain 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).
4. Claim(s) 24-27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimino (US 20220008130 A1) in view of Diamant (WO 2016035071 A1).
In regards to claim 24, Massimino 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):
an elongate member (Par. 0056 discloses the catheter shaft [110], i.e. an elongate member);
an enclosure coupled to the elongate member (Par. 0056 teaches a balloon [104] that can be filled with fluid and is connected to the shaft);
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).
While Massimino and Diamant 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 elongate member so as not to be obstructed or wherein the acoustic emitters can ablate the tissue. However, in the same field of endeavor, Pandian, teaches a catheter system for treating and ablating tissue (Abstract, Par. 0002, 0026) wherein emitting member [301] is located at a distal end of the catheter and is located outside of the lumen (Par. 0047-0050, Claim 22, and Fig. 3 – Par. 0047 teaches this configuration can be used without a balloon, thus allowing the energy emitter to be completely on the outside of the system) in order to directly target the tissue.
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 Massimino and Diamant and modified them by having the emitters on outside of the elongate member that can ablate tissue, as taught and suggested by Panain, in order to directly target the tissue.
In regards to claim 25, the combined teachings of Massimino, Diamant, and Panain 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 Massimino, Diamant, and Panain 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 Massimino, Diamant, and Panain 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 Massimino 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 Massimino, Diamant, and Panain 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 Massimino teaches using different light sources with varying ranges).
5. Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimino, Diamant, and Panain and in further view of Salahieh (US 20160051321 A1).
In regards to claim 28, Massimino, Diamant, and Panain 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 Massimino 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 Massimino, Diamant, and Panain 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).
6. Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massimino, Diamant, and Panain and in further view of McGovern (US 6517534 B1)
In regards to claim 30, the combined teachings of Massimino, Diamant, and Panain t 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 Massimino, Diamant, and Panain 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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